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임상시험 NCT06052059은(는) 궤양성 대장염에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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머크A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) 3상 1,020
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임상시험 NCT06052059은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 궤양성 대장염에 대해 진행되며, 3상 중재연구으로 현재 상태는 진행중, 모집종료입니다. 연구는 2023년 10월 25일에 시작되어 1,020명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2029년 8월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 13일에 갱신되었습니다.
간단한 개요
The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo i...더 보기
상세한 설명
The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.
공식 제목
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis
질환명
궤양성 대장염기타 연구 식별자
- 7240-001
- PR200-301 (기타 식별자) (PrometheusBio)
- jRCT2031230563 (등록 식별자) (jRCT)
- U1111-1296-0203 (등록 식별자) (UTN)
- U1111-1314-0050 (등록 식별자) (UTN)
- 2023-507473-17-00 (등록 식별자) (EU CT)
- 2024-518603-22-00 (등록 식별자) (EU CT)
NCT 번호
실제 연구 시작일
2023-10-25
최신 업데이트 게시
2026-03-13
예상 연구 완료일
2029-08-01
계획된 등록 인원
1,020
연구종류
중재연구
단계/상
3상
상태
진행중, 모집종료
키워드
Inflammatory Bowel Disease
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
사중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Study 1: High Dose Induction, High Dose Maintenance Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen. | IV Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously SC Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously |
실험적Study 1: High Dose Induction, Low Dose Maintenance Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen. | IV Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously SC Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously SC 위약 Placebo matching SC tulisokibart |
실험적Study 1: Low Dose Induction, Low Dose Maintenance Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen. | IV Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously SC Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously SC 위약 Placebo matching SC tulisokibart |
위약 대조군Study 1: Placebo Participants receive IV placebo, followed by an SC placebo regimen. | IV Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously 정맥 주사 위약 Placebo matching IV tulisokibart SC 위약 Placebo matching SC tulisokibart |
실험적Study 1: High Dose Extension Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites. | SC Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously |
실험적Study 1: Low Dose Extension Participants receive a low dose SC tulisokibart and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites. | SC Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously SC 위약 Placebo matching SC tulisokibart |
실험적Study 2: High Dose Induction Participants receive high dose IV tulisokibart. | IV Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously |
실험적Study 2: Low Dose Induction Participants receive low dose IV tulisokibart. | IV Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously |
위약 대조군Study 2: Placebo Participants receive IV placebo. | IV Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously 정맥 주사 위약 Placebo matching IV tulisokibart SC 위약 Placebo matching SC tulisokibart |
실험적Study 2: High Dose Extension Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites. | SC Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously |
실험적Study 2: Low Dose Extension Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites. | SC Tulisokibart Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously SC 위약 Placebo matching SC tulisokibart |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12 | The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. | Week 12 |
Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. | Week 52 |
Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. | Week 12 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Study 1: Percentage of Participants With One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE will be reported. | Up to approximately 52 weeks |
Study 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported. | Up to approximately 52 weeks |
Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2 | The partial Modified Mayo Score (pMMS) is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1. | Week 2 |
Study 1: Percentage of Participants With Endoscopic Improvement at Week 12 | Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 12 |
Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1. | Week 12 |
Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12 | HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | Week 12 |
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12 | pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1. | Week 12 |
Study 1: Percentage of Participants With Endoscopic Remission at Week 12 | ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0. | Week 12 |
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12 | Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more. | Week 12 |
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12 | Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0. | Week 12 |
Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12 | The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170. | Week 12 |
Study 1: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12 | The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented. | Baseline and Week 12 |
Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12 | Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. | Week 12 |
Percentage of Dx+ Participants With Endoscopic Improvement at Week 12 | Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 12 |
Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12 | HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | Week 12 |
Study 1: Percentage of Participants with Endoscopic Improvement at Week 52 | Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 52 |
Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52 | The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Corticosteroid-free clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, and no corticosteroid use for ≥90 days before Week 52. | Week 52 |
Study 1: Percentage of Participants Achieving HEMI at Week 52 | HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | Week 52 |
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52 | pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1. | Week 52 |
Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, at both Week 12 and Week 52. | Week 12 and Week 52 |
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52 | Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more. | Week 52 |
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52 | Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0. | Week 52 |
Study 1: Percentage of Participants With Endoscopic Remission at Week 52 | ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0. | Week 52 |
Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52 | Sustained endoscopic improvement is defined as an ES of 0 or 1 at both Week 12 and Week 52. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 12 and Week 52 |
Study 1: Percentage of Participants Achieving HER at Week 52 | HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | Week 52 |
Study 1: Percentage of Participants Achieving IBDQ Remission at Week 52 | The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170. | Week 52 |
Study 1: Change from Baseline in FACIT-Fatigue Score at Week 52 | The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented. | Baseline and Week 52 |
Study 1: Percentage of Dx+ Participants Achieving Clinical Remission Per MMS at Week 52 | Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. | Week 52 |
Study 1: Percentage of Dx+ Participants With Endoscopic Improvement at Week 52 | Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 52 |
Study 2: Percentage of Participants With One or More AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported. | Up to approximately 12 weeks |
Study 2: Percentage of Participants Who Discontinued Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported. | Up to approximately 12 weeks |
Study 2: Percentage of Participants with Clinical Response Per pMMS at Week 2 | pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1. | Week 2 |
Study 2: Percentage of Participants With Endoscopic Improvement at Week 12 | Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 12 |
Study 2: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1. | Week 12 |
Study 2: Percentage of Participants Achieving HEMI at Week 12 | HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | Week 12 |
Study 2: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12 | pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1. | Week 12 |
Study 2: Percentage of Participants With Endoscopic Remission at Week 12 | ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0. | Week 12 |
Study 2: Percentage of Participants Reporting No Bowel Urgency at Week 12 | Bowel urgency is measured using a numeric rating scale (NRS), which rates bowel urgency on a 0-11 scale of increasing severity. | Week 12 |
Study 2: Percentage of Participants Reporting No Abdominal Pain at Week 12 | Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0. | Week 12 |
Study 2: Percentage of Participants Achieving IBDQ Remission at Week 12 | The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170. | Week 12 |
Study 2: Change from Baseline in FACIT-Fatigue Score at Week 12 | The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented. | Baseline and Week 12 |
Study 2: Percentage of Participants Achieving HER at Week 12 | HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. | Week 12 |
참여 도우미
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
16 Years
참여 가능한 성별
전체
Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization
Has moderately to severely active UC
Weight ≥40 kg
Satisfies at least 1 of the following criteria:
- Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments
- Protocol specified corticosteroid dependence
- Has been intolerant to 1 or more protocol-specified UC treatments
Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority
A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy
- Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment.
- Has a current diagnosis of fulminant colitis and/or toxic megacolon
- Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is ~10 cm from the anal margin)
- Has a current or impending need for colostomy or ileostomy
- Has had a total proctocolectomy or partial colectomy
- Has received fecal microbial transplantation within 4 weeks before randomization
- Has had UC exacerbation requiring hospitalization within 2 weeks before screening
- Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
- Has any active or serious infections without resolution after adequate treatment
- Has had cytomegalovirus infection that resolved less than 4 weeks before screening
- Has a transplanted organ which requires continued immunosuppression
- Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
- Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB)
- Has confirmed or suspected COVID-19
- Has a history of drug or alcohol abuse within 6 months prior to screening
- Has had major surgery within 3 months before screening or has a major surgery planned during the study
- Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment
- Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization
- Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters
- Has received protocol-specified prohibited medications
- Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody
PPD, Part of Thermo Fisher Scientific연락처 정보가 없습니다.
476 45개국에 임상시험 장소
Kang-won-do
Wonju Severance Christian Hospital-Internal Medicine ( Site 3003), Wŏnju, Kang-won-do, 26426, South Korea
Kyonggi-do
The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3006), Suwon, Kyonggi-do, 16247, South Korea
Pusan-Kwangyokshi
Dong-A University Hospital ( Site 3010), Busan, Pusan-Kwangyokshi, 49201, South Korea
Inje University Haeundae Paik Hospital ( Site 3009), Haeundae-gu, Pusan-Kwangyokshi, 48108, South Korea
Seoul
Chung-Ang University Hospital ( Site 3008), Dongjak-gu, Seoul, 06973, South Korea
Taegu-Kwangyokshi
Yeungnam University Medical Center ( Site 3004), Daegu, Taegu-Kwangyokshi, 42415, South Korea
Taejon-Kwangyokshi
The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3011), Daejeon, Taejon-Kwangyokshi, 34943, South Korea
Kyung Hee University Hospital ( Site 3013), Seoul, 02447, South Korea
Seoul National University Hospital ( Site 3005), Seoul, 03080, South Korea
Kangbuk Samsung Hospital-Internal Medicine ( Site 3002), Seoul, 03181, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3012), Seoul, 03312, South Korea
Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3000), Seoul, 03722, South Korea
Asan Medical Center ( Site 3007), Seoul, 05505, South Korea
Samsung Medical Center ( Site 3001), Seoul, 06351, South Korea
Alabama
Digestive Health Specialists ( Site 0135), Dothan, Alabama, 36301, United States
IMC-Gulf Coast Gastroenterology ( Site 0157), Fairhope, Alabama, 36532, United States
Arizona
Research Solutions of Arizona ( Site 3816), Litchfield Park, Arizona, 85340, United States
One of a Kind Clinical Research Center ( Site 3852), Scottsdale, Arizona, 85258, United States
GI Alliance - Sun City ( Site 0103), Sun City, Arizona, 85351, United States
California
Clinnova Research ( Site 3803), Anaheim, California, 92805, United States
Southern California Research Center ( Site 3828), Coronado, California, 92118, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113), La Jolla, California, 92037, United States
Cedars-Sinai Medical Center ( Site 0119), Los Angeles, California, 90048, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851), Orange, California, 92868, United States
Colorado
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172), Aurora, Colorado, 80045, United States
Peak Gastroenterology Associates ( Site 0116), Colorado Springs, Colorado, 80907, United States
South Denver Gastroenterology, PC ( Site 3849), Englewood, Colorado, 80113, United States
Rocky Mountain Gastroenterology/Topography Health ( Site 3838), Littleton, Colorado, 80120, United States
Connecticut
Connecticut Clinical Research Institute ( Site 0126), Bristol, Connecticut, 06010, United States
Medical Research Center of Connecticut ( Site 0151), Hamden, Connecticut, 06518, United States
Yale University School of Medicine-Digestive Disease ( Site 0163), New Haven, Connecticut, 06510, United States
District of Columbia
Emerson Clinical Research Institute ( Site 3820), Washington D.C., District of Columbia, 20009, United States
Florida
Gastroenterology Consultants of Clearwater ( Site 0152), Clearwater, Florida, 33756, United States
University of Florida College of Medicine-Gastroenterology ( Site 3821), Gainesville, Florida, 32610, United States
Nature Coast Clinical Research - Inverness ( Site 3806), Inverness, Florida, 34452, United States
Central Florida Gastro Research ( Site 0124), Kissimmee, Florida, 34741, United States
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810), Miami, Florida, 33134, United States
Orlando Health ( Site 0145), Orlando, Florida, 32806, United States
USF Health ( Site 0169), Tampa, Florida, 33612, United States
Georgia
Emory University School of Medicine ( Site 3818), Atlanta, Georgia, 30322, United States
Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115), Atlanta, Georgia, 30342, United States
Atlanta Center for Gastroenterology ( Site 0155), Decatur, Georgia, 30033, United States
Illinois
University of Chicago Medical Center ( Site 0134), Chicago, Illinois, 60637, United States
GI Alliance - Glenview ( Site 0168), Glenview, Illinois, 60026, United States
GI ALLIANCE - GURNEE ( Site 0107), Gurnee, Illinois, 60031, United States
Iowa
Iowa Digestive Disease Center ( Site 0123), Clive, Iowa, 50325, United States
Kentucky
University of Louisville Hospital-Clinical Trials Unit ( Site 0165), Louisville, Kentucky, 40202, United States
Louisiana
Baton Rouge General Medical Center - Bluebonnet ( Site 0112), Baton Rouge, Louisiana, 70809, United States
Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154), New Orleans, Louisiana, 70112, United States
Maryland
Walter Reed National Military Medical Center ( Site 0121), Bethesda, Maryland, 20889, United States
Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835), Glen Burnie, Maryland, 21061, United States
Massachusetts
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132), Boston, Massachusetts, 02114, United States
Michigan
University of Michigan ( Site 0143), Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan, LLC ( Site 0108), Clinton Township, Michigan, 48038, United States
Michigan Center of Medical Research (MICHMER) ( Site 3850), Farmington Hills, Michigan, 48334, United States
Clinical Research Institute of Michigan, LLC ( Site 0150), Troy, Michigan, 48098, United States
Huron Gastroenterology ( Site 3836), Ypsilanti, Michigan, 48197, United States
Minnesota
Mayo Clinic in Rochester, Minnesota ( Site 0147), Rochester, Minnesota, 55905, United States
Missouri
BVL Research - Kansas ( Site 3847), Liberty, Missouri, 64068, United States
Washington University School of Medicine ( Site 0129), St Louis, Missouri, 63110, United States
New York
Circuit Clinical /Middletown Medical PC ( Site 3831), Middletown, New York, 10940, United States
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 3846), New York, New York, 10016, United States
Lenox Hill Hospital ( Site 0128), New York, New York, 10075, United States
New York Gastroenterology Associates ( Site 0159), New York, New York, 10128, United States
North Carolina
University of North Carolina Medical Center ( Site 0140), Chapel Hill, North Carolina, 27514, United States
Carolina Digestive Diseases and Endoscopy Center ( Site 3809), Greenville, North Carolina, 27834, United States
Pennsylvania
Hospital of the University of Pennsylvania ( Site 0170), Philadelphia, Pennsylvania, 19104, United States
Rhode Island
University Gastroenterology ( Site 0164), Providence, Rhode Island, 02904, United States
South Carolina
Gastroenterology Associates of Orangeburg ( Site 0149), Orangeburg, South Carolina, 29118, United States
Tennessee
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131), Nashville, Tennessee, 37204, United States
Quality Medical Research ( Site 3807), Nashville, Tennessee, 37211, United States
Texas
GI Alliance - Garland ( Site 0109), Garland, Texas, 75044, United States
Baylor College of Medicine Medical Center ( Site 3812), Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144), Houston, Texas, 77030, United States
Clinical Trial Network ( Site 3819), Houston, Texas, 77074, United States
GI Alliance - Lubbock ( Site 0167), Lubbock, Texas, 79410, United States
Caprock Gastro Research ( Site 0101), Lubbock, Texas, 79424, United States
GI Alliance: Mansfield ( Site 0161), Mansfield, Texas, 76063, United States
CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122), San Antonio, Texas, 78212, United States
Southern Star Research Institute ( Site 0106), San Antonio, Texas, 78229, United States
GI Alliance - San Marcos ( Site 0130), San Marcos, Texas, 78666, United States
GI Alliance - Southlake ( Site 0104), Southlake, Texas, 76092-9167, United States
Tyler Research Institute ( Site 0105), Tyler, Texas, 75701, United States
Texas Digestive Disease Consultants ( Site 0136), Webster, Texas, 77598, United States
Utah
Velocity Clinical Research, Salt Lake City ( Site 3801), West Jordan, Utah, 84088, United States
Virginia
Richmond VA Medical Center ( Site 3845), Richmond, Virginia, 23249, United States
Washington
Washington Gastroenterology - Bellevue ( Site 3844), Bellevue, Washington, 98004-4631, United States
University of Washington Medical Center - Montlake ( Site 0137), Seattle, Washington, 98195, United States
Washington Gastroenterology - Tacoma ( Site 0102), Tacoma, Washington, 98405, United States
Wisconsin
Medical College of Wisconsin ( Site 0141), Milwaukee, Wisconsin, 53226, United States
Buenos Aires
Centro de Investigaciones Médicas Mar del Plata ( Site 2101), Mar del Plata, Buenos Aires, 7600, Argentina
Buenos Aires F.D.
CER medical Institute-Gastroenterology ( Site 2110), Quilmes, Buenos Aires F.D., B1878DVB, Argentina
Santa Fe Province
Hospital Provincial del Centenario ( Site 2108), Rosario, Santa Fe Province, S2002KDT, Argentina
Tucumán Province
C.I.C.E. 9 de Julio-CICE 9 DE JULIO ( Site 2103), San Miguel de Tucumán, Tucumán Province, T4000IKO, Argentina
New South Wales
Nepean Hospital-Gastroenterology/Hepatology ( Site 2501), Kingswood, New South Wales, 2747, Australia
Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 2508), Sydney, New South Wales, 2139, Australia
Queensland
Royal Brisbane and Women's Hospital ( Site 2500), Brisbane, Queensland, 4029, Australia
Mater Misericordiae Limited-Gastroenterology ( Site 2506), Brisbane, Queensland, 4101, Australia
South Australia
Royal Adelaide Hospital-Gastroenterology/Hepatology ( Site 2504), Adelaide, South Australia, 5000, Australia
Victoria
Monash Health-Gastroenterology ( Site 2505), Clayton, Victoria, 3168, Australia
The Alfred Hospital-Gastroenterology ( Site 2503), Melbourne, Victoria, 3004, Australia
St Vincent's Hospital ( Site 2510), Melbourne, Victoria, 3065, Australia
Tyrol
Universitaetsklinik fuer Innere Medizin I Innsbruck ( Site 0200), Innsbruck, Tyrol, 6020, Austria
Vienna
Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202), Vienna, Vienna, 1090, Austria
Uniklinikum Salzburg-Innere Medizin I ( Site 0201), Salzburg, 5020, Austria
Oost-Vlaanderen
UZ Gent ( Site 0300), Ghent, Oost-Vlaanderen, 9000, Belgium
Vlaams-Brabant
UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301), Leuven, Vlaams-Brabant, 3000, Belgium
Federal District
L2IP - Instituto de Pesquisas Clínicas ( Site 5104), Brasília, Federal District, 70200-730, Brazil
Minas Gerais
Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida - Galileo Pesquisa Clínica ( Site 5100), Juiz de Fora, Minas Gerais, 36025-290, Brazil
Rio Grande do Sul
Hospital Moinhos de Vento ( Site 5108), Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
São Paulo
Pesquisare Saude ( Site 5112), Santo André, São Paulo, 09080-110, Brazil
Centro de Pesquisa Kaiser - CEPEK ( Site 5103), São José do Rio Preto, São Paulo, 15015-110, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 5107), São José do Rio Preto, São Paulo, 15090-160, Brazil
Pazardzhik
MC Velingrad 2017 EOOD ( Site 0406), Velingrad, Pazardzhik, 4600, Bulgaria
Sofia (stolitsa)
"Diagnostic - Consultative Center XX - Sofia" EOOD ( Site 0407), Sofia, Sofia (stolitsa), 1618, Bulgaria
Medconsult Pleven ( Site 0410), Pleven, 5800, Bulgaria
DKC V - Plovdiv ( Site 0402), Plovdiv, 4023, Bulgaria
MC Rusemed ( Site 0408), Rousse, 7013, Bulgaria
MHAT Hadzhi Dimitar-Gastroenterology ( Site 0403), Sliven, 8800, Bulgaria
Diagnostic Consultative Center 22 - Sofia ( Site 0401), Sofia, 1113, Bulgaria
4th MHAT ( Site 0409), Sofia, 1606, Bulgaria
Medica Plus Medical Center ( Site 0404), Veliko Tarnovo, 5000, Bulgaria
Alberta
Heritage Medical Research Clinic ( Site 0004), Calgary, Alberta, T2N 4Z6, Canada
Gastroenterology and internal medicine research institute ( Site 0010), Edmonton, Alberta, T5R 1W2, Canada
Prairie Institute of Liver and Luminal Advanced Research ( Site 0013), Lethbridge, Alberta, T1J 4G9, Canada
British Columbia
Fraser Clinical Trials Inc. ( Site 0019), New Westminster, British Columbia, V3L 3W4, Canada
G.I.R.I. GI Research Institute Foundation ( Site 0001), Vancouver, British Columbia, V6Z 2K5, Canada
Nova Scotia
Private Practice - Dr. Bruce Musgrave ( Site 0011), Kentville, Nova Scotia, B4N 0A3, Canada
Ontario
Barrie GI Associates ( Site 0012), Barrie, Ontario, L4M 7G1, Canada
University Hospital - London Health Sciences Centre ( Site 0002), London, Ontario, N6A 5A5, Canada
London Health Sciences Centre ( Site 0007), London, Ontario, N6A 5W9, Canada
West GTA Research Inc. ( Site 0017), Mississauga, Ontario, L5M 2S4, Canada
ABP Research Services Corp. ( Site 0016), Ontario, Ontario, L6L 5L7, Canada
Toronto Immune & Digestive Health Institute ( Site 0005), Toronto, Ontario, M6A 3B4, Canada
Toronto Digestive Disease Associates ( Site 0006), Vaughan, Ontario, L4L 4Y7, Canada
Quebec
Centre Intégré de Santé et Service Sociaux de Chaudière-Appalaches ( Site 0015), Lévis, Quebec, G6V 3Z1, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0018), Montreal, Quebec, H2X 0C1, Canada
Montreal General Hospital ( Site 0003), Montreal, Quebec, H3G 1A4, Canada
Diex Recherche Quebec ( Site 0008), Québec, Quebec, G1V 4T3, Canada
Los Ríos Region
Clinical Research Chile SpA ( Site 2201), Valdivia, Los Ríos Region, 5110683, Chile
Region M. de Santiago
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 2203), Santiago, Region M. de Santiago, 7500653, Chile
FALP-UIDO ( Site 2208), Santiago, Region M. de Santiago, 7500921, Chile
Clínica Universidad de Los Andes ( Site 2202), Santiago, Region M. de Santiago, 7620157, Chile
Clínica Alemana de Santiago ( Site 2209), Santiago, Region M. de Santiago, 7650568, Chile
Clínica MEDS La Dehesa ( Site 2207), Santiago, Region M. de Santiago, 7691236, Chile
CECIM ( Site 2200), Santiago, Region M. de Santiago, 8320000, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 2205), Santiago, Region M. de Santiago, 8330034, Chile
Anhui
The First Affiliated Hospital of Anhui Medical University ( Site 3957), Hefei, Anhui, 230022, China
Anhui Provincial Hospital ( Site 3947), Hefei, Anhui, 230036, China
Beijing Municipality
Beijing Friendship Hospital Affiliate of Capital University ( Site 3923), Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital ( Site 3909), Beijing, Beijing Municipality, 100191, China
Beijing Luhe Hospital Capital Medical University ( Site 3911), Beijing, Beijing Municipality, 101199, China
Chongqing Municipality
Chongqing University Three Gorges Hospital ( Site 3928), Chongqing, Chongqing Municipality, 404000, China
Fujian
The First Affiliated Hospital Of Fujian Medical University ( Site 3904), Fuzhou, Fujian, 350005, China
The First Affiliated hospital of Xiamen University-Gastroenterology ( Site 3954), Xiamen, Fujian, 361003, China
Guangdong
Dongguan People's Hospital-Gastroenterology department ( Site 3944), Dongguan, Guangdong, 523059, China
Guangzhou Medical University 2nd Hospital ( Site 3908), Guangzhou, Guangdong, 510260, China
Southern Medical University Nanfang Hospital-Gastroenterology ( Site 3914), Guangzhou, Guangdong, 510515, China
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3906), Guangzhou, Guangdong, 510655, China
Huizhou Municipal Central Hospital ( Site 3917), Huizhou, Guangdong, 516001, China
Yuebei People's Hospital Guangdong ( Site 3948), Shaoguan, Guangdong, 512026, China
The University of Hong Kong-Shenzhen Hospital ( Site 3955), Shenzhen, Guangdong, 518053, China
Shenzhen Hospital of Southern Medical University ( Site 3905), Shenzhen, Guangdong, 518110, China
Hebei
The Second Hospital of Hebei Medical University ( Site 3934), Shijiazhuang, Hebei, 050000, China
Henan
The Second Affiliated Hospital of Zhengzhou University ( Site 3935), Zhengzhou, Henan, 450014, China
Hubei
Taihe Hospital ( Site 3941), Shiyan, Hubei, 442099, China
The Central Hospital of Wuhan ( Site 3939), Wuhan, Hubei, 430014, China
Renmin Hospital of Wuhan University ( Site 3912), Wuhan, Hubei, 430060, China
Hunan
The Second Xiangya Hospital of Central South University ( Site 3930), Changsha, Hunan, 410011, China
Jiangsu
Changzhou No.2 People's Hospital ( Site 3950), Changzhou, Jiangsu, 213100, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3900), Nanjing, Jiangsu, 210008, China
Zhongda Hospital Southeast University ( Site 3919), Nanjing, Jiangsu, 210009, China
Wuxi People's Hospital ( Site 3920), Wuxi, Jiangsu, 214023, China
Jiangxi
The First Affiliated Hospital of Nanchang University ( Site 3926), Nanchang, Jiangxi, 330006, China
Shaanxi
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 3929), Xi'an, Shaanxi, 710038, China
Shandong
Binzhou Medical University Hospital ( Site 3953), Binzhou, Shandong, 256603, China
Taian City Central Hospital-gastroenterology department ( Site 3946), Taian, Shandong, 271000, China
Shanghai Municipality
Ruijin Hospital Shanghai Jiaotong University School of Medicine-Gastroneterology ( Site 3903), Shanghai, Shanghai Municipality, 200025, China
Shanghai East Hospital ( Site 3922), Shanghai, Shanghai Municipality, 200120, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 3915), Shanghai, Shanghai Municipality, China
Sichuan
West China Hospital, Sichuan University ( Site 3951), Chengdu, Sichuan, 610041, China
Tianjin Municipality
Tianjin Medical University General Hospital ( Site 3945), Tianjin, Tianjin Municipality, 300052, China
Xinjiang
The First Teaching Hospital of Xinjiang Medical University. ( Site 3937), Ürümqi, Xinjiang, 830054, China
Yunnan
First Affiliated Hospital of Kunming Medical University ( Site 3925), Kunming, Yunnan, 650032, China
Zhejiang
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-GI Medicine ( Site 3916), Hangzhou, Zhejiang, 310000, China
Antioquia
Clínica las Américas ( Site 2318), Medellín, Antioquia, 050034, Colombia
Clinica Medellin S.A ( Site 2317), Medellín, Antioquia, Colombia
Clinica Somer-Unidad de Investigacion y Docencia ( Site 2303), Rionegro, Antioquia, 054040, Colombia
Atlántico
Clinica de la Costa S.A.S. ( Site 2305), Barranquilla, Atlántico, 080020, Colombia
Cundinamarca
Fundacion Santa Fe de Bogota ( Site 2316), Bogota, Cundinamarca, 110111, Colombia
Risaralda Department
Oncologos del Occidente ( Site 2310), Pereira, Risaralda Department, 660001, Colombia
Valle del Cauca Department
Fundación Valle del Lili ( Site 2307), Cali, Valle del Cauca Department, 760032, Colombia
City of Zagreb
Klinička bolnica Merkur ( Site 0505), Zagreb, City of Zagreb, 10000, Croatia
Klinički bolnički centar Zagreb ( Site 0501), Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Bates ( Site 0504), Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Solmed ( Site 0502), Zagreb, City of Zagreb, 10000, Croatia
County of Osijek-Baranja
Poliklinika Borzan ( Site 0500), Osijek, County of Osijek-Baranja, 31000, Croatia
Split-Dalmatia County
Klinički Bolnički Centar Split ( Site 0503), Split, Split-Dalmatia County, 21000, Croatia
Brno-mesto
Vojenská Nemocnice Brno-Internal department ( Site 0605), Brno, Brno-mesto, 615 00, Czechia
Central Bohemia
Nemocnice Slany ( Site 0601), Slaný, Central Bohemia, 274 01, Czechia
Praha 4
Institut Klinicke a Experimentalni Mediciny-Klinika hepatogastroentrologie ( Site 0604), Prague, Praha 4, 140 21, Czechia
Hepato-Gastroenterologie HK ( Site 0602), Hradec Králové, 500 12, Czechia
Nacional
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 3601), Santo Domingo, Nacional, 10104, Dominican Republic
Pirkanmaa
Tampereen yliopistollinen sairaala ( Site 4300), Tampere, Pirkanmaa, 33520, Finland
Pohjois-Karjala
Pohjois-Karjalan keskussairaala ( Site 4302), Joensuu, Pohjois-Karjala, 80210, Finland
Southwest Finland
Turku University Hospital ( Site 4301), Turku, Southwest Finland, 20520, Finland
Alpes-Maritimes
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0706), Nice, Alpes-Maritimes, 06202, France
Aquitaine
CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0700), Pessac, Aquitaine, 33600, France
Bouches-du-Rhone
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0714), Marseille, Bouches-du-Rhone, 13915, France
Champagne-Ardenne
Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré ( Site 0705), Reims, Champagne-Ardenne, 51092, France
Doubs
CHU Besançon ( Site 0710), Besançon, Doubs, 25000, France
Gard
C.H.U. de Nimes. Hopital Caremeau ( Site 0718), Nîmes, Gard, 30029, France
Hauts-de-Seine
Hopital Beaujon ( Site 0716), Clichy, Hauts-de-Seine, 92110, France
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 0709), Neuilly-sur-Seine, Hauts-de-Seine, 92200, France
Isere
Clinique des Cèdres ( Site 0719), Échirolles, Isere, 38130, France
Languedoc-Roussillon
CHU SAINT ELOI ( Site 0711), Montpellier, Languedoc-Roussillon, 34295, France
Meurthe-et-Moselle
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 0708), Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
Pays de la Loire Region
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0701), Nantes, Pays de la Loire Region, 44093, France
Rhone
centre hospitalier lyon sud ( Site 0707), Pierre-Bénite, Rhone, 69310, France
Somme
CHU d'Amiens-Picardie - Hôpital Sud-Hepato-gastroentérology ( Site 0712), Amiens, Somme, 80054, France
Val-de-Marne
Hopital Henri Mondor ( Site 0717), Créteil, Val-de-Marne, 94010, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0715), Le Kremlin-Bicêtre, Val-de-Marne, 94270, France
Hôpital Saint Antoine ( Site 0703), Paris, 75012, France
Hôpital Saint-Louis ( Site 0702), Paris, 75475, France
Adjara
LTD High Technology Hospital Medcenter ( Site 0802), Batumi, Adjara, 6010, Georgia
Caucasus Medical Centre ( Site 0801), Tbilisi, Adjara, 0186, Georgia
Caraps Medline ( Site 0803), Tbilisi, 0159, Georgia
New Hospitals ( Site 0800), Tbilisi, 0162, Georgia
Baden-Wurttemberg
Universitaetsklinikum Ulm. ( Site 0902), Ulm, Baden-Wurttemberg, 89081, Germany
Bavaria
MVZ Dachau ( Site 0918), Dachau, Bavaria, 85221, Germany
Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik II ( Site 0907), Munich, Bavaria, 81337, Germany
Hesse
Agaplesion Markus Krankenhaus ( Site 0904), Frankfurt am Main, Hesse, Germany
Lower Saxony
Medizinische Hochschule Hannover ( Site 0913), Hanover, Lower Saxony, 30625, Germany
Klinikum Lüneburg ( Site 0908), Lüneburg, Lower Saxony, 21339, Germany
North Rhine-Westphalia
Stadtische Kliniken Duisburg, Abtlg. Innere Medizin ( Site 0916), Duisburg, North Rhine-Westphalia, 47055, Germany
Gastroenterologische Gemeinschaftspraxis Minden ( Site 0911), Minden, North Rhine-Westphalia, 32423, Germany
Medizinisches Versorgungszentrum Portal 10 ( Site 0914), Münster, North Rhine-Westphalia, 48155, Germany
Rhineland-Palatinate
St. Marien und St. Annastift Krankenhaus ( Site 0901), Ludwighafen Am Rhein, Rhineland-Palatinate, 67067, Germany
Saxony
Universitätsklinikum Leipzig ( Site 0909), Leipzig, Saxony, 04103, Germany
Schleswig-Holstein
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0903), Kiel, Schleswig-Holstein, 24105, Germany
Charité Campus Virchow-Klinikum ( Site 0906), Berlin, 13353, Germany
Universitätsklinikum Brandenburg an der Havel ( Site 0905), Brandenburg, 14770, Germany
Attica
Evangelismos General Hospital of Athens ( Site 4001), Athens, Attica, 106 76, Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 4000), Athens, Attica, 115 27, Greece
General Hospital of Nikaia-Piraeus "Agios Panteleimon" ( Site 4006), Nikaia Piraeus, Attica, 184 54, Greece
Central Macedonia
Ippokrateio General Hospital of Thessaloniki ( Site 4004), Thessaloniki, Central Macedonia, 54642, Greece
Crete
University General Hospital of Heraklion-GASTROENTEROLOGY & HEPATOLOGY ( Site 4003), Heraklion, Crete, 711 10, Greece
Baranya
Mohácsi Kórház ( Site 1008), Mohács, Baranya, 7700, Hungary
Bekescsaba
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1007), Békéscsaba, Bekescsaba, 5600, Hungary
Bács-Kiskun county
Csőszi Endoszkópos KFT ( Site 1001), Kecskemét, Bács-Kiskun county, 6000, Hungary
Heves County
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1012), Eger, Heves County, 3300, Hungary
Gyöngyösi Bugát Pál Kórház ( Site 1011), Gyöngyös, Heves County, 3200, Hungary
Komárom-Esztergom
Komarom-Esztergom Varmegyei Szent Borbala Korhaz ( Site 1010), Tatabánya, Komárom-Esztergom, 2800, Hungary
Veszprém megye
VeszLife Magánklinika ( Site 1002), Veszprém, Veszprém megye, 8200, Hungary
Synexus Magyarorszag Kft. (Budapest DRS) ( Site 1009), Budapest, 1036, Hungary
Semmelweis Egyetem ( Site 1006), Budapest, 1085, Hungary
Pannónia Magánorvosi Centrum ( Site 1004), Budapest, 1136, Hungary
Emek Medical Center ( Site 1106), Afula, 1834111, Israel
Barzilai Medical Center ( Site 1109), Ashkelon, 7830604, Israel
Rambam Health Care Campus ( Site 1101), Haifa, 3109601, Israel
Bnai Zion Medical Center ( Site 1103), Haifa, 3339419, Israel
Edith Wolfson Medical Center ( Site 1104), Holon, 5810001, Israel
Shaare Zedek Medical Center ( Site 1108), Jerusalem, 9103102, Israel
Meir Medical Center. ( Site 1102), Kfar Saba, 4428164, Israel
Rabin Medical Center ( Site 1107), Petah Tikva, 4941492, Israel
Sheba Medical Center ( Site 1100), Ramat Gan, 5265601, Israel
Cagliari
Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1207), Monserrato, Cagliari, 09042, Italy
Foggia
IRCCS Casa Sollievo della Sofferenza ( Site 1213), San Giovanni Rotondo, Foggia, 71013, Italy
Lazio
Fondazione Policlinico Tor Vergata ( Site 1209), Rome, Lazio, 00133, Italy
Lombardy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Gastroenterology and Endoscopy Unit ( Site 1202), Milan, Lombardy, 20122, Italy
Istituto Clinico Humanitas-IBD center ( Site 1201), Rozzano, Lombardy, 20089, Italy
Milano
Ospedale Di Circolo-U.O.C. di Gastroenterologia ed Endoscopia Digestiva ( Site 1216), Rho, Milano, 20017, Italy
Napoli
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 1217), Naples, Napoli, 80131, Italy
Roma
Azienda Ospedaliera San Camillo Forlanini ( Site 1204), Rome, Roma, 00149, Italy
Fatebenefratelli Isola Tiberina - Gemelli Isola ( Site 1214), Rome, Roma, 00186, Italy
Sicily
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-U.O.S.D. Malattie Infiammatorie Croniche Intestinali ( Site 1210), Palermo, Sicily, 90146, Italy
Veneto
Azienda Ospedale - Università Padova-Surgery Oncology and Gastroenterology ( Site 1211), Padua, Veneto, 35128, Italy
Verona
Ospedale Sacro Cuore Don G. Calabria ( Site 1212), Negrar, Verona, 37024, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1208), Bologna, 40138, Italy
ASST Fatebenefratelli Sacco-UOC Gastroenterologia ( Site 1200), Milan, 20100, Italy
Ospedale San Raffaele-Gastroenterology and Gastrointestinal Endoscopy ( Site 1205), Milan, 20132, Italy
Fondazione IRCCS Policlinico San Matteo-General Medicine ( Site 1206), Pavia, 27100, Italy
Aichi-ken
Aichi Medical University Hospital ( Site 2841), Nagakute, Aichi-ken, 480-1195, Japan
Chiba
Tokatsu Tsujinaka Hospital ( Site 2832), Abiko, Chiba, 270-1168, Japan
Tsujinaka Hospital - Kashiwanoha ( Site 2802), Kashiwa, Chiba, 277-0871, Japan
Toho University Sakura Medical Center ( Site 2805), Sakura, Chiba, 285-8741, Japan
Ehime
Ehime Prefectural Central Hospital ( Site 2868), Matsuyama, Ehime, 790-0024, Japan
Fukuoka
Kitakyushu Municipal Medical Center ( Site 2873), Kitakyushu, Fukuoka, 802-8561, Japan
Kurume University Hospital ( Site 2846), Kurume, Fukuoka, 830-0011, Japan
Gunma
Gunma University Hospital ( Site 2850), Maebashi, Gunma, 371-8511, Japan
Hiroshima
National Hospital Organization Fukuyama Medical Center ( Site 2831), Fukuyama, Hiroshima, 720-0825, Japan
Hokkaido
Asahikawa City Hospital ( Site 2840), Asahikawa, Hokkaido, 070-8610, Japan
Asahikawa Medical University Hospital ( Site 2815), Asahikawa, Hokkaido, 078-8510, Japan
Sapporo Tokushukai Hospital ( Site 2808), Sapporo, Hokkaido, 004-0041, Japan
Sapporo Medical University Hospital ( Site 2829), Sapporo, Hokkaido, 060-8543, Japan
Medical Corporation Sapporo IBD Clinic ( Site 2842), Sapporo, Hokkaido, 064-0919, Japan
Sapporohigashi Tokushukai Hospital ( Site 2860), Sapporo, Hokkaido, 065-0033, Japan
Hyōgo
Hyogo Medical University Hospital ( Site 2830), Nishinomiya, Hyōgo, 663-8501, Japan
Ibaraki
Hitachi General Hospital ( Site 2856), Hitachi, Ibaraki, 317-0077, Japan
Ishikawa-ken
Ishikawa Prefectural Central Hospital ( Site 2835), Kanazawa, Ishikawa-ken, 920-8530, Japan
Kanazawa University Hospital ( Site 2839), Kanazawa, Ishikawa-ken, 920-8641, Japan
Iwate
Iwate Medical University Uchimaru Medical Center ( Site 2833), Morioka, Iwate, 020-8505, Japan
Kanagawa
Gokeikai Ofuna Chuo Hospital ( Site 2801), Kamakura, Kanagawa, 247-0056, Japan
St. Marianna University Hospital ( Site 2852), Kawasaki, Kanagawa, 216-8511, Japan
Matsushima Hospital ( Site 2822), Yokohama, Kanagawa, 220-0041, Japan
Yokohama City University Medical Center ( Site 2865), Yokohama, Kanagawa, 232-0024, Japan
Mie-ken
Mie University Hospital ( Site 2838), Tsu, Mie-ken, 514-8507, Japan
Osaka
Sai Gastroenterology/Proctology Clinic ( Site 2814), Fujiidera, Osaka, 583-0027, Japan
Kansai Medical University Hospital ( Site 2823), Hirakata, Osaka, 573-1191, Japan
Shizuoka
Hamamatsu University Hospital ( Site 2874), Hamamatsu, Shizuoka, 431-3192, Japan
Matsuda Hospital ( Site 2826), Hamamatsu, Shizuoka, 432-8061, Japan
National Hospital Organization Shizuoka Medical Center ( Site 2837), Shimizu, Shizuoka, 411-8611, Japan
Tokyo
Institute of Science Tokyo Hospital ( Site 2827), Bunkyō, Tokyo, 113-8519, Japan
Ginza Central Clinic ( Site 2824), Chūō, Tokyo, 104-0061, Japan
The Jikei University Hospital ( Site 2843), Minato, Tokyo, 105-8471, Japan
Toranomon Hospital ( Site 2828), Minato-ku, Tokyo, 105-8470, Japan
Kitasato University Kitasato Institute Hospital ( Site 2817), Minato-ku, Tokyo, 108-8642, Japan
Kyorin University Hospital ( Site 2804), Mitaka-shi, Tokyo, 181-8611, Japan
NTT Medical Center Tokyo ( Site 2834), Shinagawa-ku, Tokyo, 141-0022, Japan
Yamanashi
Yamanashi Prefectural Central Hospital ( Site 2836), Kofu, Yamanashi, 400-8506, Japan
Fukui Prefectural Hospital ( Site 2844), Fukui, 910-0846, Japan
Fukuoka University Hospital ( Site 2818), Fukuoka, 814-0180, Japan
Hiroshima University Hospital ( Site 2845), Hiroshima, 734-8551, Japan
Kagoshima University Hospital ( Site 2848), Kagoshima, 890-8520, Japan
Kagoshima IBD Gastroenterology Clinic ( Site 2821), Kagoshima, 892-0843, Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 2819), Kyoto, 602-8566, Japan
National Hospital Organization Kyoto Medical Center ( Site 2813), Kyoto, 612-8555, Japan
Okayama University Hospital ( Site 2870), Okayama, 700-8558, Japan
Infusion Clinic ( Site 2806), Osaka, 530-0011, Japan
National Hospital Organization Osaka National Hospital ( Site 2869), Osaka, 540-0006, Japan
Ishida Clinic of IBD and Gastroenterology ( Site 2820), Ōita, 870-0823, Japan
Saga University Hospital ( Site 2812), Saga, 849-8501, Japan
Tokitokai Tokito Clinic Coloproctology Center ( Site 2811), Saitama, 336-0963, Japan
Tokyo Yamate Medical Center ( Site 2803), Tokyo, 169-0073, Japan
Toyama Prefectural Central Hospital ( Site 2807), Toyama, 930-0975, Japan
Yamagata University Hospital ( Site 2849), Yamagata, 990-9585, Japan
Liepaja Regional Hospital ( Site 4501), Liepāja, 3414, Latvia
P.Stradins Clinical University Hospital Center of Gastroenterology Hepatology and Nutrition ( Site 4503), Riga, LV1002, Latvia
Ādaži
SIA M & M Centrs ( Site 4502), Ādaži, Ādaži, 2164, Latvia
Kaunas County
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 4600), Kaunas, Kaunas County, 50161, Lithuania
Vilniaus Miestas
VUL SANTAROS KLINIKOS ( Site 4601), Vilnius, Vilniaus Miestas, 08406, Lithuania
Johor
Hospital Sultanah Aminah ( Site 4702), Johor Bahru, Johor, 80100, Malaysia
Kelantan
Hospital Universiti Sains Malaysia ( Site 4704), Kubang Kerian, Kelantan, 16150, Malaysia
Negeri Sembilan
Hospital Tuanku Jaafar Seremban ( Site 4705), Seremban, Negeri Sembilan, 70300, Malaysia
Selangor
Hospital Ampang ( Site 4703), Ampang, Selangor, 68000, Malaysia
Guanajuato
Morales Vargas Centro de Investigacion ( Site 2411), León, Guanajuato, 37000, Mexico
Jalisco
PanAmerican Clinical Research - Guadalajara ( Site 2400), Guadalajara, Jalisco, 44670, Mexico
Centro Medico Clinico Quirurgico Especializado en Investigación ( Site 2403), Tlajumulco de Zuniga, Jalisco, 45640, Mexico
Mexico City
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 2406), Mexico City, Mexico City, 14050, Mexico
Nuevo León
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2409), Monterrey, Nuevo León, 64460, Mexico
Yucatán
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 2407), Mérida, Yucatán, 97130, Mexico
ICARO Investigaciones en Medicina ( Site 2405), Chihuahua City, 31000, Mexico
Centro de Investigación y Gastroenterología - S.C. ( Site 2410), Mexico City, 03330, Mexico
Oaxaca Site Management Organization S.C. ( Site 2404), Oaxaca City, 68000, Mexico
Gelderland
Radboudumc ( Site 1402), Nijmegen, Gelderland, 6525 GA, Netherlands
North Brabant
ETZ Elisabeth-Department of Gastroenterology and Hepatology ( Site 1403), Tilburg, North Brabant, 5022 GC, Netherlands
Ziekenhuis Bernhoven-Researchbureau ( Site 1401), Uden, North Brabant, 5406 PT, Netherlands
North Holland
Onze Lieve Vrouwe Gasthuis ( Site 1405), Amsterdam, North Holland, 1051 AC, Netherlands
Amsterdam UMC, locatie VUmc-IBD Trial Unit ( Site 1400), Amsterdam, North Holland, 1081 HZ, Netherlands
Overijssel
Deventer Ziekenhuis ( Site 1411), Deventer, Overijssel, 7416 SE, Netherlands
South Holland
Erasmus Medisch Centrum ( Site 1410), Rotterdam, South Holland, 3015 GD, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Gasthuis ( Site 1406), Rotterdam, South Holland, 3045 PM, Netherlands
Universitair Medisch Centrum Utrecht ( Site 1404), Utrecht, 3584 CX, Netherlands
Waikato Region
Waikato Hospital ( Site 2903), Hamilton, Waikato Region, 3204, New Zealand
Wellington Region
Hutt Valley District Health board HVDHB ( Site 2902), Lower Hutt, Wellington Region, 5010, New Zealand
Aotearoa Clinical Trials ( Site 2900), Auckland, 2025, New Zealand
Akershus
Akershus Universitetssykehus ( Site 4200), Lørenskog, Akershus, 1478, Norway
Oslo Universitetssykehus Ullevål ( Site 4201), Oslo, 0450, Norway
Greater Poland Voivodeship
Pratia Poznan ( Site 1530), Poznan, Greater Poland Voivodeship, 60-192, Poland
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.,Twoja Przychodnia PCM ( Site 1523), Poznan, Greater Poland Voivodeship, 60-324, Poland
Kuyavian-Pomeranian Voivodeship
Gastromed Sp. z o. o. ( Site 1513), Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Lesser Poland Voivodeship
Topolowa Medicenter Ryszawa & Wspolnicy sp.j. ( Site 1500), Krakow, Lesser Poland Voivodeship, 31-506, Poland
PROMED P. LACH R. GLOWACKI SP. J. ( Site 1529), Krakow, Lesser Poland Voivodeship, 31-513, Poland
Allmedica ( Site 1508), Nowy Targ, Lesser Poland Voivodeship, 34-400, Poland
NZOZ FOR MED sp. z o.o. ( Site 1511), Wadowice, Lesser Poland Voivodeship, 34-100, Poland
Lower Silesian Voivodeship
Planetmed ( Site 1506), Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
Vistamed & Vertigo Sp. z o.o. ( Site 1528), Wroclaw, Lower Silesian Voivodeship, 53-149, Poland
Melita Medical ( Site 1519), Wroclaw, Lower Silesian Voivodeship, 53-611, Poland
Penta Hospitals Przychodnie Wrocław Wejherowska ( Site 1505), Wroclaw, Lower Silesian Voivodeship, 54-239, Poland
Masovian Voivodeship
Centrum Zdrowia MDM ( Site 1512), Warsaw, Masovian Voivodeship, 00-189, Poland
ETG Warszawa ( Site 1525), Warsaw, Masovian Voivodeship, 02-677, Poland
Vivamed Sp. z o.o. ( Site 1510), Warsaw, Masovian Voivodeship, 03-580, Poland
WIP Warsaw IBD Point Profesor Kierkuś ( Site 1503), Warsaw, Masovian Voivodeship, 04-501, Poland
Silesian Voivodeship
M2M Med ( Site 1526), Chorzów, Silesian Voivodeship, 41-500, Poland
Vita Longa Sp. Zoo ( Site 1527), Katowice, Silesian Voivodeship, 40-748, Poland
West Pomeranian Voivodeship
Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 1502), Szczecin, West Pomeranian Voivodeship, 71-434, Poland
Sonomed Sp. z o. o. ( Site 1516), Szczecin, West Pomeranian Voivodeship, 71-685, Poland
Łódź Voivodeship
Med-Gastr Sp. z o.o., sp.k ( Site 1515), Lodz, Łódź Voivodeship, 91-034, Poland
AmiCare Centrum Medyczne - Zgierska ( Site 1517), Lodz, Łódź Voivodeship, 91-495, Poland
Lisbon District
Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 3306), Lisbon, Lisbon District, 1349-019, Portugal
Unidade Local de Saude de Braga - Hospital de Braga ( Site 3300), Braga, 4710-243, Portugal
Hospital dos Lusíadas Lisboa ( Site 3303), Lisbon, 1500-458, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3305), Lisbon, 1649-035, Portugal
ULSAM - Hospital de Santa Luzia ( Site 3302), Viana do Castelo, 4904 - 858, Portugal
Unidade Local de Saude Dão-Lafões - Hospital de São Teotónio ( Site 3308), Viseu, 3504-509, Portugal
București
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1606), Bucharest, București, 013823, Romania
Monza Ares SRL ( Site 1604), Bucharest, București, 021967, Romania
Fundeni Clinical Institute-Gastroenterology and Hepatology Center ( Site 1608), Bucharest, București, 022328, Romania
Cluj
Spitalul Clinic Judetean de Urgenta Cluj Napoca-Gastroenterology ( Site 1605), Cluj-Napoca, Cluj, 400006, Romania
GastroMed ( Site 1609), Cluj-Napoca, Cluj, 400394, Romania
Mureș County
Spitalul Clinic Judetean Mures-Gastroenterology ( Site 1607), Târgu Mureş, Mureș County, 540205, Romania
Timiș County
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L-Gastroenterology ( Site 1601), Timișoara, Timiș County, 300002, Romania
Asociatia Oncohelp ( Site 1610), Timișoara, Timiș County, 300239, Romania
Beograd
Clinical Hospital Center Dragisa Misovic ( Site 1708), Belgrade, Beograd, 11 000, Serbia
Clinical Hospital Center Zvezdara-Gastroenterology and hepatology Department ( Site 1705), Belgrade, Beograd, 11000, Serbia
University Medical Center "Bezanijska kosa"-Gastroenterology and hepatology ( Site 1704), Belgrade, Beograd, 11080, Serbia
Clinical Center Kragujevac ( Site 1703), Kragujevac, Beograd, 34000, Serbia
Srednjebanatski Okrug
General Hospital "Djordje Joanovic" ( Site 1707), Zrenjanin, Srednjebanatski Okrug, 23000, Serbia
Central Singapore
Singapore General Hospital ( Site 4801), Singapore, Central Singapore, 169608, Singapore
Tan Tock Seng Hospital-Gastroenterology and Hepatology ( Site 4800), Singapore, Central Singapore, 308433, Singapore
Banská Bystrica Region
Breznianske centrum gastroenterologie ( Site 1806), Brezno, Banská Bystrica Region, 977 01, Slovakia
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 1802), Slovakia, Banská Bystrica Region, 974 01, Slovakia
Bratislava Region
Cliniq s.r.o. ( Site 1800), Bratislava, Bratislava Region, 811 09, Slovakia
Košice Region
ENDOMED ( Site 1801), Košice, Košice Region, 040 13, Slovakia
Nitra Region
KM Management ( Site 1804), Nitra, Nitra Region, 949 01, Slovakia
Accout Center ( Site 1805), Šahy, Nitra Region, 936 01, Slovakia
Presov
GASTRO I ( Site 1807), Prešov, Presov, 080 01, Slovakia
Gastro LM ( Site 1808), Prešov, Presov, 080 01, Slovakia
Gauteng
Wits Clinical Research-Research ( Site 3208), Johannesburg, Gauteng, 2193, South Africa
Wits Clinical Research-Wits Clinical Research Bara ( Site 3206), Soweto, Gauteng, 2013, South Africa
Western Cape
Panorama Medical Centre ( Site 3209), Cape Town, Western Cape, 7506, South Africa
Spoke Research ( Site 3210), Cape Town, Western Cape, 7700, South Africa
Life Kingsbury Hospital ( Site 3203), Cape Town, Western Cape, 7708, South Africa
Private Practice - Dr. M.N. Rajabally ( Site 3213), Cape Town, Western Cape, 7800, South Africa
Barcelona
Hospital Germans Trias i Pujol ( Site 3413), Badalona, Barcelona, 08916, Spain
Hospital Universitari Mutua Terrassa ( Site 3416), Terrassa, Barcelona, 08221, Spain
Bizkaia
Hospital Galdakao-Usansolo ( Site 3409), Galdakao-Usansolo, Bizkaia, 48960, Spain
Madrid
Hospital Universitario de Fuenlabrada-Digestive ( Site 3415), Fuenlabrada, Madrid, 28942, Spain
Madrid, Comunidad de
Hospital La Princesa-Gastroenterology ( Site 3411), Madrid, Madrid, Comunidad de, 28006, Spain
Fundación Jimenez Diaz ( Site 3420), Madrid, Madrid, Comunidad de, 28040, Spain
Hospital Universitario de Torrejon ( Site 3417), Torrejón de Ardoz, Madrid, Comunidad de, 28850, Spain
Valencia
Hospital Universitari i Politecnic La Fe-Enfermedad Inflamatoria Intestinal ( Site 3405), Valencia, Valencia, 46026, Spain
Valenciana, Comunitat
HOSPITAL CLINICO DE VALENCIA ( Site 3406), Valencia, Valenciana, Comunitat, 46010, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Aparato Digestivo ( Site 3403), Madrid, 28028, Spain
Hospital Universitario La Paz-Unidad de Enfermedad Inflamatoria Intestinal ( Site 3402), Madrid, 28046, Spain
Stockholm County
Danderyds Sjukhus ( Site 4401), Danderyd, Stockholm County, 182 88, Sweden
Karolinska Universitetssjukhuset Solna ( Site 4400), Stockholm, Stockholm County, 171 64, Sweden
Uppsala County
Akademiska Sjukhuset ( Site 4403), Uppsala, Uppsala County, 75185, Sweden
Östergötland County
Universitetssjukhuset i Linköping ( Site 4402), Linköping, Östergötland County, 581 85, Sweden
Canton of Bern
INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 1902), Bern, Canton of Bern, 3012, Switzerland
Canton of St. Gallen
Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 1901), Sankt Gallen, Canton of St. Gallen, 9000, Switzerland
Canton of Zurich
UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 1900), Zurich, Canton of Zurich, 8091, Switzerland
Changhua
Changhua Christian Hospital ( Site 3104), Changhua County, Changhua, 50006, Taiwan
Hsinchu
National Taiwan University BioMedical Park Hospital ( Site 3103), Zhubei, Hsinchu, 302058, Taiwan
China Medical University Hospital ( Site 3100), Taichung, 404332, Taiwan
National Taiwan University Hospital ( Site 3102), Taipei, 10002, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 3101), Taoyuan District, 333, Taiwan
Istanbul
Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3503), Istanbul- Fatih, Istanbul, 34098, Turkey (Türkiye)
ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 3507), Ankara, 06230, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 3500), Ankara, 06230, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Gastroenterology ( Site 3501), Ankara, 06800, Turkey (Türkiye)
Antalya Egitim ve Arastirma Hastanesi ( Site 3508), Antalya, 07100, Turkey (Türkiye)
Trakya University Medical Faculty Hospital ( Site 3510), Edirne, 22030, Turkey (Türkiye)
Eskisehir Osmangazi University Faculty of Medicine ( Site 3512), Eskişehir, 26040, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 3505), Istanbul, 34899, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital ( Site 3509), Kocaeli, 41380, Turkey (Türkiye)
Ivano-Frankivsk Oblast
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 4115), Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine
Kyivska Oblast
Center of Family Medicine Plus-Treatment Prevention Unit ( Site 4103), Kyiv, Kyivska Oblast, 04210, Ukraine
Lviv Oblast
Communal Non-profit Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"-proctology ( Site 4109), Lviv, Lviv Oblast, 79010, Ukraine
Vinnytsia Oblast
Limited liability company "Medical center Health Clinic"-Gastroenterology, Hepatology and Endocrino ( Site 4107), Vinnytsia, Vinnytsia Oblast, 21009, Ukraine
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical -Gastroenterology department ( Site 4114), Vinnytsia, Vinnytsia Oblast, 21018, Ukraine
Communal Non-Commercial Enterprise "Vinnytsia City Clinical -Clinical Therapeutic Department #1 ( Site 4111), Vinnytsia, Vinnytsia Oblast, 21029, Ukraine
Volyn Oblast
Municipal Enterprise "Volyn Regional Clinical Hospital" of V-surgery department (abdominal, colopro ( Site 4113), Lutsk, Volyn Oblast, 43005, Ukraine
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 4100), Kyiv, 03057, Ukraine
Dobrobut Medical Center ( Site 4101), Kyiv, 03151, Ukraine
Medical Center of Private Enterprise "Sygma" ( Site 4108), Kyiv, 04116, Ukraine
Bristol, City of
Southmead Hospital ( Site 2004), Bristol, Bristol, City of, BS10 5NB, United Kingdom
Cambridgeshire
Addenbrooke's Hospital ( Site 2005), Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Devon
Royal Devon & Exeter Hospital-IBD Research Group ( Site 2001), Exeter, Devon, EX2 5DW, United Kingdom
England
Doncaster Royal Infirmary ( Site 2006), Doncaster, England, DN2 5LT, United Kingdom
Huddersfield Royal Infirmary ( Site 2010), Huddersfield, England, HD3 3EA, United Kingdom
Whipps Cross University Hospital-Clinical Research Unit ( Site 2000), London, England, E11 1NR, United Kingdom
St. George's Hospital ( Site 2007), London, England, SW17 0QT, United Kingdom
Hampshire
Southampton General Hospital-Gastroenterology ( Site 2003), Southampton, Hampshire, SO16 0YD, United Kingdom
London, City of
University College London Hospital-Clinical Research Facility ( Site 2002), London, London, City of, NW1 2PG, United Kingdom
Walsall
Walsall Manor Hospital ( Site 2009), West Midlands, Walsall, WS2 9PS, United Kingdom