임상 레이더 AI | ||
|---|---|---|
임상시험 NCT07363590은(는) 전신 홍반성 루푸스, 류마티스 관절염에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
검색으로 돌아가기
머크A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) 1상 21
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07363590은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 전신 홍반성 루푸스, 류마티스 관절염에 대해 진행되며, 1상 중재연구으로 현재 상태는 모집중입니다. 연구는 2026년 2월 19일에 시작되어 21명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2029년 7월 16일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 9일에 갱신되었습니다.
간단한 개요
This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).
공식 제목
A Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1045 in Participants With Systemic Lupus Erythematosus and Rheumatoid Arthritis
질환명
전신 홍반성 루푸스류마티스 관절염기타 연구 식별자
- 1045-004
- U1111-1326-4816 (등록 식별자) (UTN)
- 2025-523412-36-00 (등록 식별자) (EU CT)
- MK-1045-004 (기타 식별자) (MSD)
- jRCT2031250748 (등록 식별자) (Japan Registry of Clinical Trials (jRCT))
NCT 번호
실제 연구 시작일
2026-02-19
최신 업데이트 게시
2026-03-09
예상 연구 완료일
2029-07-16
계획된 등록 인원
21
연구종류
중재연구
단계/상
1상
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
순차설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Part 1 Prime Dose Escalation Panels Participants will receive single intravenous (IV) doses of MK-1045 at varying dose levels. | MK-1045 IV infusion |
실험적Part 2 Step-up Dose Escalation Panels Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval. | MK-1045 IV infusion |
실험적Part 3 Dose Expansion Panels (Optional) Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval. | MK-1045 IV infusion |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Part 1: Number of Participants with One or More Adverse Events (AEs) | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 12 weeks |
Part 1: Number of Participants who Discontinue Study Drug Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 4 weeks |
Part 2 and Part 3: Number of Participants with One or More AEs | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 52 weeks |
Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 2 weeks |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Part 1: Maximum Serum Concentration (Cmax) of MK-1045 | Blood samples will be collected to determine the Cmax, obtained directly from the measured value of the plasma concentration-time curve. | At designated time points up to 12 weeks |
Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1045 | Blood samples will be collected to determine the AUC0-Inf of MK-1045. | At designated time points up to 12 weeks |
Part 1: Percentage of Participants with a Peripheral B Cell Count Less Than the Lower Limit of Quantitation (LLOQ) at the End of Each Treatment Period | Blood samples will be collected to determine the B cell depletion in peripheral blood after treatment with MK-1045. | At designated time points up to 12 weeks |
Part 2 and Part 3: Cmax of MK-1045 | Blood samples will be collected to determine the Cmax, obtained directly from the measured value of the plasma concentration-time curve. | At designated time points up to 52 weeks |
Part 2 and Part 3: Area Under the Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) of MK-1045 | Blood samples will be collected to determine the AUCtau of MK-1045. | At designated time points up to 52 weeks |
Part 2 and Part 3: Percentage of Participants with a Peripheral B Cell Count Less Than the LLOQ at the End of the Treatment Period | Blood samples will be collected to determine the B cell depletion in peripheral blood after treatment with MK-1045. | At designated time points up to 52 weeks |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Has a body mass index between 18 and 32 kg/m^2, inclusive
- Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) 2019 classification criteria
- SLE: Is taking at least one background therapy for SLE
- RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA
- Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with anti-infectives within 8 weeks prior to the Day 1 dosing
- History of serious recurrent or chronic infection
- Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
- Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB
- Has a significant or uncontrolled medical disease in any organ system not related to RA or SLE
- For RA participants, has a history of any arthritis with onset before age 17 years
- Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments
- History of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before Day 1 dosing
- Has had a major surgery within 3 months prior to Screening or has a major surgery planned during the study.
- Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening
- Has a severe chronic pulmonary disease requiring oxygen therapy
- Has current active lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease
머크연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
3 3개국에 임상시험 장소
Limburg
Anima Diepenbeek ( Site 0601), Diepenbeek, Limburg, 3590, Belgium
Study Coordinator, 연락처, +3211949115
모집중
Arensia Exploartory Medicine ( Site 1301), Tbilisi, 0112, Georgia
Study Coordinator, 연락처, +995568404374
모집중
PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001), Chisinau, 2025, Moldova
Study Coordinator, 연락처, +37379638895
모집중