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비리디안 테라퓨틱스A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
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임상시험 NCT07155668은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 갑상선 눈 질환에 대해 진행되며, 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 7월 1일에 시작되어 75명의 참여자를 모집하고 있습니다. 비리디안 테라퓨틱스이(가) 진행하며, 2026년 11월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 4일에 갱신되었습니다.
간단한 개요
This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)
상세한 설명
This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.
공식 제목
A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)
질환/상태
갑상선 눈 질환기타 연구 식별자
- VRDN-003-304
NCT 번호
실제 연구 시작일
2025-07-01
최신 업데이트 게시
2025-09-04
예상 연구 완료일
2026-11
계획된 등록 인원
75
연구종류
중재연구
단계/상
3상
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (공개라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적VRDN-003 every 4 weeks using autoinjector 6 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 5 doses of 300mg\] | VRDN-003 VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). Autoinjector The autoinjector is a single-dose, disposable, ready-to-use delivery device |
실험적VRDN-003 every 8 weeks using autoinjector 3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\] | VRDN-003 VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). Autoinjector The autoinjector is a single-dose, disposable, ready-to-use delivery device |
실험적VRDN-003 every 8 weeks using vial and syringe 3 subcutaneous administrations of VRDN-003 \[1 loading dose of 600mg and 2 doses of 300mg\] | VRDN-003 VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R). |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Treatment Emergent Adverse Event (TEAE) incidence rate | Treatment Emergent Adverse Event (TEAE) incidence rate | Through Week 24 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Pharmacokinetic outcome measures | Time of maximum serum concentration (Tmax) of VRDN-003 | Through Week 24 |
Pharmacokinetic outcome measures | Maximum serum concentration (Cmax) of VRDN-003 | Through Week 24 |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
- Not require immediate ophthalmological or orbital surgery in the study eye for any reason
- Must agree to use highly effective contraception as specified in the protocol
- Female TED participants must have a negative serum pregnancy test at screening
- Must not have received prior treatment with another anti-IGF-1R therapy
- Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.
- Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED, within 12 weeks prior to first dose
- Must not have received an investigational agent/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) prior to first dose
- Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
- Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
- Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
- Must not have abnormal hearing test before first dose or history of ear conditions considered significant by study doctor
- Must not have a history of inflammatory bowel disease
- Female TED participants must not be pregnant or breastfeeding
비리디안 테라퓨틱스5개의 진행 중인 임상시험 탐색 가능연락처 정보가 없습니다.
4 1개국에 임상시험 장소
California
United Medical Research Institute, Inglewood, California, 90301, United States
Study Coordinator, 연락처, 310-645-4673, [email protected]
모집중
Florida
Ilumina Medical Research, Kissimmee, Florida, 34744, United States
Study Coordinator, 연락처, 407-807-6506, [email protected]
모집중
Hype Clinical Research, LLC, Miami, Florida, 33145, United States
Study Coordinator, 연락처, 305-833-0053, [email protected]
모집중
Michigan
Fraser Eye Center, Fraser, Michigan, 48026, United States
Study Coordinator, 연락처, 586-296-7250, [email protected]
모집중