임상 레이더 AI | ||
|---|---|---|
임상시험 NCT07047612은(는) Non Segmental Vitiligo에 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
ICP-332 in Subjects With Non-segmental Vitiligo 2상, 3상 603 무작위 배정 이중 눈가림 위약 대조 적응형 설계
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 NCT07047612은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 Non Segmental Vitiligo에 대해 진행되며, 2상 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 5월 9일에 시작되어 603명의 참여자를 모집하고 있습니다. Beijing InnoCare Pharma Tech Co., Ltd.이(가) 진행하며, 2029년 4월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 8월 7일에 갱신되었습니다.
간단한 개요
This a phase II/III randomized, double-blind, placebo-controlled, parallel group, adaptive design, multi-center study to evaluate the efficacy and safety of ICP-332 in subjects with non-segmental vitiligo。The study consisted an phase 2 part and an phase 3 part.
공식 제목
A Phase II/III Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive Design, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Subjects With Non-segmental Vitiligo
질환명
Non Segmental Vitiligo기타 연구 식별자
- ICP-CL-00607
NCT 번호
실제 연구 시작일
2025-05-09
최신 업데이트 게시
2025-08-07
예상 연구 완료일
2029-04
계획된 등록 인원
603
연구종류
중재연구
단계/상
2상
3상
3상
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
사중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적ICP-332 dose A（Phase2） | ICP-332 Tablets ICP-332 will be administered as tablet |
위약 대조군Placebo（Phase2） | ICP-332 Placebo Tablets ICP-332 Placebo will be administered as tablet |
실험적ICP-332 dose B（Phase2:） | ICP-332 Tablets ICP-332 will be administered as tablet |
실험적ICP-332 dose A or dose B（Phase3） | ICP-332 Tablets ICP-332 will be administered as tablet |
위약 대조군Placebo（Phase3） | ICP-332 Placebo Tablets ICP-332 Placebo will be administered as tablet |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24. | 24 weeks | |
Phase3: Proportion of subjects achieving F-VASI 75 at Week 52. | 52 weeks |
참여 도우미
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
12 Years
참여 가능한 성별
전체
Male or female subjects aged ≥18 years and ≤75 years (Phase II portion). Male or female subjects ≥12 years of age and ≤75 years of age, adolescent subjects must weigh ≥40 kg (Phase III portion).
Eligible subjects must meet all of the following criteria at screening and baseline:
- The clinical diagnosis was non-segmental vitiligo for at least 3 months.
- Involvement of BSA≥5%.
- Facial involvement BSA≥0.5%.
- F-VASI≥0.5 and T-VASI between 5 and 50.
- Active or stable non-segmental vitiligo was present at both screening and baseline visits.
Women of childbearing potential (WOCBP) and Men must agree to contraception.
Before beginning any screening or study specific procedures, subjects must voluntarily sign informed consent.
Any of the following vitiligo related medical conditions and other skin diseases/conditions.
a) Subjects had other types of vitiligo (including but not limited to segmental vitiligo and mixed vitiligo) that did not meet the criteria for active or stable vitiligo described in Inclusion criteria 2.
History of any clinically major diseases, with the exception of vitiligo.
Pregnant or breastfeeding females.
The investigator considers that the subject is not suitable for participation in this study for any reason.
Beijing InnoCare Pharma Tech Co., Ltd.연구 대표 연락처
연락처: Flora Xiang, Doctor, 021-52887775, [email protected]
45 1개국에 임상시험 장소
Anhui
The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, 241001, China
Chao Ci, 연락처
대상자모집전
The Second Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China
Ruzhi Zhang, 연락처
대상자모집전
Beijing Municipality
Peking University Third Hospital, Beijing, Beijing Municipality, 100191, China
Chunlei Zhang, 연락처
대상자모집전
Beijing Chao-yang Hospital,Capital Medical University, Beijing, Beijing Municipality, China
Fang Liu, 연락처
대상자모집전
Beijing Tongren Hospital, Beijing, Beijing Municipality, China
Aihua Wei, 연락처
대상자모집전
Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400016, China
Bin Wei, 연락처
대상자모집전
Chongqing Traditional Chinese Medicine Hospital, Chongqing, Chongqing Municipality, 400021, China
Qingchun 400000 Diao, 연락처
모집중
Fujian
Union Hospital affiliated to Fujian Medical, Fuzhou, Fujian, 350001, China
Huichun Su, 연락처
대상자모집전
The First Affiliated Hospital of Fujian Medical, Fuzhou, Fujian, 350005, China
Niu Xiang, 연락처
대상자모집전
Guangdong
Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Guangzhou, Guangdong, 510120, China
Liangchun Wang, 연락처
대상자모집전
Deramatology Hospital of Southern Medical Univercity, Guangzhou, Guangdong, 516006, China
Xiaowei Shi, 연락처
대상자모집전
Nanfang Hospital, Guangzhou, Guangdong, China
Yue Zheng, 연락처
대상자모집전
Hebei
The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050051, China
Yanling Li, 연락처
대상자모집전
Henan
The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China
Bin Zhang, 연락처
대상자모집전
Nanyang First People's Hospital, Nanyang, Henan, 473000, China
Rixin Chen, 연락처
대상자모집전
The First Affiliated Hospital of Xinxiang Medical College, Weihui, Henan, 453100, China
Dandan Fu, 연락처
대상자모집전
Henan Provincial People's Hospital, Zhengzhou, Henan, China
Jianguo Li, 연락처
대상자모집전
Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, China
Zixue Chen, 연락처
대상자모집전
Hubei
Jingzhou Central Hospital, Jingzhou, Hubei, 434020, China
Yi Sun, 연락처
대상자모집전
Shiyan People's Hospital, Shiyan, Hubei, China
Zudong Meng, 연락처
대상자모집전
Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine), Wuhan, Hubei, 430022, China
Liuqing Chen, 연락처
대상자모집전
Hunan
Xiangya Hospital of Central South University, Changsha, Hunan, 410008, China
Juan Li, 연락처
대상자모집전
The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China
Yunsheng Liang, 연락처
대상자모집전
The First Affiliated Hospital of University Of South China, Hengyang, Hunan, China
Zhijun Liu, 연락처
대상자모집전
Jiangsu
The First People's Hospital of Lianyungang, Lianyungang, Jiangsu, 222061, China
Hong Ren, 연락처
대상자모집전
Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, Jiangsu, 210042, China
Qianjin Lu, 연락처
대상자모집전
Suzhou Municipal Hospital, Suzhou, Jiangsu, 215002, China
Jun Gu, 연락처
대상자모집전
Jiangxi
Dermatology hospital of jiangxi province, Nanchang, Jiangxi, 330000, China
Xiaoyi Wen, 연락처
대상자모집전
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
Xianwei Cao, 연락처
대상자모집전
Jilin
The first hospital of Jilin Univercity, Changchun, Jilin, 130021, China
Shanshan Li, 연락처
대상자모집전
Liaoning
Shenyang Medical College Affiliated Central Hospital, Shenyang, Liaoning, China
Xiaodong Li, 연락처
대상자모집전
Shandong
Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China
Yin Li, 연락처
모집중
Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital), Jinan, Shandong, 250022, China
Furen Zhang, 연락처
대상자모집전
Zibo Central Hospital, Zibo, Shandong, China
Guowei Zhao, 연락처
대상자모집전
Shanghai Municipality
Huashan Hospital Fudan University, Shanghai, Shanghai Municipality, 200040, China
Folra Xiang, 연락처
모집중
Shanghai Dermatology Hospital, Shanghai, Shanghai Municipality, 200050, China
Yangfeng Ding, 연락처
대상자모집전
Shanxi
Shaanxi Provincial People's Hospital, Xian, Shanxi, 710068, China
Li Yang, 연락처
대상자모집전
Sichuan
Chengdu Second People's Hospital, Chengdu, Sichuan, 610021, China
Yanping Feng, 연락처
대상자모집전
Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610072, China
Lixia Zhang, 연락처
대상자모집전
Yunnan
The First Affiliated Hospital Of Kunming Medical University, Kunming, Yunnan, 650032, China
Dongjie Sun, 연락처
대상자모집전
Zhejiang
Hangzhou Third People's Hospital, Hangzhou, Zhejiang, 310009, China
Aie Xu, 연락처
모집중
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, China
Liming Wu, 연락처
대상자모집전
The First Affiliated Hospital Of Ningbo University, Ningbo, Zhejiang, 315100, China
Bingjiang Lin, 연락처
대상자모집전
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Zhiming Li, 연락처
대상자모집전
The Fourth Affiliated Hospital, Zhejiang University School Of Medicine, Yiwu, Zhejiang, 322000, China
Lunfei Liu, 연락처
대상자모집전