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L'essai clinique NCT07047612 pour Non Segmental Vitiligo est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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ICP-332 in Subjects With Non-segmental Vitiligo Phase II, Phase III 603 Randomisé Double aveugle Contrôlé par placebo Design adaptatif
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07047612 est conçu pour étudier le traitement de Non Segmental Vitiligo. Il s'agit d'une étude interventionnel en Phase II Phase III. Son statut actuel est : en recrutement. L'étude a débuté le 9 mai 2025 et vise à recruter 603 participants. Dirigée par Beijing InnoCare Pharma Tech Co., Ltd., l'étude devrait être terminée d'ici le 1 avril 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 7 août 2025.
Résumé succinct
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.
Titre officiel
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
Pathologies
Non Segmental VitiligoAutres identifiants de l'étude
- ICP-CL-00607
Numéro NCT
Date de début (réel)
2025-05-09
Dernière mise à jour publiée
2025-08-07
Date de fin (estimée)
2029-04
Inscription (estimée)
603
Type d'étude
Interventionnel
PHASE
Phase II
Phase III
Phase III
Statut
En recrutement
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Quadruple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalICP-332 dose A（Phase2） | ICP-332 Tablets ICP-332 will be administered as tablet |
Comparateur placeboPlacebo（Phase2） | ICP-332 Placebo Tablets ICP-332 Placebo will be administered as tablet |
ExpérimentalICP-332 dose B（Phase2:） | ICP-332 Tablets ICP-332 will be administered as tablet |
ExpérimentalICP-332 dose A or dose B（Phase3） | ICP-332 Tablets ICP-332 will be administered as tablet |
Comparateur placeboPlacebo（Phase3） | ICP-332 Placebo Tablets ICP-332 Placebo will be administered as tablet |
Critère principal d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
12 Years
Sexes éligibles
Tous
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.Contact central de l'étude
Contact: Flora Xiang, Doctor, 021-52887775, [email protected]
45 Centres de l'étude dans 1 pays
Anhui
The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, 241001, China
Chao Ci, Contact
Pas encore en recrutement
The Second Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China
Ruzhi Zhang, Contact
Pas encore en recrutement
Beijing Municipality
Peking University Third Hospital, Beijing, Beijing Municipality, 100191, China
Chunlei Zhang, Contact
Pas encore en recrutement
Beijing Chao-yang Hospital,Capital Medical University, Beijing, Beijing Municipality, China
Fang Liu, Contact
Pas encore en recrutement
Beijing Tongren Hospital, Beijing, Beijing Municipality, China
Aihua Wei, Contact
Pas encore en recrutement
Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400016, China
Bin Wei, Contact
Pas encore en recrutement
Chongqing Traditional Chinese Medicine Hospital, Chongqing, Chongqing Municipality, 400021, China
Qingchun 400000 Diao, Contact
En recrutement
Fujian
Union Hospital affiliated to Fujian Medical, Fuzhou, Fujian, 350001, China
Huichun Su, Contact
Pas encore en recrutement
The First Affiliated Hospital of Fujian Medical, Fuzhou, Fujian, 350005, China
Niu Xiang, Contact
Pas encore en recrutement
Guangdong
Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Guangzhou, Guangdong, 510120, China
Liangchun Wang, Contact
Pas encore en recrutement
Deramatology Hospital of Southern Medical Univercity, Guangzhou, Guangdong, 516006, China
Xiaowei Shi, Contact
Pas encore en recrutement
Nanfang Hospital, Guangzhou, Guangdong, China
Yue Zheng, Contact
Pas encore en recrutement
Hebei
The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050051, China
Yanling Li, Contact
Pas encore en recrutement
Henan
The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China
Bin Zhang, Contact
Pas encore en recrutement
Nanyang First People's Hospital, Nanyang, Henan, 473000, China
Rixin Chen, Contact
Pas encore en recrutement
The First Affiliated Hospital of Xinxiang Medical College, Weihui, Henan, 453100, China
Dandan Fu, Contact
Pas encore en recrutement
Henan Provincial People's Hospital, Zhengzhou, Henan, China
Jianguo Li, Contact
Pas encore en recrutement
Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, China
Zixue Chen, Contact
Pas encore en recrutement
Hubei
Jingzhou Central Hospital, Jingzhou, Hubei, 434020, China
Yi Sun, Contact
Pas encore en recrutement
Shiyan People's Hospital, Shiyan, Hubei, China
Zudong Meng, Contact
Pas encore en recrutement
Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine), Wuhan, Hubei, 430022, China
Liuqing Chen, Contact
Pas encore en recrutement
Hunan
Xiangya Hospital of Central South University, Changsha, Hunan, 410008, China
Juan Li, Contact
Pas encore en recrutement
The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China
Yunsheng Liang, Contact
Pas encore en recrutement
The First Affiliated Hospital of University Of South China, Hengyang, Hunan, China
Zhijun Liu, Contact
Pas encore en recrutement
Jiangsu
The First People's Hospital of Lianyungang, Lianyungang, Jiangsu, 222061, China
Hong Ren, Contact
Pas encore en recrutement
Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, Jiangsu, 210042, China
Qianjin Lu, Contact
Pas encore en recrutement
Suzhou Municipal Hospital, Suzhou, Jiangsu, 215002, China
Jun Gu, Contact
Pas encore en recrutement
Jiangxi
Dermatology hospital of jiangxi province, Nanchang, Jiangxi, 330000, China
Xiaoyi Wen, Contact
Pas encore en recrutement
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
Xianwei Cao, Contact
Pas encore en recrutement
Jilin
The first hospital of Jilin Univercity, Changchun, Jilin, 130021, China
Shanshan Li, Contact
Pas encore en recrutement
Liaoning
Shenyang Medical College Affiliated Central Hospital, Shenyang, Liaoning, China
Xiaodong Li, Contact
Pas encore en recrutement
Shandong
Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China
Yin Li, Contact
En recrutement
Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital), Jinan, Shandong, 250022, China
Furen Zhang, Contact
Pas encore en recrutement
Zibo Central Hospital, Zibo, Shandong, China
Guowei Zhao, Contact
Pas encore en recrutement
Shanghai Municipality
Huashan Hospital Fudan University, Shanghai, Shanghai Municipality, 200040, China
Folra Xiang, Contact
En recrutement
Shanghai Dermatology Hospital, Shanghai, Shanghai Municipality, 200050, China
Yangfeng Ding, Contact
Pas encore en recrutement
Shanxi
Shaanxi Provincial People's Hospital, Xian, Shanxi, 710068, China
Li Yang, Contact
Pas encore en recrutement
Sichuan
Chengdu Second People's Hospital, Chengdu, Sichuan, 610021, China
Yanping Feng, Contact
Pas encore en recrutement
Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610072, China
Lixia Zhang, Contact
Pas encore en recrutement
Yunnan
The First Affiliated Hospital Of Kunming Medical University, Kunming, Yunnan, 650032, China
Dongjie Sun, Contact
Pas encore en recrutement
Zhejiang
Hangzhou Third People's Hospital, Hangzhou, Zhejiang, 310009, China
Aie Xu, Contact
En recrutement
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, China
Liming Wu, Contact
Pas encore en recrutement
The First Affiliated Hospital Of Ningbo University, Ningbo, Zhejiang, 315100, China
Bingjiang Lin, Contact
Pas encore en recrutement
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Zhiming Li, Contact
Pas encore en recrutement
The Fourth Affiliated Hospital, Zhejiang University School Of Medicine, Yiwu, Zhejiang, 322000, China
Lunfei Liu, Contact
Pas encore en recrutement