Trial Radar IA | ||
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Lo studio clinico NCT07047612 per Non Segmental Vitiligo è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
ICP-332 in Subjects With Non-segmental Vitiligo Fase II, Fase III 603 Randomizzato Doppio cieco Controllato con placebo Disegno adattativo
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07047612 è uno studio interventistico di Fase II Fase III volto a esaminare il trattamento per Non Segmental Vitiligo, attualmente in arruolamento. Avviato il 9 maggio 2025, prevede di arruolare 603 partecipanti. Sotto la guida di Beijing InnoCare Pharma Tech Co., Ltd., dovrebbe concludersi entro il 1 aprile 2029. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 7 agosto 2025.
Sommario breve
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.
Titolo ufficiale
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
Patologie
Non Segmental VitiligoAltri ID dello studio
- ICP-CL-00607
Numero NCT
Data di inizio (effettiva)
2025-05-09
Ultimo aggiornamento pubblicato
2025-08-07
Data di completamento (stimata)
2029-04
Arruolamento (previsto)
603
Tipo di studio
Interventistico
FASE
Fase II
Fase III
Fase III
Stato
In arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Quadruplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleICP-332 dose A（Phase2） | ICP-332 Tablets ICP-332 will be administered as tablet |
Comparatore placeboPlacebo（Phase2） | ICP-332 Placebo Tablets ICP-332 Placebo will be administered as tablet |
SperimentaleICP-332 dose B（Phase2:） | ICP-332 Tablets ICP-332 will be administered as tablet |
SperimentaleICP-332 dose A or dose B（Phase3） | ICP-332 Tablets ICP-332 will be administered as tablet |
Comparatore placeboPlacebo（Phase3） | ICP-332 Placebo Tablets ICP-332 Placebo will be administered as tablet |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
12 Years
Sessi idonei
Tutti
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.Contatti principali dello studio
Contatto: Flora Xiang, Doctor, 021-52887775, [email protected]
45 Centri dello studio in 1 paesi
Anhui
The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, 241001, China
Chao Ci, Contatto
Non ancora in arruolamento
The Second Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China
Ruzhi Zhang, Contatto
Non ancora in arruolamento
Beijing Municipality
Peking University Third Hospital, Beijing, Beijing Municipality, 100191, China
Chunlei Zhang, Contatto
Non ancora in arruolamento
Beijing Chao-yang Hospital,Capital Medical University, Beijing, Beijing Municipality, China
Fang Liu, Contatto
Non ancora in arruolamento
Beijing Tongren Hospital, Beijing, Beijing Municipality, China
Aihua Wei, Contatto
Non ancora in arruolamento
Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400016, China
Bin Wei, Contatto
Non ancora in arruolamento
Chongqing Traditional Chinese Medicine Hospital, Chongqing, Chongqing Municipality, 400021, China
Qingchun 400000 Diao, Contatto
In arruolamento
Fujian
Union Hospital affiliated to Fujian Medical, Fuzhou, Fujian, 350001, China
Huichun Su, Contatto
Non ancora in arruolamento
The First Affiliated Hospital of Fujian Medical, Fuzhou, Fujian, 350005, China
Niu Xiang, Contatto
Non ancora in arruolamento
Guangdong
Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Guangzhou, Guangdong, 510120, China
Liangchun Wang, Contatto
Non ancora in arruolamento
Deramatology Hospital of Southern Medical Univercity, Guangzhou, Guangdong, 516006, China
Xiaowei Shi, Contatto
Non ancora in arruolamento
Nanfang Hospital, Guangzhou, Guangdong, China
Yue Zheng, Contatto
Non ancora in arruolamento
Hebei
The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050051, China
Yanling Li, Contatto
Non ancora in arruolamento
Henan
The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China
Bin Zhang, Contatto
Non ancora in arruolamento
Nanyang First People's Hospital, Nanyang, Henan, 473000, China
Rixin Chen, Contatto
Non ancora in arruolamento
The First Affiliated Hospital of Xinxiang Medical College, Weihui, Henan, 453100, China
Dandan Fu, Contatto
Non ancora in arruolamento
Henan Provincial People's Hospital, Zhengzhou, Henan, China
Jianguo Li, Contatto
Non ancora in arruolamento
Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, China
Zixue Chen, Contatto
Non ancora in arruolamento
Hubei
Jingzhou Central Hospital, Jingzhou, Hubei, 434020, China
Yi Sun, Contatto
Non ancora in arruolamento
Shiyan People's Hospital, Shiyan, Hubei, China
Zudong Meng, Contatto
Non ancora in arruolamento
Wuhan NO.1 Hospital(Wuhan Hospital of Traditional Chinese and Western Medicine), Wuhan, Hubei, 430022, China
Liuqing Chen, Contatto
Non ancora in arruolamento
Hunan
Xiangya Hospital of Central South University, Changsha, Hunan, 410008, China
Juan Li, Contatto
Non ancora in arruolamento
The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China
Yunsheng Liang, Contatto
Non ancora in arruolamento
The First Affiliated Hospital of University Of South China, Hengyang, Hunan, China
Zhijun Liu, Contatto
Non ancora in arruolamento
Jiangsu
The First People's Hospital of Lianyungang, Lianyungang, Jiangsu, 222061, China
Hong Ren, Contatto
Non ancora in arruolamento
Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, Jiangsu, 210042, China
Qianjin Lu, Contatto
Non ancora in arruolamento
Suzhou Municipal Hospital, Suzhou, Jiangsu, 215002, China
Jun Gu, Contatto
Non ancora in arruolamento
Jiangxi
Dermatology hospital of jiangxi province, Nanchang, Jiangxi, 330000, China
Xiaoyi Wen, Contatto
Non ancora in arruolamento
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
Xianwei Cao, Contatto
Non ancora in arruolamento
Jilin
The first hospital of Jilin Univercity, Changchun, Jilin, 130021, China
Shanshan Li, Contatto
Non ancora in arruolamento
Liaoning
Shenyang Medical College Affiliated Central Hospital, Shenyang, Liaoning, China
Xiaodong Li, Contatto
Non ancora in arruolamento
Shandong
Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China
Yin Li, Contatto
In arruolamento
Shandong First Medical University Affiliated Dermatology Hospital (Shandong Institute of Dermatology and Venereology, Shandong Dermatology Hospital), Jinan, Shandong, 250022, China
Furen Zhang, Contatto
Non ancora in arruolamento
Zibo Central Hospital, Zibo, Shandong, China
Guowei Zhao, Contatto
Non ancora in arruolamento
Shanghai Municipality
Huashan Hospital Fudan University, Shanghai, Shanghai Municipality, 200040, China
Folra Xiang, Contatto
In arruolamento
Shanghai Dermatology Hospital, Shanghai, Shanghai Municipality, 200050, China
Yangfeng Ding, Contatto
Non ancora in arruolamento
Shanxi
Shaanxi Provincial People's Hospital, Xian, Shanxi, 710068, China
Li Yang, Contatto
Non ancora in arruolamento
Sichuan
Chengdu Second People's Hospital, Chengdu, Sichuan, 610021, China
Yanping Feng, Contatto
Non ancora in arruolamento
Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610072, China
Lixia Zhang, Contatto
Non ancora in arruolamento
Yunnan
The First Affiliated Hospital Of Kunming Medical University, Kunming, Yunnan, 650032, China
Dongjie Sun, Contatto
Non ancora in arruolamento
Zhejiang
Hangzhou Third People's Hospital, Hangzhou, Zhejiang, 310009, China
Aie Xu, Contatto
In arruolamento
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, China
Liming Wu, Contatto
Non ancora in arruolamento
The First Affiliated Hospital Of Ningbo University, Ningbo, Zhejiang, 315100, China
Bingjiang Lin, Contatto
Non ancora in arruolamento
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Zhiming Li, Contatto
Non ancora in arruolamento
The Fourth Affiliated Hospital, Zhejiang University School Of Medicine, Yiwu, Zhejiang, 322000, China
Lunfei Liu, Contatto
Non ancora in arruolamento