ICP-332 in Subjects With Non-segmental Vitiligo
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICP-332 Tablets, ICP-332 Placebo Tablets.
- Who it may be relevant to
- Registry conditions: Non Segmental Vitiligo. Basic parameters: 12 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug ICP-332 Tablets
ICP-332 will be administered as tablet - Drug ICP-332 Placebo Tablets
ICP-332 Placebo will be administered as tablet
Primary outcome measures
- Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24. [Time frame: 24 weeks]
- Phase3: Proportion of subjects achieving F-VASI 75 at Week 52. [Time frame: 52 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 45 centers
- The First Affiliated Hospital of Wannan Medical College — Wuhu
- The Second Affiliated Hospital of Wannan Medical College — Wuhu
- Peking University Third Hospital — Beijing
- Beijing Chao-yang Hospital,Capital Medical University — Beijing
- Beijing Tongren Hospital — Beijing
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
- Chongqing Traditional Chinese Medicine Hospital — Chongqing
- Union Hospital affiliated to Fujian Medical — Fuzhou
- … and 37 more centers
Identifiers
NCT: NCT07047612 · ICP-CL-00607