ICP-332 in Subjects With Non-segmental Vitiligo
ConditionNon Segmental Vitiligo
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age12-75
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
The clinical diagnosis was non-segmental vitiligo for at least 3 months.
Involvement of BSA≥5%.
Facial involvement BSA≥0.5%.
Disqualifiers
Any of the following vitiligo related medical conditions and other skin diseases/conditions.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ICP-332 Tablets
DrugICP-332 will be administered as tablet
ICP-332 Placebo Tablets
DrugICP-332 Placebo will be administered as tablet
Treatment groups
603 Participants
are divided into 5 treatment groupsGroup A: ICP-332 dose A（Phase2）Experimental treatment 1 intervention
Group B: Placebo（Phase2）Placebo comparator 1 intervention
Group C: ICP-332 dose B（Phase2:）Experimental treatment 1 intervention
Group D: ICP-332 dose A or dose B（Phase3）Experimental treatment 1 intervention
Group E: Placebo（Phase3）Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24.
Time frame
24 weeks2
Phase3: Proportion of subjects achieving F-VASI 75 at Week 52.
Time frame
52 weeksSponsors and contacts
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Source ClinicalTrials.gov