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
Qualifiers
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
Treatments tested in this trial
- ICP-332 Tablets
- ICP-332 Placebo Tablets
Treatment groups
603 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov