NCT07047612 ICP-332 in Subjects With Non-segmental Vitiligo
| NCT ID | NCT07047612 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. |
| Condition | Non Segmental Vitiligo |
| Study Type | INTERVENTIONAL |
| Enrollment | 603 participants |
| Start Date | 2025-05-09 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 603 participants in total. It began in 2025-05-09 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. 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). 2. Eligible subjects must meet all of the following criteria at screening and baseline: 1. The clinical diagnosis was non-segmental vitiligo for at least 3 months. 2. Involvement of BSA≥5%. 3. Facial involvement BSA≥0.5%. 4. F-VASI≥0.5 and T-VASI between 5 and 50. 5. Active or stable non-segmental vitiligo was present at both screening and baseline visits. 3. Women of childbearing potential (WOCBP) and Men must agree to contraception. 4. Before beginning any screening or study specific procedures, subjects must voluntarily sign informed consent. Exclusion Criteria: 1. 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. 2. History of any clinically major diseases, with the exception of vitiligo. 3. Pregnant or breastfeeding females. 4. The investigator considers that the subject is not suitable for participation in this study for any reason.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07047612 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 75 Years, studying Non Segmental Vitiligo. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07047612 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07047612 currently recruiting?
Yes, NCT07047612 is actively recruiting participants. Contact the research team at flora_xiang@vip.163.com for enrollment information.
Where is the NCT07047612 trial being conducted?
This trial is being conducted at Wuhu, China, Wuhu, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT07047612 clinical trial?
NCT07047612 is sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. The trial plans to enroll 603 participants.