Phase II/III Study of FXS5626 in Participants With Non-segmental Vitiligo
Condition(s) studied
Investigational drug(s) / intervention(s)
Intervention1: FXS5626 Tablets: FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Intervention2: FXS5626 Tablets: FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Intervention3: FXS5626 Tablets: FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Intervention4: FXS5626 Tablets: FXS5626 tablets administered orally twice daily (BID) for 52 weeks.
Intervention5: FXS5626 Placebo Tablets: FXS5626 placebo tablets administered orally twice daily (BID) for 24 weeks.
Intervention6: FXS5626 Placebo Tablets: FXS5626 placebo tablets administered orally twice daily (BID) for 52 weeks.
Study summary
This is a multicenter, randomized, double-blind, placebo-controlled, adaptive seamless design, Phase II/III study evaluating the efficacy and safety of FXS5626 in participants with non-segmental vitiligo.
Eligibility
Primary outcome measure(s)
- Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24 in Phase 2 study. — 24 weeks
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome. - Proportion of participants achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75, at least 75% improvement from baseline) at Week 52 in Phase 3 study. — 52 weeks
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome. F-VASI 75 denotes a at least 75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality |
More Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07840820 on ClinicalTrials.gov ↗ ← All trials in China