Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase II/III Study of FXS5626 in Participants With Non-segmental Vitiligo
Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
12 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2026-10-30
Completion Date
2027-12-08
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China