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NOT YET RECRUITING
NCT07840820
PHASE2/PHASE3

Phase II/III Study of FXS5626 in Participants With Non-segmental Vitiligo

Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

Intervention1: FXS5626 Tablets

FXS5626 tablets administered orally twice daily (BID) for 24 weeks.

DRUG

Intervention2: FXS5626 Tablets

FXS5626 tablets administered orally twice daily (BID) for 24 weeks.

DRUG

Intervention3: FXS5626 Tablets

FXS5626 tablets administered orally twice daily (BID) for 24 weeks.

DRUG

Intervention4: FXS5626 Tablets

FXS5626 tablets administered orally twice daily (BID) for 52 weeks.

DRUG

Intervention5: FXS5626 Placebo Tablets

FXS5626 placebo tablets administered orally twice daily (BID) for 24 weeks.

DRUG

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