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Evaluation of the Efficacy and Safety of LW402 Tablets in Patients With Non-Segmental Vitiligo
Sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.
Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to assess the efficacy, safety, and tolerability of LW402 tablets in participants with non-segmental vitiligo. Drawing on the prior/preclinical data of LW402 tablets, this clinical trial will incorporate three dose groups: 50 mg twice daily (BID), 100 mg BID, and 150 mg BID. The trial will be structured into a screening period (maximum 5 weeks), a treatment period (52 weeks, encompassing a 24-week main trial phase and a 28-week extension phase), and a safety follow-up period (4 weeks). The maximum duration of participation in this study will be 61 weeks. Following the completion of 24-week data collection for all trial participants, unblinding will be performed in accordance with the pre-specified procedure. Subsequently, based on the unblinded data results, regulatory communication will be conducted with the Center for Drug Evaluation (CDE) regarding the initiation of the Phase III confirmatory clinical trial. Participants who have undergone unblinding will continue to attend scheduled study visits to complete the trial.
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of LW402 Tablets in Patients With Non-Segmental Vitiligo
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-05-31
Completion Date
2028-12-31
Last Updated
2026-04-29
Healthy Volunteers
No
Conditions
Interventions
Experimental LW402 Tablet
LW402 Tablets
Placebo
LW402 Placebo Tablets