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.

Phase: Phase 2.

What is being studied: drugs — Experimental LW402 Tablet, Placebo.

Who can take part: ages 18 Years to 75 Years, 180 participants planned.

Enrollment status: Opening soon. The study started 31 May 2026 and is expected to finish 31 December 2028.

Contact: Barbara Chen.

Source: ClinicalTrials.gov, NCT07556471 (https://clinicaltrials.gov/study/NCT07556471).