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Evaluation of the Efficacy and Safety of LW402 Tablets in Patients With Non-Segmental Vitiligo

NCT07556471 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Non-Segmental Vitiligo (NSV)

Interventions

DRUG

Experimental LW402 Tablet

LW402 Tablets

DRUG

Placebo

LW402 Placebo Tablets

Sponsors & Collaborators

  • Clinical Service, China

    collaborator INDUSTRY

  • Shanghai Longwood Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Leihong Xiang, Doctor · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-02-01
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07556471 on ClinicalTrials.gov