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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Segmental Vitiligo (NSV)
• Intervention / Treatment: Drug: Placebo; Drug: Experimental LW402 Tablet

Detailed Description

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.

Eligible trial participants will be stratified by disease severity (T-VASI < 15 vs. ≥ 15) and randomly allocated in a 1:1:1:1 ratio to three active treatment groups (50 mg BID, 100 mg BID, and 150 mg BID) and one placebo group. The planned sample size is 45 participants per group, with a total of 180 participants expected to be enrolled. Following 24 weeks of continuous dosing, participants in the placebo group will be re-randomized in a 1:1:1 ratio to the 50 mg BID, 100 mg BID, and 150 mg BID treatment groups for continued dosing until Week 52.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Barbara Chen; Phone Number: +86-21-63634910; Email: barbara@lwbiopharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 to 75 years (inclusive), with no restriction on gender;
• Clinically diagnosed with non-segmental vitiligo at screening;
• At the screening visit and baseline visit, the Facial Vitiligo Area Scoring Index (F-VASI) is ≥ 0.5 and the Total Vitiligo Area Scoring Index (T-VASI) is ≥ 3;
• At the screening visit and baseline visit, the disease is in the progressive stage or stable stage;

Exclusion Criteria:

• Individuals with a known allergy to Janus kinase inhibitors；
• Segmental vitiligo, mixed vitiligo, or undetermined vitiligo；
• White hair is present in more than 33% of facial skin lesions due to vitiligo, or in more than 33% of total skin lesions due to vitiligo;
• Skin lesions due to vitiligo are restricted to hairless areas, or hairless regions account for ≥30% of the lesion sites (e.g., lips, palms, fingers, labia);
• Individuals with other active hypopigmentary conditions during the screening period (including but not limited to Vogt-Koyanagi-Harada syndrome, hypopigmentation associated with malignant tumors [melanoma and mycosis fungoides], post-inflammatory hypopigmentation, pityriasis alba [a mild manifestation of atopic dermatitis], senile leukoderma [age-related depigmentation], chemical/drug-induced leukoderma, ataxia-telangiectasia, tuberous sclerosis complex, melasma, and congenital hypopigmentary disorders [including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, hereditary symmetrical dyschromatosis, xeroderma pigmentosum, and nevus depigmentosus]) are excluded. Note: Coexisting halo nevus (also referred to as Sutton nevus) is permitted;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LW402 50mg,PO.BID; LW402 Tablet,50mg,BID	Drug: Experimental LW402 Tablet; LW402 Tablets
Experimental: LW402 100mg,PO.BID; LW402 Tablet,100mg,BID	Drug: Experimental LW402 Tablet; LW402 Tablets
Experimental: LW402 150mg,PO.BID; LW402 Tablet,150mg,BID	Drug: Experimental LW402 Tablet; LW402 Tablets
Placebo Comparator: LW402 Placebo; LW402 Placebo Tablet,BID	Drug: Placebo; LW402 Placebo Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in F-VASI at Week 24 relative to baseline	Evaluation of the efficacy of LW402 tablets in the treatment of non-segmental vitiligo in trial participants at 24 weeks	Baseline to Week 24

Collaborators and Investigators

• Sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd.
• Collaborators: Clinical Service, China
• Investigators: Principal Investigator: Leihong Xiang, Doctor, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: LW402 Tablets,Phase II,Non-segmental Vitiligo
• Other Study ID Numbers: LW402-II-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No