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

NCT07556471 | Not Yet Recruiting Phase 2

• 1 other identifier: LW402-II-03
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

LW402 Tablets,Phase II,Non-segmental Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

LW402 50mg,PO.BID

EXPERIMENTAL

LW402 Tablet,50mg,BID

Drug: Experimental LW402 Tablet

LW402 100mg,PO.BID

EXPERIMENTAL

LW402 Tablet,100mg,BID

Drug: Experimental LW402 Tablet

LW402 150mg,PO.BID

EXPERIMENTAL

LW402 Tablet,150mg,BID

Drug: Experimental LW402 Tablet

LW402 Placebo

PLACEBO COMPARATOR

LW402 Placebo Tablet,BID

Drug: Placebo

Interventions

Experimental LW402 Tablet DRUG

LW402 Tablets

LW402 100mg,PO.BID; LW402 150mg,PO.BID; LW402 50mg,PO.BID

Placebo DRUG

LW402 Placebo Tablets

LW402 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Longwood Biopharmaceuticals Co., Ltd.: lead
• Clinical Service, China: collaborator

Study Officials

• Leihong Xiang, Doctor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Chen

CONTACT

+86-21-63634910; barbara@lwbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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（ twice daily）, 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 Record Dates

• First Submitted: April 16, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04