A Trial of SHR0302Base in Patients With Vitiligo

Phase 2

Recruiting

• Conditions: Vitiligo
• Interventions: Drug: SHR0302Base gel; Drug: SHR0302Base gel placebo

• Registration Number: NCT06790862
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of SHR0302Base in participants with nonsegmental vitiligo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-24
• Study Start: 2025-02-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

1. Clinically diagnosis of non-segmental vitiligo.
2. The disease has been stable for more than 3 months (90 days) (stable disease is defined as no expansion of the original lesion and no new lesions).
3. Subjects and their partners do not plan to have children, do not donate sperm/eggs, and voluntarily use highly effective contraception during the study period until 6 months (female subjects) or 3 months (male subjects) after dosing. Female subjects must have a negative serum pregnancy test and be non-lactating.

Exclusion Criteria

1. Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; Or previously diagnosed with other skin pigmentation disorders (except nevus halos).
2. Conditions at baseline that would interfere with evaluation of vitiligo.
3. Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
4. Use of protocol-defined treatments within the indicated washout period before baseline.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 1	SHR0302Base gel	-
Treatment group 4	SHR0302Base gel placebo	-
Treatment group 2	SHR0302Base gel	-
Treatment group 3	SHR0302Base gel	-

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who achieved at least a 50% improvement from baseline in the facial-neck vitiligo area score (F-VASI 50 response).	At week 24.

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects who achieved at least a 75% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 75 response).	At week 24.
The proportion of subjects who achieved at least a 90% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 90 response).	At week 24.
The proportion of subjects who achieved at least a 90% improvement from baseline in the facial-neck vitiligo area score (F-VASI 90 response).	At week 24.
The proportion of subjects who achieved at least a 50% improvement from baseline in the overall vitiligo area score index from baseline (T-VASI 50 response).	At week 24.
The proportion of subjects who achieved at least a 75% improvement from baseline in the facial-neck vitiligo area score (F-VASI 75 response).	At week 24.

Trial Locations

Locations (1)

Dermatology Hospital affiliated to Shandong First Medical University; 🇨🇳 Jinan, Shandong, China