A Trial of SHR0302Base in Patients With Vitiligo

Phase 2Active Not RecruitingNCT06790862

Jiangsu HengRui Medicine Co., Ltd.155 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

155

Conditions

Vitiligo

Interventions

SHR0302Base gelDRUG

SHR0302Base gel.

SHR0302Base gel placeboDRUG

SHR0302Base gel placebo.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dermatology Hospital affiliated to Shandong First Medical University

Jinan, Shandong, China

Outcomes

Primary Outcomes

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

Time frame: At week 24.

Secondary Outcomes

The proportion of subjects who achieved at least a 75% improvement from baseline in the facial-neck vitiligo area score (F-VASI 75 response).

Time frame: 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).

Time frame: 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).

Time frame: At week 24.

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).

Time frame: 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).

Time frame: At week 24.

Data from ClinicalTrials.gov

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