A Trial of SHR0302Base in Patients With Vitiligo

NCT ID: NCT06790862

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-13

Study Completion Date

2026-04-30

Brief Summary

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

Detailed Description

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Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR0302Base compared with placebo.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group 1

Group Type EXPERIMENTAL

SHR0302Base gel

Intervention Type DRUG

SHR0302Base gel.

Treatment group 2

Group Type EXPERIMENTAL

SHR0302Base gel

Intervention Type DRUG

SHR0302Base gel.

Treatment group 3

Group Type EXPERIMENTAL

SHR0302Base gel

Intervention Type DRUG

SHR0302Base gel.

Treatment group 4

Group Type PLACEBO_COMPARATOR

SHR0302Base gel placebo

Intervention Type DRUG

SHR0302Base gel placebo.

Interventions

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SHR0302Base gel

SHR0302Base gel.

Intervention Type DRUG

SHR0302Base gel placebo

SHR0302Base gel placebo.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dermatology Hospital affiliated to Shandong First Medical University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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SHR0302Base-201

Identifier Type: -

Identifier Source: org_study_id

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