A Trial of SHR0302Base in Patients With Vitiligo

Last updated: March 18, 2025
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Vitiligo

Treatment

SHR0302Base gel placebo

SHR0302Base gel

Clinical Study ID

NCT06790862
SHR0302Base-201
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinically diagnosis of non-segmental vitiligo.

  2. The disease has been stable for more than 3 months (90 days) (stable disease isdefined 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 6months (female subjects) or 3 months (male subjects) after dosing. Female subjectsmust have a negative serum pregnancy test and be non-lactating.

Exclusion

Exclusion Criteria:

  1. Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; Or previouslydiagnosed 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 vitiligoor other pigmented areas.

  4. Use of protocol-defined treatments within the indicated washout period beforebaseline.

Study Design

Total Participants: 152
Treatment Group(s): 2
Primary Treatment: SHR0302Base gel placebo
Phase: 2
Study Start date:
February 11, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Dermatology Hospital affiliated to Shandong First Medical University

    Jinan, Shandong 250022
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.