Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06790862

A Trial of SHR0302Base in Patients With Vitiligo

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Hospital affiliated to Shandong First Medical University

Jinan, Shandong, 250022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically diagnosis of non-segmental vitiligo.
  • 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).
  • 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

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

Treatment and study plan

SHR0302Base gel

Drug

SHR0302Base gel.

SHR0302Base gel placebo

Drug

SHR0302Base gel placebo.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Parallel, Excipient-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of SHR0302Base in Subjects With Nonsegmental Vitiligo

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.