A Trial of SHR0302Base in Patients With Vitiligo

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06790862

Enrollment

155

Registered

2025-01-24

Start date

2025-02-13

Completion date

2026-04-30

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo

Brief summary

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

Interventions

DRUGSHR0302Base gel

SHR0302Base gel.

DRUGSHR0302Base gel placebo

SHR0302Base gel placebo.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

SHR0302Base compared with placebo.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.
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 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026