A Trial of SHR0302Base in Patients With Vitiligo

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Vitiligo

Treatments: Drug: SHR0302Base gel; Drug: SHR0302Base gel placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06790862

SHR0302Base-201

Details and patient eligibility

About

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

Enrollment: 155 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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155 participants in 4 patient groups, including a placebo group

Treatment group 1

Experimental group

Treatment:

Drug: SHR0302Base gel

Treatment group 2

Experimental group

Treatment:

Drug: SHR0302Base gel

Treatment group 3

Experimental group

Treatment:

Drug: SHR0302Base gel

Treatment group 4

Placebo Comparator group

Treatment:

Drug: SHR0302Base gel placebo