Active — Not RecruitingPhase 2

A Trial of SHR0302Base in Patients With Vitiligo

China155 participantsStarted 2025-02-13

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

The proportion of subjects who achieved at least a 50% improvement from baseline in the facial-neck vitiligo area score (F-VASI 50 response).

Timeframe: At week 24.

NCT IDNCT06790862

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-03