Clinical trial NCT06790862: A Trial of SHR0302Base in Patients With Vitiligo
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Vitiligo
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR0302Base compared with placebo.
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: The proportion of subjects who achieved at least a 75% improvement from baseline in the facial-neck vitiligo area score (F-VASI 75 response).
timeFrame: At week 24.
measure: The proportion of subjects who achieved at least a 90% improvement from baseline in the facial-neck vitiligo area score (F-VASI 90 response).
timeFrame: At week 24.
measure: 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).
timeFrame: At week 24.
measure: 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).
timeFrame: At week 24.
measure: 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).
timeFrame: At week 24.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Dermatology Hospital affiliated to Shandong First Medical University
state: Shandong
Study officials:
References: