Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate SHR0302 Tablets Alone or with SHR0302 Base Gel in Non-segmental Vitiligo
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-02-18
176
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of SHR0302 tablets alone or combined with SHR0302 Base gel for treating patients with non-segmental vitiligo. This randomized, double-blind, placebo-controlled Phase II trial aims to better understand how these treatments impact vitiligo, a condition causing skin depigmentation. The study is sponsored by Jiangsu HengRui Medicine Co., Ltd. and includes adult patients between 18 and 75 years old. Participants are assigned to one of four groups: low-dose SHR0302 tablets, high-dose SHR0302 tablets, SHR0302 tablets combined with SHR0302 Base gel, or placebo tablets with placebo gel. The treatments are given according to the assigned group, and the study monitors patients for up to 48 weeks to assess changes in vitiligo symptoms and quality of life. During the trial, participants will have regular evaluations including measuring the percentage change in facial vitiligo area score index at 24 weeks as the primary outcome. Secondary outcomes include changes in total body vitiligo area, physician assessments, quality of life measures, and blood tests for drug levels and immune markers. Safety and effectiveness will be carefully monitored throughout the study until its completion in September 2027.
CONDITIONS
Brief Title
A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before the clinical trial.
- Age between 18 and 75 years old, male or female.
- Participants and their partners agree to use effective contraception during the study and for one month after stopping the drug.
- Negative serum pregnancy test for female participants and not breastfeeding.
- Clinically diagnosed with non-segmental vitiligo during screening.
- Agree to stop all vitiligo treatments and therapeutic cosmetic products during the study.
You will not qualify if you...
- Diagnosed with segmental, mixed, or undifferentiated vitiligo or other skin pigmentation disorders.
- Facial vitiligo lesions covering more than 33% of the area with white hair.
- Other active skin lesions or infections interfering with study drug use or evaluation.
- History of infections or communicable diseases.
- Known or suspected immunosuppression.
- Tuberculosis or latent tuberculosis infection.
- Positive for HIV, syphilis, hepatitis B or C infection.
- Current or past malignant tumors.
- Abnormal thyroid function or recent thrombotic, cardiovascular, or cerebrovascular events within 12 months.
- Serious abnormalities in major body systems including cardiovascular, mental, renal, liver, immune, gastrointestinal, urogenital, nervous, skeletal-muscular, skin, sensory, endocrine, or hematological.
- Pregnant or lactating women, or planning pregnancy during the study.
- Known allergy to the study drug or any of its components.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 weeks
Participants receive SHR0302 tablets alone or with SHR0302 base gel or placebo as part of the study treatment for non-segmental vitiligo.
Regular visits according to study schedule
Trial Site Locations
Total: 1 location
1
Dermatology Hospital affiliated to Shandong First Medical University
Jinan, Shandong, China, 250022
Actively Recruiting
Research Team
H
Hui Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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