RecruitingPhase 2NCT07251595

A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR0302 Tablets as Single Therapy or in Combination With SHR0302 Base Gel in the Treatment of Patients With Non-segmental Vitiligo

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

176 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Non-segmental Vitiligo

Summary

The study is being conducted to evaluate the efficacy, and safety of SHR0302 tablets as single therapy or in combination with SHR0302 Base gel for patients with non-segmental vitiligo.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

Sign the informed consent form before the clinical trial.
On the day of signing the informed consent form, the age must be between 18 and 75 years old (inclusive), and it can be either male or female.
The subjects and their partners had no intention of having children during the study period and within one month after the administration of the drug, did not donate sperm or eggs, and voluntarily adopted effective contraceptive measures. The serum pregnancy test results of the female subjects must be negative and they must not be in the lactation period.
During the screening process, it was clinically diagnosed as non-segmental vitiligo.
Throughout the entire research process, the participants agreed to stop using all treatments related to vitiligo as well as any cosmetic products with therapeutic effects.

Exclusion Criteria12

Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; or subjects previously diagnosed with other skin pigmentation disorders.
When the facial skin lesions caused by vitiligo cover more than 33% of the area with white hair.
During the screening period or at the baseline, there were other active skin lesions or skin infections that might interfere with the use of the study drug or the evaluation of the drug's efficacy.
Subjects with a history of related infections/communicable diseases or infection/contagion history.
Known or suspected history of immunosuppression.
Tuberculosis (TB) or latent tuberculosis infection.
Positive for human immunodeficiency virus antibody HIV-Ab, positive for syphilis-specific antibody, positive for hepatitis C virus antibody HCV-Ab, or hepatitis B virus (HBV) infection.
Subjects who have malignant tumors or have a history of malignant tumors.
Abnormal thyroid function, with a history of thrombotic diseases within the previous 12 months, and having experienced a cardiovascular or cerebrovascular event that required hospitalization within the previous 12 months.
There are serious abnormalities in the cardiovascular, mental, renal, liver, immune, gastrointestinal, urogenital, nervous, skeletal-muscular, skin, sensory, endocrine or hematological systems.
Pregnant women, lactating women, or female participants who plan to become pregnant during the study period.
Those who are known to be allergic to the test drug or any component of the test drug.