RecruitingPhase 2

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

China176 participantsStarted 2025-12-05

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

The percentage change in the facial vitiligo area score index (F-VASI) from the baseline.

Timeframe: At Week 24.

Trial details

NCT IDNCT07251595

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Hui Wang

+86-0518-82342973 hui.wang.hw119@hengrui.com

View on ClinicalTrials.gov More Non-segmental Vitiligo trials