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

Last updated: January 13, 2026
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Vitiligo

Treatment

SHR0302 Placebo Tablets

SHR0302 Base Placebo Gel

SHR0302 Base Gel

Clinical Study ID

NCT07251595
SHR0302-202
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Sign the informed consent form before the clinical trial.

  2. On the day of signing the informed consent form, the age must be between 18 and 75years old (inclusive), and it can be either male or female.

  3. The subjects and their partners had no intention of having children during the studyperiod and within one month after the administration of the drug, did not donatesperm or eggs, and voluntarily adopted effective contraceptive measures. The serumpregnancy test results of the female subjects must be negative and they must not bein the lactation period.

  4. During the screening process, it was clinically diagnosed as non-segmental vitiligo.

  5. Throughout the entire research process, the participants agreed to stop using alltreatments related to vitiligo as well as any cosmetic products with therapeuticeffects.

Exclusion

Exclusion Criteria:

  1. Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; or subjectspreviously diagnosed with other skin pigmentation disorders.

  2. When the facial skin lesions caused by vitiligo cover more than 33% of the area withwhite hair.

  3. During the screening period or at the baseline, there were other active skin lesionsor skin infections that might interfere with the use of the study drug or theevaluation of the drug's efficacy.

  4. Subjects with a history of related infections/communicable diseases orinfection/contagion history.

  5. Known or suspected history of immunosuppression.

  6. Tuberculosis (TB) or latent tuberculosis infection.

  7. Positive for human immunodeficiency virus antibody HIV-Ab, positive forsyphilis-specific antibody, positive for hepatitis C virus antibody HCV-Ab, orhepatitis B virus (HBV) infection.

  8. Subjects who have malignant tumors or have a history of malignant tumors.

  9. Abnormal thyroid function, with a history of thrombotic diseases within the previous 12 months, and having experienced a cardiovascular or cerebrovascular event thatrequired hospitalization within the previous 12 months.

  10. There are serious abnormalities in the cardiovascular, mental, renal, liver, immune,gastrointestinal, urogenital, nervous, skeletal-muscular, skin, sensory, endocrineor hematological systems.

  11. Pregnant women, lactating women, or female participants who plan to become pregnantduring the study period.

  12. Those who are known to be allergic to the test drug or any component of the testdrug.

Study Design

Total Participants: 176
Treatment Group(s): 4
Primary Treatment: SHR0302 Placebo Tablets
Phase: 2
Study Start date:
December 05, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Dermatology Hospital affiliated to Shandong First Medical University

    Jinan 1805753, Shandong 1796328 250022
    China

    Active - Recruiting

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