SHR0302 tablets with or without SHR0302 base gel for 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

This trial will test whether SHR0302 tablets, alone or together with an SHR0302 base gel, help adults with non-segmental vitiligo and are safe to use.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07251595 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial compares oral SHR0302 tablets given alone or in combination with an SHR0302 base gel against matching placebos in adults with non-segmental vitiligo. Participants must stop other vitiligo treatments and therapeutic cosmetic products and meet age and contraception requirements. The study uses active and placebo tablets and gels to measure repigmentation outcomes and collect safety data. The trial is conducted at a dermatology center in Jinan, China, with clinical assessments and adverse event monitoring over the treatment period.

Who should consider this trial

Good fit: Adults aged 18–75 with a clinical diagnosis of non-segmental vitiligo who can stop other vitiligo treatments and follow contraception requirements are eligible.

Not a fit: People with segmental, mixed, or undifferentiated vitiligo, pregnant or breastfeeding individuals, those outside the 18–75 age range, or those unwilling to stop other treatments are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, SHR0302 could provide an effective oral option, alone or combined with a topical gel, to improve skin repigmentation in non-segmental vitiligo.

How similar studies have performed: Other oral and topical JAK inhibitor approaches have shown encouraging repigmentation results in vitiligo, but SHR0302 is a newer agent with limited published data.

Eligibility criteria

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 75 years old (inclusive), and it can be either male or female.
3. 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.
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 all treatments related to vitiligo as well as any cosmetic products with therapeutic effects.

Exclusion Criteria:

1. Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; or subjects previously diagnosed with other skin pigmentation disorders.
2. When the facial skin lesions caused by vitiligo cover more than 33% of the area with white hair.
3. 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.
4. Subjects with a history of related infections/communicable diseases or infection/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 for syphilis-specific antibody, positive for hepatitis C virus antibody HCV-Ab, or hepatitis 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 that required 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, endocrine or hematological systems.
11. Pregnant women, lactating women, or female participants who plan to become pregnant during the study period.
12. Those who are known to be allergic to the test drug or any component of the test drug.

Where this trial is running

Jinan, Shandong

• Dermatology Hospital affiliated to Shandong First Medical University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Hui Wang

Conditions: Non-segmental Vitiligo