A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo
NCT ID: NCT07251595
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
176 participants
INTERVENTIONAL
2025-12-05
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SHR0302 tablets in low dose group
SHR0302 Tablets
SHR0302 tablets.
SHR0302 Base Placebo Gel
SHR0302 Base placebo gel.
SHR0302 tablets in high dose group
SHR0302 Tablets
SHR0302 tablets.
SHR0302 Base Placebo Gel
SHR0302 Base placebo gel.
SHR0302 tablets + SHR0302 Base gel group
SHR0302 Tablets
SHR0302 tablets.
SHR0302 Base Gel
SHR0302 Base gel.
SHR0302 placebo tablets + SHR0302 Base placebo gel group
SHR0302 Placebo Tablets
SHR0302 placebo tablets.
SHR0302 Base Placebo Gel
SHR0302 Base placebo gel.
Interventions
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SHR0302 Tablets
SHR0302 tablets.
SHR0302 Base Gel
SHR0302 Base gel.
SHR0302 Placebo Tablets
SHR0302 placebo tablets.
SHR0302 Base Placebo Gel
SHR0302 Base placebo gel.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Dermatology Hospital affiliated to Shandong First Medical University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR0302-202
Identifier Type: -
Identifier Source: org_study_id
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