SHR0302 TabletsSHR0302 Base GelSHR0302 Placebo TabletsSHR0302 Base Placebo Gel
SHR0302 Tablets: SHR0302 tablets.
SHR0302 Base Gel: SHR0302 Base gel.
SHR0302 Placebo Tablets: SHR0302 placebo tablets.
SHR0302 Base Placebo Gel: SHR0302 Base placebo gel.
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
The percentage change in the facial vitiligo area score index (F-VASI) from the baseline. — At Week 24.
Trial sites (1)
Facility
City
Region
Status
Dermatology Hospital affiliated to Shandong First Medical University
Jinan
Shandong
Recruiting
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.