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.
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.
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.
Parallel
SHR0302 Tablets
DrugSHR0302 tablets.
SHR0302 Base Gel
DrugSHR0302 Base gel.
SHR0302 Placebo Tablets
DrugSHR0302 placebo tablets.
SHR0302 Base Placebo Gel
DrugSHR0302 Base placebo gel.
The percentage change in the facial vitiligo area score index (F-VASI) from the baseline.
The percentage change in F-VASI compared to the baseline.
Except for Week 24.
The percentage change in the total body vitiligo area score index (T-VASI) compared to the baseline.
The proportion of subjects who achieved an improvement of at least 50%/75%/90% compared to the baseline on the F-VASI (F-VASI 50/75/90 response).
The proportion of subjects who achieved at least a 50%/75%/90% improvement in T-VASI compared to the baseline (T-VASI 50/75/90 response).
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