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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SHR0302 Tablets
  • SHR0302 Base Gel
  • SHR0302 Placebo Tablets
  • SHR0302 Base Placebo Gel

Treatment groups

176 Participants
are divided into 4 treatment groups