Vitiligo Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
China
Dermatology Hospital affiliated to Shandong First Medical University
RECRUITING
Jinan
Contact Information
Primary
Hui Wang
hui.wang.hw119@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-12-05
Estimated Completion Date: 2027-09
Participants
Target number of participants: 176
Treatments
Experimental: SHR0302 tablets in low dose group
Experimental: SHR0302 tablets in high dose group
Experimental: SHR0302 tablets + SHR0302 Base gel group
Placebo_comparator: SHR0302 placebo tablets + SHR0302 Base placebo gel group
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov