Evaluating SHR0302Base for treating vitiligo

A Multicenter, Randomized, Double-blind, Parallel, Excipient-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of SHR0302Base in Subjects With Nonsegmental Vitiligo

This study is testing a new topical gel called SHR0302Base to see if it can improve skin color in people with stable non-segmental vitiligo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06790862 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of SHR0302Base, a topical gel, in patients diagnosed with non-segmental vitiligo. Participants will be monitored for changes in their skin condition over the course of the study, comparing the effects of the active treatment against a placebo. The study focuses on individuals whose vitiligo has been stable for at least three months, ensuring that any observed effects can be attributed to the treatment. The trial will also enforce strict eligibility criteria to ensure a homogeneous study population.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with stable non-segmental vitiligo who meet the specified inclusion criteria.

Not a fit: Patients with segmental or other forms of vitiligo, or those who have used certain treatments recently, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve skin pigmentation and quality of life for patients with vitiligo.

How similar studies have performed: While there have been various treatments for vitiligo, the specific approach of using SHR0302Base is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Clinically diagnosis of non-segmental vitiligo.
2. The disease has been stable for more than 3 months (90 days) (stable disease is defined as no expansion of the original lesion and no new lesions).
3. Subjects and their partners do not plan to have children, do not donate sperm/eggs, and voluntarily use highly effective contraception during the study period until 6 months (female subjects) or 3 months (male subjects) after dosing. Female subjects must have a negative serum pregnancy test and be non-lactating.

Exclusion Criteria:

1. Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; Or previously diagnosed with other skin pigmentation disorders (except nevus halos).
2. Conditions at baseline that would interfere with evaluation of vitiligo.
3. Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
4. Use of protocol-defined treatments within the indicated washout period before baseline.

Where this trial is running

Jinan, Shandong

• Dermatology Hospital affiliated to Shandong First Medical University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Hui Wang, M.M

Conditions: Vitiligo