A Trial of SHR0302Base in Patients With Vitiligo

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jan 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR0302Base for people with non-segmental vitiligo, a skin condition that causes loss of color in patches. The main goal of the study is to see how effective and safe this treatment is for individuals diagnosed with this condition. The trial is currently looking for participants aged between 18 and 75 years who have had stable vitiligo for at least three months, meaning their skin condition hasn’t changed during this time.

To be eligible for the trial, participants must not have any other significant skin issues and should not have used certain treatments that might interfere with the study results. Additionally, both male and female participants must agree to use effective birth control during the study and for a period after treatment. If you decide to join, you will be closely monitored to assess how well the treatment works and if there are any side effects. This is an important opportunity to help researchers learn more about potential new options for managing vitiligo.

Gender

ALL

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.