6 locations in USA - 01 Oct `24A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo

This Phase 1 clinical trial, sponsored by Teva Branded Pharmaceutical Products R&D, Inc., aims to evaluate the safety and effectiveness of TEV-53408, administered via subcutaneous injection, as a potential treatment for adults with vitiligo. Additionally, the trial will further evaluate the safety of the treatment over time.
 
Study Overview 

The trial involves participation over a period of 84 weeks, including:

• A screening period of up to 4 weeks.
• A 24-week open-label treatment period, during which all participants receive the study drug.
• A 16-week washout period to monitor effects after discontinuation.
• A 40-week follow-up period for long-term safety and efficacy evaluation.

Inclusion Criteria 

Participants must meet the following conditions to be eligible: 

1. Must have active or stable vitiligo for at least 3 months. 
2. Body mass index (BMI) must be between 18.5 and 40.0 kg/m². 
3. Women of Childbearing Potential (WOCBP) must: 
- Not be pregnant or breastfeeding.
- Use a highly effective contraceptive method.
- Agree not to donate eggs for reproduction during the study and for a specified period thereafter.
4. Men must: 
- Refrain from sperm donation. 
- Abstain from heterosexual intercourse or use a condom with female partners during the study and for a specified period thereafter. 
5. Must be capable of providing signed, informed consent. 
6. Agree to discontinue all agents and procedures used to treat vitiligo during the trial.
7. Concomitant Medications: If taking other permitted medications for conditions unrelated to vitiligo, must be on a stable regimen. 
8. Must avoid prolonged sun exposure, use sunscreen consistently, and refrain from using tanning booths, sun lamps, or ultraviolet light sources.
> Note: Additional criteria apply; please contact the investigator for further details.
 
Exclusion Criteria 

Participants will not be eligible if they meet any of the following: 
1. Vitiligo caused by chemical exposure or immunotherapy. 
2. Current or previous diagnosis of autoimmune diseases requiring systemic immunotherapy. 
3. History of malignancy within the last 5 years (excluding fully treated basal cell carcinoma). 
4. Evidence of active or chronic infections. 
5. Use of skin bleaching agents for previous treatment of vitiligo or other pigmented areas. 
6. History of melanocyte-keratinocyte transplantation or similar surgical treatments for vitiligo. 
7. Blood Donations: 
- Donated or received blood products within 60 days before screening. 
- Donated blood more than twice within 6 months or plasma within 7 days before screening. 
8. History of alcohol or substance abuse.

Note: Additional criteria apply; please contact the investigator for further details.