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

The Phase 2 trial, sponsored by Teva Branded Pharmaceutical Products, aims to evaluate the safety of subcutaneously administered TEV-53408 in adults with vitiligo. Each participant will take part in the study for up to 84 weeks, including a screening period (up to 4 weeks), a 24-week open-label treatment phase, a 16-week washout period, and a 40-week follow-up phase.

Inclusion Criteria 

• Must have active or stable vitiligo for at least 3 months. 
• Body mass index (BMI) must be between 18.5 and 40.0 kg/m². 
• 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.
• Men must refrain from sperm donation and abstain from heterosexual intercourse or use a condom with female partners during the study and for a specified period thereafter. 
• Must be capable of providing signed, informed consent. 
• Agree to discontinue all agents and procedures used to treat vitiligo during the trial.
• Concomitant Medications: If taking other permitted medications for conditions unrelated to vitiligo, must be on a stable regimen.
• Must avoid prolonged sun exposure, use sunscreen consistently, and refrain from using tanning booths, sun lamps, or ultraviolet light sources.

Exclusion Criteria 

• Vitiligo caused by chemical exposure or immunotherapy. 
• Current or previous diagnosis of autoimmune diseases requiring systemic immunotherapy. 
• History of malignancy within the last 5 years (excluding fully treated basal cell carcinoma). 
• Evidence of active or chronic infections. 
• Use of skin bleaching agents for previous treatment of vitiligo or other pigmented areas. 
• History of melanocyte-keratinocyte transplantation or similar surgical treatments for vitiligo. 
• 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. 
• History of alcohol or substance abuse.

For a complete list of inclusion and exclusion criteria, interested individuals should contact the study team or visit the official ClinicalTrials.gov page (NCT06625177). Only the research staff can determine if a person fully qualifies for the study.
 
This study has three locations in USA (Arizona, California and Texas.)