TEV-53408 for Vitiligo
Trial Summary
What is the purpose of this trial?
The primary objective of the trial is to evaluate the safety of TEV-53408 administered subcutaneously for the treatment of adults with vitiligo. A secondary objective is to further evaluate the safety of TEV-53408. The planned study period per participant is 84 weeks including a screening period (up to 4 weeks), a 24-week open-label treatment period, a 16-week washout period, and a 40-week follow-up period.
Will I have to stop taking my current medications?
The trial requires participants to stop all treatments specifically for vitiligo during the treatment period. However, if you are taking medications for other conditions, you can continue them as long as your regimen is stable.
Research Team
Teva Medical Expert, MD
Principal Investigator
Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria
This trial is for adults with vitiligo, a skin condition causing loss of pigment. Participants must have had vitiligo for at least 3 months, have a BMI between 18.5 and 40.0 kg/m2, agree to use effective contraception if necessary, not be pregnant or breastfeeding, and avoid sun exposure during the trial.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TEV-53408 administered subcutaneously in an open-label manner
Washout
Participants undergo a washout period to clear the drug from their system
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TEV-53408
Find a Clinic Near You
Who Is Running the Clinical Trial?
Teva Branded Pharmaceutical Products R&D, Inc.
Lead Sponsor
Dr. Eric Hughes
Teva Branded Pharmaceutical Products R&D, Inc.
Chief Medical Officer since 2022
MD and PhD from Yale School of Medicine
Richard Francis
Teva Branded Pharmaceutical Products R&D, Inc.
Chief Executive Officer since 2022
Bachelor's degree in Biochemistry from the University of Manchester