A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo

Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · Oct 1, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called TEV-53408 for people with vitiligo, a condition that causes skin to lose its color. The main goals of the trial are to see if TEV-53408 is safe to use and if it helps improve the skin in adults with active or stable vitiligo. The study will last about 84 weeks for each participant, which includes time for screening, treatment, and follow-up.

To join the trial, participants need to be adults aged 18 to 75 with a diagnosis of vitiligo for at least 3 months and have a healthy body weight. Women who can get pregnant must use effective birth control, and men must agree to avoid sperm donation during the study. Participants will need to stop using other treatments for vitiligo while in the trial and take precautions to avoid sun exposure. If you’re interested in learning more about this study or checking if you qualify, please reach out to the study team for additional information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The participant has a diagnosis of active or stable vitiligo for at least 3 months.
• • The participant has a body mass index (BMI) within the range of 18.5 to 40.0 kg/m2
• • A female participant is eligible if she is not pregnant or breastfeeding AND is a woman of nonchildbearing potential OR is a women of childbearing potential using a contraceptive method that is highly effective AND agrees not to donate eggs for the purpose of reproduction for the required period
• • A male participant is eligible if he agrees to refrain from donating sperm PLUS remain abstinent from heterosexual intercourse OR use a male condom with a female partner for the required period
• • The participant is capable of giving signed, informed consent
• • The participant agrees to discontinue all agents and procedures used to treat vitiligo during the treatment period in the trial
• • If receiving permitted concomitant medications for any reason other than vitiligo, the participant must be on a stable regimen,
• • The participant must agree to avoid prolonged exposure to the sun, must use sunscreen, and must not use tanning booths, sun lamps, or other ultraviolet light sources
• • NOTE - Additional criteria apply, please contact the investigator for more information
• Exclusion Criteria:
• • The participant suffers from vitiligo induced by exposure to chemicals or immunotherapy known to induce vitiligo
• • The participant has other autoimmune diseases for which systemic immunotherapy is or may be warranted
• • The participant has current or history of malignancy or treatment of malignancy in the last 5 years, excluding fully-treated basal cell carcinoma
• • Infectious disease
• • The participant has used skin bleaching treatments for past treatment of vitiligo or other pigmented areas
• • The participant has a history of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo. After 2 or more years since last melanocyte-keratinocyte transplantation procedure, the participants may be included in the trial.
• • The participant has donated or received any blood or blood products (white blood cells, platelets, etc) within the 60 days prior to screening or has donated blood or blood products on 2 or more occasions within the 6 months prior to IMP administration, or has donated plasma within 7 days before the screening visit, or has planned donations during the trial
• • The participant has current or history of alcohol or other substance abuse
• • NOTE- Additional criteria apply, please contact the investigator for more information