Testing TEV-53408 for treating vitiligo
A Phase 1b, Open-Label Trial to Assess Safety and Exploratory Efficacy of TEV-53408 in Participants With Vitiligo
This study is testing a new treatment called TEV-53408 to see if it can help adults with vitiligo improve their skin color over an 84-week period.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 11 sites (Scottsdale, Arizona and 10 other locations) |
| Trial ID | NCT06625177 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the safety and efficacy of TEV-53408, administered subcutaneously, in adults diagnosed with vitiligo. Participants will undergo an 84-week study period, which includes a screening phase, a 24-week open-label treatment phase, a 16-week washout period, and a 40-week follow-up. The study will assess both the primary and secondary safety objectives of the treatment. Participants must discontinue any other vitiligo treatments during the trial.
Who should consider this trial
Good fit: Ideal candidates are adults with active or stable vitiligo for at least 3 months and a BMI between 18.5 and 40.0 kg/m2.
Not a fit: Patients who are currently pregnant, breastfeeding, or unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals suffering from vitiligo.
How similar studies have performed: While this approach is novel, similar studies targeting vitiligo have shown varying degrees of success, indicating potential for this treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scottsdale, Arizona and 10 other locations
- Teva Investigational Site 12043 — Scottsdale, Arizona, United States (Recruiting)
- Teva Investigational Site 12052 — Hot Springs, Arkansas, United States (Recruiting)
- Teva Investigational Site 12044 — Fremont, California, United States (Recruiting)
- Teva Investigational Site 12046 — Pasadena, California, United States (Recruiting)
- Teva Investigational Site 12049 — Miramar, Florida, United States (Recruiting)
- Teva Investigational Site 12047 — Chicago, Illinois, United States (Recruiting)
- Teva Investigational Site 12053 — Louisville, Kentucky, United States (Recruiting)
- Teva Investigational Site 12048 — Canton, Michigan, United States (Recruiting)
- Teva Investigational Site 12054 — Portland, Oregon, United States (Recruiting)
- Teva Investigational Site 12045 — Dallas, Texas, United States (Recruiting)
- Teva Investigational Site 12055 — South Jordan, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Teva U.S. Medical Information
- Email: USMedInfo@tevapharm.com
- Phone: 1-888-483-8279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.