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

A vizsgálat adatai

Ki végzi

Teva Branded Pharmaceutical Products R&D LLC

Azonosító

NCT06625177

A regiszteradat frissítve

2026. október 29.

Eredeti leírás

The purpose of the trial is to evaluate the safety of TEV-53408 when given as an under the skin injection to adults with vitiligo. Vitiligo is a condition where patches of skin lose color (pigment) and turn white.A teljes eredeti leírásKevesebb

A Phase 1b, Open-Label Trial to Assess Safety and Exploratory Efficacy of TEV-53408 in Participants With Vitiligo

The purpose of the trial is to evaluate the safety of TEV-53408 when given as an under the skin injection to adults with vitiligo. Vitiligo is a condition where patches of skin lose color (pigment) and turn white.

Bevonási feltételek: 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.

Kizáró feltételek: 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 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 current or history of alcohol or other substance abuse; NOTE- Additional criteria apply, please contact the investigator for more information; 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 used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.

ClinicalTrials.gov NCT06625177