Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo

A vizsgálat adatai

Ki végzi

Teva Branded Pharmaceutical Products R&D LLC

Azonosító

NCT07920211EU 2026-527760-32-00

A regiszteradat frissítve

2026. november 5.

Eredeti leírás

The goal of these clinical trials is to learn if TEV-53408 can help adults with Non-Segmental Vitiligo (NSV). Vitiligo causes patches of skin to lose their color.A teljes eredeti leírásKevesebb

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Program Consisting of a Phase 2b Trial and a Phase 3 Trial to Evaluate the Efficacy and Safety of TEV-53408 in Participants With Non-Segmental Vitiligo

The goal of these clinical trials is to learn if TEV-53408 can help adults with Non-Segmental Vitiligo (NSV). Vitiligo causes patches of skin to lose their color.

The main questions the trials aim to answer are:

Can TEV-53408 help bring color back to the skin on the face? Can TEV-53408 help bring color back to the skin on the body? What side effects may happen with TEV-53408?

TEV-53408 will be compared with placebo to see if it helps bring color back to the skin.

Participants will:

Receive TEV-53408 or placebo as an injection under the skin Have their skin checked during the trials Answer questions about how vitiligo affects their daily life Have blood tests and other health checks

Bevonási feltételek: The participant must have a diagnosis of Non-Segmental Vitiligo (NSV) for at least 3 months prior to screening. Participants of all skin types, as assessed by the Fitzpatrick scale, may be included; Stable or active NSV for at least 3 months prior to screening and the VASI scores: The participant has an F-VASI score ≥0.5 and a T-VASI score ≥5 and ≤60; A female participant is not pregnant or breastfeeding and agrees to refrain from donating oocytes throughout the duration of the trial; A male participant agrees to Refrain from donating sperm, EITHER abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR agrees to use a male condom with female partner; NOTE- Additional criteria may apply at screening for clinical trial participation.

Kizáró feltételek: The participant has an active infection(s) requiring treatment with intravenous (iv) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to screening or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to screening; The participant has used skin bleaching treatments for past treatment of vitiligo or other pigmented areas. If necessary, the sponsor can be contacted for assessment of eligibility regarding history of prior vitiligo therapy and/or prior clinical trial experience; The participant has a history of chronic alcohol or substance abuse disorder within the previous 2 years; NOTE- Additional criteria may apply at screening for clinical trial participation; The participant has autoimmune diseases for which systemic immunotherapy is or may be warranted including, but not limited to, rheumatoid arthritis, inflammatory bowel disease (Crohn's disease/ulcerative colitis), systemic lupus erythematosus, psoriasis, psoriatic arthritis, or multiple sclerosis. Conditions such as type 1 diabetes, stable hypothyroidism (Hashimoto's disease), and alopecia are not exclusionary; The participant has current or history of malignancy or treatment of malignancy in the last 5 years, excluding treated basal cell carcinoma; The participant has a history of disseminated herpes simplex, multidermatomal, ophthalmic or recurrent herpes zoster, or herpes encephalitis; The participant has a history of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo; The participant has a body mass index outside the range of 18.5 to 40.0 kg/m2 (inclusive); The participant has a known genetic or acquired immune deficiency.

ClinicalTrials.gov NCT07920211 · EU CTIS 2026-527760-32-00