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

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 body mass index outside the range of 18.5 to 40.0 kg/m2 (inclusive).
• 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 a known genetic or acquired immune deficiency.
• The participant has a history of disseminated herpes simplex, multidermatomal, ophthalmic or recurrent herpes zoster, or herpes encephalitis.
• 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 melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
• 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.