A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease

The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease. The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease. A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease. The expected trial duration per participant is approximately 86 weeks.

Inclusion Criteria: * Diagnosis of celiac disease at least 12 months prior to screening * On a gluten-free diet for at least 12 months prior to screening * Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the trial period * Male participants (including vasectomized) with women of child-bearing potential partners (whether pregnant or not) must use condoms and also agree not to donate sperm for the designated period NOTE - Additional criteria apply, please contact the investigator for more information. Exclusion Criteria: * A diagnosis or suspicion of refractory celiac disease * History of severe celiac-related symptoms following gluten exposure that require acute medical care or intervention of a health care professional * Any other gastrointestinal disease or condition that may interfere with the assessment of celiac disease * Current or history of malignancy or treatment of malignancy in the last 5 years, excluding treated basal cell carcinoma * Pregnant or lactating woman, or plans to become pregnant during the trial; any man who is considering fathering a child or donating sperm during the trial * A history of chronic alcohol or substance abuse disorder within the previous 2 years. * 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 * Received or intends to receive any live vaccine within 4 weeks or any non-live vaccine 2 weeks prior to investigational medicinal product administration. NOTE- Additional criteria apply, please contact the investigator for more information