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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Trial to Characterize the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease While Undergoing Oral Gluten Exposure

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