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

Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.