Overview
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.
Eligibility
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