A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
- Study Title
- 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
- Teva Identifier
- TV53408-IMM-20042
- ClinicalTrials.gov Identifier
- NCT06807463
- Study Status
- Recruiting
- Trial Condition(s)
- Celiac Disease
- Interventions
- Drug: TEV-53408, Placebo
- Study Description
- Primary objectives: 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. Secondary objective: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.
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Adult
- Age Range
- 18 Years to 64 Years
- Trial Duration
- March 31, 2025-September 14, 2027
- Phase
- Phase 2
