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
Not yet recruiting
Trial Condition(s)
Celiac Disease
Interventions
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.

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Participation criteria and map of study locations


Key Participation Requirements

Gender
Female, Male
Age Range
18 Years to 64 Years
Trial Duration
February 17, 2025 - August 09, 2027
Phase
Phase 2

Study Type

Interventional