NCT06807463

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	TEV-53408	Solution for subcutaneous (sc) injection
DRUG	Placebo	Solution for subcutaneous (sc) injection

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-09-15
• Completion: 2027-09-14
• First posted: 2025-02-04
• Last updated: 2026-04-08

Locations

21 sites across 3 countries: United States, Australia, Finland

Regulatory

• FDA-regulated drug study