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ACTIVE NOT RECRUITING
NCT06807463
PHASE2

A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease

Sponsor: Teva Branded Pharmaceutical Products R&D LLC

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-03-31

Completion Date

2027-09-14

Last Updated

2026-04-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

TEV-53408

Solution for subcutaneous (sc) injection

DRUG

Placebo

Solution for subcutaneous (sc) injection

Locations (21)

Teva Investigational Site 12138

Murrieta, California, United States

Teva Investigational Site 12131

Colorado Springs, Colorado, United States

Teva Investigational Site 12134

Inverness, Florida, United States

Teva Investigational Site 12126

Miami Lakes, Florida, United States

Teva Investigational Site 12135

New Port Richey, Florida, United States

Teva Investigational Site 12130

Atlanta, Georgia, United States

Teva Investigational Site 12133

Marrero, Louisiana, United States

Teva Investigational Site 12132

Clinton Township, Michigan, United States

Teva Investigational Site 12121

Wyoming, Michigan, United States

Teva Investigational Site 12129

Rochester, Minnesota, United States

Teva Investigational Site 12128

New York, New York, United States

Teva Investigational Site 12125

Greenville, North Carolina, United States

Teva Investigational Site 12127

Winston-Salem, North Carolina, United States

Teva Investigational Site 12137

Waco, Texas, United States

Teva Investigational Site 12122

Ogden, Utah, United States

Teva Investigational Site 12123

Lynchburg, Virginia, United States

Teva Investigational Site 78139

Fitzroy, Australia

Teva Investigational Site 78140

Maroochydore, Australia

Teva Investigational Site 78137

Midland, Australia

Teva Investigational Site 40063

Helsinki, Finland

Teva Investigational Site 40062

Tampere, Finland