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A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
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
TEV-53408
Solution for subcutaneous (sc) injection
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