A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
TEV-53408: Solution for subcutaneous (sc) injection
Placebo: Solution for subcutaneous (sc) injection
Study 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.
Eligibility
Primary outcome measure(s)
- Change From Baseline in Villous Atrophy as Measured by Villous Height to Crypt Depth Ratio (Vh:Cd) — Baseline, Week 8
Vh:Cd is used to assess the severity of celiac disease. It is calculated by dividing the villous height by the crypt depth. A lower ratio indicates more damage. - Number of Participants With at Least One Treatment-Emergent Adverse Event — Up to Week 28
- Number of Participants With at Least One Treatment-Emergent Serious Adverse Event — Up to Week 28
- Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest (PDAESI) — Up to Week 28
- Number of Participants Who Discontinued From the Study Due to an Adverse Event — Up to Week 28
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Teva Investigational Site 12138 | Murrieta | California | |
| Teva Investigational Site 12131 | Colorado Springs | Colorado | |
| Teva Investigational Site 12134 | Inverness | Florida | |
| Teva Investigational Site 12126 | Miami Lakes | Florida | |
| Teva Investigational Site 12135 | New Port Richey | Florida | |
| Teva Investigational Site 12130 | Atlanta | Georgia | |
| Teva Investigational Site 12133 | Marrero | Louisiana | |
| Teva Investigational Site 12132 | Clinton Township | Michigan | |
| Teva Investigational Site 12121 | Wyoming | Michigan | |
| Teva Investigational Site 12129 | Rochester | Minnesota | |
| Teva Investigational Site 12128 | New York | New York | |
| Teva Investigational Site 12125 | Greenville | North Carolina | |
| Teva Investigational Site 12127 | Winston-Salem | North Carolina | |
| Teva Investigational Site 12137 | Waco | Texas | |
| Teva Investigational Site 12122 | Ogden | Utah | |
| Teva Investigational Site 12123 | Lynchburg | Virginia | |
| 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 |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06807463 on ClinicalTrials.gov ↗ ← All trials in the USA