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NCT06807463 · ClinicalTrials.gov registry record · Phase 2
A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
A Phase 2 study of Celiac Disease, sponsored by Teva Branded Pharmaceutical Products R&D.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT06807463: Recruiting Phase 2 study of Celiac Disease, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT06807463 is a Phase 2 study of Celiac Disease that is actively recruiting participants, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 48 participants, below the 1,978-participant average among 24 other Celiac Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06807463, a Phase 2 study of Celiac Disease, is actively recruiting participants, sponsored by Teva Branded Pharmaceutical Products R&D.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TEV-53408
Study Locations (20)
Other
- Teva Investigational Site 78139 - Fitzroy
- Teva Investigational Site 78140 - Maroochydore
- Teva Investigational Site 78137 - Midland
- Teva Investigational Site 40063 - Helsinki
Florida
- Teva Investigational Site 12134 - Inverness
- Teva Investigational Site 12126 - Miami Lakes
- Teva Investigational Site 12135 - New Port Richey
Michigan
- Teva Investigational Site 12132 - Clinton Township
- Teva Investigational Site 12121 - Wyoming
North Carolina
- Teva Investigational Site 12125 - Greenville
- Teva Investigational Site 12127 - Winston-Salem
California
- Teva Investigational Site 12138 - Murrieta
Colorado
- Teva Investigational Site 12131 - Colorado Springs
Georgia
- Teva Investigational Site 12130 - Atlanta
Louisiana
- Teva Investigational Site 12133 - Marrero
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2025-03-31 |
| Est. Completion | 2027-09-14 |
| Phase | Phase 2 |
What NCT06807463 shows while recruiting
NCT06807463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,978-participant average among 24 other Celiac Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Celiac Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06807463 names 20 study sites across 13 states, led by Other, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT06807463 about?
NCT06807463 is a clinical study titled "A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease". 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...
What is the current status of trial NCT06807463?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2025-03-31. Estimated completion is 2027-09-14.
What conditions does trial NCT06807463 study?
This clinical trial studies the following conditions: Celiac Disease.
What interventions are being tested in trial NCT06807463?
The interventions under investigation include: Placebo (DRUG), TEV-53408 (DRUG).
Who is sponsoring clinical trial NCT06807463?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06807463 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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