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RECRUITING Phase 2

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

NCT06807463 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 48 participants
Start Date 2025-03-31
Est. Completion 2027-09-14
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06807463

The ClinicalTrials.gov registry entry for NCT06807463 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 103 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06807463 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06807463?

The interventions under investigation include: Placebo (DRUG), TEV-53408 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06807463?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 103 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial