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Active, not recruiting Phase 2

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

NCT06807463 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2025-03-31
Last updated
2026-10-09

Condition(s) studied

Celiac Disease

Investigational drug(s) / intervention(s)

TEV-53408 →Placebo

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

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of celiac disease at least 12 months prior to screening * On a gluten-free diet for at least 12 months prior to screening * Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the trial period * Male participants (including vasectomized) with women of child-bearing potential partners (whether pregnant or not) must use condoms and also agree not to donate sperm for the designated period NOTE - Additional criteria apply, please contact the investigator for more information. Exclusion Criteria: * A diagnosis or suspicion of refractory celiac disease * History of severe celiac-related symptoms following gluten exposure that require acute medical care or intervention of a health care professional * Any other gastrointestinal disease or condition that may interfere with the assessment of celiac disease * Current or history of malignancy or treatment of malignancy in the last 5 years, excluding treated basal cell carcinoma * Pregnant or lactating woman, or plans to become pregnant during the trial; any man who is considering fathering a child or donating sperm during the trial * A history of chronic alcohol or substance abuse disorder within the previous 2 years. * An active infection(s) requiring treatment with intravenous (iv) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to screening or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to screening * Received or intends to receive any live vaccine within 4 weeks or any non-live vaccine 2 weeks prior to investigational medicinal product administration. NOTE- Additional criteria apply, please contact the investigator for more information

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)

FacilityCityRegionStatus
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
Official registry record

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