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

April 7, 2026 updated by: Teva Branded Pharmaceutical Products R&D LLC

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fitzroy, Australia, 3065
        • Teva Investigational Site 78139
      • Maroochydore, Australia, 4558
        • Teva Investigational Site 78140
      • Midland, Australia, 6056
        • Teva Investigational Site 78137
  • Finland
      • Helsinki, Finland, 00180
        • Teva Investigational Site 40063
      • Tampere, Finland, 33520
        • Teva Investigational Site 40062
  • United States
    • California
      • Murrieta, California, United States, 92563
        • Teva Investigational Site 12138
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Teva Investigational Site 12131
    • Florida
      • Inverness, Florida, United States, 34452
        • Teva Investigational Site 12134
      • Miami Lakes, Florida, United States, 33016
        • Teva Investigational Site 12126
      • New Port Richey, Florida, United States, 34653
        • Teva Investigational Site 12135
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Teva Investigational Site 12130
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Teva Investigational Site 12133
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Teva Investigational Site 12132
      • Wyoming, Michigan, United States, 49519
        • Teva Investigational Site 12121
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Teva Investigational Site 12129
    • New York
      • New York, New York, United States, 10032
        • Teva Investigational Site 12128
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Teva Investigational Site 12125
      • Winston-Salem, North Carolina, United States, 27103
        • Teva Investigational Site 12127
    • Texas
      • Waco, Texas, United States, 76712
        • Teva Investigational Site 12137
    • Utah
      • Ogden, Utah, United States, 84405
        • Teva Investigational Site 12122
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Teva Investigational Site 12123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Solution for subcutaneous (sc) injection
Experimental: TEV-53408
Drug: TEV-53408
Solution for subcutaneous (sc) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Villous Atrophy as Measured by Villous Height to Crypt Depth Ratio (Vh:Cd)
Time Frame: 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.
Baseline, Week 8
Number of Participants With at Least One Treatment-Emergent Adverse Event
Time Frame: Up to Week 28
Up to Week 28
Number of Participants With at Least One Treatment-Emergent Serious Adverse Event
Time Frame: Up to Week 28
Up to Week 28
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest (PDAESI)
Time Frame: Up to Week 28
Up to Week 28
Number of Participants Who Discontinued From the Study Due to an Adverse Event
Time Frame: Up to Week 28
Up to Week 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Intraepithelial Lymphocyte (IEL) Density
Time Frame: Baseline, Week 8
Baseline, Week 8
Change From Baseline in the VCIEL score
Time Frame: Baseline, Week 8
VCIEL score is a calculation using the standardized Vh:Cd and standardized IEL. The standardized Vh:Cd is calculated as the difference between the mean Vh:Cd subtracted from each Vh:Cd divided by the Vh:Cd standard deviation. The standardized IEL is calculated as the difference between the mean IEL subtracted from each IEL divided by the IEL standard deviation. VCIEL is the standardized Vh:Cd minus the standardized IEL.
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Investigators

  • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 14, 2027

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

February 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV53408-IMM-20042
  • 2024-517081-42-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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