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

June 16, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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