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New shot aims to shield celiac patients from gluten damage

NCT ID NCT06807463

Disease control Sponsor: Teva Branded Pharmaceutical Products R&D LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 6 times

Summary

This study tests an injectable drug called TEV-53408 in 50 adults with celiac disease who follow a gluten-free diet. Participants will be exposed to small amounts of gluten to see if the drug can prevent intestinal damage. The trial is placebo-controlled and lasts about 86 weeks, focusing on safety and how well the drug protects the gut lining.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TEV-53408 (injectable drug)
What this could lead to
If it works, this could point toward a treatment that helps people with celiac disease tolerate accidental gluten exposure without gut damage.
What could go wrong
This is an early Phase 2a trial with only 50 people. It may not show enough benefit or could have side effects. Success in this small study does not guarantee a future approved treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

celiac disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease

Contacts and locations

Locations

  • Teva Investigational Site 12121

    Wyoming, Michigan, 49519, United States

  • Teva Investigational Site 12122

    Ogden, Utah, 84405, United States

  • Teva Investigational Site 12123

    Lynchburg, Virginia, 24502, United States

  • Teva Investigational Site 12125

    Greenville, North Carolina, 27834, United States

  • Teva Investigational Site 12126

    Miami Lakes, Florida, 33016, United States

  • Teva Investigational Site 12127

    Winston-Salem, North Carolina, 27103, United States

  • Teva Investigational Site 12128

    New York, New York, 10032, United States

  • Teva Investigational Site 12129

    Rochester, Minnesota, 55905, United States

  • Teva Investigational Site 12130

    Atlanta, Georgia, 30328, United States

  • Teva Investigational Site 12131

    Colorado Springs, Colorado, 80907, United States

  • Teva Investigational Site 12132

    Clinton Township, Michigan, 48038, United States

  • Teva Investigational Site 12133

    Marrero, Louisiana, 70072, United States

  • Teva Investigational Site 12134

    Inverness, Florida, 34452, United States

  • Teva Investigational Site 12135

    New Port Richey, Florida, 34653, United States

  • Teva Investigational Site 12137

    Waco, Texas, 76712, United States

  • Teva Investigational Site 12138

    Murrieta, California, 92563, United States

  • Teva Investigational Site 40062

    Tampere, 33520, Finland

  • Teva Investigational Site 40063

    Helsinki, 00180, Finland

  • Teva Investigational Site 78137

    Midland, 6056, Australia

  • Teva Investigational Site 78139

    Fitzroy, 3065, Australia

  • Teva Investigational Site 78140

    Maroochydore, 4558, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.