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New celiac drug trial aims to tame gluten reactions

NCT ID NCT06310291

Disease control Sponsor: Barinthus Biotherapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage trial tests a new medicine called VTP-1000 in 45 adults with celiac disease. The goal is to see if it is safe and how the body handles it, especially when exposed to gluten. Participants will receive either the drug or a placebo, and some will take a controlled gluten challenge to measure immune response.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Nov 2026

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 70 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 as confirmed by positive serology and intestinal histology * Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype * Participants who are on a well controlled gluten restricted diet * Anti-tissue transglutaminase (tTG) IgA antibodies less than 2 times the upper limit of normal and anti-deamidated gliadin peptide IgG (anti-DGP)-IgA/IgA antibodies less than 3 times the upper limit of normal * Non-pregnant or breast feeding females * No other clinical significant findings at screening Exclusion Criteria: * Refractory celiac disease * Selective IgA deficiency * Positive for HLA-DQ8 * Known wheat allergy or that is Type I hypersensitivity * Active inflammatory bowel disease or other condition with symptoms that will be similar to celiac disease

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centricity Research

    RECRUITING

    Columbus, Ohio, 43213, United States

  • Clinical Research Institute of Michigan

    RECRUITING

    Clinton Township, Michigan, 48038, United States

  • Clinical Research Partners

    RECRUITING

    Richmond, Virginia, 23226, United States

  • GCP Research

    RECRUITING

    St. Petersburg, Florida, 33705, United States

  • Jacksonville Center for Clinical Research

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • NYU Langone - Gastroenterology Associates

    RECRUITING

    New York, New York, 10016, United States

  • North Carolina Clinical Research

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • PPD Research Unit

    RECRUITING

    Austin, Texas, 78744, United States

  • Parexel EPCU Baltimore

    RECRUITING

    Baltimore, Maryland, 21225, United States

  • Parexel EPCU LA

    RECRUITING

    Los Angeles, California, 91206, United States

  • Peak Gastroenterology Associates

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Velocity Clinical Research, Salt Lake City

    RECRUITING

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research, Seattle

    RECRUITING

    Seattle, Washington, 98105, United States

  • West Michigan Clinical Research Center

    RECRUITING

    Wyoming, Michigan, 49159, United States

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