Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for celiac sufferers: drug targets gut damage despite strict diet

NCT ID NCT07239336

Disease control Sponsor: Chugai Pharmaceutical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 5 times

Summary

This study tests an experimental drug called DONQ52 in people with active celiac disease who still have gut damage and symptoms even after following a gluten-free diet for at least a year. About 92 adults will receive either the drug or a placebo to see if it can heal the small intestine and reduce symptoms like belly pain and bloating. The goal is to find a treatment that works alongside the diet to better control the disease.

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

About 92 people

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

Started

Dec 2025

Expected to finish

Dec 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 75 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: * Body mass index (BMI) of 18 to 40 (kg/m2) at screening. * Willingness to ingest a gluten-free product and Simulated Inadvertent Gluten Exposure (SIGE) products as per the study protocol. * History of medically diagnosed, and adequately documented (i.e., included in the participant's medical records), CeD * Attempting a GFD for at least 12 months prior to the screening visit. \- The participants should be instructed not to alter dietary habits including a GFD during the study period. * Valid results from central testing of blood documenting a positive result for the HLA DQ2.5 genotype (HLA-DQA1\*05 and HLA-DQB1\*02) (homozygous or heterozygous). * Experienced at least 2 gluten-related symptom events (i.e., 2 different gluten-related symptoms which are diarrhea, abdominal pain, bloating, nausea, tiredness or 1 gluten-related symptom occurred twice) within a month before the screening. * Willingness to undergo 2 on-study upper gastrointestinal endoscopies with duodenal biopsies. * Presence of ongoing duodenal mucosal damage defined as Vh:Cd of 2.5 or less Exclusion Criteria: * Participants with documented history (i.e., included in the participant's medical records) of medically diagnosed Refractory Celiac Disease (RCD) or suspected RCD by the investigator. * History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in gluten-free and SIGE products used in this study (i.e., methylcellulose, and gelatin). * History of cancer, including hematological malignancy and solid tumors, within 5 years prior to the screening visit, or history of T cell lymphoma or B cell lymphoma ever. * History of hypersensitivity reactions including anaphylaxis to a biological medical product or any of the excipients. * Participants who carry the HLA-DQ8 (HLA-DQA1\*03 and DQB1\*0302) genotype (homozygous or heterozygous). * Any other chronic, active gastrointestinal disease (e.g., inflammatory bowel disease, microscopic colitis, eosinophilic esophagitis, peptic ulcer, gastroesophageal reflux disease, functional dyspepsia, or irritable bowel syndrome) that might in the investigator's opinion, interfere with the assessment of GI symptoms or small intestinal histology. * Helicobacter pylori tests that indicate current infection. * Positive either human immunodeficiency virus (HIV) antigen or antibody test at screening. * Positive hepatitis B surface antigen (HBsAg) test or total hepatitis B core (HBc) antibody test at screening. * Positive hepatitis C virus (HCV) antibody test at screening, except in participants who have negative results for HCV ribonucleic acid (RNA) test at screening. * Positive for QuantiFERON-TB Gold test at screening that indicates active tuberculosis (TB) at screening.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Celiac disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

    74 sites in 3 countries. 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

  • Advanced Research Institute

    RECRUITING

    Reno, Nevada, 89511, United States

  • Advanced Research Institute

    RECRUITING

    Ogden, Utah, 84405, United States

  • Advanced Research Institute Sandy

    RECRUITING

    Sandy City, Utah, 84070, United States

  • Akron Gastro Research, LLC

    RECRUITING

    Akron, Ohio, 44320, United States

  • Associates in Gastroenterology, PC

    RECRUITING

    Colorado Springs, Colorado, 80923, United States

  • Asthma and Allergy Associates, PC

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Birmingham Digestive Health Research

    RECRUITING

    Homewood, Alabama, 35209, United States

  • Blue Ridge Medical Research

    RECRUITING

    Lynchburg, Virginia, 24502, United States

  • Box Hill Hospital

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • CGM Research Trust

    RECRUITING

    Christchurch, Nan, 8011, New Zealand

  • California Research Foundation

    RECRUITING

    San Diego, California, 92123, United States

  • Care Access Research - Ogden

    RECRUITING

    Ogden, Utah, 84403, United States

  • Central Sooner Research

    RECRUITING

    Norman, Oklahoma, 73071, United States

  • Chandler Clinical Trials

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Clinical Applications Laboratories

    RECRUITING

    San Diego, California, 92103, United States

  • Clinical Research Partners, LLC

    RECRUITING

    Richmond, Virginia, 23226, United States

  • Columbia Digestive Health Research

    RECRUITING

    Columbia, South Carolina, 29204, United States

  • DM Clinical Research - Cyfair Clinical Research Center

    RECRUITING

    Tomball, Texas, 77375, United States

  • Digestive Health Research of North Texas

    RECRUITING

    Wichita Falls, Texas, 76301, United States

  • Digestive Health Research, LC

    RECRUITING

    Hermitage, Tennessee, 37076, United States

  • Digestive Research of Central Texas, LLC

    RECRUITING

    Waco, Texas, 76301, United States

  • East View Medical Research

    RECRUITING

    Mobile, Alabama, 36608, United States

  • Encore Borland Groover Clinical Research LLC

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • GI Alliance

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • GI Alliance

    RECRUITING

    Bellevue, Washington, 98405, United States

  • GI Alliance - Garland

    RECRUITING

    Garland, Texas, 75044, United States

  • GI Alliance - Glenview

    RECRUITING

    Glenview, Illinois, 60026, United States

  • GI Alliance -Gurnee

    RECRUITING

    Gurnee, Illinois, 60031, United States

  • GI Alliance Rhode Island

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • GI Associates Research, LLC

    RECRUITING

    Columbia, Missouri, 65201, United States

  • GMC Clinical Research, LLC

    RECRUITING

    Folsom, California, 95630, United States

  • Gastroenterology and Liver Institute

    RECRUITING

    Escondido, California, 92025, United States

  • Gateway GI Research, LLC

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Global Life Research Network

    RECRUITING

    Miami, Florida, 33155, United States

  • Great Lakes Gastroenterology Research, LLC

    RECRUITING

    Mentor, Ohio, 44060, United States

  • Guardian Angel Research Center

    RECRUITING

    Tampa, Florida, 33614, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mater

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55905-0001, United States

  • Momentum Clinical Research - Pukekohe

    RECRUITING

    Pukekohe, Nan, 2120, New Zealand

  • Momentum Clinical Research Dunedin

    RECRUITING

    Dunedin, Nan, 9016, New Zealand

  • Mountain View Clinical Research, Inc.

    RECRUITING

    Denver, Colorado, 80209, United States

  • Novum Clinical Research

    RECRUITING

    Clermont, Florida, 34711, United States

  • Oasis Clinical Research

    RECRUITING

    Las Vegas, Nevada, 89121, United States

  • Ocala GI Research

    RECRUITING

    Ocala, Florida, 34471, United States

  • Om Research LLC

    RECRUITING

    Lancaster, California, 93534, United States

  • One of a Kind Clinical Research Center LLC

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • P3 Research Limited (Wellington)

    RECRUITING

    Wellington, Nan, 6021, New Zealand

  • PCRN Wellington

    RECRUITING

    Upper Hutt, Nan, 5018, New Zealand

  • Pacific Clinical Research Network Auckland

    RECRUITING

    Auckland, Nan, 0622, New Zealand

  • Pacific Clinical Research Network Hamilton, Waikato

    RECRUITING

    Hamilton, 3200, New Zealand

  • Pinnacle Research Group, LLC

    RECRUITING

    Anniston, Alabama, 36207, United States

  • Pioneer Clinical Research

    RECRUITING

    North Sydney, New South Wales, 2060, Australia

  • Portland Gastroenterology Center

    RECRUITING

    Portland, Maine, 04101, United States

  • Research Solutions of Arizona, PC

    RECRUITING

    Litchfield, Arizona, 85340, United States

  • Rockford Gastroenterology Associates, Ltd.

    RECRUITING

    Rockford, Illinois, 61107, United States

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Scottsdale Clinical Trials

    RECRUITING

    Scottsdale, Arizona, 85260, United States

  • St John of God Midland

    RECRUITING

    Midland, Western Australia, 6056, Australia

  • St. Johns Center for Clinical Research

    RECRUITING

    Saint Augustine, Florida, 32086, United States

  • Stamford Therapeutics Consortium

    RECRUITING

    Stamford, Connecticut, 06905, United States

  • Susquehanna Research Group, LLC

    RECRUITING

    Harrisburg, Pennsylvania, 17110, United States

  • Sydney Clinical Trials Pty Ltd

    RECRUITING

    Campbelltown, New South Wales, 2560, Australia

  • Texas Medical Center

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • Tropical Clinical Trials

    RECRUITING

    Palmetto Bay, Florida, 33176, United States

  • University of The Sunshine Coast Clinical Trials Centre (Sippy Downs)

    RECRUITING

    Sippy Downs, Queensland, 4556, Australia

  • University of the Sunshine Coast Clinical Trials Centre

    RECRUITING

    Morayfield, Queensland, 4506, Australia

  • University of the Sunshine Coast Clinical Trials Centre (SouthBank)

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Velocity Clinical Research New Orleans

    RECRUITING

    New Orleans, Louisiana, 70119, United States

  • Velocity Clinical Research, Gardena

    RECRUITING

    Gardena, California, 90247, United States

  • Velocity Clinical Research, Salt Lake City

    RECRUITING

    West Jordan, Utah, 84088, United States

  • Vitality Clinical Research

    RECRUITING

    Katy, Texas, 77494, United States

  • Vitality Digestive Institute Clinical Research

    RECRUITING

    Katy, Texas, 77494, United States

  • Wellness Clinical Research

    RECRUITING

    Miami Lakes, Florida, 33016, United States

More trials for these conditions

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