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Celiac DiseasePhase 2NCT07239336

Study of DONQ52 in Active Celiac Disease

A Phase 2 study testing Simulated Inadvertent Gluten Exposure (SIGE) capsule and DONQ52 in people with Celiac Disease, run by Chugai Pharmaceutical at 74 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Celiac Disease
What is being tested?
Simulated Inadvertent Gluten Exposure (SIGE) capsule and DONQ52
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
74 sitesin 3 countries
Study dates
16 Dec 2025to 15 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 9Show fewer
  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

74 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Clinical trials information contact

only use Email

clinical-trials@chugai-pharm.co.jp

74 sites in 3 countries

United States58 sites, 58 recruiting

  • Akron Gastro Research, LLC

    Akron, Ohio, 44320

    Recruiting

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

    Recruiting

  • GI Alliance

    Bellevue, Washington, 98405

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Chandler Clinical Trials

    Chandler, Arizona, 85224

    Recruiting

  • Novum Clinical Research

    Clermont, Florida, 34711

    Recruiting

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado, 80907

    Recruiting

  • Associates in Gastroenterology, PC

    Colorado Springs, Colorado, 80923

    Recruiting

  • GI Associates Research, LLC

    Columbia, Missouri, 65201

    Recruiting

  • Columbia Digestive Health Research

    Columbia, South Carolina, 29204

    Recruiting

  • Mountain View Clinical Research, Inc.

    Denver, Colorado, 80209

    Recruiting

  • Gastroenterology and Liver Institute

    Escondido, California, 92025

    Recruiting

  • GMC Clinical Research, LLC

    Folsom, California, 95630

    Recruiting

  • Velocity Clinical Research, Gardena

    Gardena, California, 90247

    Recruiting

  • GI Alliance - Garland

    Garland, Texas, 75044

    Recruiting

  • GI Alliance - Glenview

    Glenview, Illinois, 60026

    Recruiting

  • GI Alliance -Gurnee

    Gurnee, Illinois, 60031

    Recruiting

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania, 17110

    Recruiting

  • Digestive Health Research, LC

    Hermitage, Tennessee, 37076

    Recruiting

  • Birmingham Digestive Health Research

    Homewood, Alabama, 35209

    Recruiting

  • Encore Borland Groover Clinical Research LLC

    Jacksonville, Florida, 32256

    Recruiting

  • Vitality Clinical Research

    Katy, Texas, 77494

    Recruiting

  • Vitality Digestive Institute Clinical Research

    Katy, Texas, 77494

    Recruiting

  • Om Research LLC

    Lancaster, California, 93534

    Recruiting

  • Oasis Clinical Research

    Las Vegas, Nevada, 89121

    Recruiting

  • Research Solutions of Arizona, PC

    Litchfield, Arizona, 85340

    Recruiting

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

    Recruiting

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

    Recruiting

  • GI Alliance

    Metairie, Louisiana, 70006

    Recruiting

  • Global Life Research Network

    Miami, Florida, 33155

    Recruiting

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

    Recruiting

  • East View Medical Research

    Mobile, Alabama, 36608

    Recruiting

  • Velocity Clinical Research New Orleans

    New Orleans, Louisiana, 70119

    Recruiting

  • Central Sooner Research

    Norman, Oklahoma, 73071

    Recruiting

  • Ocala GI Research

    Ocala, Florida, 34471

    Recruiting

  • Care Access Research - Ogden

    Ogden, Utah, 84403

    Recruiting

  • Advanced Research Institute

    Ogden, Utah, 84405

    Recruiting

  • Tropical Clinical Trials

    Palmetto Bay, Florida, 33176

    Recruiting

  • Portland Gastroenterology Center

    Portland, Maine, 04101

    Recruiting

  • GI Alliance Rhode Island

    Providence, Rhode Island, 02905

    Recruiting

  • Advanced Research Institute

    Reno, Nevada, 89511

    Recruiting

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

    Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905-0001

    Recruiting

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois, 61107

    Recruiting

  • St. Johns Center for Clinical Research

    Saint Augustine, Florida, 32086

    Recruiting

  • Clinical Applications Laboratories

    San Diego, California, 92103

    Recruiting

  • California Research Foundation

    San Diego, California, 92123

    Recruiting

  • Advanced Research Institute Sandy

    Sandy City, Utah, 84070

    Recruiting

  • One of a Kind Clinical Research Center LLC

    Scottsdale, Arizona, 85258

    Recruiting

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260

    Recruiting

  • Gateway GI Research, LLC

    St Louis, Missouri, 63141

    Recruiting

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

    Recruiting

  • Texas Medical Center

    Sugar Land, Texas, 77478

    Recruiting

  • Guardian Angel Research Center

    Tampa, Florida, 33614

    Recruiting

  • DM Clinical Research - Cyfair Clinical Research Center

    Tomball, Texas, 77375

    Recruiting

  • Digestive Research of Central Texas, LLC

    Waco, Texas, 76301

    Recruiting

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

    Recruiting

  • Digestive Health Research of North Texas

    Wichita Falls, Texas, 76301

    Recruiting

Other trials in United States

Australia9 sites, 9 recruiting

  • Box Hill Hospital

    Box Hill, Victoria, 3128

    Recruiting

  • Sydney Clinical Trials Pty Ltd

    Campbelltown, New South Wales, 2560

    Recruiting

  • St John of God Midland

    Midland, Western Australia, 6056

    Recruiting

  • University of the Sunshine Coast Clinical Trials Centre

    Morayfield, Queensland, 4506

    Recruiting

  • Pioneer Clinical Research

    North Sydney, New South Wales, 2060

    Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

    Recruiting

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

    Sippy Downs, Queensland, 4556

    Recruiting

  • Mater

    South Brisbane, Queensland, 4101

    Recruiting

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

    South Brisbane, Queensland, 4101

    Recruiting

Other trials in Australia

New Zealand7 sites, 7 recruiting

  • Pacific Clinical Research Network Auckland

    Auckland, Nan, 0622

    Recruiting

  • CGM Research Trust

    Christchurch, Nan, 8011

    Recruiting

  • Momentum Clinical Research Dunedin

    Dunedin, Nan, 9016

    Recruiting

  • Pacific Clinical Research Network Hamilton, Waikato

    Hamilton, 3200

    Recruiting

  • Momentum Clinical Research - Pukekohe

    Pukekohe, Nan, 2120

    Recruiting

  • PCRN Wellington

    Upper Hutt, Nan, 5018

    Recruiting

  • P3 Research Limited (Wellington)

    Wellington, Nan, 6021

    Recruiting

Other trials in New Zealand

About this study

Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate The Efficacy and Safety of DONQ52 in Active Celiac Disease Patients Who Have Duodenal Mucosal Damage and Persistent Symptoms Despite Attempting A Gluten-free Diet (DAISY STUDY)

The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

Conditions
Celiac Disease
Being tested
Placebo DONQ52, Simulated Inadvertent Gluten Exposure (SIGE) capsule, DONQ52
Medical subject headings
Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo DONQ52Drug

    Placebo DONQ52 subcutaneous injection

  • Simulated Inadvertent Gluten Exposure (SIGE) capsuleDietary supplement

    SIGE gluten capsules orally

  • DONQ52Drug

    DONQ52 subcutaneous injection

  • Simulated Inadvertent Gluten Exposure (SIGE) capsuleDietary supplement

    SIGE gluten capsules orally

Study groups in NCT07239336
Study groupRoleWhat they receive
Placebo + SIGE Gluten capsulePlacebo comparatorPlacebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
Receives: Drug: Placebo DONQ52; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) capsule
DONQ52 + SIGE Gluten capsuleExperimentalDONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
Receives: Drug: DONQ52; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Villous Height to Crypt Depth Ratio (Vh:Cd)

    The Vh:Cd ratio represents mucosal architectural changes and a lower Vh:Cd ratio indicates more severe intestinal injury characterized by a flattening of the mucosa. The difference in the adjusted mean change from baseline (Run-in) to Week 27 in Vh:Cd between DONQ52 and placebo groups will be estimated using the analysis of covariance (ANCOVA) method. A negative change from baseline indicates worsening disease.

    Measured: Baseline to Week 27

Secondary outcomes (8)

  1. Change in Average of total score of Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) domain (abdominal pain, diarrhea, nausea, and bloating) calculated as two-week average.

    CDSD symptom severity score is an average of the daily symptom severity scores during the week. The daily symptom severity score is the average of the severity score for diarrhea, abdominal pain, bloating, nausea, and tiredness ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement.

    Measured: Baseline to Week 27

  2. Change in Average of the total score of non-stool GI symptoms (abdominal pain, nausea, and bloating) calculated as two-week average.

    CDSD GI symptom severity score is an average of the daily non-stool GI symptom severity scores during the week. The daily non-stool GI symptom severity score is the average of the severity score for abdominal pain, nausea, and bloating, ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement.

    Measured: Baseline to Week 27

  3. Change in Average of diarrhea frequency score as assessed by CDSD frequency supplement calculated as two-week average.

    Diarrhea frequency score assessed by CDSD frequency supplement is an average of the daily diarrhea frequency score during the week. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement.

    Measured: Baseline to Week 27

  4. Relationship between the total score of CDSD GI domain and Patient Global Impression of Severity (PGI-S) or Patient Global Impression of Change (PGI-C).

    The PGI-S is a Patient-Reported Outcome (PRO) measure assessing participant's impression of overall severity of disease symptoms. The PGI-S consists of single-item which asks participant's disease severity over the past 7 days and 14 days. It is rated on a 5-point scale from None to Very Severe. This PGI-S has been specifically modified to focus on celiac disease symptoms (i.e., abdominal pain, bloating, diarrhea, and nausea), adapting the standard PGI-S framework to be celiac disease-specific.

    The PGI-C is a PRO measure assessing participant's impression of the overall change in disease symptoms. The PGI-C consists of single-item which asks the change of participant's clinical status since the start of the study. It is rated on a 7-point scale from Very Much Improved to Very Much Worse. This PGI-C has been specifically modified to focus on celiac disease symptoms (i.e., CDSD GI items), adapting the standard PGI-C framework to be celiac disease-specific.

    Measured: Baseline to 47 weeks

  5. Incidence and severity of adverse events (AEs) and their causal relationship to the investigational medicinal products (IMPs).

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a markedly abnormal physical examination finding, vital sign value, laboratory test value), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.The investigator clinically judges whether an AE was caused by the IMP. This assessment of causality, often categorized as "related" or "not related," is a distinct step performed after an event has been identified and recorded as an AE.

    Measured: Baseline to 47 weeks

  6. Serum DONQ52 concentration.

    Measured: Day1 to 47 weeks

  7. Prevalence of anti-drug antibodies (ADAs) to DONQ52.

    Measured: Day1 to 47 weeks

  8. Incidence of anti-drug antibodies (ADAs) to DONQ52.

    Measured: Day1 to 47 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start16 Dec 2025
  3. Primary completion15 Jun 2027 (estimated)
  4. Study completion15 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07239336
Sponsor's protocol ID
DQB104CT
Status last verified
Aug 2026
First submitted
16 Nov 2025
Last updated
14 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Simulated Inadvertent Gluten Exposure (SIGE) capsule and DONQ52 in people with Celiac Disease, run by Chugai Pharmaceutical at 74 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical trials information (only use Email, clinical-trials@chugai-pharm.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Villous Height to Crypt Depth Ratio (Vh:Cd) (time frame: Baseline to Week 27). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07239336.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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