Study of DONQ52 in Active Celiac Disease

NCT07239336 | Recruiting Phase 2 FDA Drug

• 1 other identifier: DQB104CT
• Study Type: interventional
• Target: 92
• Locations: 3 countries
• Sites: 56

Brief 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.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (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.

  Baseline to Week 27

Secondary Outcomes (8)

• 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.

  Baseline to Week 27

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

  Baseline to Week 27

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

  Baseline to Week 27

• 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).

  Baseline to 47 weeks

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

  Baseline to 47 weeks

Study Arms (2)

Placebo + SIGE Gluten capsule

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally

Drug: Placebo DONQ52; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) capsule

DONQ52 + SIGE Gluten capsule

EXPERIMENTAL

DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally

Drug: DONQ52; Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) capsule

Interventions

DONQ52 DRUG

DONQ52 subcutaneous injection

DONQ52 + SIGE Gluten capsule

Placebo DONQ52 DRUG

Placebo DONQ52 subcutaneous injection

Placebo + SIGE Gluten capsule

Simulated Inadvertent Gluten Exposure (SIGE) capsule DIETARY_SUPPLEMENT

SIGE gluten capsules orally

Placebo + SIGE Gluten capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (56)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

RECRUITING

Birmingham Digestive Health Research

Homewood, Alabama, 35209, United States

RECRUITING

East View Medical Research

Mobile, Alabama, 36608, United States

RECRUITING

Chandler Clinical Trials

Chandler, Arizona, 85224, United States

RECRUITING

Research Solutions of Arizona, PC

Litchfield, Arizona, 85340, United States

RECRUITING

One of a Kind Clinical Research Center LLC

Scottsdale, Arizona, 85258, United States

RECRUITING

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260, United States

RECRUITING

GMC Clinical Research, LLC

Folsom, California, 95630, United States

RECRUITING

Velocity Clinical Research, Gardena

Gardena, California, 90247, United States

RECRUITING

Om Research LLC

Lancaster, California, 93534, United States

RECRUITING

Clinical Applications Laboratories

San Diego, California, 92103, United States

RECRUITING

California Research Foundation

San Diego, California, 92123, United States

RECRUITING

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907, United States

RECRUITING

Associates in Gastroenterology, PC

Colorado Springs, Colorado, 80923, United States

RECRUITING

Mountain View Clinical Research, Inc.

Denver, Colorado, 80209, United States

RECRUITING

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

RECRUITING

Novum Clinical Research

Clermont, Florida, 34711, United States

RECRUITING

Encore Borland Groover Clinical Research LLC

Jacksonville, Florida, 32256, United States

RECRUITING

Global Life Research Network

Miami, Florida, 33155, United States

RECRUITING

Wellness Clinical Research

Miami Lakes, Florida, 33016, United States

RECRUITING

Ocala GI Research

Ocala, Florida, 34471, United States

RECRUITING

Tropical Clinical Trials

Palmetto Bay, Florida, 33176, United States

RECRUITING

St. Johns Center for Clinical Research

Saint Augustine, Florida, 32086, United States

RECRUITING

Guardian Angel Research Center

Tampa, Florida, 33614, United States

RECRUITING

GI Alliance -Gurnee

Gurnee, Illinois, 60031, United States

RECRUITING

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107, United States

RECRUITING

GI Alliance

Metairie, Louisiana, 70006, United States

RECRUITING

Velocity Clinical Research New Orleans

New Orleans, Louisiana, 70119, United States

RECRUITING

Portland Gastroenterology Center

Portland, Maine, 04101, United States

RECRUITING

GI Associates Research, LLC

Columbia, Missouri, 65201, United States

RECRUITING

Gateway GI Research, LLC

St Louis, Missouri, 63141, United States

RECRUITING

Oasis Clinical Research

Las Vegas, Nevada, 89121, United States

RECRUITING

Advanced Research Institute

Reno, Nevada, 89511, United States

RECRUITING

Akron Gastro Research, LLC

Akron, Ohio, 44320, United States

RECRUITING

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

RECRUITING

Central Sooner Research

Norman, Oklahoma, 73071, United States

RECRUITING

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110, United States

RECRUITING

GI Alliance Rhode Island

Providence, Rhode Island, 02905, United States

RECRUITING

Columbia Digestive Health Research

Columbia, South Carolina, 29204, United States

RECRUITING

Vitality Clinical Research

Katy, Texas, 77494, United States

RECRUITING

Texas Medical Center

Sugar Land, Texas, 77478, United States

RECRUITING

DM Clinical Research - Cyfair Clinical Research Center

Tomball, Texas, 77375, United States

RECRUITING

Digestive Research of Central Texas, LLC

Waco, Texas, 76301, United States

RECRUITING

Digestive Health Research of North Texas

Wichita Falls, Texas, 76301, United States

RECRUITING

Care Access Research - Ogden

Ogden, Utah, 84403, United States

RECRUITING

Advanced Research Institute

Ogden, Utah, 84405, United States

RECRUITING

Advanced Research Institute Sandy

Sandy City, Utah, 84070, United States

RECRUITING

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

RECRUITING

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

RECRUITING

Sydney Clinical Trials Pty Ltd

Campbelltown, New South Wales, 2560, Australia

RECRUITING

University of the Sunshine Coast Clinical Trials Centre

Morayfield, Queensland, 4506, Australia

RECRUITING

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

Sippy Downs, Queensland, 4556, Australia

RECRUITING

Mater

South Brisbane, Queensland, 4101, Australia

RECRUITING

University of the Sunshine Coast Clinical Trials Centre (SouthBank)

South Brisbane, Queensland, 4101, Australia

RECRUITING

Momentum Clinical Research Dunedin

Dunedin, Nan, 9016, New Zealand

RECRUITING

Pacific Clinical Research Network Hamilton, Waikato

Hamilton, 3200, New Zealand

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Interventions

Capsules

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Chugai Pharmaceutical Co., Ltd.

  clinical-trials@chugai-pharm.co.jp

  STUDY DIRECTOR

Central Study Contacts

Clinical trials information

CONTACT

only use Email; clinical-trials@chugai-pharm.co.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (49); AU (5); NZ (2)