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NCT07239336PHASE2Recruiting

Study of DONQ52 in Active Celiac Disease

Chugai Pharmaceutical

Start Date

12/16/2025

Completion Date

12/15/2027

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Placebo DONQ52

DIETARY_SUPPLEMENT

Simulated Inadvertent Gluten Exposure (SIGE) capsule

DRUG

DONQ52

DIETARY_SUPPLEMENT

Simulated Inadvertent Gluten Exposure (SIGE) capsule

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Conditions

Celiac Disease

Locations

Pinnacle Research Group, LLC

Anniston, Alabama 36207

United States

Birmingham Digestive Health Research

Homewood, Alabama 35209

United States

East View Medical Research

Mobile, Alabama 36608

United States

Chandler Clinical Trials

Chandler, Arizona 85224

United States

Research Solutions of Arizona, PC

Litchfield, Arizona 85340

United States

One of a Kind Clinical Research Center LLC

Scottsdale, Arizona 85258

United States

Scottsdale Clinical Trials

Scottsdale, Arizona 85260

United States

GMC Clinical Research, LLC

Folsom, California 95630

United States

Velocity Clinical Research, Gardena

Gardena, California 90247

United States

Om Research LLC

Lancaster, California 93534

United States

Clinical Applications Laboratories

San Diego, California 92103

United States

California Research Foundation

San Diego, California 92123

United States

Asthma and Allergy Associates, PC

Colorado Springs, Colorado 80907

United States

Associates in Gastroenterology, PC

Colorado Springs, Colorado 80923

United States

Mountain View Clinical Research, Inc.

Denver, Colorado 80209

United States

Stamford Therapeutics Consortium

Stamford, Connecticut 06905

United States

Novum Clinical Research

Clermont, Florida 34711

United States

Encore Borland Groover Clinical Research LLC

Jacksonville, Florida 32256

United States

Global Life Research Network

Miami, Florida 33155

United States

Wellness Clinical Research

Miami Lakes, Florida 33016

United States

Ocala GI Research

Ocala, Florida 34471

United States

Tropical Clinical Trials

Palmetto Bay, Florida 33176

United States

St. Johns Center for Clinical Research

Saint Augustine, Florida 32086

United States

Guardian Angel Research Center

Tampa, Florida 33614

United States

GI Alliance - Glenview

Glenview, Illinois 60026

United States

GI Alliance -Gurnee

Gurnee, Illinois 60031

United States

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois 61107

United States

GI Alliance

Metairie, Louisiana 70006

United States

Velocity Clinical Research New Orleans

New Orleans, Louisiana 70119

United States

Portland Gastroenterology Center

Portland, Maine 04101

United States

Mayo Clinic - Rochester

Rochester, Minnesota 55905-0001

United States

GI Associates Research, LLC

Columbia, Missouri 65201

United States

Gateway GI Research, LLC

St Louis, Missouri 63141

United States

Oasis Clinical Research

Las Vegas, Nevada 89121

United States

Advanced Research Institute

Reno, Nevada 89511

United States

Akron Gastro Research, LLC

Akron, Ohio 44320

United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio 44060

United States

Central Sooner Research

Norman, Oklahoma 73071

United States

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania 17110

United States

GI Alliance Rhode Island

Providence, Rhode Island 02905

United States

Columbia Digestive Health Research

Columbia, South Carolina 29204

United States

GI Alliance - Garland

Garland, Texas 75044

United States

Vitality Clinical Research

Katy, Texas 77494

United States

Vitality Digestive Institute Clinical Research

Katy, Texas 77494

United States

Texas Medical Center

Sugar Land, Texas 77478

United States

DM Clinical Research - Cyfair Clinical Research Center

Tomball, Texas 77375

United States

Digestive Research of Central Texas, LLC

Waco, Texas 76301

United States

Digestive Health Research of North Texas

Wichita Falls, Texas 76301

United States

Care Access Research - Ogden

Ogden, Utah 84403

United States

Advanced Research Institute

Ogden, Utah 84405

United States

Advanced Research Institute Sandy

Sandy City, Utah 84070

United States

Velocity Clinical Research, Salt Lake City

West Jordan, Utah 84088

United States

Blue Ridge Medical Research

Lynchburg, Virginia 24502

United States

Clinical Research Partners, LLC

Richmond, Virginia 23226

United States

GI Alliance

Bellevue, Washington 98405

United States

Sydney Clinical Trials Pty Ltd

Campbelltown, New South Wales 2560

Australia

University of the Sunshine Coast Clinical Trials Centre

Morayfield, Queensland 4506

Australia

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

Sippy Downs, Queensland 4556

Australia

Mater

South Brisbane, Queensland 4101

Australia

University of the Sunshine Coast Clinical Trials Centre (SouthBank)

South Brisbane, Queensland 4101

Australia

Momentum Clinical Research Dunedin

Dunedin, Nan 9016

New Zealand

Pacific Clinical Research Network Hamilton, Waikato

Hamilton, 3200

New Zealand