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RECRUITING

NCT07239336

PHASE2

Study of DONQ52 in Active Celiac Disease

Sponsor: Chugai Pharmaceutical

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-16

Completion Date

2027-12-15

Last Updated

2026-05-20

Healthy Volunteers

Conditions

Celiac Disease

Interventions

DRUG

Placebo DONQ52

Placebo DONQ52 subcutaneous injection

DIETARY_SUPPLEMENT

Simulated Inadvertent Gluten Exposure (SIGE) capsule

SIGE gluten capsules orally

DRUG

DONQ52

DONQ52 subcutaneous injection

DIETARY_SUPPLEMENT

Simulated Inadvertent Gluten Exposure (SIGE) capsule

SIGE gluten capsules orally

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.

Locations (56)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Birmingham Digestive Health Research

Homewood, Alabama, United States

East View Medical Research

Mobile, Alabama, United States

Chandler Clinical Trials

Chandler, Arizona, United States

Research Solutions of Arizona, PC

Litchfield, Arizona, United States

One of a Kind Clinical Research Center LLC

Scottsdale, Arizona, United States

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

GMC Clinical Research, LLC

Folsom, California, United States

Velocity Clinical Research, Gardena

Gardena, California, United States

Om Research LLC

Lancaster, California, United States

Clinical Applications Laboratories

San Diego, California, United States

California Research Foundation

San Diego, California, United States

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, United States

Associates in Gastroenterology, PC

Colorado Springs, Colorado, United States

Mountain View Clinical Research, Inc.

Denver, Colorado, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Novum Clinical Research

Clermont, Florida, United States

Encore Borland Groover Clinical Research LLC

Jacksonville, Florida, United States

Global Life Research Network

Miami, Florida, United States

Wellness Clinical Research

Miami Lakes, Florida, United States

Ocala GI Research

Ocala, Florida, United States

Tropical Clinical Trials

Palmetto Bay, Florida, United States

St. Johns Center for Clinical Research

Saint Augustine, Florida, United States

Guardian Angel Research Center

Tampa, Florida, United States

GI Alliance -Gurnee

Gurnee, Illinois, United States

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, United States

GI Alliance

Metairie, Louisiana, United States

Velocity Clinical Research New Orleans

New Orleans, Louisiana, United States

Portland Gastroenterology Center

Portland, Maine, United States

GI Associates Research, LLC

Columbia, Missouri, United States

Gateway GI Research, LLC

St Louis, Missouri, United States

Oasis Clinical Research

Las Vegas, Nevada, United States

Advanced Research Institute

Reno, Nevada, United States

Akron Gastro Research, LLC

Akron, Ohio, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Central Sooner Research

Norman, Oklahoma, United States

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, United States

GI Alliance Rhode Island

Providence, Rhode Island, United States

Columbia Digestive Health Research

Columbia, South Carolina, United States

Vitality Clinical Research

Katy, Texas, United States

Texas Medical Center

Sugar Land, Texas, United States

DM Clinical Research - Cyfair Clinical Research Center

Tomball, Texas, United States

Digestive Research of Central Texas, LLC

Waco, Texas, United States

Digestive Health Research of North Texas

Wichita Falls, Texas, United States

Care Access Research - Ogden

Ogden, Utah, United States

Advanced Research Institute

Ogden, Utah, United States

Advanced Research Institute Sandy

Sandy City, Utah, United States

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Sydney Clinical Trials Pty Ltd

Campbelltown, New South Wales, Australia

University of the Sunshine Coast Clinical Trials Centre

Morayfield, Queensland, Australia

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

Sippy Downs, Queensland, Australia

Mater

South Brisbane, Queensland, Australia

University of the Sunshine Coast Clinical Trials Centre (SouthBank)

South Brisbane, Queensland, Australia

Momentum Clinical Research Dunedin

Dunedin, Nan, New Zealand

Pacific Clinical Research Network Hamilton, Waikato

Hamilton, New Zealand