RecruitingPhase 2NCT07239336

Study of DONQ52 in Active Celiac Disease

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)

Sponsor

Chugai Pharmaceutical

Enrollment

92 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

Celiac Disease

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called DONQ52, a drug called Placebo DONQ52, and others for people with celiac disease. The study is currently recruiting participants at 56 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo DONQ52

Placebo DONQ52 subcutaneous injection

DIETARY_SUPPLEMENTSimulated Inadvertent Gluten Exposure (SIGE) capsule

SIGE gluten capsules orally

DRUGDONQ52

DONQ52 subcutaneous injection

DIETARY_SUPPLEMENTSimulated Inadvertent Gluten Exposure (SIGE) capsule

SIGE gluten capsules orally

Locations(62)

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 - Glenview

Glenview, Illinois, 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

Mayo Clinic - Rochester

Rochester, Minnesota, 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

GI Alliance - Garland

Garland, Texas, United States

Vitality Clinical Research

Katy, Texas, United States

Vitality Digestive Institute 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

Blue Ridge Medical Research

Lynchburg, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

GI Alliance

Bellevue, Washington, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07239336

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