What this study is
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.
What's being tested
- Placebo DONQ52
Intervention · DRUG
Placebo DONQ52 subcutaneous injection
- Simulated Inadvertent Gluten Exposure (SIGE) capsule
Intervention · DIETARY SUPPLEMENT
- DONQ52
Intervention · DRUG
DONQ52 subcutaneous injection
- Simulated Inadvertent Gluten Exposure (SIGE) capsule
Intervention · DIETARY SUPPLEMENT
Both Simulated Inadvertent Gluten Exposure (SIGE) capsule and Simulated Inadvertent Gluten Exposure (SIGE) capsule
SIGE gluten capsules orally
Study details
- 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)
- Sponsor
- Chugai Pharmaceutical
- Conditions
- Celiac Disease
- Enrolling
- 92 people
- Starts
- 2025-12-16
- Est. completion
- 2027-12-15
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (74)
74 openPinnacle Research Group, LLC
Anniston, Alabama, United States
RecruitingBirmingham Digestive Health Research
Homewood, Alabama, United States
RecruitingEast View Medical Research
Mobile, Alabama, United States
RecruitingChandler Clinical Trials
Chandler, Arizona, United States
RecruitingResearch Solutions of Arizona, PC
Litchfield, Arizona, United States
RecruitingOne of a Kind Clinical Research Center LLC
Scottsdale, Arizona, United States
RecruitingScottsdale Clinical Trials
Scottsdale, Arizona, United States
RecruitingGastroenterology and Liver Institute
Escondido, California, United States
RecruitingGMC Clinical Research, LLC
Folsom, California, United States
RecruitingVelocity Clinical Research, Gardena
Gardena, California, United States
RecruitingOm Research LLC
Lancaster, California, United States
RecruitingClinical Applications Laboratories
San Diego, California, United States
RecruitingCalifornia Research Foundation
San Diego, California, United States
RecruitingAsthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
RecruitingAssociates in Gastroenterology, PC
Colorado Springs, Colorado, United States
RecruitingMountain View Clinical Research, Inc.
Denver, Colorado, United States
RecruitingStamford Therapeutics Consortium
Stamford, Connecticut, United States
RecruitingNovum Clinical Research
Clermont, Florida, United States
RecruitingEncore Borland Groover Clinical Research LLC
Jacksonville, Florida, United States
RecruitingGlobal Life Research Network
Miami, Florida, United States
RecruitingWellness Clinical Research
Miami Lakes, Florida, United States
RecruitingOcala GI Research
Ocala, Florida, United States
RecruitingTropical Clinical Trials
Palmetto Bay, Florida, United States
RecruitingSt. Johns Center for Clinical Research
Saint Augustine, Florida, United States
RecruitingGuardian Angel Research Center
Tampa, Florida, United States
RecruitingGI Alliance - Glenview
Glenview, Illinois, United States
RecruitingGI Alliance -Gurnee
Gurnee, Illinois, United States
RecruitingRockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States
RecruitingGI Alliance
Metairie, Louisiana, United States
RecruitingVelocity Clinical Research New Orleans
New Orleans, Louisiana, United States
RecruitingPortland Gastroenterology Center
Portland, Maine, United States
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
RecruitingMayo Clinic - Rochester
Rochester, Minnesota, United States
RecruitingGI Associates Research, LLC
Columbia, Missouri, United States
RecruitingGateway GI Research, LLC
St Louis, Missouri, United States
RecruitingOasis Clinical Research
Las Vegas, Nevada, United States
RecruitingAdvanced Research Institute
Reno, Nevada, United States
RecruitingAkron Gastro Research, LLC
Akron, Ohio, United States
RecruitingGreat Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
RecruitingCentral Sooner Research
Norman, Oklahoma, United States
RecruitingSusquehanna Research Group, LLC
Harrisburg, Pennsylvania, United States
RecruitingGI Alliance Rhode Island
Providence, Rhode Island, United States
RecruitingColumbia Digestive Health Research
Columbia, South Carolina, United States
RecruitingDigestive Health Research, LC
Hermitage, Tennessee, United States
RecruitingGI Alliance - Garland
Garland, Texas, United States
RecruitingVitality Clinical Research
Katy, Texas, United States
RecruitingVitality Digestive Institute Clinical Research
Katy, Texas, United States
RecruitingTexas Medical Center
Sugar Land, Texas, United States
RecruitingDM Clinical Research - Cyfair Clinical Research Center
Tomball, Texas, United States
RecruitingDigestive Research of Central Texas, LLC
Waco, Texas, United States
RecruitingDigestive Health Research of North Texas
Wichita Falls, Texas, United States
RecruitingCare Access Research - Ogden
Ogden, Utah, United States
RecruitingAdvanced Research Institute
Ogden, Utah, United States
RecruitingAdvanced Research Institute Sandy
Sandy City, Utah, United States
RecruitingVelocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
RecruitingBlue Ridge Medical Research
Lynchburg, Virginia, United States
RecruitingClinical Research Partners, LLC
Richmond, Virginia, United States
RecruitingGI Alliance
Bellevue, Washington, United States
Recruiting
16 sites outside the US
Sydney Clinical Trials Pty Ltd
Campbelltown, New South Wales, Australia
RecruitingPioneer Clinical Research
North Sydney, New South Wales, Australia
RecruitingUniversity of the Sunshine Coast Clinical Trials Centre
Morayfield, Queensland, Australia
RecruitingUniversity of The Sunshine Coast Clinical Trials Centre (Sippy Downs)
Sippy Downs, Queensland, Australia
RecruitingMater
South Brisbane, Queensland, Australia
RecruitingUniversity of the Sunshine Coast Clinical Trials Centre (SouthBank)
South Brisbane, Queensland, Australia
RecruitingBox Hill Hospital
Box Hill, Victoria, Australia
RecruitingRoyal Melbourne Hospital
Parkville, Victoria, Australia
RecruitingSt John of God Midland
Midland, Western Australia, Australia
RecruitingPacific Clinical Research Network Auckland
Auckland, Nan, New Zealand
RecruitingCGM Research Trust
Christchurch, Nan, New Zealand
RecruitingMomentum Clinical Research Dunedin
Dunedin, Nan, New Zealand
RecruitingMomentum Clinical Research - Pukekohe
Pukekohe, Nan, New Zealand
RecruitingPCRN Wellington
Upper Hutt, Nan, New Zealand
RecruitingP3 Research Limited (Wellington)
Wellington, Nan, New Zealand
RecruitingPacific Clinical Research Network Hamilton, Waikato
Hamilton, New Zealand
Recruiting
Study team
Sponsor
Chugai Pharmaceutical
Study ID DQB104CT
Study director
Chugai Pharmaceutical Co., Ltd.
clinical-trials@chugai-pharm.co.jp
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.