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Study of DONQ52 in Active Celiac Disease

RecruitingPhase 2

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)

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
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.

About the study

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 is being tested

Sponsor: Chugai Pharmaceutical · Participants: 92 · Started: Dec 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07239336

Locations in the U.S.

AlabamaPinnacle Research Group, LLC, Anniston
Birmingham Digestive Health Research, Homewood
East View Medical Research, Mobile
ArizonaChandler Clinical Trials, Chandler
Research Solutions of Arizona, PC, Litchfield
One of a Kind Clinical Research Center LLC, Scottsdale
Scottsdale Clinical Trials, Scottsdale
CaliforniaGastroenterology and Liver Institute, Escondido
GMC Clinical Research, LLC, Folsom
Velocity Clinical Research, Gardena, Gardena
Om Research LLC, Lancaster
California Research Foundation, San Diego
Clinical Applications Laboratories, San Diego
ColoradoAssociates in Gastroenterology, PC, Colorado Springs
Asthma and Allergy Associates, PC, Colorado Springs
Mountain View Clinical Research, Inc., Denver
ConnecticutStamford Therapeutics Consortium, Stamford
FloridaNovum Clinical Research, Clermont
Encore Borland Groover Clinical Research LLC, Jacksonville
Global Life Research Network, Miami
Wellness Clinical Research, Miami Lakes
Ocala GI Research, Ocala
Tropical Clinical Trials, Palmetto Bay
St. Johns Center for Clinical Research, Saint Augustine
Guardian Angel Research Center, Tampa
IllinoisGI Alliance - Glenview, Glenview
GI Alliance -Gurnee, Gurnee
Rockford Gastroenterology Associates, Ltd., Rockford
LouisianaGI Alliance, Metairie
Velocity Clinical Research New Orleans, New Orleans
MainePortland Gastroenterology Center, Portland
MassachusettsMassachusetts General Hospital, Boston
MinnesotaMayo Clinic - Rochester, Rochester
MissouriGI Associates Research, LLC, Columbia
Gateway GI Research, LLC, St Louis
NevadaOasis Clinical Research, Las Vegas
Advanced Research Institute, Reno
OhioAkron Gastro Research, LLC, Akron
Great Lakes Gastroenterology Research, LLC, Mentor
OklahomaCentral Sooner Research, Norman
PennsylvaniaSusquehanna Research Group, LLC, Harrisburg
Rhode IslandGI Alliance Rhode Island, Providence
South CarolinaColumbia Digestive Health Research, Columbia
TennesseeDigestive Health Research, LC, Hermitage
TexasGI Alliance - Garland, Garland
Vitality Clinical Research, Katy
Vitality Digestive Institute Clinical Research, Katy
Texas Medical Center, Sugar Land
DM Clinical Research - Cyfair Clinical Research Center, Tomball
Digestive Research of Central Texas, LLC, Waco
Digestive Health Research of North Texas, Wichita Falls
UtahAdvanced Research Institute, Ogden
Care Access Research - Ogden, Ogden
Advanced Research Institute Sandy, Sandy City
Velocity Clinical Research, Salt Lake City, West Jordan
VirginiaBlue Ridge Medical Research, Lynchburg
Clinical Research Partners, LLC, Richmond
WashingtonGI Alliance, Bellevue

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.