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)

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.

Study Overview

• Status: Recruiting
• Conditions: Celiac Disease
• Intervention / Treatment: Drug: Placebo DONQ52; Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) capsule; Drug: DONQ52

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical trials information; Phone Number: only use Email; Email: clinical-trials@chugai-pharm.co.jp

Study Locations

• Australia
  • New South Wales
    • Campbelltown, New South Wales, Australia, 2560
      • Recruiting
      • Sydney Clinical Trials Pty Ltd
  • Queensland
    • Morayfield, Queensland, Australia, 4506
      • Recruiting
      • University of the Sunshine Coast Clinical Trials Centre
    • Sippy Downs, Queensland, Australia, 4556
      • Recruiting
      • University of The Sunshine Coast Clinical Trials Centre (Sippy Downs)
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • University of the Sunshine Coast Clinical Trials Centre (SouthBank)
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Mater
• New Zealand
  • Hamilton, New Zealand, 3200
    • Recruiting
    • Pacific Clinical Research Network Hamilton, Waikato
  • Nan
    • Dunedin, Nan, New Zealand, 9016
      • Recruiting
      • Momentum Clinical Research Dunedin
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Recruiting
      • Pinnacle Research Group, LLC
    • Homewood, Alabama, United States, 35209
      • Recruiting
      • Birmingham Digestive Health Research
    • Mobile, Alabama, United States, 36608
      • Recruiting
      • East View Medical Research
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Recruiting
      • Chandler Clinical Trials
    • Litchfield, Arizona, United States, 85340
      • Recruiting
      • Research Solutions of Arizona, PC
    • Scottsdale, Arizona, United States, 85260
      • Recruiting
      • Scottsdale Clinical Trials
    • Scottsdale, Arizona, United States, 85258
      • Recruiting
      • One of a Kind Clinical Research Center LLC
  • California
    • Folsom, California, United States, 95630
      • Recruiting
      • GMC Clinical Research, LLC
    • Gardena, California, United States, 90247
      • Recruiting
      • Velocity Clinical Research, Gardena
    • Lancaster, California, United States, 93534
      • Recruiting
      • Om Research LLC
    • San Diego, California, United States, 92123
      • Recruiting
      • California Research Foundation
    • San Diego, California, United States, 92103
      • Recruiting
      • Clinical Applications Laboratories
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Recruiting
      • Asthma and Allergy Associates, PC
    • Colorado Springs, Colorado, United States, 80923
      • Recruiting
      • Associates in Gastroenterology, PC
    • Denver, Colorado, United States, 80209
      • Recruiting
      • Mountain View Clinical Research, Inc.
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Recruiting
      • Stamford Therapeutics Consortium
  • Florida
    • Clermont, Florida, United States, 34711
      • Recruiting
      • Novum Clinical Research
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Encore Borland Groover Clinical Research LLC
    • Miami, Florida, United States, 33155
      • Recruiting
      • Global Life Research Network
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Wellness Clinical Research
    • Ocala, Florida, United States, 34471
      • Recruiting
      • Ocala GI Research
    • Palmetto Bay, Florida, United States, 33176
      • Recruiting
      • Tropical Clinical Trials
    • Saint Augustine, Florida, United States, 32086
      • Recruiting
      • St. Johns Center for Clinical Research
    • Tampa, Florida, United States, 33614
      • Recruiting
      • Guardian Angel Research Center
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Recruiting
      • GI Alliance -Gurnee
    • Rockford, Illinois, United States, 61107
      • Recruiting
      • Rockford Gastroenterology Associates, Ltd.
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Recruiting
      • GI Alliance
    • New Orleans, Louisiana, United States, 70119
      • Recruiting
      • Velocity Clinical Research New Orleans
  • Maine
    • Portland, Maine, United States, 04101
      • Recruiting
      • Portland Gastroenterology Center
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Recruiting
      • GI Associates Research, LLC
    • St Louis, Missouri, United States, 63141
      • Recruiting
      • Gateway GI Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Recruiting
      • Oasis Clinical Research
    • Reno, Nevada, United States, 89511
      • Recruiting
      • Advanced Research Institute
  • Ohio
    • Akron, Ohio, United States, 44320
      • Recruiting
      • Akron Gastro Research, LLC
    • Mentor, Ohio, United States, 44060
      • Recruiting
      • Great Lakes Gastroenterology Research, LLC
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Recruiting
      • Central Sooner Research
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
      • Recruiting
      • Susquehanna Research Group, LLC
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Recruiting
      • GI Alliance Rhode Island
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Recruiting
      • Columbia Digestive Health Research
  • Texas
    • Katy, Texas, United States, 77494
      • Recruiting
      • Vitality Clinical Research
    • Sugar Land, Texas, United States, 77478
      • Recruiting
      • Texas Medical Center
    • Tomball, Texas, United States, 77375
      • Recruiting
      • DM Clinical Research - Cyfair Clinical Research Center
    • Waco, Texas, United States, 76301
      • Recruiting
      • Digestive Research of Central Texas, LLC
    • Wichita Falls, Texas, United States, 76301
      • Recruiting
      • Digestive Health Research of North Texas
  • Utah
    • Ogden, Utah, United States, 84403
      • Recruiting
      • Care Access Research - Ogden
    • Ogden, Utah, United States, 84405
      • Recruiting
      • Advanced Research Institute
    • Sandy City, Utah, United States, 84070
      • Recruiting
      • Advanced Research Institute Sandy
    • West Jordan, Utah, United States, 84088
      • Recruiting
      • Velocity Clinical Research, Salt Lake City
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Recruiting
      • Clinical Research Partners, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo + SIGE Gluten capsule; Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally	Drug: Placebo DONQ52; Placebo DONQ52 subcutaneous injection; Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) capsule; SIGE gluten capsules orally
Experimental: DONQ52 + SIGE Gluten capsule; DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally	Dietary supplement: Simulated Inadvertent Gluten Exposure (SIGE) capsule; SIGE gluten capsules orally; Drug: DONQ52; DONQ52 subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Villous Height to Crypt Depth Ratio (Vh:Cd)	The Vh:Cd ratio represents mucosal architectural changes and a lower Vh:Cd ratio indicates more severe intestinal injury characterized by a flattening of the mucosa. The difference in the adjusted mean change from baseline (Run-in) to Week 27 in Vh:Cd between DONQ52 and placebo groups will be estimated using the analysis of covariance (ANCOVA) method. A negative change from baseline indicates worsening disease.	Baseline to Week 27

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Average of total score of Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) domain (abdominal pain, diarrhea, nausea, and bloating) calculated as two-week average.	CDSD symptom severity score is an average of the daily symptom severity scores during the week. The daily symptom severity score is the average of the severity score for diarrhea, abdominal pain, bloating, nausea, and tiredness ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement.	Baseline to Week 27
Change in Average of the total score of non-stool GI symptoms (abdominal pain, nausea, and bloating) calculated as two-week average.	CDSD GI symptom severity score is an average of the daily non-stool GI symptom severity scores during the week. The daily non-stool GI symptom severity score is the average of the severity score for abdominal pain, nausea, and bloating, ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement.	Baseline to Week 27
Change in Average of diarrhea frequency score as assessed by CDSD frequency supplement calculated as two-week average.	Diarrhea frequency score assessed by CDSD frequency supplement is an average of the daily diarrhea frequency score during the week. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement.	Baseline to Week 27
Relationship between the total score of CDSD GI domain and Patient Global Impression of Severity (PGI-S) or Patient Global Impression of Change (PGI-C).	The PGI-S is a Patient-Reported Outcome (PRO) measure assessing participant's impression of overall severity of disease symptoms. The PGI-S consists of single-item which asks participant's disease severity over the past 7 days and 14 days. It is rated on a 5-point scale from None to Very Severe. This PGI-S has been specifically modified to focus on celiac disease symptoms (i.e., abdominal pain, bloating, diarrhea, and nausea), adapting the standard PGI-S framework to be celiac disease-specific. The PGI-C is a PRO measure assessing participant's impression of the overall change in disease symptoms. The PGI-C consists of single-item which asks the change of participant's clinical status since the start of the study. It is rated on a 7-point scale from Very Much Improved to Very Much Worse. This PGI-C has been specifically modified to focus on celiac disease symptoms (i.e., CDSD GI items), adapting the standard PGI-C framework to be celiac disease-specific.	Baseline to 47 weeks
Incidence and severity of adverse events (AEs) and their causal relationship to the investigational medicinal products (IMPs).	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a markedly abnormal physical examination finding, vital sign value, laboratory test value), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.The investigator clinically judges whether an AE was caused by the IMP. This assessment of causality, often categorized as "related" or "not related," is a distinct step performed after an event has been identified and recorded as an AE.	Baseline to 47 weeks
Serum DONQ52 concentration.		Day1 to 47 weeks
Prevalence of anti-drug antibodies (ADAs) to DONQ52.		Day1 to 47 weeks
Incidence of anti-drug antibodies (ADAs) to DONQ52.		Day1 to 47 weeks

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical
• Investigators: Study Director: Chugai Pharmaceutical Co., Ltd., clinical-trials@chugai-pharm.co.jp

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Nutritional and Metabolic Diseases; Celiac Disease; Pharmaceutical Preparations; Dosage Forms; Capsules
• Other Study ID Numbers: DQB104CT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No