Recruiting
Phase 2

DONQ52

Sponsor:

Chugai Pharmaceutical

Code:

NCT07239336

Conditions

Celiac Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo DONQ52

Simulated Inadvertent Gluten Exposure (SIGE) capsule

DONQ52

Simulated Inadvertent Gluten Exposure (SIGE) capsule

Study Details

Brief 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.

Conditions

Celiac Disease

Study ID

NCT07239336

Start date

Dec 16, 2025

Status verified date

Aug, 2026

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo + SIGE Gluten capsule

Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally

experimental: DONQ52 + SIGE Gluten capsule

DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally

Interventions

Placebo DONQ52

Placebo DONQ52 subcutaneous injection

Simulated Inadvertent Gluten Exposure (SIGE) capsule

SIGE gluten capsules orally

DONQ52

DONQ52 subcutaneous injection

Simulated Inadvertent Gluten Exposure (SIGE) capsule

SIGE gluten capsules orally

Primary outcome measure

  • Change in Villous Height to Crypt Depth Ratio (Vh:Cd) [ Time Frame: Baseline to Week 27 ]

Central Contacts and Locations

Central contacts

Clinical trials information

only use Emailclinical-trials@chugai-pharm.co.jp

Locations

Pinnacle Research Group, LLC

Recruiting

Anniston, Alabama, United States, 36207

Birmingham Digestive Health Research

Recruiting

Homewood, Alabama, United States, 35209

East View Medical Research

Recruiting

Mobile, Alabama, United States, 36608

Chandler Clinical Trials

Recruiting

Chandler, Arizona, United States, 85224

Research Solutions of Arizona, PC

Recruiting

Litchfield, Arizona, United States, 85340

One of a Kind Clinical Research Center LLC

Recruiting

Scottsdale, Arizona, United States, 85258

Scottsdale Clinical Trials

Recruiting

Scottsdale, Arizona, United States, 85260

Gastroenterology and Liver Institute

Recruiting

Escondido, California, United States, 92025

GMC Clinical Research, LLC

Recruiting

Folsom, California, United States, 95630

Velocity Clinical Research, Gardena

Recruiting

Gardena, California, United States, 90247

Om Research LLC

Recruiting

Lancaster, California, United States, 93534

Clinical Applications Laboratories

Recruiting

San Diego, California, United States, 92103

California Research Foundation

Recruiting

San Diego, California, United States, 92123

Asthma and Allergy Associates, PC

Recruiting

Colorado Springs, Colorado, United States, 80907

Associates in Gastroenterology, PC

Recruiting

Colorado Springs, Colorado, United States, 80923

Mountain View Clinical Research, Inc.

Recruiting

Denver, Colorado, United States, 80209

Stamford Therapeutics Consortium

Recruiting

Stamford, Connecticut, United States, 06905

Novum Clinical Research

Recruiting

Clermont, Florida, United States, 34711

Encore Borland Groover Clinical Research LLC

Recruiting

Jacksonville, Florida, United States, 32256

Global Life Research Network

Recruiting

Miami, Florida, United States, 33155

Wellness Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Ocala GI Research

Recruiting

Ocala, Florida, United States, 34471

Tropical Clinical Trials

Recruiting

Palmetto Bay, Florida, United States, 33176

St. Johns Center for Clinical Research

Recruiting

Saint Augustine, Florida, United States, 32086

Guardian Angel Research Center

Recruiting

Tampa, Florida, United States, 33614

GI Alliance - Glenview

Recruiting

Glenview, Illinois, United States, 60026

GI Alliance -Gurnee

Recruiting

Gurnee, Illinois, United States, 60031

Rockford Gastroenterology Associates, Ltd.

Recruiting

Rockford, Illinois, United States, 61107

GI Alliance

Recruiting

Metairie, Louisiana, United States, 70006

Velocity Clinical Research New Orleans

Recruiting

New Orleans, Louisiana, United States, 70119

Portland Gastroenterology Center

Recruiting

Portland, Maine, United States, 04101

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905-0001

GI Associates Research, LLC

Recruiting

Columbia, Missouri, United States, 65201

Gateway GI Research, LLC

Recruiting

St Louis, Missouri, United States, 63141

Oasis Clinical Research

Recruiting

Las Vegas, Nevada, United States, 89121

Advanced Research Institute

Recruiting

Reno, Nevada, United States, 89511

Akron Gastro Research, LLC

Recruiting

Akron, Ohio, United States, 44320

Great Lakes Gastroenterology Research, LLC

Recruiting

Mentor, Ohio, United States, 44060

Central Sooner Research

Recruiting

Norman, Oklahoma, United States, 73071

Susquehanna Research Group, LLC

Recruiting

Harrisburg, Pennsylvania, United States, 17110

GI Alliance Rhode Island

Recruiting

Providence, Rhode Island, United States, 02905

Columbia Digestive Health Research

Recruiting

Columbia, South Carolina, United States, 29204

Digestive Health Research, LC

Recruiting

Hermitage, Tennessee, United States, 37076

GI Alliance - Garland

Recruiting

Garland, Texas, United States, 75044

Vitality Clinical Research

Recruiting

Katy, Texas, United States, 77494

Vitality Digestive Institute Clinical Research

Recruiting

Katy, Texas, United States, 77494

Texas Medical Center

Recruiting

Sugar Land, Texas, United States, 77478

DM Clinical Research - Cyfair Clinical Research Center

Recruiting

Tomball, Texas, United States, 77375

Digestive Research of Central Texas, LLC

Recruiting

Waco, Texas, United States, 76301

Digestive Health Research of North Texas

Recruiting

Wichita Falls, Texas, United States, 76301

Care Access Research - Ogden

Recruiting

Ogden, Utah, United States, 84403

Advanced Research Institute

Recruiting

Ogden, Utah, United States, 84405

Advanced Research Institute Sandy

Recruiting

Sandy City, Utah, United States, 84070

Velocity Clinical Research, Salt Lake City

Recruiting

West Jordan, Utah, United States, 84088

Blue Ridge Medical Research

Recruiting

Lynchburg, Virginia, United States, 24502

Clinical Research Partners, LLC

Recruiting

Richmond, Virginia, United States, 23226

GI Alliance

Recruiting

Bellevue, Washington, United States, 98405

More Information

Sponsor

Chugai Pharmaceutical

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Chugai Pharmaceutical on 2026-08-14.