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Accepting PatientsPhase 2 (Efficacy)NCT07239336

Study of DONQ52 in Active Celiac Disease

Celiac Disease

Phase:Phase 2 (Efficacy)
Status:Accepting Patients
Age:18 - 75
Gender:All
Locations:74 sites

What This Study Is About

  • Investigates how DONQ52 may heal gut damage and lessen symptoms from gluten
  • You will take the study medication and follow a gluten‑free diet schedule
  • May improve your gut health and reduce discomfort after accidental gluten exposure
Technical Description
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.

Who Can Participate

You 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.
  • +4 more...
You Cannot 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).
  • +2 more...
Discuss With Your Doctor
  • 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.
  • 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.
View Full Eligibility Criteria
Full Criteria (from ClinicalTrials.gov)

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.

Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.

Study Locations

Pinnacle Research Group, LLC — Anniston, Alabama
Birmingham Digestive Health Research — Homewood, Alabama
East View Medical Research — Mobile, Alabama
Show all 74 locations
Chandler Clinical Trials — Chandler, Arizona
Research Solutions of Arizona, PC — Litchfield, Arizona
One of a Kind Clinical Research Center LLC — Scottsdale, Arizona
Scottsdale Clinical Trials — Scottsdale, Arizona
Gastroenterology and Liver Institute — Escondido, California
GMC Clinical Research, LLC — Folsom, California
Velocity Clinical Research, Gardena — Gardena, California
Om Research LLC — Lancaster, California
Clinical Applications Laboratories — San Diego, California
California Research Foundation — San Diego, California
Asthma and Allergy Associates, PC — Colorado Springs, Colorado
Associates in Gastroenterology, PC — Colorado Springs, Colorado
Mountain View Clinical Research, Inc. — Denver, Colorado
Stamford Therapeutics Consortium — Stamford, Connecticut
Novum Clinical Research — Clermont, Florida
Encore Borland Groover Clinical Research LLC — Jacksonville, Florida
Global Life Research Network — Miami, Florida
Wellness Clinical Research — Miami Lakes, Florida
Ocala GI Research — Ocala, Florida
Tropical Clinical Trials — Palmetto Bay, Florida
St. Johns Center for Clinical Research — Saint Augustine, Florida
Guardian Angel Research Center — Tampa, Florida
GI Alliance - Glenview — Glenview, Illinois
GI Alliance -Gurnee — Gurnee, Illinois
Rockford Gastroenterology Associates, Ltd. — Rockford, Illinois
GI Alliance — Metairie, Louisiana
Velocity Clinical Research New Orleans — New Orleans, Louisiana
Portland Gastroenterology Center — Portland, Maine
Massachusetts General Hospital — Boston, Massachusetts
Mayo Clinic - Rochester — Rochester, Minnesota
GI Associates Research, LLC — Columbia, Missouri
Gateway GI Research, LLC — St Louis, Missouri
Oasis Clinical Research — Las Vegas, Nevada
Advanced Research Institute — Reno, Nevada
Akron Gastro Research, LLC — Akron, Ohio
Great Lakes Gastroenterology Research, LLC — Mentor, Ohio
Central Sooner Research — Norman, Oklahoma
Susquehanna Research Group, LLC — Harrisburg, Pennsylvania
GI Alliance Rhode Island — Providence, Rhode Island
Columbia Digestive Health Research — Columbia, South Carolina
Digestive Health Research, LC — Hermitage, Tennessee
GI Alliance - Garland — Garland, Texas
Vitality Clinical Research — Katy, Texas
Vitality Digestive Institute Clinical Research — Katy, Texas
Texas Medical Center — Sugar Land, Texas
DM Clinical Research - Cyfair Clinical Research Center — Tomball, Texas
Digestive Research of Central Texas, LLC — Waco, Texas
Digestive Health Research of North Texas — Wichita Falls, Texas
Care Access Research - Ogden — Ogden, Utah
Advanced Research Institute — Ogden, Utah
Advanced Research Institute Sandy — Sandy City, Utah
Velocity Clinical Research, Salt Lake City — West Jordan, Utah
Blue Ridge Medical Research — Lynchburg, Virginia
Clinical Research Partners, LLC — Richmond, Virginia
GI Alliance — Bellevue, Washington
Sydney Clinical Trials Pty Ltd — Campbelltown, New South Wales
Pioneer Clinical Research — North Sydney, New South Wales
University of the Sunshine Coast Clinical Trials Centre — Morayfield, Queensland
University of The Sunshine Coast Clinical Trials Centre (Sippy Downs) — Sippy Downs, Queensland
Mater — South Brisbane, Queensland
University of the Sunshine Coast Clinical Trials Centre (SouthBank) — South Brisbane, Queensland
Box Hill Hospital — Box Hill, Victoria
Royal Melbourne Hospital — Parkville, Victoria
St John of God Midland — Midland, Western Australia
Pacific Clinical Research Network Auckland — Auckland, Nan
CGM Research Trust — Christchurch, Nan
Momentum Clinical Research Dunedin — Dunedin, Nan
Momentum Clinical Research - Pukekohe — Pukekohe, Nan
PCRN Wellington — Upper Hutt, Nan
P3 Research Limited (Wellington) — Wellington, Nan
Pacific Clinical Research Network Hamilton, Waikato — Hamilton

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Experimental Treatment

This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.

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