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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in Villous Height to Crypt Depth Ratio (Vh:Cd) — Baseline to Week 27 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.
Trial sites (74)
Facility
City
Region
Status
Pinnacle Research Group, LLC
Anniston
Alabama
Recruiting
Birmingham Digestive Health Research
Homewood
Alabama
Recruiting
East View Medical Research
Mobile
Alabama
Recruiting
Chandler Clinical Trials
Chandler
Arizona
Recruiting
Research Solutions of Arizona, PC
Litchfield
Arizona
Recruiting
One of a Kind Clinical Research Center LLC
Scottsdale
Arizona
Recruiting
Scottsdale Clinical Trials
Scottsdale
Arizona
Recruiting
Gastroenterology and Liver Institute
Escondido
California
Recruiting
GMC Clinical Research, LLC
Folsom
California
Recruiting
Velocity Clinical Research, Gardena
Gardena
California
Recruiting
Om Research LLC
Lancaster
California
Recruiting
Clinical Applications Laboratories
San Diego
California
Recruiting
California Research Foundation
San Diego
California
Recruiting
Asthma and Allergy Associates, PC
Colorado Springs
Colorado
Recruiting
Associates in Gastroenterology, PC
Colorado Springs
Colorado
Recruiting
Mountain View Clinical Research, Inc.
Denver
Colorado
Recruiting
Stamford Therapeutics Consortium
Stamford
Connecticut
Recruiting
Novum Clinical Research
Clermont
Florida
Recruiting
Encore Borland Groover Clinical Research LLC
Jacksonville
Florida
Recruiting
Global Life Research Network
Miami
Florida
Recruiting
Wellness Clinical Research
Miami Lakes
Florida
Recruiting
Ocala GI Research
Ocala
Florida
Recruiting
Tropical Clinical Trials
Palmetto Bay
Florida
Recruiting
St. Johns Center for Clinical Research
Saint Augustine
Florida
Recruiting
Guardian Angel Research Center
Tampa
Florida
Recruiting
GI Alliance - Glenview
Glenview
Illinois
Recruiting
GI Alliance -Gurnee
Gurnee
Illinois
Recruiting
Rockford Gastroenterology Associates, Ltd.
Rockford
Illinois
Recruiting
GI Alliance
Metairie
Louisiana
Recruiting
Velocity Clinical Research New Orleans
New Orleans
Louisiana
Recruiting
Portland Gastroenterology Center
Portland
Maine
Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
Mayo Clinic - Rochester
Rochester
Minnesota
Recruiting
GI Associates Research, LLC
Columbia
Missouri
Recruiting
Gateway GI Research, LLC
St Louis
Missouri
Recruiting
Oasis Clinical Research
Las Vegas
Nevada
Recruiting
Advanced Research Institute
Reno
Nevada
Recruiting
Akron Gastro Research, LLC
Akron
Ohio
Recruiting
Great Lakes Gastroenterology Research, LLC
Mentor
Ohio
Recruiting
Central Sooner Research
Norman
Oklahoma
Recruiting
+ 34 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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