Study of DONQ52 in Active Celiac Disease
Purpose
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.
Condition
- Celiac Disease
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Pinnacle Research Group, LLC
Anniston, Alabama 36207
Anniston, Alabama 36207
Birmingham Digestive Health Research
Homewood, Alabama 35209
Homewood, Alabama 35209
East View Medical Research
Mobile, Alabama 36608
Mobile, Alabama 36608
Chandler Clinical Trials
Chandler, Arizona 85224
Chandler, Arizona 85224
Research Solutions of Arizona, PC
Litchfield, Arizona 85340
Litchfield, Arizona 85340
One of a Kind Clinical Research Center LLC
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Scottsdale Clinical Trials
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
GMC Clinical Research, LLC
Folsom, California 95630
Folsom, California 95630
Velocity Clinical Research, Gardena
Gardena, California 90247
Gardena, California 90247
Om Research LLC
Lancaster, California 93534
Lancaster, California 93534
Clinical Applications Laboratories
San Diego, California 92103
San Diego, California 92103
California Research Foundation
San Diego, California 92123
San Diego, California 92123
Asthma and Allergy Associates, PC
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Associates in Gastroenterology, PC
Colorado Springs, Colorado 80923
Colorado Springs, Colorado 80923
Mountain View Clinical Research, Inc.
Denver, Colorado 80209
Denver, Colorado 80209
Stamford Therapeutics Consortium
Stamford, Connecticut 06905
Stamford, Connecticut 06905
Novum Clinical Research
Clermont, Florida 34711
Clermont, Florida 34711
Encore Borland Groover Clinical Research LLC
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Global Life Research Network
Miami, Florida 33155
Miami, Florida 33155
Wellness Clinical Research
Miami Lakes, Florida 33016
Miami Lakes, Florida 33016
Ocala GI Research
Ocala, Florida 34471
Ocala, Florida 34471
Tropical Clinical Trials
Palmetto Bay, Florida 33176
Palmetto Bay, Florida 33176
St. Johns Center for Clinical Research
Saint Augustine, Florida 32086
Saint Augustine, Florida 32086
Guardian Angel Research Center
Tampa, Florida 33614
Tampa, Florida 33614
GI Alliance -Gurnee
Gurnee, Illinois 60031
Gurnee, Illinois 60031
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois 61107
Rockford, Illinois 61107
GI Alliance
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Velocity Clinical Research New Orleans
New Orleans, Louisiana 70119
New Orleans, Louisiana 70119
Portland Gastroenterology Center
Portland, Maine 04101
Portland, Maine 04101
GI Associates Research, LLC
Columbia, Missouri 65201
Columbia, Missouri 65201
Gateway GI Research, LLC
St Louis, Missouri 63141
St Louis, Missouri 63141
Oasis Clinical Research
Las Vegas, Nevada 89121
Las Vegas, Nevada 89121
Advanced Research Institute
Reno, Nevada 89511
Reno, Nevada 89511
Akron Gastro Research, LLC
Akron, Ohio 44320
Akron, Ohio 44320
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060
Mentor, Ohio 44060
Central Sooner Research
Norman, Oklahoma 73071
Norman, Oklahoma 73071
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania 17110
Harrisburg, Pennsylvania 17110
GI Alliance Rhode Island
Providence, Rhode Island 02905
Providence, Rhode Island 02905
Columbia Digestive Health Research
Columbia, South Carolina 29204
Columbia, South Carolina 29204
Vitality Clinical Research
Katy, Texas 77494
Katy, Texas 77494
Texas Medical Center
Sugar Land, Texas 77478
Sugar Land, Texas 77478
DM Clinical Research - Cyfair Clinical Research Center
Tomball, Texas 77375
Tomball, Texas 77375
Digestive Research of Central Texas, LLC
Waco, Texas 76301
Waco, Texas 76301
Digestive Health Research of North Texas
Wichita Falls, Texas 76301
Wichita Falls, Texas 76301
Care Access Research - Ogden
Ogden, Utah 84403
Ogden, Utah 84403
Advanced Research Institute
Ogden, Utah 84405
Ogden, Utah 84405
Advanced Research Institute Sandy
Sandy City, Utah 84070
Sandy City, Utah 84070
Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088
West Jordan, Utah 84088
Clinical Research Partners, LLC
Richmond, Virginia 23226
Richmond, Virginia 23226
More Details
- Status
- Recruiting
- Sponsor
- Chugai Pharmaceutical