Actively Recruiting
Study of DONQ52 in Active Celiac Disease
Led by Chugai Pharmaceutical · Updated on 2026-04-20
92
Participants Needed
38
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of DONQ52 in Active Celiac Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 documented celiac disease
- Attempting a gluten-free diet for at least 12 months prior to the screening visit
- Valid blood test results confirming positive HLA DQ2.5 genotype (homozygous or heterozygous)
- Experienced at least 2 gluten-related symptom events within a month before screening
- Willingness to undergo 2 upper gastrointestinal endoscopies with duodenal biopsies
- Presence of ongoing duodenal mucosal damage defined as villous height to crypt depth ratio of 2.5 or less
You will not qualify if you...
- History of medically diagnosed or suspected refractory celiac disease
- History of IgE-mediated reactions to wheat, barley, rye, or ingredients in gluten-free and SIGE products
- History of cancer within 5 years prior to screening, including hematological or solid tumors, or any T cell or B cell lymphoma ever
- History of hypersensitivity reactions including anaphylaxis to biological medical products or excipients
- Carrying the HLA-DQ8 genotype (homozygous or heterozygous)
- Presence of other chronic active gastrointestinal diseases that may interfere with symptom assessment or intestinal histology
- Current Helicobacter pylori infection
- Positive HIV antigen or antibody test at screening
- Positive hepatitis B surface antigen or core antibody test at screening
- Positive hepatitis C antibody test unless RNA test is negative
- Positive QuantiFERON-TB Gold test indicating active tuberculosis at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
Actively Recruiting
2
East View Medical Research
Mobile, Alabama, United States, 36608
Actively Recruiting
3
Chandler Clinical Trials
Chandler, Arizona, United States, 85224
Actively Recruiting
4
Research Solutions of Arizona, PC
Litchfield, Arizona, United States, 85340
Actively Recruiting
5
One of a Kind Clinical Research Center LLC
Scottsdale, Arizona, United States, 85258
Actively Recruiting
6
Scottsdale Clinical Trials
Scottsdale, Arizona, United States, 85260
Actively Recruiting
7
GMC Clinical Research, LLC
Folsom, California, United States, 95630
Actively Recruiting
8
Velocity Clinical Research, Gardena
Gardena, California, United States, 90247
Actively Recruiting
9
Om Research LLC
Lancaster, California, United States, 93534
Actively Recruiting
10
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
11
Associates in Gastroenterology, PC
Colorado Springs, Colorado, United States, 80923
Actively Recruiting
12
Mountain View Clinical Research, Inc.
Denver, Colorado, United States, 80209
Actively Recruiting
13
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
Actively Recruiting
14
Novum Clinical Research
Clermont, Florida, United States, 34711
Actively Recruiting
15
Global Life Research Network
Miami, Florida, United States, 33155
Actively Recruiting
16
Wellness Clinical Research
Miami Lakes, Florida, United States, 33016
Actively Recruiting
17
Ocala GI Research
Ocala, Florida, United States, 34471
Actively Recruiting
18
Guardian Angel Research Center
Tampa, Florida, United States, 33614
Actively Recruiting
19
Portland Gastroenterology Center
Portland, Maine, United States, 04101
Actively Recruiting
20
Oasis Clinical Research
Las Vegas, Nevada, United States, 89121
Actively Recruiting
21
Akron Gastro Research, LLC
Akron, Ohio, United States, 44320
Actively Recruiting
22
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
Actively Recruiting
23
Central Sooner Research
Norman, Oklahoma, United States, 73071
Actively Recruiting
24
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, United States, 17110
Actively Recruiting
25
GI Alliance Rhode Island
Providence, Rhode Island, United States, 02905
Actively Recruiting
26
Columbia Digestive Health Research
Columbia, South Carolina, United States, 29204
Actively Recruiting
27
Vitality Clinical Research
Katy, Texas, United States, 77494
Actively Recruiting
28
DM Clinical Research - Cyfair Clinical Research Center
Tomball, Texas, United States, 77375
Actively Recruiting
29
Digestive Research of Central Texas, LLC
Waco, Texas, United States, 76301
Actively Recruiting
30
Digestive Health Research of North Texas
Wichita Falls, Texas, United States, 76301
Actively Recruiting
31
Care Access Research - Ogden
Ogden, Utah, United States, 84403
Actively Recruiting
32
Advanced Research Institute
Ogden, Utah, United States, 84405
Actively Recruiting
33
Advanced Research Institute Sandy
Sandy City, Utah, United States, 84070
Actively Recruiting
34
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States, 84088
Actively Recruiting
35
University of the Sunshine Coast Clinical Trials Centre
Morayfield, Queensland, Australia, 4506
Actively Recruiting
36
University of The Sunshine Coast Clinical Trials Centre (Sippy Downs)
Sippy Downs, Queensland, Australia, 4556
Actively Recruiting
37
Mater
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
38
University of the Sunshine Coast Clinical Trials Centre (SouthBank)
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
Research Team
C
Clinical trials information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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