Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
92 participants
INTERVENTIONAL
2025-12-16
2027-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
NCT05425446
Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease
NCT07298343
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
NCT05353985
PTG-100 for Patients With Celiac Disease
NCT04524221
A Study to Evaluate Gluten Challenge on Immune Responses in Subjects With Celiac Disease
NCT03521180
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo + SIGE Gluten capsule
Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
Placebo DONQ52
Placebo DONQ52 subcutaneous injection
Simulated Inadvertent Gluten Exposure (SIGE) capsule
SIGE gluten capsules orally
DONQ52 + SIGE Gluten capsule
DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
DONQ52
DONQ52 subcutaneous injection
Simulated Inadvertent Gluten Exposure (SIGE) capsule
SIGE gluten capsules orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chugai Pharmaceutical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Novum Clinical Research
Clermont, Florida, United States
Guardian Angel Research Center
Tampa, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DQB104CT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.