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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

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

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo + SIGE Gluten capsule 		Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
  • Drug: Placebo DONQ52
    Placebo DONQ52 subcutaneous injection
  • Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) capsule
    SIGE gluten capsules orally
Experimental
DONQ52 + SIGE Gluten capsule 		DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
  • Drug: DONQ52
    DONQ52 subcutaneous injection
  • Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) capsule
    SIGE gluten capsules orally

Recruiting Locations

Chandler Clinical Trials
Chandler, Arizona 85224

Scottsdale Clinical Trials
Scottsdale, Arizona 85260

Associates in Gastroenterology, PC
Colorado Springs, Colorado 80923

Stamford Therapeutics Consortium
Stamford, Connecticut 06905

Novum Clinical Research
Clermont, Florida 34711

Wellness Clinical Research
Miami Lakes, Florida 33016

Guardian Angel Research Center
Tampa, Florida 33614

Portland Gastroenterology Center
Portland, Maine 04101

Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060

Susquehanna Research Group, LLC
Harrisburg, Pennsylvania 17110

Vitality Clinical Research
Katy, Texas 77494

More Details

Status
Recruiting
Sponsor
Chugai Pharmaceutical

Study Contact

Clinical trials information
only use Email
clinical-trials@chugai-pharm.co.jp

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.