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New treatment option for Celiac Disease
Official title Study of DONQ52 in Active Celiac Disease
ClinicalTrials.gov ID: NCT07239336
What this study is testing
What is DONQ52?
DONQ52 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for celiac disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
You likely can't join if
- Participants with documented history (i.e., included in the participant's medical records) of medically diagnosed Refractory Celiac Disease (RCD) or...
- History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in gluten-free and SIGE products used in this study (i.e...
- History of cancer, including hematological malignancy and solid tumors, within 5 years prior to the screening visit, or history of T cell lymphoma or...
- 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...
See the full eligibility 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Anniston, Alabama, United States
- Homewood, Alabama, United States
- Mobile, Alabama, United States
- Chandler, Arizona, United States
- Litchfield, Arizona, United States
- Scottsdale, Arizona, United States
- Folsom, California, United States
- Gardena, California, United States
- Lancaster, California, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
- Denver, Colorado, United States
- Stamford, Connecticut, United States
- Clermont, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Ocala, Florida, United States
- Palmetto Bay, Florida, United States
- Saint Augustine, Florida, United States
+ 36 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anniston, Alabama, United States; Homewood, Alabama, United States; Mobile, Alabama, United States; Chandler, Arizona, United States; Litchfield, Arizona, United States; Scottsdale, Arizona, United States and 50 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.