Phase 2 Coeliac Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Your body mass index (BMI) must be between 18 and 40 at the time of your screening appointment.
• You must be willing to eat a gluten-free product and specially prepared products that simulate accidental gluten exposure as part of the study.
• You must have been formally diagnosed with celiac disease by a doctor, with that diagnosis recorded in your medical records.
• You must have been following a gluten-free diet for at least 12 months before your screening appointment, and must be willing to continue that same diet throughout the study.
• A blood test must confirm that you carry a specific genetic marker called HLA DQ2.5 (confirm with trial site).
• You must have experienced at least 2 gluten-related symptom episodes in the month before screening — these symptoms include diarrhea, stomach pain, bloating, nausea, or tiredness.
• You must be willing to have 2 internal camera examinations of your upper digestive tract (called endoscopies), which include taking small tissue samples from your small intestine.
• A tissue sample must show that there is still ongoing damage to the lining of your small intestine (confirm with trial site).

Who may not be able to join:

• You may not be eligible if you have been diagnosed with, or are suspected to have, a more severe form of celiac disease called Refractory Celiac Disease.
• You may not be eligible if you have a history of allergic reactions triggered by wheat, barley, rye, or certain ingredients used in the study products such as methylcellulose or gelatin.
• You may not be eligible if you have been diagnosed with cancer, including blood cancers or solid tumours, within the past 5 years, or if you have ever been diagnosed with T cell or B cell lymphoma.
• You may not be eligible if you have had a serious allergic reaction (including anaphylaxis) to a biological medicine or any of its ingredients.
• You may not be eligible if your genetic test shows you carry a different genetic marker called HLA-DQ8 (confirm with trial site).
• You may not be eligible if you have any other ongoing digestive condition — such as inflammatory bowel disease, irritable bowel syndrome, or acid reflux — that could affect the study results.
• You may not be eligible if tests show you currently have a stomach infection called Helicobacter pylori.
• You may not be eligible if your screening blood test is positive for HIV.
• You may not be eligible if your screening blood test shows signs of a current hepatitis B infection.
• You may not be eligible if your screening blood test is positive for hepatitis C, unless a follow-up test confirms the virus is not active in your body.
• You may not be eligible if a specific test shows you have active tuberculosis (TB) at the time of screening.

Important: Always verify eligibility with the trial site directly before applying.