Celiac Disease Clinical Trial
Official title:
A Phase IIa, Double-blind, Randomised, Placebo-controlled Study on the Efficacy and Tolerability of a 14-day Treatment With Teriflunomide vs. Placebo in Subjects With Coeliac Disease Undergoing a 3-day Gluten Challenge
The investigators will see if the drug teriflunomide (which is in use in other immune disorder (multiple sclerosis)) can inhibit the immune activation in celiac disease patients during a 3 day gluten challenge. This will be measured in a blood sample.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | August 15, 2022 |
Est. primary completion date | August 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patient aged 18-80 - Willingness to comply with the study procedures and having signed informed, written consent - Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and/or IgGDGP) and a duodenal biopsy showing villous atrophy graded as Marsh 3 - Positive gene test for HLA-DQ2.5 - Adherence to gluten-free diet Exclusion Criteria: - Known intolerance to ingredients of teriflunomide or placebo tablets - Known intolerance to gluten challenge - Known intolerance to cholestyramine - Duration of gluten free diet shorter than six months - Positive serology (IgA-TG2 below upper level of normal) at screening visit - Pregnancy or breast-feeding - Not willing to comply with proper pregnancy control (in females) - Concomitant medication that interferes with immune activation (e.g. steroids, calcineurin inhibitors, biological treatment for inflammatory bowel disease or other immune disorders, further list is given below) - Any other medical condition that in the opinion of the principal investigator makes the individual unsuitable for participation |
Country | Name | City | State |
---|---|---|---|
Norway | Dept of Gastroenterology | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adaptive T cell activation | Expression of CD38 on HLA-DQ:gluten tetramer positive T cells | Blood sample on the 4th day after a 3 day gluten challenge |
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