Status:
COMPLETED
Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease
Lead Sponsor:
Oslo University Hospital
Conditions:
Celiac Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
This is a controlled, double-blind, randomised, singlecentre, placebo-controlled, phase IIa proof-of-concept study on effects of the drug on activation and efflux of gluten specific T cells using HLA-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04806737
Start Date
April 16 2021
End Date
December 31 2023
Last Update
May 16 2025
Active Locations (1)
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1
Dept of Gastroenterology
Oslo, Oslo County, Norway, 0881