Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease

• Status: Recruiting
• Trial end date: 2022-08-15
• Target enrollment: 0
• Participant gender: All

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 challenge. This will be measured in a blood sample.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Teriflunomide

Criteria

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