A Phase 1/2 interventional study of Teriflunomide Oral Tablet in Celiac Disease, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Oslo University Hospital · Phase 1/2, Interventional, and Treatment
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.
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-DQ:gluten tetramers. The study will be conducted with two treatment groups in the form of a 2:1 parallel group comparison and will serve to compare oral treatment with 14 mg/d teriflunomide vs. placebo in subjects with well-controlled coeliac disease undergoing gluten challenge. The screening period will be up to 8 weeks, followed by a 7-day run-in treatment period with a loading dose of teriflunomide followed by a 6 day therapeutic maintenance dose, an initial 4-week treatment-free follow-up period and a 6 month closing follow-up.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's enrollment of 15 is below the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
Teriflunomide 14 mg tablets, first 7 days 5 tablets once pr day, thereafter 1 pr day for another 6 days.
Drug: Teriflunomide Oral Tablet
Sham tablets
Drug: Teriflunomide Oral Tablet
The study will be conducted with two treatment groups in the form of a 2:1 parallel group comparison and will serve to compare oral treatment with 14 mg/d teriflunomide vs. placebo in subjects with well-controlled coeliac disease undergoing gluten challenge. The screening period will be up to 8 weeks, followed by a 7-day run-in treatment period with a loading dose of teriflunomide followed by a 6 day therapeutic maintenance dose, an initial 4-week treatment-free follow-up period and a 6 month closing follow-up.
Also known as: Gluten challenge
Adaptive T cell activation
Expression of CD38 on HLA-DQ:gluten tetramer positive T cells
Time frame: Blood sample on the 4th day after a 3 day gluten challenge
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital