Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease

  • STATUS
    Recruiting
  • days left to enroll
    7
  • participants needed
    15
  • sponsor
    Oslo University Hospital
Updated on 1 May 2021

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.

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-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.

Details
Condition Celiac Disease, Celiac Disease, celiac, celiac sprue
Treatment Teriflunomide Oral Tablet
Clinical Study IdentifierNCT04806737
SponsorOslo University Hospital
Last Modified on1 May 2021

Eligibility

Yes No Not Sure

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
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