Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease

University of Oslo (UIO)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Celiac Disease

Treatments: Drug: Teriflunomide Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04806737

2020-002307-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

IMP

Active Comparator group

Description:

Teriflunomide 14 mg tablets, first 7 days 5 tablets once pr day, thereafter 1 pr day for another 6 days.

Treatment:

Drug: Teriflunomide Oral Tablet

Placebo

Placebo Comparator group

Description:

Sham tablets

Treatment:

Drug: Teriflunomide Oral Tablet