Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease

Phase 1

Completed

• Conditions: Celiac Disease
• Interventions: Drug: Teriflunomide Oral Tablet

• Registration Number: NCT04806737
• Lead Sponsor: Oslo University Hospital

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 challenge. This will be measured in a blood sample.

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-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.

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-19
• Study Start: 2021-04-16
• Primary Completion: 2022-10-15
• Study Completion: 2023-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMP	Teriflunomide Oral Tablet	Teriflunomide 14 mg tablets, first 7 days 5 tablets once pr day, thereafter 1 pr day for another 6 days.
Placebo	Teriflunomide Oral Tablet	Sham tablets

Primary Outcome Measures

Name	Time	Method
Adaptive T cell activation	Blood sample on the 4th day after a 3 day gluten challenge	Expression of CD38 on HLA-DQ:gluten tetramer positive T cells

Trial Locations

Locations (1)

Dept of Gastroenterology; 🇳🇴 Oslo, Norway