Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Celiac Disease

Clinical Trial Details

NCT number	NCT04806737
Study type	Interventional
Source	Oslo University Hospital
Contact	Siv Furholm, BSc
Phone	+4747408122
Email	siv.k.b.furholm@medisin.uio.no
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	April 16, 2021
Completion date	August 15, 2022

View Details

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