Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease

Celiac Disease Clinical Trial

Official title:

A Phase IIa, Double-blind, Randomised, Placebo-controlled Study on the Efficacy and Tolerability of a 14-day Treatment With Teriflunomide vs. Placebo in Subjects With Coeliac Disease Undergoing a 3-day Gluten Challenge

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806737
• Other study ID #: 2020-002307-18
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 16, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: April 2021
• Source: Oslo University Hospital
• Contact: Siv Furholm, BSc
• Phone: +4747408122
• Email: siv.k.b.furholm[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

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.

Locations

Country	Name	City	State
Norway	Dept of Gastroenterology	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adaptive T cell activation	Expression of CD38 on HLA-DQ:gluten tetramer positive T cells	Blood sample on the 4th day after a 3 day gluten challenge