Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease

NCT04806737 | Completed Phase 1 DMC

• 1 other identifier: 2020-002307-18
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

Immunotherapy; Gluten challenge; Teriflunomide

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

IMP

ACTIVE COMPARATOR

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

Drug: Teriflunomide Oral Tablet

Placebo

PLACEBO COMPARATOR

Sham tablets

Drug: Teriflunomide Oral Tablet

Interventions

Teriflunomide Oral Tablet DRUG

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.

Also known as: Gluten challenge

IMP; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Dept of Gastroenterology

Oslo, Oslo County, 0881, Norway

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

teriflunomide

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pål-Dag Line, MD, PhD

  Oslo University Hoapital

  STUDY CHAIR

• Knut EA Lundin, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D., PhD., Consultant gastroenterologist

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: April 16, 2021
• Primary Completion: October 15, 2022
• Study Completion: December 31, 2023
• Last Updated: May 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)