Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04806737
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Oslo University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pål-Dag Line, MD, PhDKnut EA Lundin, MD, PhD
Principal Investigator Affiliation	Oslo University HoapitalOslo University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Norway
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease

Additional Details

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.#46; 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.

Arms & Interventions

Arms

Active Comparator: IMP

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

Placebo Comparator: Placebo

Sham tablets

Interventions

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.

Contact a Trial Team

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International Sites

Dept of Gastroenterology, Oslo, Norway

Status

Recruiting

Address

Dept of Gastroenterology

Oslo, , 0881

Site Contact

Knut Erik A Lundin, MD, PhD

k.e.a.lundin@medisin.uio.no

90980325

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