A study on the efficacy and tolerability of a 14-day treatment with teriflunomide 14 mg tablets vs. placebo in subjects with well-controlled coeliac disease undergoing a 3-day gluten challenge

A phase IIa, double-blind, randomised, placebo-controlled study on the efficacy and tolerability of a 14-day treatment with teriflunomide 14 mg tablets vs. placebo in subjects with well-controlled coeliac disease undergoing a 3-day gluten challenge

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002307-18-NO

Enrollment

Registered

2020-07-06

Start date

2021-02-10

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coeliac disease MedDRA version: 20.0 Level: PT Classification code 10009839 Term: Coeliac disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Aubagio Product Name: Aubagio Pharmaceutical Form: Capsule INN or Proposed INN: TERIFLUNOMIDE CAS Number: 108605-62-5 Concentration unit: mg milligram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion 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 (IgA-TG2 or IgA Endomysium test) and a duodenal biopsy showing villous atrophy graded as Marsh 3a-3c (1, 2). • Positive gene test for HLA-DQ2.5 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • Known intolerance to investigational medical product teriflunomide • Known intolerance to gluten challenge • 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) • Any other medical condition that in the opinion of the principal investigator makes the individual unsuitable for participation

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy and tolerability of a 14 days treatment with teriflunomide in subjects with well controlled-coeliac disease undergoing a 3-day gluten challenge ;Secondary Objective: Not applicable;Primary end point(s): Induction of the activation marker CD38 on gluten reactive T cells in blood detected by HLA-DQ:gluten tetramers 6 days after the initiation of challenge.;Timepoint(s) of evaluation of this end point: 6 days after the initiation of challenge.	—

Measure

Time frame

Main Objective: To investigate the efficacy and tolerability of a 14 days treatment with teriflunomide in subjects with well controlled-coeliac disease undergoing a 3-day gluten challenge ;Secondary Objective: Not applicable;Primary end point(s): Induction of the activation marker CD38 on gluten reactive T cells in blood detected by HLA-DQ:gluten tetramers 6 days after the initiation of challenge.;Timepoint(s) of evaluation of this end point: 6 days after the initiation of challenge.

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Secondary

Measure	Time frame
Secondary end point(s): • Clinical safety of dosing teriflunomide according to the protocol (loading dose for three days, thereafter 11 days with regular dose) • Clinical safety of gluten challenge in the presence and absence of teriflunomide • Pharmacokinetic and pharmacodynamics aspects of the active drug metabolite triflunomide • Induction of gluten specific T cells binding to HLA-DQ:gluten tetramers in peripheral blood 6 days after the initiation of gluten challenge • Induction of Interleukin-2 and other cytokines in serum measured four hours after initiation of gluten challenge • Presence of gluten-specific T cells as detected with HLA-DQ:gluten tetramers and/or T cell receptor sequencing in blood at follow-up visits ;Timepoint(s) of evaluation of this end point: Please see above.	—

Measure

Time frame

Secondary end point(s): • Clinical safety of dosing teriflunomide according to the protocol (loading dose for three days, thereafter 11 days with regular dose) • Clinical safety of gluten challenge in the presence and absence of teriflunomide • Pharmacokinetic and pharmacodynamics aspects of the active drug metabolite triflunomide • Induction of gluten specific T cells binding to HLA-DQ:gluten tetramers in peripheral blood 6 days after the initiation of gluten challenge • Induction of Interleukin-2 and other cytokines in serum measured four hours after initiation of gluten challenge • Presence of gluten-specific T cells as detected with HLA-DQ:gluten tetramers and/or T cell receptor sequencing in blood at follow-up visits ;Timepoint(s) of evaluation of this end point: Please see above.

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Countries

Norway

Contacts

Public ContactKnut E. A. Lundin

Oslo University Hospital

knut.lundin@ous-hf.no+4790980325

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026