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

Oslo University Hospital0 个研究点目标入组 15 人开始时间: 2020年7月6日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•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

•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

发起方

Oslo University Hospital