A phase IIb, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet

Dr. Falk Pharma GmbH0 个研究点目标入组 400 人开始时间: 2021年8月2日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•Documented initial biopsy proven diagnosis of celiac disease at least 12 months prior to V0
•Adherence to a gluten-free diet (GFD) for at least 12 months prior to V0
•Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease
•At least one moderate or severe gastrointestinal symptom (i.e., diarrhoea, abdominal pain, bloating or nausea) during the last 4 weeks prior to Baseline Visit
•Negative diagnosis of Helicobacter pylori infection
•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 330
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•Selective immunoglobulin A deficiency
•Subjects diagnosed to have confirmed refractory celiac disease type I or II
•Severe complications of celiac disease
•Any concomitant diseases of the intestinal tract in addition to celiac disease
•Evidence of relevant systemic disease
•Suspicion of acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or confirmed diagnosis of acute coronavirus disease 2019 (COVID-19)

发起方