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12月13日最近更新: 2024年2月19日

研究概览

暂无简介。

•Signed informed consent
•Men or women between 18 and 80 years of age, inclusively
•Documented initial biopsy proven diagnosis of celiac disease or, in case of missing histological documentation, TG2-IgA > 10 x upper limit
•of normal (ULN) at diagnosis 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 A, Visit 2, and Baseline Viist B
•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

•Presence of hypo- or hyperthyroidism
•Subjects diagnosed to have confirmed refractory celiac disease type I (RCDI) or II (RCDII, with the exception that patients with a diagnosis of RCDI can be considered for inclusion if they do not have clear signs of
•T cell monoclonality or atypical T cells and if they do not present with very severe symptoms and/or parameters of significant malabsorption
•and if they have not received prior treatment with immunosuppressants such as budesonide or azathioprine
•Severe complications of celiac disease [e.g., enteropathy associated
•Tcell lymphoma (EATL), ulcerative jejunitis, perforation]
•Any concomitant diseases of the intestinal tract in addition to celiac disease that might, in the investigator's opinion, interfere with
•assessment of symptoms of abdominal pain, diarrhoea, or other components of celiac disease
•Evidence of relevant systemic disease

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