A clinical trial to evaluate ZED1227 in comparison with placebo in subjects with celiac disease experiencing symptoms despite gluten-free diet
- Conditions
- Treatment of celiac diseaseMedDRA version: 20.0Level: LLTClassification code 10007864Term: Celiac diseaseSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2020-004612-97-EE
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
•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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method