Treatment of celiac disease MedDRA version: 20.0 Level: LLT Classification code 10007864 Term: Celiac disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 Visit 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
Exclusion criteria
Exclusion criteria: •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], •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess 3 different doses and 2 different dosing schedules of ZED1227 capsules for efficacy in improvement of the duodenal mucosal morphology and improvement of celiac disease symptoms assessed by Celiac Disease Symptom Diary (CDSD) in celiac disease subjects experiencing symptoms and having mucosal damage despite gluten-free diet.;Secondary Objective: To assess efficacy of ZED1227 capsules for • Improvement and changes of duodenal mucosal morphology as measured by morphometry (VH:CrD), • Improvement in the Marsh-Oberhuber grouped classes, • Improvement and changes of celiac disease symptoms assessed by CDSD, • Changes of inflammatory cell subsets in duodenal biopsies, • Changes in serum markers of celiac inflammation, • Safety and tolerability in terms of adverse events and laboratory parameters, • Subjects’ quality of life.;Primary end point(s): Multi-component endpoint: -improvement of intestinal mucosal morphology -improvement in Non-Stool GI Specific Symptom Score OR as an improvement in Diarrhoea Severity Score ;Timepoint(s) of evaluation of this end point: 12 weeks, from Baseline Visit B1 (week 5) to Visit 7 (week 17) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Improvement of intestinal mucosal morphology • Changes in intestinal mucosal morphology • Changes in Patient Reported Outcomes (PRO) • Change in health-related quality of life (EQ-5D-5L) • Change in serological markers;Timepoint(s) of evaluation of this end point: 12 weeks, from Baseline Visit B1 (week 5) to Visit 7 (week 17) | — |
Countries
Australia, Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Estonia, Finland, France, Germany, Ireland, Italy, Lithuania, New Zealand, North Macedonia, Norway, Poland, Romania, Serbia, Spain, Sweden, Switzerland
Contacts
Public ContactDept. of Clinical Research & Develo
Dr. Falk Pharma GmbH
Outcome results
None listed