A clinical trial to evaluate ZED1227 in comparison with placebo in subjects with celiac disease experiencing symptoms despite gluten-free diet

Phase 1

• Conditions: Treatment of celiac disease; MedDRA version: 20.0Level: LLTClassification code 10007864Term: Celiac diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-004612-97-DE
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-28
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified