Clinical trial with ZED1227 capsules compared to placebo in subjects with celiac disease during a 6-week treatment.

Phase 1

• Conditions: Treatment of celiac disease; MedDRA version: 20.0Level: LLTClassification code 10007864Term: Celiac diseaseSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-002241-30-AT
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-31
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Men or women between 18 and 64 years of age, inclusively
• Documented initial biopsy proven diagnosis of celiac disease at least 12 months prior to screening
• Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease
• Negative TG2-IgA serology
• Successful adherence to a gluten-free diet for at least 12 months
• 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 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Selective immunoglobulin A deficiency,
• IgE-specific antibodies against wheat or gliadin,
• Refractory celiac disease defined as persistent or recurrent malabsorptive symptoms and signs
• Severe complications of celiac disease
• Any concomitant diseases of the intestinal tract in addition to celiac disease
• Diabetes mellitus type 1
• Evidence of relevant systemic disease

Study & Design

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