EUCTR2017-002241-30-FIActive, not recruitingPhase 1
A phase IIa, double-blind, randomised, placebo-controlled, dose-finding study on the efficacy and tolerability of a 6-week treatment with ZED1227 capsules vs. placebo in subjects with well-controlled celiac disease undergoing gluten challenge - ZED1227 capsules vs. placebo in celiac disease
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •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
Investigators
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