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-DE
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-04
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

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

Inclusion Criteria

• Men or women between 18 an 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

Primary Outcome Measures

Name	Time	Method
Main Objective: • To assess the efficacy of 3 different doses of ZED1227 capsules for prevention of gluten-induced mucosal changes in subjects with well-controlled celiac disease undergoing gluten challenge;Secondary Objective: • To assess efficacy of ZED1227 capsules in preventing the occurrence of celiac disease symptoms in subjects<br>• To assess plasma concentration of ZED1227 within the treatment phase and at Final/Withdrawal Visit<br>• To study safety and tolerability in terms of adverse events and laboratory parameters<br>• To assess subjects’ quality of life<br>;Primary end point(s): Attenuation of gluten-induced change in intestinal mucosal morphology upon biopsy morphometrically measured;Timepoint(s) of evaluation of this end point: From baseline to week 6 (Visit 4)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Attenuation of gluten-induced duodenal mucosal inflammation <br>2. Attenuation of gluten-induced duodenal mucosal morphological injury <br>3. Plasma concentrations of ZED1227 and its metabolites <br>4. Patient-reported outcome<br>5. Serological markers<br><br>Safety endpoints:<br>6. Adverse Events (AEs)<br>7. Vital signs and body weight<br>8. Haematology, blood chemistry, urinalysis<br>9. Assessment of tolerability by investigator and subject<br>;Timepoint(s) of evaluation of this end point: 1.-2. From baseline to week 6 (Visit 4)<br>3. Week 2 (visit 2) - week 6 (Visit 4)<br>4. Week 0 (Visit 1) - week 10 (Visit 5)<br>5. From baseline to week 6 (Visit 4)<br>6.-8. Week -6 (Visit 0) - week 10 (Visit 5)<br>9. Week 6 (Visit 4)