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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002241-30-LT

Enrollment

160

Registered

2017-12-21

Start date

2018-01-30

Completion date

Unknown

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of celiac disease MedDRA version: 20.0 Level: LLT Classification code 10007864 Term: Celiac disease System Organ Class: 100000004856

Interventions

Product Code: ZED1227 10 mg capsules Pharmaceutical Form: Capsule, hard INN or Proposed INN: ZED1227 Current Sponsor code: ZED1227 Concentration unit: mg milligram(s) Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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 • To assess plasma concentration of ZED1227 within the treatment phase and at Final/Withdrawal Visit • To study safety and tolerability in terms of adverse events and laboratory parameters • To assess subjects’ quality of life ;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)	—

Measure

Time frame

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 • To assess plasma concentration of ZED1227 within the treatment phase and at Final/Withdrawal Visit • To study safety and tolerability in terms of adverse events and laboratory parameters • To assess subjects’ quality of life ;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)

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Secondary

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

Measure

Time frame

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

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Countries

Austria, Estonia, Finland, Germany, Ireland, Lithuania, Norway, Switzerland

Contacts

Public ContactDept. of Clinical Research & Develo

Dr. Falk Pharma GmbH

mohrbacher@drfalkpharma.de+49 7611514 156

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026