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

• Register: EUCTR
• Last refreshed on: 1 February 2020
• Main ID: EUCTR2017-002241-30-IE
• Date of registration: 04/05/2018
• Prospective Registration: Yes
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: Clinical trial with ZED1227 capsules compared to placebo in subjects with celiac disease during a 6-week treatment.
• Scientific title: 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
• Date of first enrolment: 06/07/2018
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002241-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Dept. of Clinical Research & Develo
• Affiliation: Dr. Falk Pharma GmbH

• Name: Dept. of Clinical Research & Develo
• Affiliation: Dr. Falk Pharma GmbH

Key inclusion & exclusion 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

Intervention(s)

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
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Code: ZED1227 50 mg capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ZED1227
Current Sponsor code: ZED1227
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Code: ZED1227 100 mg capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ZED1227
Current Sponsor code: ZED1227
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: From baseline to week 6 (Visit 4)

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

Secondary Outcome(s)

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)

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

Secondary ID(s)

2017-002241-30-LT

CEC-3/CEL

Source(s) of Monetary Support

Dr. Falk Pharma GmbH

Ethics review

Status: Approved
Approval date: 17/05/2018
Contact: