Brief description of trial (Data source: BASEC)
Die Studie untersucht die Wirksamkeit eines neuen, noch nicht zugelassenen Medikaments (ZED1227), das die durch Gluten auftretenden Schleimhautveränderungen verhindern soll. Jeweils zu Beginn und am Ende der Studie soll eine Dünndarmspiegelung durchgeführt werden, bei der kleine Schleimhautproben (Biopsien) entnommen werden.Die Studie wird mit vier Behandlungsgruppen durchgeführt. 75% der Teilnehmer erhalten Studienmedikation und 25% erhalten ein Scheinmedikament (Placebo). Die Dauer der Teilnahme an der Studie wird in etwa 18 Wochen betragen: die Voruntersuchungsphase dauert bis zu 8 Wochen, gefolgt von einer 6-wöchigen Behandlungsphase sowie einer 4-wöchigen behandlungsfreien Nachbeobachtungs-phase. Alle Teilnehmer sollen ihre seit mindestens einem Jahr bestehende glutenfreie Diät weiterhin strikt einhalten, jedoch während der Behandlungsphase täglich eine definierte Menge Gluten (in Form eines Kekses) zu sich nehmen.
Health conditions investigated(Data source: BASEC)
Zöliakie
Health conditions
(Data source: WHO)
Treatment of celiac disease
MedDRA version: 20.0Level: LLTClassification code 10007864Term: Celiac diseaseSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Wirksamkeit der ZED1227 Kapseln zur unterstützenden Behandlung der Zöliakie.
Interventions
(Data source: WHO)
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
Criteria for participation in trial
(Data source: BASEC)
- Eine durch dokumentierte initiale Biopsie nachgewiesene Zöliakie-Diagnose
mindestens 12 Monate vor dem Screening,
- Vorhandensein der Zöliakie-assoziierten Merkmale des Humanen
Leukozytenantigens DQ (HLA-DQ)
- Negative TG2-IgA Serologie
Exclusion criteria
(Data source: BASEC)
- IgE-spezifische Antikörper gegen Weizen und Gliadin
- Einnahme von Kortikosteroiden oder Immunmodulatoren (z.B.
Glukokortikosteroide, Zyklosporin, Methotrexat, TNF alpha Blocker, Anti-
Integrin Therapie, Januskinase Blocker) innerhalb der letzten 3 Monate vor
der Screening Biopsie Probenentnahme
- Einnahme von nicht-steroidalen entzündungshemmenden Arzneimitteln
(NSAIDs; ausgenommen Acetylsalicylsäure, wenn die Dosis ≤ 350 mg/Tag
ist, Protonenpumpeninhibitoren (PPIs) oder selektive Serotonin-
Wiederaufnahme-Hemmer (SSRIs) innerhalb der letzten 2 Monate vor der
Screening-Biopsie Probenentnahme
Inclusion/Exclusion Criteria
(Data source: WHO)
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
-
Further information on trial
Date trial registered
Jan 4, 2018
Incorporation of the first participant
Apr 20, 2018
Recruitment status
Not Recruiting
Academic title
(Data source: WHO)
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
Type of trial
(Data source: WHO)
Interventional clinical trial of medicinal product
Design of the trial
(Data source: WHO)
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
(Data source: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no
Primary end point
(Data source: WHO)
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)
Secundary end point
(Data source: WHO)
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)
Contact information
(Data source: WHO)
Dr. Falk Pharma GmbH
Trial results
(Data source: WHO)
Results summary
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
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Zurich
Countries
(Data source: WHO)
Austria, Finland, Germany, Ireland, Lithuania, Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. Falk Pharma GmbH
+49 761 1514 156
mohrbacher@drfalkpharma.de
Contact for general information
(Data source: WHO)
Dept. of Clinical Research & Develo
Leinenweberstr. 5
Dr. Falk Pharma GmbH
+49 7611514 156
mohrbacher@drfalkpharma.de
Contact for scientific information
(Data source: WHO)
Dept. of Clinical Research & Develo
Leinenweberstr. 5
Dr. Falk Pharma GmbH
+49 7611514 156
mohrbacher@drfalkpharma.de
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
15.01.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2018-01273
Secondary ID (Data source: WHO)
CEC-3/CEL
2017-002241-30-LT
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