Descrizione riassuntiva della sperimentazione (Fonte di dati: 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.
Malattie studiate(Fonte di dati: BASEC)
Zöliakie
Health conditions
(Fonte di dati: 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]
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Wirksamkeit der ZED1227 Kapseln zur unterstützenden Behandlung der Zöliakie.
Interventions
(Fonte di dati: 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
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: 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
Criteri di esclusione
(Fonte di dati: 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
(Fonte di dati: 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
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
4 gen 2018
Inserimento del primo partecipante
20 apr 2018
Stato di reclutamento
Not Recruiting
Titolo scientifico
(Fonte di dati: 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
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional clinical trial of medicinal product
Disegno della sperimentazione
(Fonte di dati: 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
Fase
(Fonte di dati: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no
Punti finali primari
(Fonte di dati: 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)
Punti finali secondari
(Fonte di dati: 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)
Contatto per informazioni
(Fonte di dati: WHO)
Dr. Falk Pharma GmbH
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
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
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Austria, Finland, Germany, Ireland, Lithuania, Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Dr. Falk Pharma GmbH
+49 761 1514 156
mohrbacher@drfalkpharma.de
Contatto per informazioni generali
(Fonte di dati: WHO)
Dept. of Clinical Research & Develo
Leinenweberstr. 5
Dr. Falk Pharma GmbH
+49 7611514 156
mohrbacher@drfalkpharma.de
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Dept. of Clinical Research & Develo
Leinenweberstr. 5
Dr. Falk Pharma GmbH
+49 7611514 156
mohrbacher@drfalkpharma.de
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Kantonale
Ethikkommission Zürich
Data di autorizzazione da parte della commissione d’etica
15.01.2019
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2018-01273
Secondary ID (Fonte di dati: WHO)
CEC-3/CEL
2017-002241-30-LT
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