E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
CROHN'S DISEASE IN REMISSION PHASE |
MORBO DI CROHN IN REMISSIONE |
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E.1.1.1 | Medical condition in easily understood language |
CROHN'S DISEASE IN REMISSION PHASE |
MORBO DI CROHN IN REMISSIONE |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021315 |
E.1.2 | Term | Ileitis terminal |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluation of safety of GED-0301, oral administration in a long-term study. |
Valutazione della sicurezza di GED-0301, somministrazione orale, in uno studio a lungo termine. |
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E.2.2 | Secondary objectives of the trial |
Evaluation of efficacy of GED-0301 in the maintenance of Remission in patients with Crohn’s disease, defined as % of patients in remission (CDAI <150) at Week 16 and at Week 36 |
Valutazione di efficacia di GED-301-01-11 nel mantenimento della Remissione in pazienti con Morbo di Crohn,definito come % di pazienti in remissione (CDA I<150) alla Settimana 16 ed alla Settimana 36. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1 Written informed consent, personally signed and dated by the patient prior any study-related procedures is carried out. 2 Patients in remission of Crohn’s disease at the end (Week 12) of the lead-in study.( I.G.O.N. 1 Study - Prot.GED-301-01-11) 3 Female patients not of childbearing potential (women in menopause defined as surgically sterile or one year postmenopausal); female patients of childbearing potential upon negative pregnancy testing at enrollement and using effective method of birth control during the study. 4 Ability to understand and comply with study procedures and restrictions. |
1. Consenso informato scritto, firmato e datato personalmente dal paziente prima dell’esecuzione di qualsiasi procedura dello studio deve essere raccolto. 2 Pazienti con morbo di Crohn in remissione alla fine (Settimana 12) dello studio preliminare ( studio I.G.O.N. 1 - Prot.GED-301-01-11) 3 Pazienti di sesso femminile potenzialmente non fertili (donne in menopausa definite come intervento chirurgico di sterilità o in postmenopausa da un anno); pazienti di sesso femminile potenzialmente fertili con test di gravidanza negativo all’arruolamento e che facciano uso di un valido metodo contraccettivo durante lo studio. 4 Capacità di comprendere e di attenersi alle procedure e restrizioni dello studio. |
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E.4 | Principal exclusion criteria |
1. Pregnant or breast-feeding women. 2. Screening laboratory values within the following parameters: APTT > 1.5 ULN platelet count ≤100,000 /mm3 serum creatinine>1.5 ULN total bilirubin >1.5 ULN (excluding Gilbert Syndrome) AST and ALT >1.5 ULN. 3. QTc interval >450 msec for males and >470 msec for females 4. Any medical disorder emerged during/after the participation in IGON 1 that may require treatment (e.g. renal or hepatic impairment) or that make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures |
1. Donne in gravidanza o in corso di allattamento. 2. Valori dei parametri di laboratorio allo screening con i seguenti valori: APTT > 1.5 ULN Conta delle piastrine ≤100,000 /mm3) Creatinina serica >1.5 ULN Bilirubina totale >1.5 ULN (esclusa la Sindrome di Gilbert) AST e ALT >1.5 ULN 3. Intervallo QTc >450 msec per I maschi e >470 msec per le femmine 4. Qualsiasi disturbo di natura medica emerso durante/prima la partecipazione ad IGON 1 che può richiedere trattamento (es. processi degenerativi renali o epatici) o che può compromettere il completamento dello studio da parte del paziente o qualsiasi altra condizione considerata rischiosa in seguito all’assunzione del farmaco sperimentale o alle procedure dello studio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of safety of GED-0301, oral administration in a long-term study. |
Valutazione della sicurezza di GED-0301, somministrazione orale, in uno studio a lungo termine. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 16 e Week 36 |
Settimana 16 e settimana 36 |
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E.5.2 | Secondary end point(s) |
Evaluation of efficacy of GED-0301 in the maintenance of Remission in patients with Crohn’s disease, defined as % of patients in remission (CDAI <150) at Week 16 and at Week 36 |
Valutazione di efficacia di GED-301-01-11 nel mantenimento della Remissione in pazienti con Morbo di Crohn, definito come % di pazienti in remissione (CDA I<150) alla Settimana 16 ed alla Settimana 36. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16 and Week 36 |
Settimana 16 e settimana 36 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |