E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fistulizing perianal Crohn's Disease |
Malattia di Crohn perianale fistolizzante |
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E.1.1.1 | Medical condition in easily understood language |
Inflammatory bowel disease (IBD) |
Malattia infiammatoria intestinale (IBD) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10075465 |
E.1.2 | Term | Fistulizing Crohn's disease |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10075465 |
E.1.2 | Term | Fistulizing Crohn's disease |
E.1.2 | System Organ Class | 100000004856 |
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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 |
- To evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease - To assess the overall safety of guselkumab |
- Valutare l'efficacia clinica di guselkumab nel morbo di Crohn fistolizzante perianale - Valutare la sicurezza complessiva di guselkumab |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Non applicabile |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Other types of substudies Specify title, date and version of each substudy with relative objectives: - Optional Pharmacogenomic (DNA) Evaluations: A pharmacogenomic blood sample will be collected from participants who consent separately to this component of the study to allow for pharmacogenomic research, as necessary (where local regulations permit). Participant participation in pharmacogenomic research is optional.
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Altre tipologie di sottostudi specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: - Valutazioni farmacogenomiche (DNA) opzionali: Un campione di sangue farmacogenomico sarà raccolto dai partecipanti che acconsentono separatamente a questa componente dello studio per consentire la ricerca farmacogenomica, se necessario (ove le normative locali lo consentano). La partecipazione dei partecipanti alla ricerca farmacogenomica è facoltativa.
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E.3 | Principal inclusion criteria |
1. Aged 18 years or over. 2. Diagnosis of Crohn's disease with a minimum duration of at least 3 months 3. At least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening MRI results 4.1 Is naïve to biologics, or has previously demonstrated lack of initial response non-responders, responded initially but then lost response with continued therapy, or were intolerant to a maximum of 2 classes of biologic agents at a dose approved for the treatment of Crohn's disease OR History of failure to respond to, or tolerate, at least 1 of the following therapies for the treatment of Crohn's disease: oral corticosteroids (including budesonide and beclomethasone dipropionate) or immunomodulators (AZA, 6-MP, MTX) 5.1 Had a history of failure to respond to, or tolerate, at least 1 of the following therapies for fistula treatment: antibiotics.
Please refer to protocol section 5.1 for the complete list of inclusion criteria. |
1. Di età pari o superiore a 18 anni. 2. Diagnosi della malattia di Crohn con durata minima di almeno 3 mesi. 3. Almeno una fistola perianale drenante attiva come complicanza del morbo di Crohn, confermata dai risultati dello screening MRI. 4.1 Naïve agli agenti biologici, o ha precedentemente dimostrato la mancanza di risposta iniziale non responsivi, ha risposto inizialmente ma poi ha perso la risposta continuando la terapia o era intollerante a un massimo di 2 classi di agenti biologici a una dose approvata per il trattamento della malattia di Crohn. OPPURE Storia di mancata risposta o tolleranza ad almeno 1 delle seguenti terapie per la cura della malattia di Crohn: corticosteroidi orali (compresi budesonide e beclometasone dipropionato) o immunomodulatori (AZA, 6-MP, MTX) 5.1 Ha avuto una storia di mancata risposta o tolleranza almeno a 1 delle seguenti terapie per il trattamento delle fistole: antibiotici.
Fare riferimento al protocollo sezione 5.1 per l'elenco completo dei criteri di inclusione. |
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E.4 | Principal exclusion criteria |
1. Has a very severe luminal disease activity (defined as CDAI =350). 2. Has any of the following: - history of or concurrent rectovaginal fistulas, rectal and/or anal stenosis, diverting stomas with anastomotic leakage, abscess or collections which are not properly drained. - colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus. 3. Has current complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude any fistula evaluation (both clinical and radiological) to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab. Please refer to protocol section 5.2 for the complete list of exclusion criteria. |
1. Ha un'attività di malattia luminale molto grave (definita come CDAI >o= 350). 2. Ha una delle seguenti caratteristiche: - storia di fistole rettovaginali o concomitanti, stenosi rettale e/o anale, stomi devianti con perdite anastomotiche, ascessi o raccolte non adeguatamente drenate. - displasia della mucosa del colon o lesioni precancerose non rimosse, malattia demielinizzante o lupus eritematoso sistemico. 3. Presenta complicanze attuali della malattia di Crohn, come stenosi o stenosi sintomatiche, sindrome dell'intestino corto o qualsiasi altra manifestazione che potrebbe richiedere un intervento chirurgico, potrebbe precludere qualsiasi valutazione della fistola (sia clinica che radiologica) per valutare la risposta alla terapia, o potrebbe confondere la capacità di valutare l'effetto del trattamento con guselkumab. Fare riferimento al protocollo sezione 5.2 per l'elenco completo dei criteri di esclusione. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24 |
L'endpoint primario di questo studio è la percentuale di partecipanti che ottengono la remissione combinata della fistola alla settimana 24 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Week 24 |
Alla Settimana 24 |
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E.5.2 | Secondary end point(s) |
Major Secondary Endpoints: 1 Combined fistula remission 2 Clinically assessed fistula remission 3 Radiological fistula remission based on radiological findings assessed by MRI 4 Clinically assessed fistula response at Week 24 5 clinically assessed fistula response at Week 12 |
Principali endpoint secondari: 1 - Remissione fistola combinata 2 - Remissione fistola clinicamente valutata 3 - Remissione radiologica della fistola sulla base dei risultati radiologici valutati mediante risonanza magnetica 4 - Risposta fistola clinicamente valutata alla Settimana 24 5 - Risposta fistola clinicamente valutata alla Settimana 12 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints of Major Secondary Endpoints: 1 - Combined fistula remission at Week 48 2 - Clinically assessed fistula remission at Week 24 3 - Radiological fistula remission based on radiological findings assessed by MRI at Week 24 4 - Clinically assessed fistula response at Week 12 and 24 |
Tempi di rilevazione degli endpoint secondari principali: 1 - Remissione fistola combinata alla settimana 48 2 - Remissione fistola clinicamente valutata alla settimana 24 3 - Remissione della fistola radiologica sulla base dei risultati radiologici valutati mediante risonanza magnetica alla settimana 24 4 - Risposta della fistola valutata clinicamente alla settimana 12 e 24 |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Immunogenicity, Patient-Reported Outcome (PRO) |
Immunogenicità, esito riportato dal paziente (PRO) |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 3 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Egypt |
Israel |
Japan |
Jordan |
Korea, Republic of |
Saudi Arabia |
Taiwan |
United States |
France |
Poland |
Sweden |
Netherlands |
Spain |
Czechia |
Germany |
Greece |
Italy |
Belgium |
Hungary |
Portugal |
Russian Federation |
Turkey |
Ukraine |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 13 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 27 |