E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to Severely Active Crohn's Disease |
Morbo di Crohn da moderatamente a gravemente attivo |
|
E.1.1.1 | Medical condition in easily understood language |
Inflammatory bowel disease (IBD) |
Malattia infiammatoria intestinale (IBD) |
|
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 | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
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 efficacy, including clinical remission and endoscopic response, of guselkumab SC induction |
- Valutare l'efficacia, inclusa la remissione clinica e la risposta endoscopica, dell'induzione di guselkumab SC |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of guselkumab SC across a range of outcome measures -To evaluate the safety of guselkumab SC |
- Valutare l'efficacia di guselkumab SC attraverso una serie di misure di outcome - Valutare la sicurezza di guselkumab SC |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Clinically active Crohn's disease or fistulizing Crohn's disease of at least 3 months duration 2- Endoscopic evidence of active ileocolonic Crohn's disease 4- Current treatment with oral corticosteroids and/or immunomodulators, OR history of failure to respond to or tolerate oral corticosteroids and/or immunomodulators, OR history of corticosteroid dependence, OR has previously demonstrated lack of initial response, lost response or were intolerant to 1 or more biologic agents.
Please refer to protocol for the overall inclusion criteria |
1- Morbo di Crohn clinicamente attivo o morbo di Crohn fistolizzante della durata di almeno 3 mesi 2- Evidenza endoscopica di malattia di Crohn ileocolonica attiva 4- Trattamento in corso con corticosteroidi orali e/o immunomodulatori, OPPURE storia di mancata risposta o tolleranza ai corticosteroidi e/o immunomodulatori orali, OPPURE storia di dipendenza da corticosteroidi, OPPURE ha precedentemente dimostrato mancanza di risposta iniziale, perdita di risposta o intolleranza a 1 o più agenti biologici.
Fare riferimento al protocollo per tutti i criteri di inclusione |
|
E.4 | Principal exclusion criteria |
1-Has a draining stoma or ostomy. 2- Presence on screening endoscopy or history of adenomatous colonic polyps that were not removed. 3- Has previously received a biologic agent targeting IL-12/23 or IL-23.
Please refer to protocol for the overall exclusion criteria |
1-Ha una stomia o una stomia drenante. 2- Presenza all'endoscopia di screening o storia di polipi adenomatosi del colon che non sono stati rimossi. 3- Ha ricevuto in precedenza un agente biologico mirato a IL-12/23 o IL-23.
Fare riferimento al protocollo per tutti i criteri di esclusione |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1- Clinical remission 2- Endoscopic response |
1- Remissione clinica 2- Risposta endoscopica |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Week 12 |
Alla settimana 12 |
|
E.5.2 | Secondary end point(s) |
1- Clinical remission 2- PRO-2 remission 3- Clinical response |
1- Remissione clinica 2- Remissione PRO-2 3- Risposta clinica |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Clinical remission at Week 24 PRO-2 remission and clinical response at Week 12 |
Remissione clinica alla settimana 24 Remissione PRO-2 e risposta clinica alla settimana 12 |
|
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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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) | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 119 |
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 |
Belarus |
Bosnia and Herzegovina |
Brazil |
Canada |
China |
Georgia |
Japan |
Jordan |
Korea, Republic of |
New Zealand |
Russian Federation |
Serbia |
Taiwan |
Turkey |
Ukraine |
United States |
Belgium |
Croatia |
Czechia |
France |
Germany |
Greece |
Hungary |
Italy |
Lithuania |
Netherlands |
Poland |
Slovakia |
Spain |
United Kingdom |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 | 0 |