E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to Severely Active Crohn's Disease |
Enfermedad de Crohn activa de grado moderado o severo |
|
E.1.1.1 | Medical condition in easily understood language |
Inflammatory bowel disease (IBD) |
Enfermedad inflamatoria intestinal |
|
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 |
- Evaluar la eficacia, comprendidas la remisión clínica y la respuesta endoscópica, de la inducción con 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 |
- Evaluar la eficacia del guselkumab SC en diversos criterios de valoración
- Evaluar la seguridad del 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- Enfermedad de Crohn clínicamente activa o enfermedad de Crohn fistulizante de como mínimo 3 meses de duración 2- Evidencia endoscópica de enfermedad de Crohn ileocolónica activa 4- Tratamiento actual con corticosteroides orales y/o inmunomoduladores, O antecedente de no respuesta a o intolerancia a corticosteroides orales y/o inmunomoduladores, O antecedente de dependencia de corticosteroides, O demostración previa de ausencia de respuesta inicial, pérdida de la respuesta o intolerancia a 1 o más agentes biológicos.
Para información sobre los criterios completos de inclusión, sírvanse consultar el protocolo |
|
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- Presencia de estoma supurante o de ostomía. 2- Presencia en la endoscopia de cribado o antecedentes de pólipos colónicos adenomatosos que no se extirparon. 3- Tratamiento previo con un agente biológico dirigido frente a IL-12/23 o IL-23.
Para información sobre los criterios completos de exclusión, sírvanse consultar el protocolo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1- Clinical remission 2- Endoscopic response |
1- Remisión clínica 2- Respuesta endoscópica |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Week 12 |
En la semana 12 |
|
E.5.2 | Secondary end point(s) |
1- Clinical remission 2- PRO-2 remission 3- Clinical response |
1 - Remisión clínica 2- Remisión según PRO-2 3- Respuesta clínica |
|
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 |
Remisión clínica en la semana 24 Remisión según PRO-2 y respuesta clínica en la semana 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 | 5 |
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 | No |
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 |
Belgium |
Bosnia and Herzegovina |
Brazil |
Canada |
China |
Croatia |
Czechia |
France |
Georgia |
Germany |
Greece |
Hungary |
Italy |
Japan |
Jordan |
Korea, Republic of |
Latvia |
Netherlands |
New Zealand |
Poland |
Russian Federation |
Serbia |
Slovakia |
Spain |
Taiwan |
Turkey |
Ukraine |
United Kingdom |
United States |
|
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 | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
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 |