E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fistulizing perianal Crohn's Disease |
Enfermedad de Crohn perianal fistulizante |
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E.1.1.1 | Medical condition in easily understood language |
Inflammatory bowel disease (IBD) |
Enfermedad intestinal inflamatoria |
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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.1.3 | 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 |
-Evaluar la eficacia clínica de guselkumab en la enfermedad de Crohn perianal, fistulizante -Evaluar la seguridad total de guselkumab |
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E.2.2 | Secondary objectives of the trial |
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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 |
- 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. |
-Evaluaciones farmacogenómicas opcionales (DNA): Se tomará una muestra de sangre para farmacogenómica de los participantes que den su consentimiento aparte para el componente de investigación farmacogenómica del estudio, según se precise (si la normativa local lo permite). La participación en la investigación farmacogenómica es opcional para el participante. |
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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.
Please refer to protocol for the complete list of inclusion criteria. |
1. De 18 años o mayores 2. Diagnóstico de enfermedad de Crohn con un mínimo de duración de al menos 3 meses 3. Por lo menos una fístula perianal activa derivada de la enfermedad de Crohn, confirmada por los resultados de la MRI de la selección
Para información sobre la lista completa de criterios de inclusión, consulte el protocolo |
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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 (unless the participant undergoes surgical dilation prior to baseline), 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 for the complete list of exclusion criteria. |
1. Presenta enfermedad luminal de actividad muy severa (definida como CDAI >/=350). 2. Presenta cualquiera de lo siguiente: - historia de los siguientes procesos concomitantes: fístulas rectovaginales, estenosis rectal y/o anal (salvo si el participante hubiera sido sometido a dilatación quirúrgica antes del momento basal), estomas derivativos con fuga anastomótica, abscesos o acumulaciones líquidas que no drenan adecuadamente. -displasia de mucosa o lesiones precancerosas colónicas que no se han extirpado, enfermedad desmielinizante o lupus eritematoso sistémico. 3. Presenta actualmente complicaciones de la enfermedad de Crohn, como constricciones o estenosis sintomáticas, síndrome de intestino corto o cualquier otra manifestación que previsiblemente pudiera requerir cirugía, impedir la evaluación fistular (tanto clínica como radiológica) para la determinación de la respuesta al tratamiento o actuar como factor de confusión en la capacidad de evaluar el efecto del tratamiento con guselkumab.
Por favor consulte el protocolo para la lista completa de criterios de exclusión |
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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 |
El criterio principal de valoración de este estudio es el porcentaje de participantes que logren la remisión combinada de la fístula en la semana 24 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Week 24 |
En la semana 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 |
Criterios secundarios de valoración fundamentales 1 - Remisión combinada de la fístula 2 - Remisión de la fístula según la evaluación clínica 3 - Remisión radiológica de la fístula según los hallazgos radiológicos de la evaluación por MRI 4 - Respuesta de la fístula según la evaluación clínica |
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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 |
Puntos de tiempo de los criterios de valoración secundarios fundamentales: 1 - Remisión combinada de la fístula en la semana 48 2 - Remisión de la fístula según la evaluación clínica en la semana 24 3 - Remisión radiológica de la fístula según los hallazgos radiológicos de la evaluación por MRI en la semana 24 4 - Respuesta de la fístula según la evaluación clínica en las semanas 12 y 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) |
Inmunogenicidad, Resultados proporcionaldos por el paciente (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 | 7 |
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 | 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 |
Canada |
Egypt |
Israel |
Japan |
Jordan |
Korea, Republic of |
Lebanon |
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
|
LVLS |
Última visita del último paciente (LVLP) |
|
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 | 11 |
E.8.9.1 | In the Member State concerned days | 16 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |