E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crohns disease |
Enfermedad de Crohn |
|
E.1.1.1 | Medical condition in easily understood language |
Inflammatory bowel disease, autoimmune disease that causes inflammation in the gut |
Enfermedad inflamatoria intestinal, enfermedad que causa inflamación en el intestino. |
|
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 | 15.0 |
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 |
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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 compare the effect on disease activity of a single i.v. dose of NNC0114-0006 with placebo in subjects with moderately to severely active Crohn?s disease |
Comparar el efecto sobre la actividad de la enfermedad de una dosis única i.v. de NNC0114-0006 con un placebo en sujetos con enfermedad de Crohn de actividad moderada o grave |
|
E.2.2 | Secondary objectives of the trial |
- To describe the pharmacokinetics (PK) of NNC0114-0006 - To compare pharmacodynamic (PD) effects of NNC0114-0006 and placebo - To compare the effects of NNC0114-0006 and placebo on mucosal healing in a subgroup of subjects - To compare the effects of NNC0114-0006 and placebo on the use of concomitant medication for Crohn?s disease - To compare the effects of NNC0114-0006 and placebo on patient reported outcomes (PROs) - To describe the safety and tolerability of NNC0114-0006 - To describe the immunogenicity of NNC0114-0006 |
?Describir la farmacocinética (FC) de NNC0114-0006 ?Comparar los efectos farmacodinámicos (FD) de NNC0114-0006 y del placebo ?Comparar los efectos de NNC0114-0006 y del placebo en la cicatrización de la mucosa en un subgrupo de sujetos ?Comparar los efectos de NNC0114-0006 y del placebo en la utilización de medicación concomitante para la enfermedad de Crohn ?Comparar los efectos de NNC0114-0006 y del placebo en los resultados comunicados por los pacientes (RCP) ?Describir la seguridad y la tolerabilidad de NNC0114-0006 ?Describir la inmunogenicidad de NNC0114-0006. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Moderately to severely active Crohn?s disease, defined as a CDAI of 220-450 (both inclusive) at Visit 2 (Dosing), with evidence of inflammation confirmed by a C-reactive protein (CRP) ?10 mg/L or endoscopic verification (according to endoscopy imaging manual) performed at Visit 1 (Screening). - Men and women between ?18 and ?75 years of age - Biologic-naïve subjects or biologic-experienced for the treatment of Crohn?s disease. Biologic-experienced subjects are eligible if they have not failed more than one marketed biologic therapy for the treatment of Crohn?s disease due to lack of efficacy (primary or secondary efficacy failures). |
?Enfermedad de Crohn de actividad moderada o grave, definida como una puntuación CDAI de 220-450 (ambas inclusive) en la visita 2 (administración), con indicios de inflamación confirmados mediante un valor de proteína C reactiva (PCR) ?10 mg/l o verificación endoscópica (de acuerdo con el manual de endoscopia) obtenida en la visita 1 (selección) ?Varones y mujeres de entre ?18 y ?75 años de edad ?Sujetos tratados o no tratados previamente con fármacos biológicos para la enfermedad de Crohn. Los sujetos tratados previamente con fármacos biológicos son elegibles si no han presentado fracaso a más de un tratamiento biológico para la enfermedad de Crohn debido a falta de eficacia (fracasos de eficacia primario y secundario ). |
|
E.4 | Principal exclusion criteria |
- Body mass index (BMI) ?38.0 kg/m^2 - Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation, total colectomy or subtotal colectomy with less than 20 cm colon remaining, any abscesses not adequately treated - History of dysplasia in the colon |
?Índice de masa corporal (IMC) ?38,0 kg/m2 ?Cualquiera de los criterios siguientes: obstrucción intestinal sintomática, síndrome del intestino corto, ileostomía o colostomía, resección intestinal quirúrgica en los 6 meses previos a la aleatorización, colectomía total o colectomía subtotal con menos de 20 cm de colon conservados, cualquier absceso no tratado debidamente ?Antecedentes de displasia de colon ?Cualquier infección bacteriana activa o en curso en las 4 semanas previas a la aleatorización, salvo que se haya tratado y resuelto con el tratamiento adecuado ?Antecedentes de infecciones recurrentes graves que precisaron hospitalización. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in Crohn?s disease activity index (CDAI) |
Variación del índice de actividad de la enfermedad de Crohn. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to Week 4 |
Desde el momento basal hasta la semana 4 |
|
E.5.2 | Secondary end point(s) |
1. Change in CDAI 2. Clinical remission, defined as CDAI of less than 150 3. Change in the inflammatory bowel disease questionnaire (IBDQ) score 4. Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores 5. Incidence of adverse events (AEs) 6. Incidence of anti-NNC0114-0006 antibodies |
1. Variación de la puntuación del CDAI 2. Remisión clínica, definida como un CDAI menor de 150. 3. Variación de la puntuación del cuestionario de la enfermedad intestinal inflamatoria (inflammatory bowel disease questionnaire, IBDQ) 4. Variaciones de las puntuaciones de los componentes físico y mental del Cuestionario de salud abreviado (Short Form Health Survey, SF-36v2) 5. Incidencia de acontecimientos adversos (AA) 6. Incidencia de anticuerpos anti-NNC0114-0006 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. From baseline to Week 12 2. At Week 8 3. From baseline to Week 4 4. From baseline to Week 4 5. Up to Weeks 24 or 36 6. Up to Weeks 24 or 36 |
1. Desde el momento basal hasta la semana 12. 2. En la semana 8 3. Desde el momento basal hasta la semana 4. 4. Desde el momento basal hasta la semana 4. 5. Hasta las semanas 24 o 36. 6. Hasta las semanas 24 o 36. |
|
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability, immunogenicity, patient reported outcomes |
Tolerabilidad, inmunogenicidad, desenlaces comunicados por los pacientes. |
|
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
Bulgaria |
Czech Republic |
Hungary |
Poland |
Russian Federation |
Serbia |
Slovakia |
Spain |
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
|
LVLS |
Última visita del último paciente. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 9 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 9 |