E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative colitis |
COLITIS ULCEROSA |
|
E.1.1.1 | Medical condition in easily understood language |
A form of inflammatory bowel disease. |
Un tipo de enfermedad inflamatoria intestinal |
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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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
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 efficacy of etrolizumab compared with placebo for the induction of remission in patients with ulcerative colitis at Week 14. ? To evaluate the efficacy of etrolizumab compared with placebo for maintenance of remission at Week 66 for randomized patients in remission at Week 14 |
? Evaluar la eficacia de etrolizumab en comparación con placebo para la inducción de la remisión en pacientes con colitis ulcerosa en la semana 14. ? Evaluar la eficacia de etrolizumab en comparación con placebo para el mantenimiento de la remisión en la semana 66 para los pacientes aleatorizados en remisión a la semana 14. |
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E.2.2 | Secondary objectives of the trial |
? To evaluate induction of clinical remission at Week 14 ? To evaluate maintenance of clinical remission at Week 66 in patients in clinical remission at Week 14 ? To evaluate the overall safety and tolerability of etrolizumab compared with placebo during induction and maintenance therapy over a period of 66 weeks |
? Evaluar la inducción de la remisión clínica en la semana 14 ? Evaluar el mantenimiento de la remisión clínica en la semana 66 en pacientes en remisión clínica en la semana 14 ? Evaluar la seguridad y tolerabilidad generales de etrolizumab en comparación con el placebo durante el tratamiento de inducción mantenimiento durante un período de 66 semanas |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? 18-80 years of age, inclusive. ? Moderately to severely active ulcerative colitis (UC) as determined by the Mayo Clinic Score assessment (MCS). ? Intolerance, loss of response or failure to respond to treatment with at least one TNF-inhibitor within the previous 5 years. ? Background regimen for UC may include oral 5-ASA, oral corticosteroids, budenoside MMX, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period. ? Use of highly effective contraception as defined by the protocol. |
? De 18 a 80 años de edad, ambas inclusive ? Colitis ulcerosa (CU) activa de moderada a grave según se determine mediante la MCS ? Intolerancia o resistencia a uno o dos de los siguientes inhibidores del FNT en los 5 años anteriores ? El tratamiento previo contra la CU puede incluir 5-ASA, corticoesteroides por vía oral, MMX de budesonida, probióticos, AZA, 6-MP o MTX, siempre que las dosis se hayan mantenido estable durante el periodo de screening |
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E.4 | Principal exclusion criteria |
-A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis,suspicion of ischemic colitis,radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps. -Prior or planned surgery for UC. -Past or present ileostomy or colostomy. -Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol. -Chronic hepatitis B or C infection, HIV, or tuberculosis (active or latent). |
- Antecedentes o condición y enfermedades actuales que afecten al tracto digestivo, como colitis indeterminada, sospecha de colitis isquémica, colitis por radiación, o colitis microscópica, enfermedad de Crohn, fístula o absceso abdominal, displasia de la mucosa del colon, alguna constricción (estenosis) del colon, megacolon tóxico, o pólipos adenomatosos del colon que no se han eliminado -Operación quirúrgica anterior o prevista para la CU Ileostomía o colostomía anterior o presente -Haber recibido tratamiento no permitido para la enfermedad inflamatoria intestinal (incluidos natalizumab, vedolizumab y efalizumab) tal como se describe en el protocolo - Infección por hepatitis B o C crónica, VIH, o tuberculosis (activa o latente) |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Remission as determined by the Mayo Clinic Score (MCS). 2) Remission maintenance among patients with remission at Week 14. Measured by MCS. |
? Remisión según se determine mediante la puntuación de la clínica Mayo (MCS) ? Mantenimiento de la remisión para los pacientes aleatorizados en remisión a la semana 14. Mediante la puntuación de MCS |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) at week 14 2) at week 66 |
1) en la semana 14 2) en la semana 66 |
|
E.5.2 | Secondary end point(s) |
Clinical remission as determined by MCS. |
Remisión clínica según se determine mediante la puntuación de MCS |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At week 14 and 66 |
En la semana 14 y 66 |
|
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 | Yes |
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 |
Assessment of dynamic biomarker; retention of samples for genetic analysis; health-related quality of life (QOL) |
Evaluación de biomarcadores dinámicos, retención de muestras para análisis genético, cuestionario de CdV relacionado con la salud |
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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 | Yes |
E.8.1.7.1 | Other trial design description |
Cohort 1 (open label) and Cohort 2 (blinded) |
|
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 | 5 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 112 |
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 |
Argentina |
Australia |
Austria |
Belgium |
Brazil |
Canada |
Czech Republic |
Denmark |
France |
Germany |
Greece |
Hungary |
Israel |
Italy |
Korea, Republic of |
Lithuania |
Mexico |
Netherlands |
Spain |
Switzerland |
United Kingdom |
United States |
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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
|
The end of the study is defined as the last patient last safety follow up visit in this protocol or last patient transferred to the OLE SM study, whichever is later. |
El final del estudio se define como la última visita de seguimiento de la seguridad del último paciente en este protocolo o el último paciente transferido al estudio OLE-SM, lo que ocurra más tarde. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |