E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing multiple sclerosis |
Esclerosis Multiple Remitente Remitente |
|
E.1.1.1 | Medical condition in easily understood language |
Multiple sclerosis with relapses |
Esclerosis multiple con brotes |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system 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 of three doses of AIN457 in reducing the number of new Gadolinium-enhancing lesions on MRI compared to placebo |
Evaluar la eficacia de 3 dosis de AIN457 respecto al placebo, para reducir el número acumulado de nuevas lesiones realzadas con gadolinio. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of 3 doses of AIN457 |
Evaluar la seguridad y tolerabilidad de 3 dosis de AIN457 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosis of multiple sclerosis according to published criteria - Evidence of recent disease activity - Disease duration of no more than 10 years - EDSS score of 0 to 5.0 |
- Diagnostico de EM de acuerdo a los criterios publicados - Evidencia de actividad reciente de la enfermedad - Duración de la enfermedad no mayor de 10 años - EDSS entre 0 y 5
*para mas detalle refierase al protocolo* |
|
E.4 | Principal exclusion criteria |
- Patients with an active chronic disease of the immune system other than multiple sclerosis or with a known immunodeficiency syndrome - History of malignancy - Patients with active infections - Patients who have been previously treated with more than one class of multiple sclerosis disease-modifying therapy - Patients who have been treated with: Interferon-beta or glatiramer acetate within 1 month prior to randomization; Natalizumab within 6 months prior to randomization; Fingolimod within 3 months prior to randomization; Immunosuppressive medications within 6 months prior to randomization; Rituximab within 2 years prior to randomization; Cyclophosphamide, mitoxantrone, or alemtuzumab at any time; Total white blood cells (WBC) count <2,500/microL, or lymphocytes <800/microL, or neutrophils <1,500/microL; Patients unable to undergo MRI scans, including claustrophobia; Pregnant or breast-feeding females |
- Pacientes con una enfermedad crónica activa del sistema inmunitario distinta a EM o con un síndrome de inmunodeficiencia conocido. - Historia de malignidad - Pacientes con infecciones activas - Pacientes tratados previamente con más de un tratamiento modificador de la enfermedad (con la excepción de interferon-beta + acetato de glatiramero). - Pacientes que hayan sido tratados con: Interferón-beta o acetato de glatirámero en el mes previo a aleatorización; Natalizumab en los 6 meses previos a la aleatorización; Fingolimod en los 3 meses previos a la aleatorización; Fármacos inmunosupresores (p. ej., azatioprina, metotrexato) en los 6 meses previos a la aleatorización ; Rituximab, en los 2 años previos a la aleatorización; Ciclofosfamida, mitoxantrona, o alemtuzumab en cualquier momento.
*para mas detalle refierase al protocolo* |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To define the efficacy of AIN457, relative to placebo, in reducing the cumulative number of new Gadolinium-enhancing T1-weighted lesions recorded on all available MRI scans |
Definir la eficacia de AIN457 respecto al placebo, para reducir el número acumulado de nuevas lesiones realzadas con gadolinio potenciadas en T1 recogidas en todas las resonancias del ensayo disponibles. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At months 3, 4, 5 and 6 |
Mes 3, 4, 5 y 6. |
|
E.5.2 | Secondary end point(s) |
- To evaluate the safety and tolerability of three doses of AIN457, relative to placebo, in patients with relapsing multiple sclerosis - To evaluate the effect of AIN457, over a range of doses, on other parameters of disease activity as evaluated by MRI - To evaluate the effect of AIN457, over a range of doses, on clinical disease activity as evaluated by annualized relapse rate |
- Evaluar la seguridad y tolerabilidad de 3 dosis de AIN457 comparadas con placebo en pacientes con EM remitente recurrente. - Evaluar el efecto de AIN457 en un rango de dosis en otros parametros de actividad de la enfermedad como los evaluados por Resonancia Magnetica - Evaluar el efecto de AIN457 en un rango de dosis en otros parametros de actividad de la enfermedad como la tasa anualizada de brotes |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At months 0 to 6 |
Mes 0 y 6 |
|
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 | Yes |
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, Biomarker analysis |
Inmunogenicidad, analisis de biomarcadores |
|
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 | 4 |
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 | 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 |
Argentina |
Belgium |
Canada |
Colombia |
Czech Republic |
Finland |
France |
Germany |
Italy |
Japan |
Poland |
Portugal |
Romania |
Russian Federation |
Spain |
Sweden |
Switzerland |
Turkey |
United States |
|
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
|
|
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 | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 |