E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe chronic plaque-type psoriasis |
Psoriasis en placas crónica de moderada a grave |
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E.1.1.1 | Medical condition in easily understood language |
Psoriasis looks like red, raised scaly areas of the skin |
La psoriasis se manifiesta con areas de la piel de color rojo, elevadas y escamosas. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue 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 demonstrate the efficacy of secukinumab 150 mg or 300 mg in subjects with moderate to severe chronic plaque-type psoriasis, who were PASI 75 responders at Week 52 of the core study, with respect to loss of PASI 75 up to Week 68, compared to placebo. |
Demostrar la eficacia de secukinumab 150 mg o 300 mg en sujetos con psoriasis en placas crónica de moderada a grave que eran respondedores PASI 75 en la semana 52 del estudio principal, con respecto a la pérdida de PASI 75 hasta la semana 68, comparado con placebo. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of secukinumab 150 mg or 300 mg with respect to PASI 50/75/90/100 response and IGA 0 or 1 response, compared to placebo over time in subjects who were PASI 75 responders at Week 52, over time for subjects who were re-treated after relapse with secukinumab 150 mg or 300 mg, and over time in subjects who were partial responders at Week 52.
Other secondary objectives apply, please refer to the full protocol for details. |
Evaluar la eficacia de secukinumab 150 mg o 300 mg con respecto a la respuesta PASI 50/75/90/100 e IGA 0 o 1, comparado con placebo a lo largo del tiempo en sujetos respondedores PASI 75 en la semana 52, en sujetos que volvieron a ser tratados después de la recidiva con secukinumab 150 mg o 300 mg y en sujetos que eran respondedores parciales en la semana 52. Para otros objetivos secundarios, por favor refierase al protocolo. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Completed the full study treatment period of 52 weeks in either of the two preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies. 2. Written informed consent form. |
1. Los sujetos que finalizaron el periodo de tratamiento completo del estudio (52 semanas) de los estudios principales (p. ej., CAIN457A2302 o CAIN457A2303), que después de la aleatorización estuvieran recibiendo el tratamiento con secukinumab durante la fase de mantenimiento de los estudios principales y que muestren al menos una respuesta parcial (PASI 50 o mejor) en la semana 52 de los estudios principales. 2. Se debe obtener el consentimiento informado por escrito antes de realizar cualquier evaluación. |
|
E.4 | Principal exclusion criteria |
1. A protocol deviation in either of the preceding phase III studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject. 2. Ongoing use of prohibited psoriasis or non-psoriasis treatments. 7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL). 8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
Other protocol-defined exclusion criteria may apply. |
1. Una desviación del protocolo en los estudios principales que, de acuerdo con el investigador, evite el análisis significativo del estudio de extensión para un solo sujeto 2. Uso actual de tratamientos prohibidos para la psoriasis o que no sean para la psoriasis. 7. Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de la mujeres después de la concepción y hasta que finalice la gestación, confirmado por un resultado positivo en la prueba hCG (> 10 mUI/ml) 8. Mujeres potencialmente fértiles, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas que no deseen utilizar un método anticonceptivo eficaz durante el estudio y durante las 16 semanas posteriores a la finalización del tratamiento. Para el resto de criterios de exclusión, refierase al protocolo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cumulative rate of subjects who lost PASI75 response up to Week 68 |
Tasa acumulativa de sujetos que pierden la respuesta PASI75 hasta la semana 68. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- changes in PASI - IGA - time to PASI75 response - Hemoglobin count, hematocrit count, red blood cell count, white blood cell count with differential and platelet count - ECG - AEs - changes in QoL |
- cambios en PASI - IGA - tiempo hasta la respuesta PASI75 - valor de hemoglobina, hematocrito, recuento de glóbulos rojos, recuento de glóbulos blancos con diferencial (neutrófilos incluidas bandas, linfocitos, monocitos, eosinófilos, basófilos) y recuento de plaquetas - ECG - Acontecimientos Adversos - cambios en la calidad de vida (QoL) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the study at time points defined in the protocol |
A lo largo del estudio, en los puntos de tiempo marcados en el protocolo. |
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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 | 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 | Yes |
E.6.11 | Pharmacogenomic | No |
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 | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 114 |
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 |
Belgium |
Brazil |
Canada |
Colombia |
Egypt |
Estonia |
Finland |
France |
Germany |
Guatemala |
Hungary |
Iceland |
India |
Israel |
Italy |
Japan |
Korea, Democratic People's Republic of |
Latvia |
Lithuania |
Mexico |
Peru |
Philippines |
Poland |
Romania |
Singapore |
Spain |
Sweden |
Taiwan |
Turkey |
United Kingdom |
United States |
Venezuela, Bolivarian Republic of |
|
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 |
Ultima visita del ultimo sujeto |
|
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |