E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Plaque psoriasis |
Psoriasis en placas |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriasis looks like red, raised scaly areas of the skin |
La psoriasis parece como zonas rojas, engrosadas, escamosas de la piel. |
|
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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
E.1.2 | System Organ Class | 100000004858 |
|
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 300 mg when administered as 2 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoint) at Week 12, compared to placebo. |
Demostrar la eficacia de secukinumab 300 mg cuando se administra en jeringas precargadas de 2 ml comparado con placebo en paciente con psoriasis en placas con respecto a las respuestas PASI 75 e IGA mod. 2011 0 o 1 (criterio de valoración co-principal) en la semana 12 |
|
E.2.2 | Secondary objectives of the trial |
• To demonstrate the efficacy of secukinumab 300 mg when administered as 2 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to PASI 90 and PASI 100 at Week 12, compared to placebo. • To demonstrate the efficacy of secukinumab 300 mg when administered as two 1 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to PASI 100 at Week 12, compared to placebo. |
• Demostrar la eficacia de secukinumab 300 mg cuando se administra en jeringas precargadas de 2 ml comparado con placebo en paciente con psoriasis en placas con respecto a las respuestas PASI 90 y PASI 100 en la semana 12. • Demostrar la eficacia de secukinumab 300 mg cuando se administra en dos jeringas precargadas de 1 ml comparado con placebo en paciente con psoriasis en placas con respecto a la respuesta PASI 100 en la semana 12. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
* Men or women of at least 18 years of age at the time of Screening. * Moderate to severe chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization. * Candidate for systemic therapy. * Additional inclusion criteria may apply , please refer to the protocol. |
* Hombres o mujeres de al menos 18 años de edad en el momento de la selección. * Psoriasis crónica en placas existente durante al menos 6 meses y diagnosticada antes de la aleatorización. * Candidato a tratamiento sistémico. * Se pueden aplicar otros criterios de inclusión definidos en el protocolo. Por favor consulten el protocol. |
|
E.4 | Principal exclusion criteria |
* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) * Ongoing use of prohibited treatments. * Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor. * Pregnant or nursing (lactating) women *Additional exclusion criteria may apply , please refer to the protocol. |
* Formas de psoriasis salvo psoriasis crónica en placas (p. ej., psoriasis pustulosa, eritrodérmica y gutata) en la selección o aleatorización * Uso actual de tratamientos prohibidos. * Exposición previa a secukinumab (AIN457) o a cualquier otro fármaco biológico directamente dirigido contra IL-17A o el receptor de IL-17 * Mujeres embarazadas o en periodo de lactancia * Se pueden aplicar otros criterios de exclusión definidos en el protocolo. Por favor consulten el protocol. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
PASI 75 and IGA mod 2011 0 or 1 response |
Respuestas PASI 75 e IGA mod. 2011 0 o 1 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
PASI 90 and PASI 100 |
PASI 90 e PASI 100 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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 | 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) | Yes |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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 |
Belgium |
Canada |
Germany |
Iceland |
Latvia |
Poland |
Russian Federation |
Spain |
Turkey |
United Kingdom |
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 | |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |