E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe nail psoriasis |
psoriasis unguela de moderada a severa |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriasis looks like red, raised scaly areas of the skin, but it can also involves the nails and form pits, discoloration or roughening of their surface. |
La psoriasis se muestra roja, con areas de piel descamadas y engrosadas, también puede aparecer en las uñas con decoloracion o rugosidad en su superficie. |
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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 | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028703 |
E.1.2 | Term | Nail psoriasis |
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 superiority of secukinumab 150 mg and/or 300 mg to placebo in subjects with moderate to severe psoriasis affecting the nails as assessed by NAPSI at Week 16 |
Demostrar la superioridad de secukinumab 150 mg y/o 300 mg frente a placebo en pacientes con psoriasis de moderada a severa que afecte las uñas evaluada mediante el NAPSI (Índice de severidad de la psoriasis ungueal) en la Semana 16 |
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E.2.2 | Secondary objectives of the trial |
?To assess the efficacy of secukinumab in subjects with moderate to severe psoriasis affecting the nails as assessed by NAPSI over time up to Week 16 compared to placebo and over time up to Week 80 ?To assess the efficacy of secukinumab in subjects with moderate to severe psoriasis affecting the nails as assessed by PASI 75 and IGA mod 2011 response at Week 16 compared to placebo and over time up to Week 80. ?To investigate the overall safety and tolerability of secukinumab 150 mg and 300 mg |
? Evaluar la eficacia de secukinumab 150 mg y 300 mg en pacientes con psoriasis de moderada a severa que afecte las uñas evaluada mediante la NAPSI hasta la Semana 16 en comparación con placebo, y hasta la Semana 80 ? Evaluar la eficacia de secukinumab 150 mg y 300 mg en pacientes con psoriasis de moderada a severa que afecte las uñas evaluada mediante la respuesta PASI75 (Índice de severidad y área de la psoriasis) y la respuesta IGA mod 2011 (IGA de 0 o 1) en la Semana 16 en comparación con placebo y hasta la Semana 80 ? Investigar la seguridad global y la tolerabilidad de secukinumab 150 mg y 300 mg |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Men and women at least age 18 at the time of screening
Subjects who have chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization, including significant nail involvement defined by a Nail Psoriasis Severity Index (NAPSI) score ? 16 and number of fingernails involved ? 4 AND a Psoriasis Area and Severity Index (PASI) score ? 12 AND a Body Surface Area (BSA) score ? 10%. Subject is a candidate for systemic therapy, defined as having psoriasis considered inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy. |
2. Hombres o mujeres de al menos 18 años de edad en el momento de la selección 3. Psoriasis crónica en placas de moderada a severa durante al menos 6 meses antes de la aleatorización, que incluye: ? Afectación ungueal significativa definida por un NAPSI en las uñas de los dedos de las manos ? 16 y el número de uñas de los dedos de las manos afectadas ? 4 ? Y una puntuación PASI ? 12 Y una BSA? 10% 4. Candidato a terapia sistémica, definida como tener psoriasis que se considere inadecuadamente controlada mediante: ? Tratamiento tópico y/o ? Fototerapia y/o ? Terapia sistémica previa |
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E.4 | Principal exclusion criteria |
Subjects who have forms of psoriasis other than chronic plaque type psoriasis (e.g.,pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis). Subjects who have drug-induced psoriasis (e.g. new onset or current exacerbation from ?-blockers, calcium channel inhibitors or lithium). Subjects who have active ongoing inflammatory skin diseases other than psoriasis, and any other disease affecting the fingernails that might confound the evaluation of the benefit of secukinumab treatment. Subjects who have ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Subjects who have been exposed to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 Receptor. Subjects who have received any investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer. Subjects who have a history of hypersensitivity to constituents of the study treatment. Other protocol-defined inclusion/exclusion criteria may apply. |
Formas de psoriasis distintas a la psoriasis en placas crónica (p. ej., psoriasis pustulosa, pustulosis palmoplantar, acrodermatitis de Hallopeau, psoriasis eritrodérmica y en gotas) 2. Psoriasis inducida por fármacos (p. ej., nuevo inicio o exacerbación actual debido a betabloqueantes, inhibidores de los canales del calcio o litio) 3. Enfermedades cutáneas inflamatorias activas en curso distintas a la psoriasis y cualquier otra enfermedad que afecte a las uñas de los dedos de las manos que puedan confundir la evaluación del beneficio del tratamiento con secukinumab (p. ej., onicomicosis) 4. Uso actual de tratamientos prohibidos (p. ej., corticoesteroides (CS) tópicos o sistémicos, terapia UV). Han de respetarse los períodos de lavado 5. Exposición previa a secukinumab (AIN457) o a cualquier otro fármaco biológico que se dirija directamente a la IL-17 o al receptor de IL-17. 6. Recibir cualquier fármaco en investigación en las 4 semanas previas al inicio de la medicación del estudio o en un período de 5 semividas previas al inicio del tratamiento en investigación, lo que sea más largo Referisrse al protocolo para el resto de criterios de exclusion |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: change in Nail Psoriasis Severity Index (NAPSI) after 16 weeks of treatment. Each treatment group will be compared to placebo |
Eficacia: cambio en el NAPSI (Índice de severidad de la psoriasis ungueal) tras 16 semanas de tratamiento. Cada grupo se comparará con placebo. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, 16 weeks |
Basal, 16 semanas |
|
E.5.2 | Secondary end point(s) |
1. Efficacy: change in NAPSI over time up to 16 weeks of treatment compared to placebo and over time up to 80 weeks 2. Efficacy: change in Psoriasis Area and Severity Index 75 (PASI75) and change in Investigator Global Assessment (IGA mod 2011) over time up to 16 weeks of treatment compared to placebo and over time up to 80 weeks 3. Overall safety and tolerability of secukinumab 150 mg and 300 mg 4. Development of immunogenicity against secukinumab |
1. Eficacia: cambio en el NAPSI hasta las 16 semanas de tratamiento comparando con placebo y hasta las 80 semanas 2. Eficacia: la respuesta PASI75 (Índice de severidad y área de la psoriasis) y la respuesta IGA mod 2011 (IGA de 0 o 1) en la Semana 16 en comparación con placebo y hasta la Semana 80 3. Investigar la seguridad global y la tolerabilidad de secukinumab 150 mg y 300 mg 4. Investigar el desarrollo de inmunogenicidad frente a secukinumab |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 16 weeks, 80 weeks 2. 16 weeks, 80 weeks 3. Baseline, up to 88 weeks 4. Baseline, 32 weeks, 80 weeks, 88 weeks |
1. 16 Semanas, 80 semanas 2. 16 semanas, 80 semanas 3. Basal, hasta 88 semanas 4. Basal, 32 semanas, 80 semanas, 88 semanas |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Immunogenicity |
Inmunogenicidad |
|
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 | No |
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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
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 |
Australia |
Belgium |
Brazil |
Czech Republic |
Denmark |
Germany |
Greece |
Spain |
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
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LVLS |
ultima visita del ultimo paciente |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 15 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 15 |