E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Plaque Psoriasis |
Psoriasis en placas |
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E.1.1.1 | Medical condition in easily understood language |
Plaque Psoriasis |
Psoriasis en placas |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
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 |
The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. |
El objetivo principal de este estudio es evaluar la eficacia y seguridad de Risankizumab comparado con Secukinumab para el tratamiento de pacientes adultos con psoriasis en placa de moderada a grave que son candidatos a recibir tratamiento sistémico. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug: • Serum aspartate transaminase (AST) < 2 × ULN; • Serum alanine transaminase (ALT) < 2 × ULN; • Serum direct bilirubin ≤ 2.0 mg/dL; except for subjects with isolated elevation of indirect bilirubin relating to a confirmed diagnosis of Gilbert syndrome; • Total white blood cell (WBC) count > 3,000/µL; • Absolute neutrophil count (ANC) > 1,500/µL; • Platelet count > 100,000/µL; • Hemoglobin > 8 g/dL. 2. Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit; 3. Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis • Subject has ≥ 10% BSA psoriasis involvement, sPGA score of ≥ 3, and PASI ≥ 12 at Screening and Baseline Visit; 4. Subject must be a candidate for systemic therapy as assessed by the investigator; 5. Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound. |
1. Los valores de laboratorio deben cumplir los siguientes puntos en el periodo de screening hasta la primera dosis del medicamento de estudio: • Aspartato Transaminsa (AST) < 2 × ULN; • Alanina Transaminasa (ALT) < 2 × ULN; • Bilirrubina conjugada en suero ≤ 2.0 mg/dL; excepto en sujetos que tienen un valor elevado aislado de la bilirrubina no conjugada ,relacionado con un diagnóstico confirmado de síndrome de Gilbert. • Recuento total de globulos blancos (GBT) > 3,000/µL; • Recuento absoluto de neutrófilos (RAN) > 1,500/µL; • Recuento de plaquetas > 100,000/µL; • Hemoglobina > 8 g/dL. 2. Diagnóstico de psoriasis crónica de placa con o sin artritis psoriasica durante al menos 6 meses antes de la visita basal. 3.Los sujetos tienen psoriasis crónica de placa, de moderada a grave con o sin artritis psoriasica. • El sujeto tiene ≥ 10% BSA de placa de psoriasis de recubrimiento, puntuación de sPGA ≥ 3 y PASI ≥ 12 en el Screening y en la visita Basal. 4.Los sujetos deben ser candidatos para terapias sistémicas, evaluado por el investigador. 5. El sujeto debe ser un candidato aceptable para recibir secukinumab de acuerdo con la clasificación local para este componente. |
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E.4 | Principal exclusion criteria |
1. No history of: • Erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; • Active skin disease other than psoriasis that could interfere with the assessment of psoriasis; • Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB /PPD test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines. The patient will not be eligible for randomization if latent tuberculosis is present and is untreated as per local guidelines. Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold) prior to Baseline Visit, as assessed by the investigator; 2. No history of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix; 3. No previous exposure to risankizumab; 4. No previous exposure to secukinumab; 5. Subject must not have been treated with any investigational drug within 30 days or 5 half lives of the drug (whichever is longer) prior to the first dose of study drug or currently be enrolled in another clinical study. |
1. No historial de: • Psoriasis eritrodérmica, psoriasis pustular generalizada o localizada, psoriasis inducida por medicación o exacerbada por medicamentos, o psoriasis guttata de nueva aparición.
• Otra enfermedad activa de piel que no sea psoriasis que pueda interferir con la evaluación de psoriasis. • Infecciones crónicas incluyendo VIH, hepatitis vírica (hepatitis C, hepatitis B), y/o tuberculosis activa. Sujetos con QuantiFERON®-TB /PPD test positivo, pueden participar en el estudio si una evaluación futura (de acuerdo con la práctica local) establece que el sujeto no tiene evidencia de tuberculosis activa. Si se establece que hay presencia de tuberculosis latente, entonces el tratamiento debe haberse iniciado y mantenido de acuerdo con las pautas locales del país. Los pacientes no son susceptibles de elección para ser randomizados si están diagnosticados con tuberculosis latente y no están tratados según las indicaciones locales. Infecciones sistémicas activas durante las dos últimas 2 semanas (excepto: resfriado común) antes de la visita de basal, a evaluación del investigador. 2. No historial documentado de malignidad activa o sospechada en los últimos 5 años, exceptuando cáncer de piel no-melanoma tratado exitosamente o carcinoma de cervix localizado in situ. 3. No exposición previa a Risankizumab. 4. No exposición previa a Secukinumab. 5. Los sujetos no deben de haber sido tratados con ningún tratamiento en investigación en los últimos 30 días o 5 medias vidas de la medicación (lo que sea más largo) previo a la primera dosis de la medicación de estudio o actualmente estar reclutado en otro estudio clínico. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The 2 primary endpoints are: • Proportion of subjects achieving a PASI 90 response at Week 52; superiority of risankizumab vs. secukinumab. • Proportion of subjects achieving a PASI 90 response at Week 16; non-inferiority of risankizumab vs. secukinumab with non-inferiority margin of 12%. |
Los 2 objetivos principales son: •Proporción de sujetos que alcanzan una respuesta de PASI 90 en la semna 52; superioridad de risankizumab frente a secukinumab. • Proporción de sujetos que alcanzan una repsuesta de de PASI 90 en la semna 16; no inferioridad de risankizumab frente a secukinumab con un margen de no inferioridad del 12%. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 52, Week 16 |
Semana 52, Semana 16 |
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E.5.2 | Secondary end point(s) |
The multiplicity-controlled key secondary endpoints are: • Proportion of subjects achieving a PASI 100 response at Week 52; superiority of risankizumab vs. secukinumab; • Proportion of subjects achieving an sPGA 0 or 1 at Week 52; superiority of risankizumab vs. secukinumab; • Proportion of subjects achieving a PASI 75 response at Week 52; superiority of risankizumab vs. secukinumab.
Other efficacy endpoints include change and percent change from baseline in PASI and body surface area (BSA) as well as multiple levels of PASI and sPGA responses at all visits. |
Los objetivos secundarios clave controlados por multiplicidad son: • Proporcion de sujetos que alcanzan una respuesta de PASI 100 en la semana 52; superioridad de risankizumab en comparación con secukinumab. •Proporción de sujetos que alcanzan una respuesta de sPGA 0 o 1en la semana 52;superioridad de risankizumab en comparación con secukinumab. • Proporción de sujetos que alcanzan una respuesta de PASI 75 en la semana 52; superioridad de risankizumab en comparación con secukinumab.
Otros puntos finales de eficacia incluyen cambio y porcentaje de cambio desde el inicio en PASI y área de superficie corporal (BSA), así como múltiples niveles de respuestas PASI y sPGA en todas las visitas |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 38 |
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 |
Canada |
France |
Germany |
Italy |
Netherlands |
Poland |
Spain |
United Kingdom |
United States |
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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
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The end-of-study is defined as the date of the last subject's last visit (Week 52/Final or Early Termination Visit) |
El fin del estudio está definido como la última visita del ultimo paciente(semana 52/ The end-of-study is defined as the date of the last subject's last visit (Week 52/visita final o anticipada) |
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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 | 1 |
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 | 1 |
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 |