E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque psoriasis |
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E.1.1.1 | Medical condition in easily understood language |
Plaque psoriasis appears as raised, red patches covered with silvery, scaly dead skin cells. |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
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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 |
The primary objectives of this study are to assess whether 80 mg ixekizumab every 2-week (Q2W) is: 1. noninferior to ustekinumab at Week 12 in the treatment of patients with moderate to severe psoriasis, as measured by proportion of patients achieving Psoriasis Area and Severity Index (PASI) 90, and then 2. superior to ustekinumab at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis, as measured by proportion of patients achieving PASI 90 |
Los objetivos principales de este estudio son evaluar si la dosis de 80 mg de ixekizumab, administrada cada 2 semanas (C2S): 1. No es inferior a ustekinumab en la semana 12 de tratamiento, en pacientes con psoriasis moderada o grave, de acuerdo con el porcentaje de pacientes que alcancen un índice PASI 90, y, posteriormente. 2. Es superior a ustekinumab en la semana 12 de tratamiento, en pacientes con psoriasis moderada o grave, de acuerdo con el porcentaje de pacientes que alcancen un índice PASI 90. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to assess whether ixekizumab is superior to ustekinumab at the study visits in the treatment of patients with moderate-to-severe plaque psoriasis as measured by: -proportion of patients achieving a ?75% improvement in PASI (PASI 75), a ?90% improvement in PASI (PASI 90), and a 100% improvement of PASI (PASI 100) from baseline -proportion of patients with an static Physician Global Assessment (sPGA) (0,1) with at least a 2-point improvement from baseline -proportion of patients achieving an sPGA (0) (remission) -proportion of patients achieving dermatology-specific quality of life index (DLQI) (0,1) -proportion of patients reaching Itch Numeric Rating Scale (NRS) responder definition (decrease of 4 points in the Itch NRS in patients with baseline score ?4 points) -change from baseline in Itch NRS -change from baseline Skin Pain visual analog scale (VAS) |
Los obj. secundarios son evaluar si ixekizumab es superior a ustekinumab en las visitas del estudio, en el tto. de pacientes con psoriasis en placas moderada o grave, de acuerdo con: -% pacientes que alcancen una mejoría ? 75% en el índice PASI (PASI 75), una mejoría ? 90% en el índice PASI (PASI 90) y una mejoría del 100 % en el índice PASI (PASI 100) respecto al período basal. -% pacientes con evaluación global estática del médico (sPGA) (0,1) con al menos una mejoría de 2 puntos respecto al período basal. -% pacientes que alcancen una sPGA (0) (remisión) -% pacientes que alcancen un índice DLQI (0,1) -% pacientes que respondan al tratamiento, de acuerdo con la definición de la escala de valoración numérica (EVN) del prurito (disminución de 4 puntos en la EVN del prurito en pacientes con una puntuación basal ? 4 puntos). -El cambio en la EVN del prurito respecto al período basal. -El cambio en la escala visual analógica (EVA) del dolor cutáneo respecto al período basal |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetic analysis: a blood sample will be collected for pharmacogenetic analysis where local regulations allows. |
Análisis Farmacogenético: se estraerá una muestra sanguinea para realizar análisis farmacogenéticos donde la regulación local lo permita. |
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E.3 | Principal inclusion criteria |
-Are at least 18 years of age -Have had moderate to severe plaque psoriasis for at least 6 months -Have had a failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy) |
-Tener una edad mínima de 18 años. -Haber presentado psoriasis en placas crónica, al menos durante 6 meses -No haber respondido o no haber tolerado al menos 1 tratamiento sistémico (incluidos ciclosporina, MTX o fototerapia), o que este esté contraindicado. |
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E.4 | Principal exclusion criteria |
-Have forms of psoriasis other than plaque psoriasis. -Have recently received certain treatments for their psoriasis (in particular within the last 4 weeks but the restriction can go up to 12 months for some treatments). -Have received ustekinumab. -Have already been treated with ixekizumab or another drug with a similar mode of action. -Have received excessive sun exposure or have used tanning booths within 4 weeks prior to receiving treatment in this study or expect to do so during the study. -Have recently received a live vaccine (within 12 weeks prior to receiving treatment in this study) or plan to do so during the study. -Have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year. -Have an active or recent infection. -Have active or dormant tuberculosis. -Have a compromised immune system. -Have another disease which is not currently under control, including heart disease, uncontrolled arterial hypertension, mental illness, and other diseases. Have either a current diagnosis or a recent history of malignant disease. -Have allergies to certain treatments or latex. -Are pregnant or breastfeeding. |
-Presentar otras formas de psoriasis diferente a la psoriasis en placas. -Haber recibido recientemente algunos tratamientos para su psoriasis (en particular dentro de las 4 últimas semanas, pero la restricción puede ser hasta 12 meses para algunos tratamientos). -Haber recibido ustekinumab -Haber sido tratado ya con ixekizumab u otro fármaco con mecanismo de acción similar. -Haber recibido exposición solar excesiva o haber utilizado cabinas de bronceado durante las 4 semanas previas a recibir el tratamiento del estudio, o espera hacerlo durante el estudio. -Haber recibido una vacuna elaborada con microbios vivos (dentro de las 12 semanas previas a recibir el tratamiento del estudio) o planea recibirla durante el estudio. -Haber recibido una vacuna con el bacilo de Calmette-Guérin (BCG) dentro del último año. -Tener o haber tenido una infección recientemente -Tener tuberculosis activa o latente -Tener un Sistema Inmune comprometido -Tener otra enfermedad sin controlar, incluida enfermedad cardíaca, hipertensión arterial no controlada, enfermedad mental, y otras enfermedades. -Tener o un diagnóstico actual o historia reciente de enfermedad maligna -Tener alergia a algunos tratamientos o al latex. -Estar embarazada o en periodo de lactancia |
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E.5 End points |
E.5.1 | Primary end point(s) |
Psoriasis Area and Severity Index (PASI) 90 response (at least a (?)90% improvement in PASI score from baseline) |
(PASI)90 Mejoría de al menos un (?) 90 % en la puntuación PASI respecto al período basal |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
PASI 100, PASI 90, PASI 75, Static Physician's Global Assessment (sPGA), Nail Psoriasis Severity Index (NAPSI), Psoriasis Scalp Severity Index (PSSI), Palmoplantar Psoriasis Severity Index (PPASI) Body Surface Area (BSA) percentage involvement of psoriasis,
Additionally the following Patient Reported Outcome Measures: Itch Numeric Rating Scale (NRS), Dermatology Life Quality Index (DLQI), Skin Pain Visual Analog Scale (VAS), Hospital Anxiety and Depression Scale (HADS), Short Form (36-item) Health Survey, Patient?s Global Assessment of Disease Severity, Work Productivity Activity Impairment questionnaire ? Psoriasis (WPAI), and European Quality of Life ? 5 Dimensions 5 Level + Bolt On (EQ 5D 5L) |
PASI 100, PASI 90, PASI 75, Evaluación global estática del médico (sPGA), Índice de la gravedad de la psoriasis ungueal (NAPSI), Índice de la gravedad de la psoriasis en el cuero cabelludo (PSSI), Índice de la gravedad de la psoriasis palmoplantar (PPASI), porcentaje de superficie corporal afectada por psoriasis (SC),
Adicionalmente: escala de valoración numérica del prurito (EVN) índice de calidad de vida en dermatología (DLQI) escala visual analógica (EVA) del dolor cutáneo Escala hospitalaria de depresión y ansiedad (HADS) cuestionario abreviado de salud de 36 ítems (SF-36) evaluación global por parte del paciente de la gravedad de la enfermedad cuestionario sobre productividad laboral y deterioro de la actividad: psoriasis (WPAI) y cuestionario europeo de calidad de vida - 5 dimensiones ? 5 niveles (EQ-5D 5L). |
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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 | Yes |
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 | 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) | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 47 |
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 |
Austria |
Belgium |
Brazil |
Canada |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Spain |
Sweden |
Switzerland |
United Kingdom |
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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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End of Study is the date of the last visit or last scheduled procedure for the last active subject in the study. |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 4 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 4 |