E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate-to-Severe Plaque Psoriasis |
Psoriasis en placas de moderada a grave |
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E.1.1.1 | Medical condition in easily understood language |
A Study of Ixekizumab (LY2439821) in Participants From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis. |
Estudio de Ixekizumab (LY2439821) en pacientes con psoriasis en placas de moderada a grave y entre 6 y < 18 años |
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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 | 19.1 |
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 |
To assess whether ixekizumab Q4W is superior to placebo at Week 12 (Visit 7) in the treatment of pediatric subjects (children and adolescents) with moderate-to-severe plaque psoriasis, as measured by PASI 75 and by sPGA (0,1) |
evaluar si ixekizumab C4S es superior al placebo en la semana 12 (visita 7) en el tratamiento de sujetos pediátricos (niños y adolescentes) con psoriasis en placas de moderada a grave, de acuerdo con la puntuación PASI 75 y la sPGA (0,1). |
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E.2.2 | Secondary objectives of the trial |
To assess whether ixekizumab Q4W is superior to placebo at Week 12 as measured by: PASI 90, sPGA (0), PASI 100, and Itch NRS. |
evaluar si ixekizumab C4S es superior al placebo en la semana 12, en relación con los siguientes parámetros: PASI 90, sPGA (0), PASI 100 y EVN del picor |
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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 |
Protocol Addendum I1F-MC-RHCD(1): Multicenter, Double-Blind, Randomized, Placebo Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients from 6 to Less than 18 Years of Age with Moderate-to-Severe Plaque Psoriasis. Version date: 30Nov2016. Objective: Describes additional PK sampling for a subgroup of subjects, which will be used to help define the PK of ixekizumab in pediatric subjects. Protocol Addendum I1F-MC-RHCD(2): Multicenter, Double-Blind, Randomized, Placebo Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients from 6 to Less than 18 Years of Age with Moderate-to-Severe Plaque Psoriasis. Version Date: 30Nov2016. Objectives: States that in countries where etanercept is approved for severe pediatric Ps treatment only (emerging markets and European countries), subjects may be randomized to etanercept. This addendum contains an active-controlled reference group (etanercept) during the Double-Blind Treatment Period (Period 2). Additionally, subjects from EU countries who meet the response criterion (defined as sPGA [0,1]) at Week 60 will be re-randomized to ixekizumab or placebo (1:1 ratio) during a 48-Week Double-Blind, Randomized Withdrawal Period. |
Adenda al protocolo I1F-MC-RHCD(1): Estudio multicéntrico, doble ciego, aleatorizado, comparado con placebo, en el que se evalúan la seguridad, la tolerabilidad y la eficacia de ixekizumab en pacientes con psoriasis en placas de moderada a grave y entre 6 y < 18 años Fecha de la versión: 30 de noviembre de 2016 Objetivo: Se describe un muestreo FC adicional para un subgrupo de pacientes, que se utilizará para intentar definir la FC de ixekizumab en pacientes menores de edad. Adenda al protocolo I1F-MC-RHCD(2): Estudio multicéntrico, doble ciego, aleatorizado, comparado con placebo, en el que se evalúan la seguridad, la tolerabilidad y la eficacia de ixekizumab en pacientes con psoriasis en placas de moderada a grave y entre 6 y < 18 años. Fecha de la versión: 30 de noviembre de 2016 Objetivos: Se indica que en los países en los que etanercept está autorizado únicamente como tratamiento contra la psoriasis en placas grave en niños y adolescentes (mercados emergentes y países europeos), se podrá aleatorizar a los pacientes al tratamiento con etanercept. En esta adenda se incluye un grupo comparativo con tratamiento activo (etanercept) durante el período de tratamiento con enmascaramiento doble (período 2). Por otra parte, se volverá a aleatorizar a los pacientes de los países de la UE que en la semana 60 cumplan el criterio de respuesta (evaluación estática global realizada por el médico (sPGA) [0,1]), bien a ixekizumab, bien al placebo (en una relación 1:1), durante un período de retirada aleatorizada con enmascaramiento doble y de 48 semanas de duración. |
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E.3 | Principal inclusion criteria |
Males and females from 6 years to <18 years of age. Have a diagnosis of moderate-to-severe plaque-type Ps for at least 6 months prior to baseline (Week 0; Visit 2), as determined by the investigator. Have PASI score ≥12 and a sPGA ≥3 and body area involved ≥10% of whole body surface at screening (Visit 1) and baseline (Week 0; Visit 2). Are candidates for phototherapy or systemic treatment of Ps (may be either naive or have a prior history of previous treatment) or have Ps considered by the investigator as poorly controlled with topical therapy. |
Pacientes de ambos sexos de 6 a < 18 años. Diagnóstico de psoriasis en placas de moderada a grave al menos 6 meses antes del período basal (semana 0; visita 2), según el criterio del investigador. Puntuación PASI ≥ 12, puntuación sPGA ≥ 3 y superficie corporal afectada ≥ 10 % durante la selección (visita 1) y el período basal (semana 0; visita 2). Candidatos a recibir fototerapia o tratamiento sistémico contra la psoriasis (independientemente de que hayan recibido o no tratamiento previo) o que presenten psoriasis mal controlada con tratamiento tópico, según el investigador. |
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E.4 | Principal exclusion criteria |
Pustular, erythrodermic, and/or guttate forms of Ps or have drug induced psoriasis. Have used any therapeutic agent targeted at reducing IL-17. Previously treated with etanercept (Note: criteria applicable to all countries) Concurrent or recent use of any biologic agent within the following washout periods: 1) Adalimumab and infliximab ≥60 days, abatacept >90 days, anakinra >7 days, or any other biologic DMARD >5 half-lives prior to baseline Systemic therapy for Ps and PsA (other than above, eg, MTX, cyclosporine), phototherapy (eg, PUVA) in the previous 4 weeks; 2) Any investigational drugs in the previous 4 weeks or 5 half-lives, whichever is longer; 3) UVA-therapy, UVB-therapy; topical treatments (except in face, scalp, and genital area during screening) in the previous 4 weeks. Have latent TB, active TB, acute or chronic viral hepatitis, active infection (within 4 weeks of baseline), history of immune deficiency syndrome, history of malignancy, History of major immunologic reaction, history of sepsis or risk of sepsis. |
Psoriasis pustulosa, eritrodérmica, gutata o medicamentosa. Haber recibido cualquier fármaco para disminuir la concentración de IL-17. Haber recibido anteriormente etanercept (nota: criterio aplicable a todos los países). Administración reciente o simultánea de cualquier fármaco biológico, en el transcurso de los siguientes períodos de reposo farmacológico: 1) Adalimumab e infliximab ≥ 60 días, abatacept > 90 días, anakinra > 7 días o cualquier otro FARME biológico > 5 semividas antes del período basal. Tratamiento sistémico contra la psoriasis y la artritis psoriásica (salvo los mencionados anteriormente, por ejemplo, MTX, ciclosporina), fototerapia (por ejemplo, PUVA) en las 4 últimas semanas; 2) cualquier fármaco en investigación en las 4 últimas semanas o 5 semividas (el período más prolongado); 3) tratamiento con UVA, tratamiento con UVB, tratamientos tópicos (salvo los administrados durante la selección en la cara, el cuero cabelludo y la zona genital) en las 4 últimas semanas. TB latente, TB activa, hepatitis vírica crónica o aguda, infección activa (en el transcurso de las 4 semanas anteriores al período basal), antecedentes de síndrome de inmunodeficiencia, neoplasias malignas, reacciones inmunitarias importantes o sepsis, o riesgo de sepsis. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving PASI 75. Proportion of subjects achieving sPGA (0,1). |
Proporcion de pacientes que alcancen PASI 75. Proporcion de pacientes que alcancen sPGA (0,1) |
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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) |
Proportion of subjects achieving PASI 90. Proportion of subjects achieving sPGA (0). Proportion of subjects achieving PASI 100. Proportion of subjects achieving PASI 75. Proportion of subjects achieving sPGA (0,1). Improvement ≥4 for subjects who had a baseline Itch NRS score ≥4. |
Proporcion de pacientes que alcancen PASI 90. Proporcion de pacientes que alcancen sPGA (0). Proporcion de pacientes que alcancen PASI 100. Proporcion de pacientes que alcancen PASI 75. Proporcion de pacientes que alcancen sPGA (0,1). mejora de ≥4 para los sujetos que partian de ≥4 en EVN del picor. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
PASI 75 and sPGA 0,1 are measured at Week 2. All the others at Week 12. |
PASI 75 y sPGA 1,1 son medidas en la semana 2. las demas en la semana 12 |
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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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
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 |
Canada |
Czech Republic |
France |
Germany |
Hungary |
Mexico |
Netherlands |
Poland |
Russian Federation |
Spain |
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, 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 | 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 | 9 |