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 |
|
E.1.1.1 | Medical condition in easily understood language |
Scaly skin rash |
Erupción cutánea escamosa |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
|
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 objective of this study is to evaluate the long-term safety of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis |
El objetivo principal de este estudio es evaluar la seguridad a largo plazo de apremilast en niños y adolescentes (de 6 a 17 años) con psoriasis en placas de moderada a grave. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate maintenance of effect as measured by static Physician Global Assessment (sPGA) |
Evaluar el mantenimiento del efecto, lo que se medirá mediante la Evaluación global estática por el médico (sPGA). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject is male or female 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian. 2. Subject must have a weight of ≥ 20 kg. 3. Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents (CDC, 2000). 4. Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003. 5. Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted. |
1.Pacientes de ambos sexos de 6 a 17 años, ambos inclusive, en el momento de la firma del consentimiento informado por el tutor legal. 2.Los pacientes deben tener un peso ≥ 20 kg. 3.Los pacientes deberán tener un IMC específico de la edad y el sexo no inferior al quinto percentil de la tabla de crecimiento de los Centers for Disease Control (CDC) para niños y adolescentes (CDC, 2000). 4.El paciente debe haber completado la semana 52 (fase de extensión con apremilast) del estudio CC-10004-PPSO-003. 5.El paciente debe ser capaz de firmar un asentimiento y tener un tutor legal que comprenda y firme voluntariamente un consentimiento informado antes de que empiecen a realizarse las evaluaciones y procedimientos relacionados con el estudio. |
|
E.4 | Principal exclusion criteria |
1. Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were to participate in the study. 2. Subject has a condition that confounds the ability to interpret data from the study. 3. Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments. 4. Subject is pregnant or breastfeeding. 5. Subject has guttate, erythrodermic, or pustular psoriasis. |
1.El paciente tiene un trastorno, incluida la presencia de anomalías analíticas o de una enfermedad psiquiátrica, que pueda entrañar un riesgo inaceptable para el paciente en caso de participar en el estudio. 2.El paciente tiene un trastorno que altera la capacidad de interpretar los datos del estudio. 3.El paciente tiene signos de enfermedades de la piel, distintas de la psoriasis, que pueden interferir en las evaluaciones clínicas. 4.La paciente está embarazada o dando el pecho. 5.El paciente tiene psoriasis en gotas, eritrodérmica o pustulosa. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Adverse Events: Type, frequency, severity, and relationship to apremilast from Week 0 (Visit 1) through end of Observational Follow-up 2. Columbia-Suicide Severity Rating Scale (C-SSRS) Questionnaire to monitor depression, suicidal thoughts and behavior 3. Tanner Staging Assessment of sexual maturity 4. Body weight, height and BMI: Monitor growth - Height and body weight are measured at each visit |
1. Acontecimientos adversos: Tipo, frecuencia, intensidad y relación con el apremilast desde la semana 0 (visita 1) hasta el final del seguimiento observacional. 2. Escala de valoración del riesgo de suicidio de Columbia (C-SSRS). Cuestionario para vigilar la depresión y los pensamientos y el comportamiento suicidas. 3.Determinación del estadio de Tanner. Evaluación de la madurez sexual. 4. Peso corporal, estatura e IMC: vigilar el crecimiento - La estatura y el peso se medirán en todas las visitas. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
end points 1 and 2 for the entire the study duration end point 3 at Week 0 (Visit 1) and then every 52 weeks. Also Early Termination visit end point 4 at every study visit |
Plazo para el criterio de valoracion 1 y 2 - toda la duración del estudio Plazo para el criterio de valoracion 3 - en la semana 0 (visita 1) y luego cada 52 semanas. También visita de terminación anticipada Plazo para el criterio de valoracion 4 - en cada visita de estudio |
|
E.5.2 | Secondary end point(s) |
sPGA - Proportion of subjects with an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline |
sPGA - Proporción de pacientes con una puntuación en la sPGA de sin lesiones (0) o casi sin lesiones (1), con una disminución de al menos 2 puntos con respecto al momento basal. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at every study visit |
Todas las visitas |
|
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 | No |
E.8.1.1 | Randomised | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 |
Czech Republic |
France |
Germany |
Israel |
Italy |
Netherlands |
Russian Federation |
Spain |
United States |
|
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
|
The End of Trial is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as prespecified in the protocol, whichever is the later date. |
El final del ensayo se define como la fecha de la última visita del último paciente que complete el seguimiento posterior al tratamiento, o la fecha de recepción de los últimos datos correspondientes al último paciente que sean necesarios para los análisis principales, secundarios o exploratorios, según se especifique en el protocolo, lo que ocurra más tarde. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
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 | 0 |