E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Plaque Psoriasis |
Psoriasi a placche da moderata a grave |
|
E.1.1.1 | Medical condition in easily understood language |
Scaly skin rash |
Eruzione cutanea desquamante |
|
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 |
L’obiettivo primario di questo studio è valutare la sicurezza a lungo termine di apremilast in bambini e adolescenti (di età da 6 a 17 anni) affetti da psoriasi a placche da moderata a grave |
|
E.2.2 | Secondary objectives of the trial |
To evaluate maintenance of effect as measured by static Physician Global Assessment (sPGA) |
Valutare il mantenimento dell’effetto misurato mediante la Valutazione globale statica del medico (static Physician Global Assessment, [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. Soggetto di sesso maschile o femminile, di età da 6 a 17 anni, compresi, al momento della firma del documento di consenso informato da parte del tutore legale. 2. Il soggetto deve avere un peso>=20 kg. 3. Il soggetto deve presentare un valore di IMC specifico per età e sesso non inferiore al 5° percentile secondo la tabella di crescita per bambini e adolescenti dei Centers for Disease Control (CDC) (Centri per il controllo delle malattie) (CDC, 2000). 4. Il soggetto deve avere completato la Settimana 52 (Fase di estensione con apremilast) dello studio CC-10004-PPSO-003. 5. Il soggetto è in grado di firmare un assenso e dispone di uno o più tutori legali che comprendono e firmano volontariamente un consenso informato prima della conduzione di qualsiasi valutazione/procedura correlata allo studio. |
|
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. Il soggetto presenta una condizione, incluse eventuali anomalie di laboratorio, o una malattia psichiatrica che potrebbe comportare un rischio inaccettabile in caso di partecipazione allo studio. 2. Il soggetto presenta una condizione che compromette la possibilità di interpretare i dati dello studio. 3. Il soggetto presenta evidenza di condizioni cutanee, diverse dalla psoriasi, che potrebbero interferire con le valutazioni cliniche. 4. Il soggetto è in gravidanza o allattamento |
|
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. Eventi avversi: tipo, frequenza, gravità e relazione con apremilast dalla Settimana 0 (Visita 1) fino alla fine del follow-up osservazionale 2. Questionario della Scala della Columbia University per la valutazione della gravità del rischio di suicidio (Columbia-Suicide Severity Rating Scale, [C-SSRS]) per il monitoraggio di depressione, pensieri suicidari e comportamento suicidario 3. Valutazione della maturità sessuale secondo la stadiazione di Tanner 4. Peso corporeo, altezza e IMC: monitoraggio della crescita - Altezza e peso corporeo saranno misurati a ogni visita |
|
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 |
endpoint 1 e 2 per l’intera durata dello studio endpoint 3 alla Settimana 0 (Visita 1), quindi ogni 52 settimane, nonché alla Visita di interruzione anticipata endpoint 4 a ogni visita dello studio |
|
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 - Proporzione di soggetti con punteggio sPGA di risoluzione completa (0) o quasi completa (1), con riduzione di almeno 2 punti rispetto al basale |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at every study visit; sPGA - Proporzione di soggetti con punteggio sPGA di risoluzione completa (0) o quasi completa (1), con riduzione di almeno 2 punti rispetto al basale |
|
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 | No |
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 | 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 | 2 |
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 | Information not present in EudraCT |
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 |
Canada |
Israel |
Russian Federation |
United States |
Belgium |
France |
Germany |
Italy |
Netherlands |
Spain |
Czechia |
|
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. |
La Fine della sperimentazione è definita come la data dell’ultima visita dell’ultimo soggetto per completare il follow-up post trattamento, oppure la data di ricezione degli ultimi dati dell’ultimo soggetto necessari per l’analisi primaria, secondaria e/o esplorativa, come prespecificato nel protocollo, a seconda di quale data sia posteriore. |
|
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 |