E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
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 |
To compare the safety of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis (excluding the face and scalp).
To evaluate the effect of twice daily use of calcitriol 3 mcg/g ointment versus vehicle on calcium metabolism in children aged 2 to 12 years with plaque psoriasis (excluding face and scalp).
To compare the efficacy of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis (excluding face and scalp). |
-Comparare la sicurezza del trattamento fino a 8 settimane con calcitriolo da 3 mcg/g unguento verso veicolo, quando usati due volte al giorno, senza occlusione, per trattare bambini di età compresa tra i 2 e i 12 anni, affetti da psoriasi a placche (escludendo il viso e il cuoio capelluto). - Valutare l'effetto dell'uso di calcitriolo da 3 mcg/g unguento verso veicolo due volte al giorno sul metabolismo del calcio nei bambini di età compresa tra i 2 e i 12 anni affetti da psoriasi a placche(escludendo il viso e il cuoio capelluto). - Comparare l'efficacia del trattamento fino a 8 settimane con calcitriolo da 3 mcg/g unguento verso veicolo, quando usato due volte al giorno, senza occlusione, per trattare bambini di età compresa tra i 2 e i 12 anni, affetti da psoriasi a placche(escludendo il viso e il cuoio capelluto). |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Non Applicabile |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female pediatric subjects (2 to 12 years of age, inclusive) at Screening.
- Clinical diagnosis of stable plaque psoriasis with an IGA score of 2 or 3 at Screening and Baseline. |
- Soggetti pediatrici di sesso maschile o femminile (da 2 a 12 anni di età inclusi) alla selezione. - Diagnosi clinica di psoriasi a placche stabile con un punteggio IGA equivalente a 2 o 3 alla selezione e al basale |
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E.4 | Principal exclusion criteria |
- Subjects with guttate psoriasis, erythrodermic psoriasis or active infection (i.e., an infection associated with fever, swollen lymph nodes, and/or signs of localized inflammation of tissue and/or joints) Note: allergic or vasomotor rhinitis is not exclusionary.
- Subject has hypercalcemia (serum albumin-adjusted calcium level above the upper normal range) at Screening.
- Subjects with known or suspected disorders of calcium metabolism. |
ngrossamento dei linfonodi e/o segni di infiammazione localizzata del tessuto e/o delle articolazioni) Nota: non è da escludere rinite allergica o vasomotoria. - Il soggetto presenta ipercalcemia (livelli sierici del calcio corretti in relazione al livello di albumina superiori al range di normalità) alla selezione. - Soggetti con disturbi del metabolismo del calcio noti o sospetti. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy Endpoints/Variables The primary endpoint variable is success rate defined as the percentage of subjects with an IGA of 0 (clear) or 1 (almost clear), and at least a 2 grade improvement from baseline.
Safety endpoints: - Serum albumin-adjusted calcium, urine calcium: creatinine ratio, phosphorus, and PTH |
1
Endpoint/variabili dell'efficacia primaria L'endpoint primario variabile è il grado di successo definito come la percentuale di soggetti con un IGA equivalente a 0 (chiaro) o 1 (quasi chiaro), e almeno un miglioramento di 2 gradi dalla baseline. Endpoint di sicurezza Calcio sierico corretto in relazione al livello di albumina, rapporto calcio:creatinina nelle urine, fosforo e PTH |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At each visit |
Ad ogni visita |
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E.5.2 | Secondary end point(s) |
Secondary Efficacy Endpoints/Variables - Change from Baseline in Pruritus - Change from Baseline in %BSA |
1
Endpoint/variabili dell'efficacia secondaria - Variazioni nel prurito rispetto alla baseline - Variazioni della %BSA rispetto alla baseline |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At each visits |
Ad ogni visita |
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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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
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 |
Germany |
Hungary |
Italy |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 21 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 21 |
E.8.9.2 | In all countries concerned by the trial days | 0 |