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.1.2 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 |
To evaluate the safety of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 17 years of age) with plaque psoriasis. |
Valutare la sicurezza del trattamento fino a 26 settimane con calcitriolo da 3 mcg/g unguento quando usato due volte al giorno, senza occlusione, per trattare soggetti pediatrici (di età compresa tra i 2 e i 17 anni) affetti da psoriasi a
placche. |
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E.2.2 | Secondary objectives of the trial |
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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 17 years of age, inclusive) at Screening.
- The subject has a clinical diagnosis of stable mild to moderate plaque type psoriasis. |
- Soggetti pediatrici di sesso maschile o femminile (da 2 a 17 anni di età inclusi) alla selezione.
- Il soggetto ha una diagnosi clinica di psoriasi a placche stabile da lieve a moderata. |
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E.4 | Principal exclusion criteria |
- Subjects with guttate psoriasis, pustular 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).
- Subject has hypercalcemia (serum albumin-adjusted calcium level above the upper normal range) at Screening.
- Subjects with known or suspected disorders of calcium metabolism.
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- Soggetti affetti da psoriasi guttata, psoriasi eritrodermica o infezione attiva (ad esempio, un'infezione associata a febbre,
ingrossamento dei linfonodi e/o segni di infiammazione localizzata del tessuto e/o delle articolazioni).
- 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) |
Efficacy endpoints:
- Percentage of subjects with an IGA Score of 0 (clear) or 1 (almost clear).
- Change from Baseline in Pruritus.
- Change from Baseline in % BSA.
Safety endpoints:
- include Serum albumin-adjusted calcium, urine calcium:creatinine ratio, phosphorus, and PTH. |
Endpoints di efficacia: - Percentuale di soggetti con un punteggio IGA equivalente a 0 (chiaro) o 1 (quasi chiaro). - Variazioni nel prurito rispetto al basale. - Variazioni della %BSA rispetto al basale. Endpoints sulla 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 |
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E.5.2 | Secondary end point(s) |
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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 | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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 |
Canada |
Germany |
Italy |
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 | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 24 |