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). |
Comparar la seguridad de hasta 8 semanas de tratamiento con calcitriol 3 µg/g pomada frente a su vehículo cuando se usa dos veces al día, sin oclusión, para tratar a niños de 2 a 12 años de edad con psoriasis en placas (exceptuando cara y cuero cabelludo). Evaluar el efecto del uso dos veces al día de calcitriol 3 µg/g pomada frente al vehículo sobre el metabolismo del calcio en niños de 2 a 12 años de edad con psoriasis en placas (exceptuando cara y cuero cabelludo). Comparar la eficacia de hasta 8 semanas de tratamiento con calcitriol 3 µg/g pomada frente a su vehículo, cuando se usa dos veces al día sin oclusión, para tratar a niños de 2 a 12 años de edad con psoriasis en placas (exceptuando cara y cuero cabelludo). |
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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 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. |
Sujetos de ambos sexos pediátricos (de 2 a 12 años de edad, inclusive) en la visita selección. Diagnóstico clínico de psoriasis en placas estable con una puntuación IGA [escala evaluación global del investigador] de 2 o 3 en la visita de selección e inicial. |
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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. |
-Sujetos con psoriasis en gotas, psoriasis eritrodérmica o infección activa (es decir, una infección asociada a fiebre, ganglios inflamados y/o signos de inflamación localizada de tejido y/o articulaciones). Nota: La rinitis alérgica o vasomotora no es motivo de exclusión.
-Sujetos con hipercalcemia (nivel sérico de calcio corregido por albúmina por encima del intervalo superior normal) en la visita de selección.
-Sujetos con trastornos conocidos o sospechados de metabolismo del calcio. |
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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 |
El criterio principal de valoración es la tasa de éxito definida como el porcentaje de sujetos con una puntuación IGA de 0 (remisión) o 1 (casi remisión) y una mejora de al menos 2 grados desde el inicio del estudio.
Los criterios de valoración de la seguridad son: Nivel sérico de calcio corregido por albúmina, relación calcio:creatinina en orina, fósforo y PTH. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At each visit |
En cada 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 |
Criterios secundarios de valoración de la eficacia ?Cambio respecto al valor inicial en el prurito. ?Cambio respecto al valor inicial en el porcentaje de ASC |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At each visits |
En cada 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 6 |
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 | |
E.8.9.1 | In the Member State concerned months | 21 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 21 |