- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02547714
Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
A Multi-center, Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety for 16 Weeks in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Aichi
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Nagoya city, Aichi, Japón, 467-8602
- Novartis Investigative Site
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Fukuoka
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Fukuoka-city, Fukuoka, Japón, 814-0180
- Novartis Investigative Site
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Kanagawa
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Isehara-city, Kanagawa, Japón, 259-1193
- Novartis Investigative Site
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Osaka
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Osaka-city, Osaka, Japón, 550-0012
- Novartis Investigative Site
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Tochigi
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Shimotsuke-city, Tochigi, Japón, 329-0498
- Novartis Investigative Site
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Tokyo
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Chiyoda-ku, Tokyo, Japón, 102-8798
- Novartis Investigative Site
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Itabashi-ku, Tokyo, Japón, 173-8610
- Novartis Investigative Site
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Itabashi-ku, Tokyo, Japón, 173-8606
- Novartis Investigative Site
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Minato-ku, Tokyo, Japón, 105-8471
- Novartis Investigative Site
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Shinagawa-ku, Tokyo, Japón, 141 8625
- Novartis Investigative Site
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Shinjuku-Ku, Tokyo, Japón, 169-0073
- Novartis Investigative Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- Plaque psoriasis diagnosed for at least 6 months before baseline - Treated with cyclosporine A for at least 12 weeks prior to baseline
Currently treated with cyclosporine A at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by:
- PASI score of 10 or greater and
- IGA mod 2011 score of 2 or greater (based on a scale of 0 to 4)
Exclusion Criteria:
- Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis). -Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium).
- Patients who have to discontinue cyclosporine A treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 μmol/L [2.0 mg/dL]) and hypertension at screening.
Other protocol-defined inclusion/exclusion criteria may apply
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Secukinumab (AIN457) 300 mg
Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
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Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)
Periodo de tiempo: Week 16
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI.
For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum).
Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
PASI 75 was defined as participants achieving >= 75% improvement from baseline.
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Week 16
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Percent Change From Baseline in PASI Score
Periodo de tiempo: Week 4
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI.
For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum).
Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
A negative change from baseline indicates improvement.
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Week 4
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Percentage of Participants Achieving PASI 50 or PASI 75
Periodo de tiempo: Week 4
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50 and PASI 75 were defined as participants achieving >= 50% or >= 75% improvement from baseline, respectively. |
Week 4
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Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response
Periodo de tiempo: Week 16
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 90 was defined as participants achieving >= 90% improvement from baseline. The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of assessment and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. |
Week 16
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Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Periodo de tiempo: Week 16
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The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts.
It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities.
Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much).
"Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses.
Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
A negative mean percentage change from baseline indicates improvement.
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Week 16
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Percentage of Participants Achieving DLQI 0 or 1
Periodo de tiempo: Week 16
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The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts.
It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities.
Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much).
"Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses.
Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
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Week 16
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CAIN457AJP01
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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