- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01412944
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (STATURE)
17 de marzo de 2015 actualizado por: Novartis Pharmaceuticals
A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
43
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Essen, Alemania, 45147
- Novartis Investigative Site
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Frankfurt, Alemania, 60590
- Novartis Investigative Site
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Hamburg, Alemania, 22143
- Novartis Investigative Site
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Luebeck, Alemania, 23538
- Novartis Investigative Site
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Mainz, Alemania, 55131
- Novartis Investigative Site
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Graz, Austria, A-8036
- Novartis Investigative Site
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Vienna, Austria, A-1220
- Novartis Investigative Site
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Wels, Austria, 4600
- Novartis Investigative Site
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Ontario
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Barrie, Ontario, Canadá, L4M 6L2
- Novartis Investigative Site
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Waterloo, Ontario, Canadá, N2J 1C4
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, Canadá, H2K 4L5
- Novartis Investigative Site
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Slovak Republic
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Kosice, Slovak Republic, Eslovaquia, 040 15
- Novartis Investigative Site
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Florida
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Jacksonville, Florida, Estados Unidos, 32216
- Novartis Investigative Site
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West Palm Beach, Florida, Estados Unidos, 33409
- Novartis Investigative Site
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Novartis Investigative Site
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Missouri
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St. Louis, Missouri, Estados Unidos, 63117
- Novartis Investigative Site
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North Carolina
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Greensboro, North Carolina, Estados Unidos, 27401
- Novartis Investigative Site
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South Carolina
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Greer, South Carolina, Estados Unidos, 29651
- Novartis Investigative Site
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Rouen, Francia, 76031
- Novartis Investigative Site
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Toulouse Cedex, Francia, 31059
- Novartis Investigative Site
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Karnataka
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Mangalore, Karnataka, India, 575 004
- Novartis Investigative Site
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Maharashtra
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Nagpur, Maharashtra, India, 440 010
- Novartis Investigative Site
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Nashik, Maharashtra, India, 422 001
- Novartis Investigative Site
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Chiba
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Kisarazu, Chiba, Japón, 292-8535
- Novartis Investigative Site
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Tokyo
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Hachioji-city, Tokyo, Japón, 193-0998
- Novartis Investigative Site
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Minato-ku, Tokyo, Japón, 105-8471
- Novartis Investigative Site
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Shinjuku-ku, Tokyo, Japón, 160-0023
- Novartis Investigative Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion criteria:
- Written Informed Consent must be obtained before any assessment is performed,
- Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
- Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
A partial response is defined as having achieved ≥ PASI 50 but < 75 response.
Exclusion criteria
- Pregnant women or lactating women
- Forms of psoriasis other than chronic plaque -type
- Ongoing use of prohibited psoriasis treatments
- Ongoing use of other non-psoriasis prohibited treatments
- Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
- Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
- UV therapy or excessive exposure to sunlight
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: AIN457 subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c.
injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4.
During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
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secukinumab 150mg (2 injections per dose)
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Experimental: AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4.
During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
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secukinumab 10mg/kg i.v.
regimen
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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 a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI
Periodo de tiempo: Week 8
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PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease).
Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for 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).
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Week 8
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Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response
Periodo de tiempo: Week 8
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The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the 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.
Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
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Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Periodo de tiempo: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for 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, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the 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.
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Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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Mean Percent Change From Baseline in PASI Scores
Periodo de tiempo: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease).
Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for 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 mean percentage change indicates improvement.
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Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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Percentage of Participants in Each IGA Mod 2011 Score Category
Periodo de tiempo: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the 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.
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Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Periodo de tiempo: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
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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 DLQI of 0 or 1 indicates no impairment or little impairment, respectively.
A negative mean percentage change from baseline indicates improvement.
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Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
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Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
Periodo de tiempo: Baseline, weeks 8, 16, 24, 32 and 40
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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 worts.
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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Baseline, weeks 8, 16, 24, 32 and 40
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Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
Periodo de tiempo: Baseline, weeks 8, 16, 24, 32 and 40
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The EQ-5D is an instrument used to assess a participant's health status.
The instrument includes a descriptive profile and a visual analog scale (VAS).
The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension had 3 response levels: no problems, some problems and severe problems.
The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state).
This outcome measures the percent change in VAS score.
Positive mean percent changes indicate improvement.
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Baseline, weeks 8, 16, 24, 32 and 40
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Number of Participants Who Developed Anti-secukinumab Antibodies
Periodo de tiempo: Baseline, weeks 12, 24 and 40
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The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
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Baseline, weeks 12, 24 and 40
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Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy
Periodo de tiempo: End of study
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This outcome measure was not analyzed due to the small sample size of the study (43 participants).
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End of study
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2011
Finalización primaria (Actual)
1 de abril de 2013
Finalización del estudio (Actual)
1 de abril de 2013
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2011
Primero enviado que cumplió con los criterios de control de calidad
8 de agosto de 2011
Publicado por primera vez (Estimar)
9 de agosto de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de marzo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
17 de marzo de 2015
Última verificación
1 de marzo de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CAIN457A2307
- 2011-002510-36 (Número EudraCT)
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. .
Ensayos clínicos sobre Psoriasis tipo placa
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ProgenaBiomeReclutamientoSoriasis | Psoriasis vulgar | Psoriasis del cuero cabelludo | Placa psoriásica | Psoriasis universal | Rostro de psoriasis | Clavo de la psoriasis | Psoriasis difusa | Psoriasis Punctata | Psoriasis palmar | Psoriasis circinata | Psoriasis anular | Psoriasis genital | Psoriasis GeográficaEstados Unidos
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Centre of Evidence of the French Society of DermatologyReclutamientoSoriasis | Psoriasis vulgar | Psoriasis del cuero cabelludo | Placa psoriásica | Psoriasis universal | Psoriasis palmar | Eritrodermia psoriásica | Uña psoriásica | Psoriasis en gotas | Psoriasis inversa | Psoriasis pustulosaFrancia
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Clin4allReclutamientoPsoriasis del cuero cabelludo | Clavo de la psoriasis | Psoriasis palmar | Psoriasis genital | Psoriasis plantarFrancia
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Herlev and Gentofte HospitalReclutamientoInfarto de miocardio | Isquemia miocardica | Enfermedades cardíacas | Enfermedades cardiovasculares | Insuficiencia cardiaca | Carrera | Soriasis | Insuficiencia Cardíaca Diastólica | Psoriasis vulgar | Factor de riesgo cardiovascular | Insuficiencia Cardíaca Sistólica | Disfunción Ventricular Izquierda | Psoriasis... y otras condicionesDinamarca
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UCB Biopharma S.P.R.L.TerminadoPsoriasis moderada a severa | Psoriasis Pustular Generalizada y Psoriasis EritrodérmicaJapón
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Innovaderm Research Inc.TerminadoPsoriasis del cuero cabelludo | Psoriasis pustulosa palmo-plantar | Psoriasis palmoplantar no pustulosa | Psoriasis de codo | Psoriasis de la parte inferior de la piernaCanadá
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AmgenTerminadoPsoriasis tipo psoriasis | Psoriasis tipo placaEstados Unidos
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TakedaReclutamientoPsoriasis pustulosa generalizada | Psoriasis eritrodérmicaJapón
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Assiut UniversityDesconocidoPacientes con psoriasis
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Shanghai Huaota Biopharmaceutical Co., Ltd.ReclutamientoPsoriasis pustulosa generalizada (PPG)Porcelana
Ensayos clínicos sobre secukinumab 150mg
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Novartis PharmaceuticalsTerminadoPsoriasis tipo placaAlemania, Estados Unidos, Francia, Estonia, Canadá
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Novartis PharmaceuticalsTerminadoPsoriasis pustulosa palmoplantarAlemania, Bélgica, Austria, Italia, España, Francia, Suecia, Reino Unido, Federación Rusa, Polonia
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PfizerTerminadoEnfermedad inflamatoria intestinalPorcelana
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.DesconocidoNeuropatía diabética periférica
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Novartis PharmaceuticalsReclutamiento
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Technical University of MunichNovartisTerminado
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Novartis PharmaceuticalsTerminadoSoriasis en placasTailandia
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Novartis PharmaceuticalsTerminadoSoriasis en placasEstados Unidos
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University of Erlangen-Nürnberg Medical SchoolActivo, no reclutando
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Novartis PharmaceuticalsTerminadoArtritis psoriásica | Espondiloartritis axialEspaña