Estudio para evaluar la farmacocinética (PK), la seguridad y la tolerabilidad hasta durante 6 años de secukinumab intravenoso (i.v.) en participantes pediátricos con artritis psoriásica juvenil (JPsA).
Un estudio multicéntrico de etiqueta abierta para evaluar la farmacocinética, la seguridad y la tolerabilidad durante hasta 6 años de infusiones intravenosas de secukinumab en participantes pediátricos con artritis psoriásica juvenil
The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a multicenter, open-label study with an optional treatment extension period to evaluate pharmacokinetics, safety and tolerability (up to 6 years) of i.v. secukinumab in pediatric patients with JPsA.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Novartis Pharmaceuticals
- Número de teléfono: 1-888-669-6682
- Correo electrónico: novartis.email@novartis.com
Copia de seguridad de contactos de estudio
- Nombre: Novartis Pharmaceuticals
Ubicaciones de estudio
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California
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Loma Linda, California, Estados Unidos, 92354
- Reclutamiento
- Loma Linda University Health
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Contacto:
- Monica Pizana
- Número de teléfono: +1 909 558 5830
- Correo electrónico: mpizana@llu.edu
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Investigador principal:
- Wendy De La Pena
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Florida
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Gainesville, Florida, Estados Unidos, 32610-8068
- Reclutamiento
- University of Florida
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Investigador principal:
- Christian Oliveros
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Contacto:
- Joel Ravel
- Correo electrónico: Joal.Ravel@UFHelath.ORG
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Reclutamiento
- Ann and Robert H Lurie Childs Hosp
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Investigador principal:
- Pooja Patel
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Contacto:
- Gabrielle Morgan
- Número de teléfono: +1 312 227 4811
- Correo electrónico: gamorgan@luriechildrens.org
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New York
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New York, New York, Estados Unidos, 10032
- Reclutamiento
- Col Uni Med Center New York Presby
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Contacto:
- Marcela Arizabaleta
- Número de teléfono: +1 646 317 1669
- Correo electrónico: ma5005@cumc.columbia.edu
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Investigador principal:
- Lisa Imundo
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28203
- Reclutamiento
- Levine Childrens Hospital
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Investigador principal:
- Sheetal Vora
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Contacto:
- Haley D Furr
- Número de teléfono: +1 800 821 1535
- Correo electrónico: Haley.Furr@advocatehealth.org
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Reclutamiento
- Cincinnati Childrens Hospital
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Investigador principal:
- Hermine Brunner
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Contacto:
- Megan Quinlan-Waters
- Número de teléfono: +1 513 636 7261
- Correo electrónico: Megan.Quinlan-Waters@cchmc.org
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Cleveland, Ohio, Estados Unidos, 44106-5028
- Reclutamiento
- Univ Hosp Cleveland Medical Center
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Investigador principal:
- Ezequiel Borgia
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Contacto:
- Katrina Gogin
- Número de teléfono: +1 216 844 7164
- Correo electrónico: katrina.gogin@uhhospitals.org
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Oregon
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Portland, Oregon, Estados Unidos, 97232
- Reclutamiento
- Legacy Emanuel Research Hosp Portland
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Investigador principal:
- Daniel Joseph Kingsbury
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Contacto:
- Brenna Bogle
- Número de teléfono: +1 503 413 5447
- Correo electrónico: bbogle@lhs.org
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Reclutamiento
- Childrens Hosp Pittsburgh UPMC
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Investigador principal:
- Margalit Rosenkranz
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Contacto:
- Vibha Chauhan
- Número de teléfono: +1 412 692 6327
- Correo electrónico: vibha.chauhan@chp.edu
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Texas
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El Paso, Texas, Estados Unidos, 79902
- Reclutamiento
- Texas Arthritis Center
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Investigador principal:
- Sanjay Chabra
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Contacto:
- Melissa Lopez
- Correo electrónico: melissa.lopez@aara.care
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Utah
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Salt Lake City, Utah, Estados Unidos, 84113
- Reclutamiento
- University of Utah
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Contacto:
- Tressie Rollins
- Número de teléfono: +1 415 515 8212
- Correo electrónico: tressie.rollins@hsc.utah.edu
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Investigador principal:
- Peter Chiraseveenuprapund
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
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Participants parent's or legal representative(s) written informed consent and child's assent, if appropriate, must be obtained before any study related activity or assessment is performed. Of note, if the participant reaches age of consent (as per local law) during the study, they will also need to sign the corresponding study ICF (Informed Consent Form).
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Males and females ≥2 years old to <18 years old at the time of screening.
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Confirmed diagnosis of JPsA according to the modified International League of Associations for Rheumatology (ILAR) classification criteria that must have occurred at least 6 months prior to screening.
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Active JPsA disease defined as ≥3 active joints (swollen or if not swollen must be both tender and limited range of motion) at baseline (BSL).
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Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening.
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Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening.
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Concomitant use of the following second-line agents such as disease-modifying and/or immunosuppressive drugs to treat the JPsA will be allowed:
- Stable dose of methotrexate (MTX) (maximum of 20 mg/ m2 BSA/ week) for at least 4 weeks prior to the BSL visit, with folic/folinic acid supplementation (according to standard medical practice of the center).
- Stable dose of an oral corticosteroid (CS) at a prednisone equivalent dose of <0.2 mg/kg/day or up to 10 mg/day maximum, whichever is less, for at least 7 days prior to BSL.
- Stable dose of no more than one NSAID for at least 1 week prior to BSL.
Key Exclusion Criteria:
- Participants with body weight less than 10 kg at screening.
- Use of other investigational drugs within 4 weeks or 5 half-lives of BSL, or until the expected pharmacodynamic effect has returned to BSL, whichever is longer.
- History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.
- Participants with active inflammatory bowel disease or active uveitis at screening or BSL.
- Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL.
- Participants treated with prohibited medication
- Participants taking any non-biologic DMARD at screening except for MTX.
- Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
Other inclusion/exclusion criteria may apply
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- 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
Secukinumab administered intravenously in pediatric participants with JPsA |
Intravenous secukinumab
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maximum concentration on Day 1
Periodo de tiempo: Pre-infusion and end of infusion (EOI) at Day 1
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Maximum concentration of secukinumab on Day 1 |
Pre-infusion and end of infusion (EOI) at Day 1
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Maximum concentration at steady-state (Cmax, ss)
Periodo de tiempo: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
|
Maximum concentration at steady-state. |
Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
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Minimum concentration at steady-state (Cmin, ss)
Periodo de tiempo: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
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Minimum concentration at steady-state |
Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
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Area under the concentration-time curve at steady-state (AUCtau, ss)
Periodo de tiempo: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
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Area under the concentration-time curve at steady-state during a dosing interval |
Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
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Average concentration at steady-state (Cavg,ss)
Periodo de tiempo: Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
|
Average concentration at steady-state |
Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Up to Week 20
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Number of participants with AEs and SAEs as a measure of safety and tolerability |
Up to Week 20
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Number of participants with clinically significant changes in clinical laboratory measures and vital signs.
Periodo de tiempo: Up to Week 20
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Number of participants with clinically significant changes in clinical laboratory measures and vital signs as a measure of safety and tolerability |
Up to Week 20
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- CAIN457G22101
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .