Estudo para avaliar a farmacocinética (PK), segurança e tolerabilidade até 6 anos de secuquinumabe intravenoso (iv) em participantes pediátricos com artrite psoriática juvenil (JPsA).
Um estudo multicêntrico aberto para avaliar a farmacocinética, a segurança e a tolerabilidade até 6 anos de infusões intravenosas de secuquinumabe em participantes pediátricos com artrite psoriática 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Novartis Pharmaceuticals
- Número de telefone: 1-888-669-6682
- E-mail: novartis.email@novartis.com
Estude backup de contato
- Nome: Novartis Pharmaceuticals
Locais de estudo
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California
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Loma Linda, California, Estados Unidos, 92354
- Recrutamento
- Loma Linda University Health
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Contato:
- Monica Pizana
- Número de telefone: +1 909 558 5830
- E-mail: 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
- Recrutamento
- University of Florida
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Investigador principal:
- Christian Oliveros
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Contato:
- Joel Ravel
- E-mail: Joal.Ravel@UFHelath.ORG
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Recrutamento
- Ann and Robert H Lurie Childs Hosp
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Investigador principal:
- Pooja Patel
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Contato:
- Gabrielle Morgan
- Número de telefone: +1 312 227 4811
- E-mail: gamorgan@luriechildrens.org
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New York
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New York, New York, Estados Unidos, 10032
- Recrutamento
- Col Uni Med Center New York Presby
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Contato:
- Marcela Arizabaleta
- Número de telefone: +1 646 317 1669
- E-mail: 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
- Recrutamento
- Levine Childrens Hospital
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Investigador principal:
- Sheetal Vora
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Contato:
- Haley D Furr
- Número de telefone: +1 800 821 1535
- E-mail: Haley.Furr@advocatehealth.org
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Recrutamento
- Cincinnati Childrens Hospital
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Investigador principal:
- Hermine Brunner
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Contato:
- Megan Quinlan-Waters
- Número de telefone: +1 513 636 7261
- E-mail: Megan.Quinlan-Waters@cchmc.org
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Cleveland, Ohio, Estados Unidos, 44106-5028
- Recrutamento
- Univ Hosp Cleveland Medical Center
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Investigador principal:
- Ezequiel Borgia
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Contato:
- Katrina Gogin
- Número de telefone: +1 216 844 7164
- E-mail: katrina.gogin@uhhospitals.org
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Oregon
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Portland, Oregon, Estados Unidos, 97232
- Recrutamento
- Legacy Emanuel Research Hosp Portland
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Investigador principal:
- Daniel Joseph Kingsbury
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Contato:
- Brenna Bogle
- Número de telefone: +1 503 413 5447
- E-mail: bbogle@lhs.org
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Recrutamento
- Childrens Hosp Pittsburgh UPMC
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Investigador principal:
- Margalit Rosenkranz
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Contato:
- Vibha Chauhan
- Número de telefone: +1 412 692 6327
- E-mail: vibha.chauhan@chp.edu
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Texas
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El Paso, Texas, Estados Unidos, 79902
- Recrutamento
- Texas Arthritis Center
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Investigador principal:
- Sanjay Chabra
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Contato:
- Melissa Lopez
- E-mail: melissa.lopez@aara.care
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Utah
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Salt Lake City, Utah, Estados Unidos, 84113
- Recrutamento
- University of Utah
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Contato:
- Tressie Rollins
- Número de telefone: +1 415 515 8212
- E-mail: tressie.rollins@hsc.utah.edu
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Investigador principal:
- Peter Chiraseveenuprapund
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Secukinumab
Secukinumab administered intravenously in pediatric participants with JPsA |
Intravenous secukinumab
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maximum concentration on Day 1
Prazo: 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)
Prazo: 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
|
|
Minimum concentration at steady-state (Cmin, ss)
Prazo: 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
|
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)
Prazo: 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
|
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
|
|
Average concentration at steady-state (Cavg,ss)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: Up to Week 20
|
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.
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CAIN457G22101
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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
Informações sobre medicamentos e dispositivos, documentos de estudo
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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