Studio per valutare la farmacocinetica (PK), la sicurezza e la tollerabilità fino a 6 anni di secukinumab per via endovenosa (i.v.) in partecipanti pediatrici affetti da artrite psoriasica giovanile (JPsA).
Uno studio multicentrico in aperto per valutare la farmacocinetica, la sicurezza e la tollerabilità fino a 6 anni di infusioni endovenose di secukinumab in partecipanti pediatrici con artrite psoriasica giovanile
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Novartis Pharmaceuticals
- Numero di telefono: 1-888-669-6682
- Email: novartis.email@novartis.com
Backup dei contatti dello studio
- Nome: Novartis Pharmaceuticals
Luoghi di studio
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California
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Loma Linda, California, Stati Uniti, 92354
- Reclutamento
- Loma Linda University Health
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Contatto:
- Monica Pizana
- Numero di telefono: +1 909 558 5830
- Email: mpizana@llu.edu
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Investigatore principale:
- Wendy De La Pena
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Florida
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Gainesville, Florida, Stati Uniti, 32610-8068
- Reclutamento
- University of Florida
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Investigatore principale:
- Christian Oliveros
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Contatto:
- Joel Ravel
- Email: Joal.Ravel@UFHelath.ORG
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Reclutamento
- Ann and Robert H Lurie Childs Hosp
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Investigatore principale:
- Pooja Patel
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Contatto:
- Tyler Sorensen
- Numero di telefono: +1 312 227 4811
- Email: tsorensen@luriechildrens.org
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New York
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New York, New York, Stati Uniti, 10032
- Reclutamento
- Col Uni Med Center New York Presby
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Contatto:
- Marcela Arizabaleta
- Numero di telefono: +1 646 317 1669
- Email: ma5005@cumc.columbia.edu
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Investigatore principale:
- Lisa Imundo
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28203
- Reclutamento
- Levine Childrens Hospital
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Investigatore principale:
- Sheetal Vora
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Contatto:
- Haley D Furr
- Numero di telefono: +1 800 821 1535
- Email: Haley.Furr@advocatehealth.org
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45229
- Reclutamento
- Cincinnati Childrens Hospital
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Investigatore principale:
- Hermine Brunner
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Contatto:
- Megan Quinlan-Waters
- Numero di telefono: +1 513 636 7261
- Email: Megan.Quinlan-Waters@cchmc.org
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Cleveland, Ohio, Stati Uniti, 44106-5028
- Reclutamento
- Univ Hosp Cleveland Medical Center
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Investigatore principale:
- Ezequiel Borgia
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Contatto:
- Katrina Gogin
- Numero di telefono: +1 216 844 7164
- Email: katrina.gogin@uhhospitals.org
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Oregon
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Portland, Oregon, Stati Uniti, 97232
- Reclutamento
- Legacy Emanuel Research Hosp Portland
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Investigatore principale:
- Daniel Joseph Kingsbury
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Contatto:
- Brenna Bogle
- Numero di telefono: +1 503 413 5447
- Email: bbogle@lhs.org
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15224
- Reclutamento
- Childrens Hosp Pittsburgh UPMC
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Investigatore principale:
- Margalit Rosenkranz
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Contatto:
- Vibha Chauhan
- Numero di telefono: +1 412 692 6327
- Email: vibha.chauhan@chp.edu
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Texas
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El Paso, Texas, Stati Uniti, 79902
- Reclutamento
- Texas Arthritis Center
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Investigatore principale:
- Sanjay Chabra
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Contatto:
- Jose Cos
- Email: j.cos@aara.care
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Utah
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Salt Lake City, Utah, Stati Uniti, 84113
- Reclutamento
- University of Utah
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Contatto:
- Tressie Rollins
- Numero di telefono: +1 415 515 8212
- Email: tressie.rollins@hsc.utah.edu
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Investigatore principale:
- Peter Chiraseveenuprapund
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Secukinumab
Secukinumab administered intravenously in pediatric participants with JPsA |
Intravenous secukinumab
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum concentration on Day 1
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
|
Area under the concentration-time curve at steady-state (AUCtau, ss)
Lasso di tempo: 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
|
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Average concentration at steady-state (Cavg,ss)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: 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.
Lasso di tempo: Up to Week 20
|
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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CAIN457G22101
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .