Onderzoek ter evaluatie van de farmacokinetiek (PK), veiligheid en verdraagbaarheid tot 6 jaar intraveneuze (i.v.) Secukinumab bij pediatrische deelnemers met juveniele artritis psoriatica (JPsA).
Een open-label, multicenter onderzoek ter evaluatie van de farmacokinetiek, veiligheid en verdraagbaarheid gedurende maximaal 6 jaar intraveneuze Secukinumab-infusies bij pediatrische deelnemers met juveniele artritis psoriatica
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Novartis Pharmaceuticals
- Telefoonnummer: 1-888-669-6682
- E-mail: novartis.email@novartis.com
Studie Contact Back-up
- Naam: Novartis Pharmaceuticals
Studie Locaties
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California
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Loma Linda, California, Verenigde Staten, 92354
- Werving
- Loma Linda University Health
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Contact:
- Monica Pizana
- Telefoonnummer: +1 909 558 5830
- E-mail: mpizana@llu.edu
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Hoofdonderzoeker:
- Wendy De La Pena
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Florida
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Gainesville, Florida, Verenigde Staten, 32610-8068
- Werving
- University of Florida
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Hoofdonderzoeker:
- Christian Oliveros
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Contact:
- Joel Ravel
- E-mail: Joal.Ravel@UFHelath.ORG
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Werving
- Ann and Robert H Lurie Childs Hosp
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Hoofdonderzoeker:
- Pooja Patel
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Contact:
- Tyler Sorensen
- Telefoonnummer: +1 312 227 4811
- E-mail: tsorensen@luriechildrens.org
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New York
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New York, New York, Verenigde Staten, 10032
- Werving
- Col Uni Med Center New York Presby
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Contact:
- Marcela Arizabaleta
- Telefoonnummer: +1 646 317 1669
- E-mail: ma5005@cumc.columbia.edu
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Hoofdonderzoeker:
- Lisa Imundo
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28203
- Werving
- Levine Childrens Hospital
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Hoofdonderzoeker:
- Sheetal Vora
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Contact:
- Haley D Furr
- Telefoonnummer: +1 800 821 1535
- E-mail: Haley.Furr@advocatehealth.org
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45229
- Werving
- Cincinnati Childrens Hospital
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Hoofdonderzoeker:
- Hermine Brunner
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Contact:
- Megan Quinlan-Waters
- Telefoonnummer: +1 513 636 7261
- E-mail: Megan.Quinlan-Waters@cchmc.org
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Cleveland, Ohio, Verenigde Staten, 44106-5028
- Werving
- Univ Hosp Cleveland Medical Center
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Hoofdonderzoeker:
- Ezequiel Borgia
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Contact:
- Katrina Gogin
- Telefoonnummer: +1 216 844 7164
- E-mail: katrina.gogin@uhhospitals.org
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Oregon
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Portland, Oregon, Verenigde Staten, 97232
- Werving
- Legacy Emanuel Research Hosp Portland
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Hoofdonderzoeker:
- Daniel Joseph Kingsbury
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Contact:
- Brenna Bogle
- Telefoonnummer: +1 503 413 5447
- E-mail: bbogle@lhs.org
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15224
- Werving
- Childrens Hosp Pittsburgh UPMC
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Hoofdonderzoeker:
- Margalit Rosenkranz
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Contact:
- Vibha Chauhan
- Telefoonnummer: +1 412 692 6327
- E-mail: vibha.chauhan@chp.edu
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Texas
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El Paso, Texas, Verenigde Staten, 79902
- Werving
- Texas Arthritis Center
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Hoofdonderzoeker:
- Sanjay Chabra
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Contact:
- Jose Cos
- E-mail: j.cos@aara.care
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84113
- Werving
- University of Utah
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Contact:
- Tressie Rollins
- Telefoonnummer: +1 415 515 8212
- E-mail: tressie.rollins@hsc.utah.edu
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Hoofdonderzoeker:
- Peter Chiraseveenuprapund
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Secukinumab
Secukinumab administered intravenously in pediatric participants with JPsA |
Intravenous secukinumab
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Maximum concentration on Day 1
Tijdsspanne: Pre-infusion and end of infusion (EOI) at Day 1
|
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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CAIN457G22101
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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