Undersøgelse til evaluering af farmakokinetikken (PK), sikkerhed og tolerabilitet op til 6 års intravenøs (i.v.) Secukinumab hos pædiatriske deltagere med juvenil psoriasisarthritis (JPsA).
Et åbent, multicenter-studie til evaluering af farmakokinetik, sikkerhed og tolerabilitet i op til 6 års intravenøse Secukinumab-infusioner hos pædiatriske deltagere med juvenil psoriasisgigt
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Novartis Pharmaceuticals
- Telefonnummer: 1-888-669-6682
- E-mail: novartis.email@novartis.com
Undersøgelse Kontakt Backup
- Navn: Novartis Pharmaceuticals
Studiesteder
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California
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Loma Linda, California, Forenede Stater, 92354
- Rekruttering
- Loma Linda University Health
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Kontakt:
- Monica Pizana
- Telefonnummer: +1 909 558 5830
- E-mail: mpizana@llu.edu
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Ledende efterforsker:
- Wendy De La Pena
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Florida
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Gainesville, Florida, Forenede Stater, 32610-8068
- Rekruttering
- University of Florida
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Ledende efterforsker:
- Christian Oliveros
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Kontakt:
- Joel Ravel
- E-mail: Joal.Ravel@UFHelath.ORG
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Rekruttering
- Ann and Robert H Lurie Childs Hosp
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Ledende efterforsker:
- Pooja Patel
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Kontakt:
- Tyler Sorensen
- Telefonnummer: +1 312 227 4811
- E-mail: tsorensen@luriechildrens.org
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New York
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New York, New York, Forenede Stater, 10032
- Rekruttering
- Col Uni Med Center New York Presby
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Kontakt:
- Marcela Arizabaleta
- Telefonnummer: +1 646 317 1669
- E-mail: ma5005@cumc.columbia.edu
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Ledende efterforsker:
- Lisa Imundo
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28203
- Rekruttering
- Levine Childrens Hospital
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Ledende efterforsker:
- Sheetal Vora
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Kontakt:
- Haley D Furr
- Telefonnummer: +1 800 821 1535
- E-mail: Haley.Furr@advocatehealth.org
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- Rekruttering
- Cincinnati Childrens Hospital
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Ledende efterforsker:
- Hermine Brunner
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Kontakt:
- Megan Quinlan-Waters
- Telefonnummer: +1 513 636 7261
- E-mail: Megan.Quinlan-Waters@cchmc.org
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Cleveland, Ohio, Forenede Stater, 44106-5028
- Rekruttering
- Univ Hosp Cleveland Medical Center
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Ledende efterforsker:
- Ezequiel Borgia
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Kontakt:
- Katrina Gogin
- Telefonnummer: +1 216 844 7164
- E-mail: katrina.gogin@uhhospitals.org
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Oregon
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Portland, Oregon, Forenede Stater, 97232
- Rekruttering
- Legacy Emanuel Research Hosp Portland
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Ledende efterforsker:
- Daniel Joseph Kingsbury
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Kontakt:
- Brenna Bogle
- Telefonnummer: +1 503 413 5447
- E-mail: bbogle@lhs.org
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Rekruttering
- Childrens Hosp Pittsburgh UPMC
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Ledende efterforsker:
- Margalit Rosenkranz
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Kontakt:
- Vibha Chauhan
- Telefonnummer: +1 412 692 6327
- E-mail: vibha.chauhan@chp.edu
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Texas
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El Paso, Texas, Forenede Stater, 79902
- Rekruttering
- Texas Arthritis Center
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Ledende efterforsker:
- Sanjay Chabra
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Kontakt:
- Jose Cos
- E-mail: j.cos@aara.care
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Utah
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Salt Lake City, Utah, Forenede Stater, 84113
- Rekruttering
- University of Utah
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Kontakt:
- Tressie Rollins
- Telefonnummer: +1 415 515 8212
- E-mail: tressie.rollins@hsc.utah.edu
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Ledende efterforsker:
- Peter Chiraseveenuprapund
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Secukinumab
Secukinumab administered intravenously in pediatric participants with JPsA |
Intravenous secukinumab
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Maximum concentration on Day 1
Tidsramme: 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)
Tidsramme: 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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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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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 |
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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: 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.
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CAIN457G22101
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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