Studie zur Bewertung der Pharmakokinetik (PK), Sicherheit und Verträglichkeit von intravenösem (i.v.) Secukinumab über einen Zeitraum von bis zu 6 Jahren bei pädiatrischen Teilnehmern mit juveniler Psoriasis-Arthritis (JPsA).
Eine offene, multizentrische Studie zur Bewertung der Pharmakokinetik, Sicherheit und Verträglichkeit von intravenösen Secukinumab-Infusionen über einen Zeitraum von bis zu 6 Jahren bei pädiatrischen Teilnehmern mit juveniler Psoriasis-Arthritis
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: Novartis Pharmaceuticals
- Telefonnummer: 1-888-669-6682
- E-Mail: novartis.email@novartis.com
Studieren Sie die Kontaktsicherung
- Name: Novartis Pharmaceuticals
Studienorte
-
-
California
-
Loma Linda, California, Vereinigte Staaten, 92354
- Rekrutierung
- Loma Linda University Health
-
Kontakt:
- Monica Pizana
- Telefonnummer: +1 909 558 5830
- E-Mail: mpizana@llu.edu
-
Hauptermittler:
- Wendy De La Pena
-
-
Florida
-
Gainesville, Florida, Vereinigte Staaten, 32610-8068
- Rekrutierung
- University of Florida
-
Hauptermittler:
- Christian Oliveros
-
Kontakt:
- Joel Ravel
- E-Mail: Joal.Ravel@UFHelath.ORG
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 60611
- Rekrutierung
- Ann and Robert H Lurie Childs Hosp
-
Hauptermittler:
- Pooja Patel
-
Kontakt:
- Tyler Sorensen
- Telefonnummer: +1 312 227 4811
- E-Mail: tsorensen@luriechildrens.org
-
-
New York
-
New York, New York, Vereinigte Staaten, 10032
- Rekrutierung
- Col Uni Med Center New York Presby
-
Kontakt:
- Marcela Arizabaleta
- Telefonnummer: +1 646 317 1669
- E-Mail: ma5005@cumc.columbia.edu
-
Hauptermittler:
- Lisa Imundo
-
-
North Carolina
-
Charlotte, North Carolina, Vereinigte Staaten, 28203
- Rekrutierung
- Levine Childrens Hospital
-
Hauptermittler:
- Sheetal Vora
-
Kontakt:
- Haley D Furr
- Telefonnummer: +1 800 821 1535
- E-Mail: Haley.Furr@advocatehealth.org
-
-
Ohio
-
Cincinnati, Ohio, Vereinigte Staaten, 45229
- Rekrutierung
- Cincinnati Childrens Hospital
-
Hauptermittler:
- Hermine Brunner
-
Kontakt:
- Megan Quinlan-Waters
- Telefonnummer: +1 513 636 7261
- E-Mail: Megan.Quinlan-Waters@cchmc.org
-
Cleveland, Ohio, Vereinigte Staaten, 44106-5028
- Rekrutierung
- Univ Hosp Cleveland Medical Center
-
Hauptermittler:
- Ezequiel Borgia
-
Kontakt:
- Katrina Gogin
- Telefonnummer: +1 216 844 7164
- E-Mail: katrina.gogin@uhhospitals.org
-
-
Oregon
-
Portland, Oregon, Vereinigte Staaten, 97232
- Rekrutierung
- Legacy Emanuel Research Hosp Portland
-
Hauptermittler:
- Daniel Joseph Kingsbury
-
Kontakt:
- Brenna Bogle
- Telefonnummer: +1 503 413 5447
- E-Mail: bbogle@lhs.org
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15224
- Rekrutierung
- Childrens Hosp Pittsburgh UPMC
-
Hauptermittler:
- Margalit Rosenkranz
-
Kontakt:
- Vibha Chauhan
- Telefonnummer: +1 412 692 6327
- E-Mail: vibha.chauhan@chp.edu
-
-
Texas
-
El Paso, Texas, Vereinigte Staaten, 79902
- Rekrutierung
- Texas Arthritis Center
-
Hauptermittler:
- Sanjay Chabra
-
Kontakt:
- Jose Cos
- E-Mail: j.cos@aara.care
-
-
Utah
-
Salt Lake City, Utah, Vereinigte Staaten, 84113
- Rekrutierung
- University of Utah
-
Kontakt:
- Tressie Rollins
- Telefonnummer: +1 415 515 8212
- E-Mail: tressie.rollins@hsc.utah.edu
-
Hauptermittler:
- Peter Chiraseveenuprapund
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Key Inclusion Criteria:
-
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).
-
Males and females ≥2 years old to <18 years old at the time of screening.
-
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.
-
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).
-
Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening.
-
Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening.
-
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Secukinumab
Secukinumab administered intravenously in pediatric participants with JPsA |
Intravenous secukinumab
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Maximum concentration on Day 1
Zeitfenster: 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
|
|
Maximum concentration at steady-state (Cmax, ss)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: Up to Week 20
|
Number of participants with AEs and SAEs as a measure of safety and tolerability |
Up to Week 20
|
|
Number of participants with clinically significant changes in clinical laboratory measures and vital signs.
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CAIN457G22101
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .