Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06751238
Phase
PHASE1
Status
Recruiting

Conditions

  • Juvenile Psoriatic Arthritis

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

First listed
Dec 27, 2024
Start date
Sep 24, 2025
Status verified
Jul 2026
Primary completion
Nov 30, 2032
Completion
Dec 1, 2032

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab
    Secukinumab administered intravenously in pediatric participants with JPsA

Primary Outcome Measure

Maximum concentration on Day 1 [ Time Frame: Pre-infusion and end of infusion (EOI) at Day 1 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610 8068
Andrew Sokolow
Christian Oliveros (PRINCIPAL_INVESTIGATOR)
Ann and Robert H Lurie Childs HospChicagoIllinois60611
Tyler Sorensen
+1 312 227 4811
Pooja Patel (PRINCIPAL_INVESTIGATOR)
Levine Childrens HospitalCharlotteNorth Carolina28203
Jessica Lindley
+1 800 821 1535
Sheetal Vora (PRINCIPAL_INVESTIGATOR)
Cincinnati Childrens HospitalCincinnatiOhio45229
Megan Quinlan-Waters
+1 513 636 7261
Hermine Brunner (PRINCIPAL_INVESTIGATOR)
Univ Hosp Cleveland Medical CenterClevelandOhio44106-5028
Katrina Gogin
+1 216 844 7164
Ezequiel Borgia (PRINCIPAL_INVESTIGATOR)
Legacy Emanuel Research Hosp PortlandPortlandOregon97232
Brenna Bogle
+1 503 413 5447
Daniel Joseph Kingsbury (PRINCIPAL_INVESTIGATOR)
Childrens Hosp Pittsburgh UPMCPittsburghPennsylvania15224
Vibha Chauhan
+1 412 692 6327
Margalit Rosenkranz (PRINCIPAL_INVESTIGATOR)
Texas Arthritis CenterEl PasoTexas79902
Melissa Lopez
Sanjay Chabra (PRINCIPAL_INVESTIGATOR)

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