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).

June 1, 2026 updated by: Novartis Pharmaceuticals

An Open-label, Multicenter Study to Evaluate Pharmacokinetics, Safety and Tolerability up to 6 Years of Intravenous Secukinumab Infusions in Pediatric Participants With Juvenile Psoriatic 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610 8068
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Melissa Elder
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann and Robert H Lurie Childs Hosp
        • Principal Investigator:
          • Pooja Patel
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Childrens Hospital
        • Contact:
        • Principal Investigator:
          • Hermine Brunner
      • Cleveland, Ohio, United States, 44106-5028
        • Recruiting
        • Univ Hosp Cleveland Medical Center
        • Principal Investigator:
          • Ezequiel Borgia
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97232
        • Recruiting
        • Legacy Emanuel Research Hosp Portland
        • Principal Investigator:
          • Daniel Joseph Kingsbury
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Childrens Hosp Pittsburgh UPMC
        • Contact:
        • Principal Investigator:
          • Margalit Rosenkranz
    • Texas
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Texas Arthritis Center
        • Principal Investigator:
          • Sanjay Chabra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Secukinumab
Secukinumab administered intravenously in pediatric participants with JPsA
Biological: Secukinumab
Intravenous secukinumab
Other Names:
  • AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum concentration on Day 1
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 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.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2025

Primary Completion (Estimated)

November 30, 2032

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457G22101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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