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).

Official title

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

Overview

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

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.

Interventions

• Biological Secukinumab
  Intravenous secukinumab

Primary outcome measures

• Maximum concentration on Day 1 [Time frame: 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]
• 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]
• 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]
• 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]

Secondary outcome measures (2)

• Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to Week 20]
• Number of participants with clinically significant changes in clinical laboratory measures and vital signs. [Time frame: Up to Week 20]

Eligibility criteria

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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 8 centers

• University of Florida — Gainesville
• Ann and Robert H Lurie Childs Hosp — Chicago
• Levine Childrens Hospital — Charlotte
• Cincinnati Childrens Hospital — Cincinnati
• Univ Hosp Cleveland Medical Center — Cleveland
• Legacy Emanuel Research Hosp Portland — Portland
• Childrens Hosp Pittsburgh UPMC — Pittsburgh
• Texas Arthritis Center — El Paso

Identifiers

NCT: NCT06751238 · CAIN457G22101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗