Secukinumab given by infusion in children with juvenile psoriatic arthritis
Tests secukinumab infusions for safety and how the body handles them in children.
Plain-language title generated from the registry record
Registry title: 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).
Key facts
- Where
- Charlotte, Chicago, Cincinnati, Cleveland, El Paso, Gainesville, Loma Linda, New York, Pittsburgh, Portland, and Salt Lake City, United StatesSee the 11 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Source: NCT06751238, who can take part
Where in United States
- Levine Childrens HospitalCharlotte, United StatesTaking people
- Ann and Robert H Lurie Childs HospChicago, United StatesTaking people
- Cincinnati Childrens HospitalCincinnati, United StatesTaking people
- Univ Hosp Cleveland Medical CenterCleveland, United StatesTaking people
- Texas Arthritis CenterEl Paso, United StatesTaking people
- University of FloridaGainesville, United StatesTaking people
- Loma Linda University HealthLoma Linda, United StatesTaking people
- Col Uni Med Center New York PresbyNew York, United StatesTaking people
- Childrens Hosp Pittsburgh UPMCPittsburgh, United StatesTaking people
- Legacy Emanuel Research Hosp PortlandPortland, United StatesTaking people
- University of UtahSalt Lake City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06751238
- Record updated
- 9 November 2026
- Original description
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 JPsARead full original descriptionShow less
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
Inclusion: 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: 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; Participants treated with prohibited medication; 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; 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; Participants with body weight less than 10 kg at screening; Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL; Participants taking any non-biologic DMARD at screening except for MTX.