Actively Recruiting
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
Led by Novartis Pharmaceuticals · Updated on 2026-06-02
20
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics, safety, and tolerability of multiple doses of intravenous secukinumab in children with juvenile psoriatic arthritis (JPsA). This open-label, multicenter study focuses on pediatric patients aged 2 to under 18 years diagnosed with active JPsA, aiming to gather data over a period of up to 6 years. Participants receive intravenous infusions of secukinumab, a biological drug, with dosing schedules including pre-infusion and end-of-infusion measurements on Days 1, 29, 57, and weekly visits up to Day 85. An optional treatment extension period allows continued evaluation beyond the initial treatment phase. During the study, children will have blood samples taken at various time points to measure drug concentration and monitor safety through laboratory tests, vital signs, and adverse event reporting. Researchers will assess drug levels at steady state and track any side effects over the course of treatment, with follow-up visits extending up to one year or longer if the optional extension is chosen.
CONDITIONS
Brief 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).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legal representative's written consent and child's assent (if appropriate) obtained before study activities
- Males and females aged 2 to under 18 years at screening
- Confirmed diagnosis of juvenile psoriatic arthritis (JPsA) per modified ILAR criteria at least 6 months before screening
- Active JPsA with 3 or more active joints at baseline
- Inadequate response or intolerance to at least 1 NSAID for 1 month or more
- Inadequate response or intolerance to 2 or more months of at least 1 DMARD
- Allowed stable use of methotrexate (up to 20 mg/m2/week) with folic/folinic acid for at least 4 weeks before baseline
- Allowed stable dose of oral corticosteroids at prednisone equivalent less than 0.2 mg/kg/day or up to 10 mg/day for at least 7 days before baseline
- Allowed stable dose of no more than one NSAID for at least 1 week before baseline
You will not qualify if you...
- Body weight less than 10 kg at screening
- Use of other investigational drugs within 4 weeks or 5 half-lives before baseline
- History of hypersensitivity to secukinumab or similar drugs
- Active inflammatory bowel disease or active uveitis at screening or baseline
- Meeting criteria for any other juvenile idiopathic arthritis category besides JPsA at baseline
- Use of prohibited medications
- Use of any non-biologic DMARD at screening except methotrexate
- Any medical or psychiatric condition that could prevent adherence to the study or completion per protocol
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 years
Participants receive intravenous secukinumab infusions to evaluate pharmacokinetics, safety, and tolerability.
Multiple visits for infusions and assessments including weekly visits between Day 64 and Day 85, and additional visits on Day 1, Day 29, Day 57, Day 141, and Day 365
Trial Site Locations
Total: 8 locations
1
University of Florida
Gainesville, Florida, United States, 32610 8068
Actively Recruiting
2
Ann and Robert H Lurie Childs Hosp
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Levine Childrens Hospital
Charlotte, North Carolina, United States, 28203
Actively Recruiting
4
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
5
Univ Hosp Cleveland Medical Center
Cleveland, Ohio, United States, 44106-5028
Actively Recruiting
6
Legacy Emanuel Research Hosp Portland
Portland, Oregon, United States, 97232
Actively Recruiting
7
Childrens Hosp Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
8
Texas Arthritis Center
El Paso, Texas, United States, 79902
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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