Actively Recruiting
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).
Led by Novartis Pharmaceuticals · Updated on 2026-03-11
20
Participants Needed
7
Research Sites
375 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 consent and child assent obtained before any study activity
- Boys and girls aged 2 to under 18 years at screening
- Confirmed diagnosis of juvenile psoriatic arthritis (JPsA) 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 disease-modifying anti-rheumatic drug (DMARD)
- Stable dose of methotrexate (up to 20 mg/m2/week) for at least 4 weeks before baseline with folic/folinic acid
- Stable dose of oral corticosteroid (less than 0.2 mg/kg/day prednisone equivalent or up to 10 mg/day) for at least 7 days before baseline
- 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 allergy to study drug or similar drugs
- Active inflammatory bowel disease or uveitis at screening or baseline
- Meeting criteria for juvenile idiopathic arthritis (JIA) categories other than JPsA at baseline
- Use of prohibited medications
- Taking any non-biologic DMARD at screening except methotrexate
- Any medical or psychiatric condition that would prevent following the study or completing it as planned
- Other unspecified inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 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
Texas Arthritis Center
El Paso, Texas, United States, 79902
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
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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