Juvenile Psoriatic Arthritis
| Clinical Trial Title | An open-label, multicenter study to evaluate the pharmacokinetics, safety and tolerability up to 6 years of intravenous secukinumab infusions in pediatric participants with Juvenile Psoriatic Arthritis |
| Trial Status | Open to Enrollment |
| Start Date | 02/25/2025 |
| Location | Randall Children’s Rheumatology |
| Trial Type | Pediatric Rheumatology |
| Specific Condition | Juvenile Psoriatic Arthritis |
| 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. |
| Eligibility Criteria | • 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. |
| IRB Number | 10909 |
| Notes | https://clinicaltrials.gov/study/NCT06751238?term=CAIN457G22101&viewType=Card&rank=1#:~:text=Study%20to%20Evaluate%20the%20Pharmacokinetics%20(PK)%2C%20Safety%20and%20Tolerability%20up%20to%206%20Years%20of%20Intravenous%20(i.v.)%20Secukinumab%20in%20Pediatric%20Participants%20With%20Juvenile%20Psoriatic%20Arthritis%20(JPsA) |
| Principal Investigator | Daniel Kingsbury, MD |
| Contact Name | Brenna Bogle |
| Contact Phone | 503-413-3508 |
| Contact Fax | 503-413-3543 |
| Contact E-Mail | bbogle@lhs.org |
