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).
Part of paid clinical trials in Loma Linda, California.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT06751238
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Juvenile Psoriatic Arthritis
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Secukinumab — BIOLOGICALIntravenous secukinumab
Study Details
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
Key Dates
- First listed
- Dec 27, 2024
- Start date
- Sep 24, 2025
- Status verified
- Aug 2026
- Primary completion
- Oct 31, 2029
- Completion
- Mar 11, 2031
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: SecukinumabSecukinumab administered intravenously in pediatric participants with JPsA
Primary Outcome Measure
Maximum concentration on Day 1 [ Time Frame: Pre-infusion and end of infusion (EOI) at Day 1 ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Loma Linda University Health | Loma Linda | California | 92354 | Wendy De La Pena (PRINCIPAL_INVESTIGATOR) |
| University of Florida | Gainesville | Florida | 32610 8068 | Joel Ravel Christian Oliveros (PRINCIPAL_INVESTIGATOR) |
| Ann and Robert H Lurie Childs Hosp | Chicago | Illinois | 60611 | Pooja Patel (PRINCIPAL_INVESTIGATOR) |
| Col Uni Med Center New York Presby | New York | New York | 10032 | Lisa Imundo (PRINCIPAL_INVESTIGATOR) |
| Levine Childrens Hospital | Charlotte | North Carolina | 28203 | Sheetal Vora (PRINCIPAL_INVESTIGATOR) |
| Cincinnati Childrens Hospital | Cincinnati | Ohio | 45229 | Hermine Brunner (PRINCIPAL_INVESTIGATOR) |
| Univ Hosp Cleveland Medical Center | Cleveland | Ohio | 44106-5028 | Ezequiel Borgia (PRINCIPAL_INVESTIGATOR) |
| Legacy Emanuel Research Hosp Portland | Portland | Oregon | 97232 | Daniel Joseph Kingsbury (PRINCIPAL_INVESTIGATOR) |
| Childrens Hosp Pittsburgh UPMC | Pittsburgh | Pennsylvania | 15224 | Margalit Rosenkranz (PRINCIPAL_INVESTIGATOR) |
| Texas Arthritis Center | El Paso | Texas | 79902 | Melissa Lopez Sanjay Chabra (PRINCIPAL_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84113 | Peter Chiraseveenuprapund (PRINCIPAL_INVESTIGATOR) |
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