drugset / Trial / NCT07517575
Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis
Phase 2
Recruiting
71 enrolled
R-Pharm International, LLC
Exacte Labs LLC · collabKeystat, LLC · collabR-Pharm · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of olokizumab (OKZ) in patients with polyarticular juvenile idiopathic arthritis aged \>2 and \<18 years in two doses (64 mg or 48 mg every 4 weeks) depending on patient's weight. Secondary objectives are to evaluate the pharmacodynamic (PD) profile, the long-term efficacy and safety of olokizumab in patients with polyarticular juvenile idiopathic arthritis aged \>2 and \<18 years.
Timeline
- Start
- 2023-03-17
- Primary completion
- 2026-09
- Completion
- 2030-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olokizumab | Monoclonal antibody | 48 mg | Subcutaneous |
| Subject | Olokizumab | Monoclonal antibody | 64 mg | Subcutaneous |