NCT07517575

Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis

An Open-label, Multicenter Study of the Pharmacokinetics, Efficacy and Safety of Olokizumab in Pediatric and Adolescent Patients With Active Juvenile Idiopathic Arthritis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: R-Pharm International, LLC · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a multicenter, open-label, non-randomized, uncontrolled study with an interim analysis of endpoints after 12 weeks of therapy, a final analysis of endpoints after 24 weeks of therapy, and an additional analysis at the end of all study visits. The total number of study subjects screened is 71 subjects. Up to 50 patients will begin treatment. This study includes: 1. A screening period of up to 2 weeks 2. A main period of open label treatment from Week 0 to Week 24 (24 weeks) 3. A period of extended open label treatment from Week 24 to Week 164 (140 weeks) 4. Safety follow-up period from Week 165 to Week 186 (22 weeks) The total study duration for patients is approximately 188 weeks (including the screening period).

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	OKZ q4w	Subcutaneous (SC) injections of OKZ every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection
DRUG	OKZ q4w	SC injections of OKZ 48 mg every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection

Timeline

• Start date: 2023-03-17
• Primary completion: 2026-09-01
• Completion: 2030-06-01
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

14 sites across 1 country: Russia