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RECRUITING
NCT07517575
PHASE2

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

Sponsor: R-Pharm International, LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2023-03-17

Completion Date

2030-06

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

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

Locations (14)

Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation

Kazan', Russia

Federal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology"

Moscow, Russia

State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's City Clinical Hospital of the Moscow City Health Department" (GBUZ "Morozovskaya DGBK DZM")

Moscow, Russia

Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation (Sechenov University)

Moscow, Russia

Federal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation

Moscow, Russia

Limited Liability Company "Healthy Family Medical Center"

Novosibirsk, Russia

Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation

Rostov-on-Don, Russia

LLC "Medical Technologies"

Saint Petersburg, Russia

Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation

Saratov, Russia

Limited Liability Company "Scientific Medical Center of General Therapy and Pharmacology" (LLC "TERAPHARM")

Stavropol, Russia

State Budgetary Healthcare Institution of the Samara Region "Tolyatti City Clinical Hospital No. 5"

Tolyatti, Russia

Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation

Ufa, Russia

Federal State Budgetary Educational Institution of Higher Education "Voronezh State Medical University named after N.N. Burdenko" of the Ministry of Health of the Russian Federation

Voronezh, Russia

State Budgetary Institution of Healthcare of the Yaroslavl Region "Regional Children's Clinical Hospital"

Yaroslavl, Russia