Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07670546
PHASE3

A Phase III Study of the Efficacy and Safety of Olokizumab in Patients With Polymyalgia Rheumatica

Sponsor: R-Pharm International, LLC

View on ClinicalTrials.gov

Summary

The primary objective of the study is to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously every 2 weeks compared with placebo in participants with polymyalgia rheumatica (PMR). The secondary objectives are to evaluate the steroid-sparing effect, inflammatory markers, safety, tolerability, immunogenicity, and pharmacokinetics of OKZ in participants with PMR compared with placebo. The exploratory objectives are to evaluate OKZ efficacy in selected participant subgroups, biomarkers of bone metabolism, pharmacodynamic parameters, glucocorticoid-related effects, and quality of life in participants with PMR compared with placebo

Official title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Olokizumab in Patients With Polymyalgia Rheumatica

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2025-06-11

Completion Date

2026-07-09

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

Olokizumab

Solution for subcutaneous injection in a prefilled syringe (1 mL) with a concentration of 160 mg/mL, administered as a 64 mg/0.4 mL dose

DRUG

Placebo

0.9% Sodium Chloride solution for Injection

Locations (20)

Udmurt Republic Clinical and Diagnostic Center, Ministry of Health of the Udmurt Republic

Izhevsk, Russia

Family Polyclinic No. 4 LLC

Korolyov, Russia

A.S. Loginov Moscow Clinical Scientific Center

Moscow, Russia

V.A. Nasonova Research Institute of Rheumatology

Moscow, Russia

I.M. Sechenov First Moscow State Medical University, Center for Clinical Studies of Medicinal Products

Moscow, Russia

M.F. Vladimirsky Moscow Regional Research and Clinical Institute (MONIKI)

Moscow, Russia

Russian Gerontology Research and Clinical Center, Pirogov Russian National Research Medical University

Moscow, Russia

N.A. Semashko Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, Russia

Healthy Family Medical Center LLC

Novosibirsk, Russia

Research Institute of Clinical and Experimental Lymphology - Branch of the Federal Research Center Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences

Novosibirsk, Russia

Omsk Regional Clinical Hospital

Omsk, Russia

Academician I.P. Pavlov Ryazan State Medical University

Ryazan, Russia

Interleukin LLC

Saint Petersburg, Russia

Medical and Sanitary Unit No. 157 LLC

Saint Petersburg, Russia

Smolensk Regional Rheumatology Center at the Clinical Hospital "RZD-Medicine" of the City of Smolensk (Private Healthcare Institution)

Smolensk, Russia

Siberian State Medical University, Ministry of Health of the Russian Federation

Tomsk, Russia

State Budgetary Healthcare Institution Republican Clinical Hospital named after G.G. Kuvatov

Ufa, Russia

Biomed LLC

Vladimir, Russia

Yaroslavl Central City Hospital

Yaroslavl, Russia

Center for Medical Consultations and Research - PRAKTIKA LLC

Yaroslavl, Russia