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Efficacy and Safety of Olokizumab in Patients With Polymyalgia Rheumatica (PROMISE)

NCT07670546 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-06-30

No results posted yet for this study

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

Conditions

  • Polymyalgia Rheumatica

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

Sponsors & Collaborators

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2026-04-10
Completion
2026-07-09

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07670546 on ClinicalTrials.gov