Clinical Trial

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

Active, Not Recruiting Phase 3
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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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-19.
Trial Details
NCT Number NCT07670546
Lead Sponsor R-Pharm International, LLC
Conditions Polymyalgia Rheumatica
Enrollment 125 participants
Start Date 2025-06-11
Primary Completion 2026-04-10 (estimated)
Study Completion 2026-07-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-30