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

This is a Phase 3, double‐blind, placebo‐controlled, parallel‐group study. A total of 120participants with active polymyalgia rheumatica are planned to be randomized in a 1:1ratio to one of the following treatment arms: ‐ OKZ arm: subcutaneous injections of OKZ 64 mg every 2 weeks ‐ Placebo arm: subcutaneous placebo injections every 2 weeksParticipants may continue stable methotrexate or leflunomide therapy during the screeningand treatment periodsThe treatment period lasts 16 weeks, during which participants visit the study centerevery 2 weeks for safety assessments and evaluation of treatment response. Starting fromWeek 6 (Visit 4), in participants with PMR‐AS <10, a gradual weekly glucocorticoid taperis initiated, decreasing by 2.5 mg/week until a dose of 5 mg/day is reached, followed byreductions of 1.25 mg/week until complete discontinuation of glucocorticoids. If completediscontinuation is not feasible at a dose of 5 mg/day or lower, tapering may be pausedbased on the investigator's clinical judgmentParticipants who do not enter an open‐label extension study after completion of the16‐week double‐blind treatment period enter a 22‐week safety follow‐up (SFU) period.During follow‐up, participants attend clinic visits at 2, 10, and 22 weeks after theend‐of‐treatment (EOT) visit for SFU assessments. The total duration of the study forparticipants is approximately 42 weeks