NCT07266168

Efficacy and Safety of Ivarmacitinib in the Treatment of Patients With Polymyalgia Rheumatica

Efficacy and Safety of Ivarmacitinib in the Treatment of Patients With Polymyalgia Rheumatica: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study intends to explore the efficacy and safety of Ivarmacitinib in therapy for polymyalgia rheumatica through a multicenter, randomized, double-blind, placebo-controlled study, and to explore the effectiveness of Ivarmacitinib as an oral glucocorticoid-sparing alternative in the treatment of polymyalgia rheumatica.

Detailed description

This study plans to enroll 80 patients with clinically confirmed severe active polymyalgia rheumatica. After enrollment, participants will be randomly assigned in a 1:1 ratio to either the experimental group or the placebo group. All patients will receive a single dose of long-acting glucocorticoid in Week 1. Both groups will continue their assigned treatment until Week 12, when unblinding will occur. Thereafter, the placebo group will switch to ivarmacitinib, and both groups will continue treatment until Week 48, followed by a 4-week safety follow-up period until Week 52.

Conditions

• Polymyalgia Rheumatics (PMR)

Interventions

Type	Name	Description
DRUG	Ivarmacitinib tablet	Targets JAK kinases to block signal transduction of the JAK-STAT pathway
DRUG	placebo for lvarmacitinib	Treatment using blank placebo

Timeline

• Start date: 2026-01-20
• Primary completion: 2027-12-30
• Completion: 2028-11-30
• First posted: 2025-12-05
• Last updated: 2025-12-05