NCT05767034

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 360 PMR patients who had recently relapsed. The study consists of: screening (up to 6 weeks); treatment period (52 weeks, with last IMP administration at 48 weeks, active drug or placebo) in combination with prednisone tapered over 24 weeks; treatment-free follow-up (up to 24 weeks). Adult males and females of at least 50 years of age with a recent PMR relapse (within 12 weeks from Baseline) will be included. Dosing will be once every week for the first 4 weeks, and once every 4 weeks thereafter via pre-filled syringe. The primary objective is to demonstrate the efficacy of secukinumab 300 mg subcutaneously in combination with a 24-week glucocorticoid (GC) taper regimen compared with placebo with respect to the proportion of patients in sustained remission at Week 52. Primary secondary objectives are to assess difference in proportion of patients achieving complete sustained remission at Week 52, adjusted annual cumulative GC dose and time to first use of escape treatment or rescue treatment through Week 52. Key safety data will be collected, along with Patient Reported Outcomes.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Secukinumab 300 mg	Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
DRUG	Secukinumab 150 mg	Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
OTHER	Placebo to secukinumab	Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

Timeline

• Start date: 2023-03-22
• Primary completion: 2025-09-10
• Completion: 2026-02-16
• First posted: 2023-03-14
• Last updated: 2026-03-09

Locations

133 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Japan, Lebanon, Mexico, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study