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

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.

Timeline

Start

2023-03-22

Primary completion

2025-09-10

Completion

2026-02-16

Publications

• Stone JH, Buttgereit F, Saraux A, Schmidt WA, Dejaco C, Spiera R, Dasgupta B, Drescher E, Jordan A, Novosad L, Nakagomi D, Koyama Y, Duran-Barragan S, Tracey G, Ruyssen-Witrand A, Rubbert Roth A, Fang J, Ng J, Hiremath R, Raffner R, Martin R, Napoletano S, Huang S, Storim J, Patekar M; REPLENISH Investigators. Phase 3 Trial of Secukinumab in Polymyalgia Rheumatica. N Engl J Med. 2026 Jun 3. doi: 10.1056/NEJMoa2602567. Online ahead of print.
• Sun MM, Pope JE. Polymyalgia rheumatica and giant cell arteritis: diagnosis and management. Curr Opin Rheumatol. 2025 Jan 1;37(1):32-38. doi: 10.1097/BOR.0000000000001059. Epub 2024 Oct 14.

Drugs

Indications