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
Outcome
Met primary endpoint
paper in 40.6% (95% CI, 32.2 to 49.0) of those in the SEC-150 group, and in 20.4% (95% CI, 13.6 to 27.2) of those in the placebo group PMID 42234540 ↗
paper (P<0.001 for the comparison of each secukinumab dose with placebo). PMID 42234540 ↗
release “Novartis today announced that Cosentyx® (secukinumab) met the primary endpoint and all secondary endpoints in the Phase III REPLENISH trial” novartis.com ↗
release “All primary and secondary endpoints of the REPLENISH trial were met across both Cosentyx 300mg and 150mg treatment arms” novartis.com ↗
release “the pivotal REPLENISH Phase III trial in which all primary and secondary endpoints were met” novartis.com ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |