The primary phase of the Phase 3 study (NCT05767034) investigating secukinumab for patients with polymyalgia rheumatica (PMR) completed on 2025-09-10. This trial evaluated the efficacy and safety of secukinumab in combination with a glucocorticoid taper regimen.
Background
Secukinumab is under investigation as a potential treatment for polymyalgia rheumatica (PMR). The drug is being studied for its efficacy and safety when administered in combination with a glucocorticoid taper regimen in adult participants with PMR who have recently relapsed.
Trial design
The Phase 3 study, NCT05767034, titled "Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)," enrolled 381 participants. This randomized, placebo-controlled trial is evaluating secukinumab 300 mg and secukinumab 150 mg administered subcutaneously for 52 weeks, alongside a prednisone taper over 24 weeks, in adult patients with polymyalgia rheumatica who have recently relapsed. The comparator arm is placebo.
What this means
The completion of the primary phase of this Phase 3 trial marks a significant milestone in the evaluation of secukinumab for polymyalgia rheumatica. This event precedes the eventual analysis and disclosure of trial results, which will provide crucial insights into the drug's efficacy and safety profile for this condition.
Source
The information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT05767034 was posted on 2025-09-10 on clinicaltrials.gov.