Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilumab regimens. The study will consist of the following visits: Visit 1 (D-42 to D-1): Screening, Visit 2 (D1): Baseline, randomization, first study drug administration, Visit 3 to 12 (Week 2 to Week 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.

NCT Number	NCT07286214
Lead Sponsor	Sanofi Collaborators: Regeneron Pharmaceuticals
Conditions	Polymyalgia Rheumatica
Enrollment	300 participants
Start Date	2026-05-12
Primary Completion	2029-06-04 (estimated)
Study Completion	2029-07-16 (estimated)
Updated on ClinicalTrials.gov	2026-06-23