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Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

StatusRecruiting
PhasePhase 4
SponsorSanofi
Started2026-05-12
View on ClinicalTrials.gov ↗
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.

Amendment history 4 changes detected by DataLookout

2026-06-24
minor
Trial sites expanded: 9 → 14 locations
2026-06-09
minor
Trial sites expanded: 5 → 9 locations
2026-05-20
notable
Recruitment opened
2026-05-20
minor
Trial sites expanded: 0 → 5 locations
Trial Details
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