Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

StatusRecruiting
PhasePhase 4
SponsorSanofi
Started

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Record History

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  1. Trial sites expanded: 74 → 85 locations
  2. Primary endpoints: details revised at 1 of 1 entry
    • Trial sites expanded: 14 → 74 locations
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 9 entries
  3. Trial sites expanded: 9 → 14 locationsv5
  4. Trial sites expanded: 5 → 9 locationsv4
  5. Recruitment opened
    • Trial sites expanded: 0 → 5 locations
    • Start date changed from estimate of Apr 15, 2026 to May 12, 2026
    v3
  6. Start date: Jan 19, 2026 to Apr 15, 2026v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
285 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT07286214
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Polymyalgia Rheumatica
Related terms Polymyalgia Rheumatica
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov