NCT07286214

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Each of Two Dose Levels of Sarilumab in Adults With Early Polymyalgia Rheumatica

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Sarilumab	Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
DRUG	Sarilumab	Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous

Timeline

• Start date: 2026-04-15
• Primary completion: 2029-06-04
• Completion: 2029-07-16
• First posted: 2025-12-16
• Last updated: 2026-02-10

Regulatory

• FDA-regulated drug study