Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
Start Date
5/12/2026
Completion Date
7/16/2029
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.
Eligibility Criteria
Age Range: 50 years to No maximum
Interventions
Sarilumab
Sarilumab
Placebo
Conditions
Locations
Denver Arthritis Clinic - Lowry- Site Number : 8400001
Denver, Colorado 80230
United States
Clinical Research of West Florida - Phase I Unit- Site Number : 8400024
Clearwater, Florida 33765
United States
Vitalia Medical Research - Margate- Site Number : 8400021
Margate, Florida 33063
United States
Florida Research Center- Site Number : 8400084
Miami, Florida 33174
United States
Innovia Research Center- Site Number : 8400029
Miramar, Florida 33027
United States
Discovery Clinical Research - Plantation- Site Number : 8400091
Plantation, Florida 33324
United States
Vantage Clinical Trials - Tampa- Site Number : 8400064
Tampa, Florida 33614
United States
Willow Rheumatology and Wellness- Site Number : 8400012
Willowbrook, Illinois 60527
United States
Inspire Santa Fe Medical Group- Site Number : 8400077
Santa Fe, New Mexico 87505
United States
Altoona Center for Clinical Research - Duncansville- Site Number : 8400018
Duncansville, Pennsylvania 16635
United States
Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013
Wyomissing, Pennsylvania 19610
United States
West Tennessee Research Institute- Site Number : 8400009
Jackson, Tennessee 38305
United States
TAD Clinical Research - Lufkin- Site Number : 8400069
Lufkin, Texas 75904
United States
Investigational Site Number : 1240003
Sherbrooke, Quebec J1G 2E8
Canada