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Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
Sponsor: Sanofi
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.
Official title: 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
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-05-12
Completion Date
2029-07-16
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Sarilumab
Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
Sarilumab
Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
Placebo
Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
Locations (74)
Arizona Arthritis & Rheumatology Research - West Beverly Lane- Site Number : 8400055
Avondale, Arizona, United States
Arizona Arthritis & Rheumatology Associates - East Bell Road- Site Number : 8400010
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Associates - Tucson- Site Number : 8400039
Tucson, Arizona, United States
Care Access - Huntington Beach- Site Number : 8400087
Huntington Beach, California, United States
Southland Arthritis- Site Number : 8400047
Temecula, California, United States
Cohen Medical Centers- Site Number : 8400023
Thousand Oaks, California, United States
Solace Clinical Research - Tustin- Site Number : 8400101
Tustin, California, United States
Comprehensive Rheumatology Center- Site Number : 8400060
West Hills, California, United States
Denver Arthritis Clinic - Lowry- Site Number : 8400001
Denver, Colorado, United States
Arthritis and Rheumatic Disease Specialties- Site Number : 8400014
Aventura, Florida, United States
Clinical Research of West Florida - Phase I Unit- Site Number : 8400024
Clearwater, Florida, United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400092
DeBary, Florida, United States
University of Florida Health - Gainesville- Site Number : 8400035
Gainesville, Florida, United States
Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400034
Margate, Florida, United States
Vitalia Medical Research - Margate- Site Number : 8400021
Margate, Florida, United States
Rheumwell Comprehensive Rheumatology- Site Number : 8400004
Miami, Florida, United States
Florida Research Center- Site Number : 8400084
Miami, Florida, United States
Innovia Research Center- Site Number : 8400029
Miramar, Florida, United States
Discovery Clinical Research - Plantation- Site Number : 8400091
Plantation, Florida, United States
Sarasota Arthritis Center- Site Number : 8400073
Sarasota, Florida, United States
Vantage Clinical Trials - Tampa- Site Number : 8400064
Tampa, Florida, United States
Arthritis & Rheumatology Center Pc- Site Number : 8400038
Cumming, Georgia, United States
Arthritis Center of North Georgia - Gainesville- Site Number : 8400102
Gainesville, Georgia, United States
Willow Rheumatology and Wellness- Site Number : 8400012
Willowbrook, Illinois, United States
Klein and Associates- Site Number : 8400003
Hagerstown, Maryland, United States
Arthritis And Rheumatism Associates- Site Number : 8400083
Rockville, Maryland, United States
Arthritis Consultants - St. Louis- Site Number : 8400063
St Louis, Missouri, United States
Logan Health Research - Glacier View Research Institute - Oncology- Site Number : 8400056
Kalispell, Montana, United States
Inspire Santa Fe Medical Group- Site Number : 8400077
Santa Fe, New Mexico, United States
Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400005
Charlotte, North Carolina, United States
Digestive Health Associates - Rowan Diagnostic Clinic- Site Number : 8400019
Salisbury, North Carolina, United States
Altoona Center for Clinical Research - Duncansville- Site Number : 8400018
Duncansville, Pennsylvania, United States
Rheumatology Specialty Center - Willow Grove- Site Number : 8400042
Willow Grove, Pennsylvania, United States
Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013
Wyomissing, Pennsylvania, United States
West Tennessee Research Institute- Site Number : 8400009
Jackson, Tennessee, United States
Murfreesboro Medical Clinic - Shores Road- Site Number : 8400040
Murfreesboro, Tennessee, United States
Lone Star Arthritis & Rheumatology - Denton- Site Number : 8400044
Denton, Texas, United States
Stryde Consulting- Site Number : 8400070
Frisco, Texas, United States
Prolato Clinical Research Center- Site Number : 8400045
Houston, Texas, United States
TAD Clinical Research - Lufkin- Site Number : 8400069
Lufkin, Texas, United States
Rheumatology Associates Of South Texas- Site Number : 8400050
San Antonio, Texas, United States
Accurate Clinical Management - Sugar Land- Site Number : 8400061
Sugar Land, Texas, United States
Overlake Arthritis and Osteoporosis Center- Site Number : 8400002
Bellevue, Washington, United States
Investigational Site Number : 0400003
Graz, Austria
Investigational Site Number : 0400001
Vienna, Austria
Investigational Site Number : 0560006
Bruges, Belgium
Investigational Site Number : 0560004
Brussels, Belgium
Investigational Site Number : 0560002
Genk, Belgium
Investigational Site Number : 0560007
Ghent, Belgium
Investigational Site Number : 0560001
Leuven, Belgium
Investigational Site Number : 0560003
Liège, Belgium
Investigational Site Number : 1240003
Sherbrooke, Quebec, Canada
Investigational Site Number : 1240002
Trois-Rivières, Quebec, Canada
Investigational Site Number : 2030005
Hlučín, Czechia
Investigational Site Number : 2030004
Ostrava, Czechia
Investigational Site Number : 2030001
Prague, Czechia
Investigational Site Number : 2030002
Uherské Hradiště, Czechia
Investigational Site Number : 2030003
Zlín, Czechia
Investigational Site Number : 2500006
Toulouse, France
Investigational Site Number : 2760010
Berlin, Germany
Investigational Site Number : 2760003
Hamburg, Germany
Investigational Site Number : 2760001
Herne, Germany
Investigational Site Number : 2760009
Würzburg, Germany
Investigational Site Number : 5280003
Almelo, Netherlands
Investigational Site Number : 5280002
Leeuwarden, Netherlands
Investigational Site Number : 5280004
Rotterdam, Netherlands
Investigational Site Number : 5280001
Venlo, Netherlands
Investigational Site Number : 7240005
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240006
A Coruña, Galicia [Galicia], Spain
Investigational Site Number : 7240004
Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240009
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Investigational Site Number : 7240002
Madrid, Spain
Investigational Site Number : 7240008
Málaga, Spain
Investigational Site Number : 7240001
Sabadell, Spain