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NCT07286214PHASE4Recruiting

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Sanofi

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

Inclusion Criteria: * Adults ≥50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria * Meet criteria for newly diagnosed PMR (received ≤6 weeks of corticosteroids prior to randomization) or for early relapsing PMR (initiated corticosteroid treatment within last year, treated with prednisone ≥10 mg/day for ≥ 8 weeks, and experienced flare within prior 12 weeks while receiving ≥5 mg/d prednisone) * Participants must be willing and able to take prednisone of 15 mg/day at randomization * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Exclusion Criteria: * Diagnosis of Giant Cell Arteritis (GCA) * Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia * Inadequately treated hypothyroidism * Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster * Patients with uncontrolled diabetes mellitus (HbA1c ≥9%) * Immunosuppressive therapies including systemic corticosteroids * Malignancy * Organ transplant recipient The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Interventions

DRUG

Sarilumab

DRUG

Sarilumab

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Polymyalgia Rheumatica

Locations

Arizona Arthritis & Rheumatology Research - West Beverly Lane- Site Number : 8400055

Avondale, Arizona 85392

United States

Arizona Arthritis & Rheumatology Associates - East Bell Road- Site Number : 8400010

Phoenix, Arizona 85032

United States

Arizona Arthritis & Rheumatology Associates - Tucson- Site Number : 8400039

Tucson, Arizona 85704

United States

Care Access - Huntington Beach- Site Number : 8400087

Huntington Beach, California 92648

United States

Southland Arthritis- Site Number : 8400047

Temecula, California 92592

United States

Cohen Medical Centers- Site Number : 8400023

Thousand Oaks, California 91360

United States

Solace Clinical Research - Tustin- Site Number : 8400101

Tustin, California 92780

United States

Comprehensive Rheumatology Center- Site Number : 8400060

West Hills, California 91307

United States

Denver Arthritis Clinic - Lowry- Site Number : 8400001

Denver, Colorado 80230

United States

Arthritis and Rheumatic Disease Specialties- Site Number : 8400014

Aventura, Florida 33180

United States

Clinical Research of West Florida - Phase I Unit- Site Number : 8400024

Clearwater, Florida 33765

United States

Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400092

DeBary, Florida 32713

United States

University of Florida Health - Gainesville- Site Number : 8400035

Gainesville, Florida 32606

United States

Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400034

Margate, Florida 33063

United States

Vitalia Medical Research - Margate- Site Number : 8400021

Margate, Florida 33063

United States

Rheumwell Comprehensive Rheumatology- Site Number : 8400004

Miami, Florida 33143

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

Sarasota Arthritis Center- Site Number : 8400073

Sarasota, Florida 34239

United States

Vantage Clinical Trials - Tampa- Site Number : 8400064

Tampa, Florida 33614

United States

Arthritis & Rheumatology Center Pc- Site Number : 8400038

Cumming, Georgia 30040

United States

Arthritis Center of North Georgia - Gainesville- Site Number : 8400102

Gainesville, Georgia 30501

United States

Willow Rheumatology and Wellness- Site Number : 8400012

Willowbrook, Illinois 60527

United States

Klein and Associates- Site Number : 8400003

Hagerstown, Maryland 21740

United States

Arthritis And Rheumatism Associates- Site Number : 8400083

Rockville, Maryland 20850

United States

Arthritis Consultants - St. Louis- Site Number : 8400063

St Louis, Missouri 63141

United States

Logan Health Research - Glacier View Research Institute - Oncology- Site Number : 8400056

Kalispell, Montana 59901

United States

Inspire Santa Fe Medical Group- Site Number : 8400077

Santa Fe, New Mexico 87505

United States

Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400005

Charlotte, North Carolina 28207

United States

Digestive Health Associates - Rowan Diagnostic Clinic- Site Number : 8400019

Salisbury, North Carolina 28144

United States

Altoona Center for Clinical Research - Duncansville- Site Number : 8400018

Duncansville, Pennsylvania 16635

United States

Rheumatology Specialty Center - Willow Grove- Site Number : 8400042

Willow Grove, Pennsylvania 19090

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

Murfreesboro Medical Clinic - Shores Road- Site Number : 8400040

Murfreesboro, Tennessee 37128

United States

Lone Star Arthritis & Rheumatology - Denton- Site Number : 8400044

Denton, Texas 76205

United States

Stryde Consulting- Site Number : 8400070

Frisco, Texas 75033

United States

Prolato Clinical Research Center- Site Number : 8400045

Houston, Texas 77054

United States

TAD Clinical Research - Lufkin- Site Number : 8400069

Lufkin, Texas 75904

United States

Rheumatology Associates Of South Texas- Site Number : 8400050

San Antonio, Texas 78258

United States

Accurate Clinical Management - Sugar Land- Site Number : 8400061

Sugar Land, Texas 77479

United States

Overlake Arthritis and Osteoporosis Center- Site Number : 8400002

Bellevue, Washington 98004

United States

Investigational Site Number : 0400003

Graz, 8036

Austria

Investigational Site Number : 0400001

Vienna, 1090

Austria

Investigational Site Number : 0560006

Bruges, 8000

Belgium

Investigational Site Number : 0560004

Brussels, 1070

Belgium

Investigational Site Number : 0560002

Genk, 3600

Belgium

Investigational Site Number : 0560007

Ghent, 9000

Belgium

Investigational Site Number : 0560001

Leuven, 3000

Belgium

Investigational Site Number : 0560003

Liège, 4000

Belgium

Investigational Site Number : 1240003

Sherbrooke, Quebec J1G 2E8

Canada

Investigational Site Number : 1240002

Trois-Rivières, Quebec G8Z 1Y2

Canada

Investigational Site Number : 2030005

Hlučín, 748 01

Czechia

Investigational Site Number : 2030004

Ostrava, 722 00

Czechia

Investigational Site Number : 2030001

Prague, 128 00

Czechia

Investigational Site Number : 2030002

Uherské Hradiště, 686 01

Czechia

Investigational Site Number : 2030003

Zlín, 760 01

Czechia

Investigational Site Number : 2500006

Toulouse, 31059

France

Investigational Site Number : 2760010

Berlin, 13125

Germany

Investigational Site Number : 2760003

Hamburg, 20095

Germany

Investigational Site Number : 2760001

Herne, 44649

Germany

Investigational Site Number : 2760009

Würzburg, 97080

Germany

Investigational Site Number : 5280003

Almelo, 7609 PP

Netherlands

Investigational Site Number : 5280002

Leeuwarden, 8934 AD

Netherlands

Investigational Site Number : 5280004

Rotterdam, 3079 DZ

Netherlands

Investigational Site Number : 5280001

Venlo, 5912 BL

Netherlands

Investigational Site Number : 7240005

Barcelona, Catalunya [Cataluña] 08035

Spain

Investigational Site Number : 7240006

A Coruña, Galicia [Galicia] 15006

Spain

Investigational Site Number : 7240004

Madrid, Madrid, Comunidad de 28046

Spain

Investigational Site Number : 7240009

San Cristóbal de La Laguna, Santa Cruz De Tenerife 38320

Spain

Investigational Site Number : 7240002

Madrid, 28041

Spain

Investigational Site Number : 7240008

Málaga, 29010

Spain

Investigational Site Number : 7240001

Sabadell, 08208

Spain