Recruiting

Phase 3

SarilumabSarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Sponsor:

Sanofi

Code:

NCT07286214

Conditions

Polymyalgia Rheumatica

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Sarilumab

Placebo

Study Details

Brief summary:

This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 3, 3-arm 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 44): Receiving study drug (prednisone taper ends at the end of Week 50), Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.

Conditions

Polymyalgia Rheumatica

Study ID

NCT07286214

Start date

May 12, 2026

Status verified date

Oct, 2026

Completion date

Jul 16, 2029

Anticipated

Primary completion date

Jun 4, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adults ≥50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria
Meet criteria for newly diagnosed PMR (newly diagnosed PMR must have met the EULAR/ACR classification criteria for a first-time diagnosis of PMR within 8 weeks prior to randomization) OR for early relapsing PMR (early relapsing PMR must have met the EULAR/ACR classification criteria prior to initiating treatment for PMR) AND
Have initiated treatment with corticosteroid(s) (CS) for PMR no more than 1 year prior to randomization,
Be on a prednisone dose of at least 7.5 mg/day (or equivalent) and not exceeding 20 mg/day at screening and during the screening period,
Have a history of being treated for at least 8 weeks with prednisone (at a dose of ≥10 mg/day prednisone or equivalent),
Had at least one episode of unequivocal PMR flare while attempting to taper prednisone at a dose that is ≥5 mg/day (or equivalent) within the past 12 weeks prior to screening: (unequivocal symptoms of PMR flare include shoulder and/or hip girdle pain associated with inflammatory stiffness)
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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Participants will receive placebo with prednisone taper

experimental: Sarilumab 150 mg

Participants will receive 150 mg sarilumab q2w with prednisone taper

experimental: Sarilumab 200 mg

Participants will receive 200 mg sarilumab q2w with prednisone taper

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

Primary outcome measure

Sustained remission at Week 52 (yes/no) in participants with early relapsing polymyalgia rheumatica (PMR) who received sarilumab 200 mg q2w with 52-week prednisone taper [ Time Frame: at Week 52 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610 Contact-US@sanofi.com

Locations

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

Recruiting

Avondale, Arizona, United States, 85392

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

Recruiting

Phoenix, Arizona, United States, 85032

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

Recruiting

Tucson, Arizona, United States, 85704

Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 8400028

Recruiting

Covina, California, United States, 91722

Care Access - Huntington Beach- Site Number : 8400087

Recruiting

Huntington Beach, California, United States, 92648

Southland Arthritis- Site Number : 8400047

Recruiting

Temecula, California, United States, 92592

Cohen Medical Centers- Site Number : 8400023

Recruiting

Thousand Oaks, California, United States, 91360

Solace Clinical Research - Tustin- Site Number : 8400101

Recruiting

Tustin, California, United States, 92780

Comprehensive Rheumatology Center- Site Number : 8400060

Recruiting

West Hills, California, United States, 91307

Denver Arthritis Clinic - Lowry- Site Number : 8400001

Recruiting

Denver, Colorado, United States, 80230

Arthritis and Rheumatic Disease Specialties- Site Number : 8400014

Recruiting

Aventura, Florida, United States, 33180

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

Recruiting

Clearwater, Florida, United States, 33765

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

Recruiting

DeBary, Florida, United States, 32713

University of Florida Health - Gainesville- Site Number : 8400035

Recruiting

Gainesville, Florida, United States, 32606

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

Recruiting

Margate, Florida, United States, 33063

Vitalia Medical Research - Margate- Site Number : 8400021

Recruiting

Margate, Florida, United States, 33063

Rheumwell Comprehensive Rheumatology- Site Number : 8400004

Recruiting

Miami, Florida, United States, 33143

Florida Research Center- Site Number : 8400084

Recruiting

Miami, Florida, United States, 33174

Innovia Research Center- Site Number : 8400029

Recruiting

Miramar, Florida, United States, 33027

Discovery Clinical Research - Plantation- Site Number : 8400091

Recruiting

Plantation, Florida, United States, 33324

Sarasota Arthritis Center- Site Number : 8400073

Recruiting

Sarasota, Florida, United States, 34239

Vantage Clinical Trials - Tampa- Site Number : 8400064

Recruiting

Tampa, Florida, United States, 33614

Arthritis & Rheumatology Center Pc- Site Number : 8400038

Recruiting

Cumming, Georgia, United States, 30040

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

Recruiting

Gainesville, Georgia, United States, 30501

Willow Rheumatology and Wellness- Site Number : 8400012

Recruiting

Willowbrook, Illinois, United States, 60527

Klein and Associates- Site Number : 8400003

Recruiting

Hagerstown, Maryland, United States, 21740

Arthritis And Rheumatism Associates- Site Number : 8400083

Recruiting

Rockville, Maryland, United States, 20850

HealthPartners Specialty Center- Site Number : 8400094

Recruiting

Saint Paul, Minnesota, United States, 55130

Arthritis Consultants - St. Louis- Site Number : 8400063

Recruiting

St Louis, Missouri, United States, 63141

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

Recruiting

Kalispell, Montana, United States, 59901

Inspire Santa Fe Medical Group- Site Number : 8400077

Recruiting

Santa Fe, New Mexico, United States, 87505

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

Recruiting

Charlotte, North Carolina, United States, 28207

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

Recruiting

Salisbury, North Carolina, United States, 28144

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

Recruiting

Duncansville, Pennsylvania, United States, 16635

Rheumatology Specialty Center - Willow Grove- Site Number : 8400042

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013

Recruiting

Wyomissing, Pennsylvania, United States, 19610

West Tennessee Research Institute- Site Number : 8400009

Recruiting

Jackson, Tennessee, United States, 38305

Murfreesboro Medical Clinic - Shores Road- Site Number : 8400040

Recruiting

Murfreesboro, Tennessee, United States, 37128

Accurate Clinical Management - Baytown- Site Number : 8400109

Recruiting

Baytown, Texas, United States, 77521

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

Recruiting

Denton, Texas, United States, 76205

Stryde Consulting- Site Number : 8400070

Recruiting

Frisco, Texas, United States, 75033

Prolato Clinical Research Center- Site Number : 8400045

Recruiting

Houston, Texas, United States, 77054

TAD Clinical Research - Lufkin- Site Number : 8400069

Recruiting

Lufkin, Texas, United States, 75904

Rheumatology Associates Of South Texas- Site Number : 8400050

Recruiting

San Antonio, Texas, United States, 78258

Accurate Clinical Management - Sugar Land- Site Number : 8400061

Recruiting

Sugar Land, Texas, United States, 77479

Overlake Arthritis and Osteoporosis Center- Site Number : 8400002

Recruiting

Bellevue, Washington, United States, 98004

Rheumatic Disease Center - Glendale- Site Number : 8400006

Recruiting

Glendale, Wisconsin, United States, 53217

Investigational Site Number : 1240003

Recruiting

Sherbrooke, Quebec, Canada, J1G 2E8

Investigational Site Number : 1240002

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 1Y2

More Information

Sponsor

Sanofi

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.