Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
Sanofi · with Regeneron Pharmaceuticals · NCT07286214
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 300
- US sites recruiting
- 47
- Study start
- May 12, 2026
- Record last updated
- October 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Sarilumab; Sarilumab; Placebo
Conditions: Polymyalgia Rheumatica
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Arizona Arthritis & Rheumatology Research - West Beverly Lane- Site Number : 8400055
Avondale, AZ 85392
Arizona Arthritis & Rheumatology Associates - East Bell Road- Site Number : 8400010
Phoenix, AZ 85032
Arizona Arthritis & Rheumatology Associates - Tucson- Site Number : 8400039
Tucson, AZ 85704
Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 8400028
Covina, CA 91722
Care Access - Huntington Beach- Site Number : 8400087
Huntington Beach, CA 92648
Southland Arthritis- Site Number : 8400047
Temecula, CA 92592
Cohen Medical Centers- Site Number : 8400023
Thousand Oaks, CA 91360
Solace Clinical Research - Tustin- Site Number : 8400101
Tustin, CA 92780
Comprehensive Rheumatology Center- Site Number : 8400060
West Hills, CA 91307
Denver Arthritis Clinic - Lowry- Site Number : 8400001
Denver, CO 80230
Arthritis and Rheumatic Disease Specialties- Site Number : 8400014
Aventura, FL 33180
Clinical Research of West Florida - Phase I Unit- Site Number : 8400024
Clearwater, FL 33765
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400092
DeBary, FL 32713
University of Florida Health - Gainesville- Site Number : 8400035
Gainesville, FL 32606
Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400034
Margate, FL 33063
Vitalia Medical Research - Margate- Site Number : 8400021
Margate, FL 33063
Rheumwell Comprehensive Rheumatology- Site Number : 8400004
Miami, FL 33143
Florida Research Center- Site Number : 8400084
Miami, FL 33174
Innovia Research Center- Site Number : 8400029
Miramar, FL 33027
Discovery Clinical Research - Plantation- Site Number : 8400091
Plantation, FL 33324
Sarasota Arthritis Center- Site Number : 8400073
Sarasota, FL 34239
Vantage Clinical Trials - Tampa- Site Number : 8400064
Tampa, FL 33614
Arthritis & Rheumatology Center Pc- Site Number : 8400038
Cumming, GA 30040
Arthritis Center of North Georgia - Gainesville- Site Number : 8400102
Gainesville, GA 30501
Willow Rheumatology and Wellness- Site Number : 8400012
Willowbrook, IL 60527
Klein and Associates- Site Number : 8400003
Hagerstown, MD 21740
Arthritis And Rheumatism Associates- Site Number : 8400083
Rockville, MD 20850
HealthPartners Specialty Center- Site Number : 8400094
Saint Paul, MN 55130
Arthritis Consultants - St. Louis- Site Number : 8400063
St Louis, MO 63141
Logan Health Research - Glacier View Research Institute - Oncology- Site Number : 8400056
Kalispell, MT 59901
Inspire Santa Fe Medical Group- Site Number : 8400077
Santa Fe, NM 87505
Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400005
Charlotte, NC 28207
Digestive Health Associates - Rowan Diagnostic Clinic- Site Number : 8400019
Salisbury, NC 28144
Altoona Center for Clinical Research - Duncansville- Site Number : 8400018
Duncansville, PA 16635
Rheumatology Specialty Center - Willow Grove- Site Number : 8400042
Willow Grove, PA 19090
Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013
Wyomissing, PA 19610
West Tennessee Research Institute- Site Number : 8400009
Jackson, TN 38305
Murfreesboro Medical Clinic - Shores Road- Site Number : 8400040
Murfreesboro, TN 37128
Accurate Clinical Management - Baytown- Site Number : 8400109
Baytown, TX 77521
Lone Star Arthritis & Rheumatology - Denton- Site Number : 8400044
Denton, TX 76205
Stryde Consulting- Site Number : 8400070
Frisco, TX 75033
Prolato Clinical Research Center- Site Number : 8400045
Houston, TX 77054
TAD Clinical Research - Lufkin- Site Number : 8400069
Lufkin, TX 75904
Rheumatology Associates Of South Texas- Site Number : 8400050
San Antonio, TX 78258
Accurate Clinical Management - Sugar Land- Site Number : 8400061
Sugar Land, TX 77479
Overlake Arthritis and Osteoporosis Center- Site Number : 8400002
Bellevue, WA 98004
Rheumatic Disease Center - Glendale- Site Number : 8400006
Glendale, WI 53217
Study contacts (from the official record)
- Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com