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Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
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
Who can join
Ages 50 and older · All sexes
Full eligibility 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.
About the study
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.
What is being tested
- Sarilumab (drug)
- Sarilumab (drug)
- Placebo (drug)
Sponsor: Sanofi · Participants: 300 · Started: May 12, 2026
Contact the study team
- Trial Transparency email recommended (Toll free for US & Canada) · Phone: 800-633-1610
Official record on ClinicalTrials.gov — NCT07286214
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.