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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

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.

About the study

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.

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.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.