Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Age
50 years or above
Gender
All
Phase
Phase 3
Participants needed
300
Locations
2
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Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Polymyalgia Rheumatica
  • Age: 50 years or above
  • Gender: All

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.

Updated on 16 Oct 2026. Study ID: NCT07286214

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