Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Study of an Investigational Study Drug With Prednisone for Early Polymyalgia Rheumatica

Age
50 years or above
Gender
All
Phase
Phase 3
Participants needed
300
Locations
5
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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.

The purpose of this research study is to learn about the effects and safety of an investigational study drug in adults with early polymyalgia rheumatica (PMR). The study is for people who were recently diagnosed with PMR or who have had an early return of PMR symptoms while lowering their prednisone dose.

Participants will receive either the investigational study drug or a placebo. A placebo looks like the investigational study drug but does not contain active medication. Everyone will also take prednisone, with a planned dose reduction over time.

Who can participate:
Adults with early polymyalgia rheumatica (PMR) may be able to participate if they:

  • Are 50 years old or older
  • Have newly diagnosed PMR (diagnosed within the past eight weeks) or early relapsing PMR
  • Have started corticosteroid treatment for PMR within the past year and are currently taking prednisone
  • Have had a PMR flare (return of symptoms such as shoulder and/or hip pain with inflammatory stiffness) while trying to lower prednisone in the past 12 weeks

Study timeline and visits:
Participation lasts about 58 weeks. There will be 14 study visits, including a screening visit, a baseline visit, regular visits during treatment, an end-of-treatment visit, and an end-of-study visit.

Updated on 16 Oct 2026. Study ID: NCT07286214

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