Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Investigating How Well an Investigational Medication Works and Its Safety in Adults with Early Polymyalgia Rheumatica

Recruiting
50 years or above
All
Phase 4
300 participants needed
5 Locations

Study Overview

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.

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 (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.

This study investigates early polymyalgia rheumatica. The purpose of this study is to explore the effects of an investigational medication on this condition.

Researchers will evaluate the safety and tolerability of the investigational medication. They will focus on its general effects on individuals with early polymyalgia rheumatica.

  • Who can participate: Adults 50 years and older with early polymyalgia rheumatica can participate. They should meet specific criteria related to their condition and treatment history, such as recent corticosteroid use.
  • Study details: Participants will take part in a study where they will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. All participants will follow a prednisone tapering schedule.
  • Study timelines and visits: The study will last 58 weeks. The study requires 14 visits.
Updated on 15 May 2026. Study ID: NCT07286214

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