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NCT Number: NCT07286214

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

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.

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Key information

Conditions

Polymyalgia Rheumatica Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number : 1240003, Sherbrooke, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sarilumab

Drug

Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous

Other names: Kevzara®

Placebo

Drug

Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous

Primary outcomes

  1. Sustained remission at Week 52 (yes/no) in participants with early relapsing polymyalgia rheumatica (PMR) who received sarilumab 200 mg q2w with 52-week prednisone taper

    Time frame: at Week 52

    No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy).

Secondary outcomes

  1. Sustained remission at Week 52 (yes/no) in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 200 mg q2w with prednisone taper

    Time frame: at Week 52

    No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy).

  2. Sustained remission at Week 52 (yes/no) in participants with early relapsing PMR, as well as in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 150 mg q2w with prednisone taper

    Time frame: at Week 52

    No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy).

  3. Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), abnormalities in laboratory values, anti-drug antibody

    Time frame: over the entire study period (up to Week 58)

    AEs that develop or worsen or became serious during the treatment period (from first dose to 60 days after last dose).

  4. Corticosteroid-free remission at Week 52

    Time frame: at Week 52

    Remission, without receipt of systemic corticosteroids (CS) or rescue treatment within 7 days prior to the assessment time point.

  5. Remission at Week 24

    Time frame: at Week 24

    Achievement of remission at Week 24.

  6. Time in remission through Week 52

    Time frame: through Week 52

    The duration (in days) in remission to first PMR flare, up to Week 52.

  7. Incidence rate of flare through Week 52

    Time frame: through Week 52

    The number of flares and raw incidence rate over the 52-week treatment period.

  8. Change from baseline in PMR activity score and its components at Weeks 24 and 52

    Time frame: at Weeks 24 and 52

    PMR activity score is a composite score based on serum inflammatory markers, physician's global assessment of disease activity visual analog scale (VAS), patient's assessment of pain visual analog score (VAS), morning stiffness and shoulder range of motion.

  9. Changes from baseline at Weeks 24 and 52 in the physical component summary and mental component summary from Short-form 36-item questionnaire (SF-36v2)

    Time frame: at Weeks 24 and 52

    The SF-36v2 yields scores for eight domains (Physical Functioning, Role-Physical, Bodily pain, General health, Vitality, Social Functioning, Role-Emotional, and Mental Health), as well as 2 standardized summary scores - the physical component summary (PCS) and mental component summary (MCS).

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 16, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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