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

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.

Study Overview

• Status: Recruiting
• Conditions: Polymyalgia Rheumatica
• Intervention / Treatment: Drug: Placebo; Drug: Sarilumab

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: Contact-US@sanofi.com

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80230
      • Recruiting
      • Denver Arthritis Clinic - Lowry- Site Number : 8400001
  • Florida
    • Clearwater, Florida, United States, 33765
      • Recruiting
      • Clinical Research of West Florida - Phase I Unit- Site Number : 8400024
    • Margate, Florida, United States, 33063
      • Recruiting
      • Vitalia Medical Research - Margate- Site Number : 8400021
    • Miramar, Florida, United States, 33027
      • Recruiting
      • Innovia Research Center- Site Number : 8400029
    • Tampa, Florida, United States, 33614
      • Recruiting
      • Vantage Clinical Trials - Tampa- Site Number : 8400064

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo with prednisone taper	Drug: Placebo; Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
Experimental: Sarilumab 150 mg; Participants will receive 150 mg sarilumab q2w with prednisone taper	Drug: Sarilumab; Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous; Other Names: Kevzara®
Experimental: Sarilumab 200 mg; Participants will receive 200 mg sarilumab q2w with prednisone taper	Drug: Sarilumab; Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous; Other Names: Kevzara®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy).	at Week 52
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	No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy).	at Week 52
Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), abnormalities in laboratory values, anti-drug antibody	AEs that develop or worsen or became serious during the treatment period (from first dose to 60 days after last dose).	over the entire study period (up to Week 58)
Corticosteroid-free remission at Week 52	Remission, without receipt of systemic corticosteroids (CS) or rescue treatment within 7 days prior to the assessment time point.	at Week 52
Remission at Week 24	Achievement of remission at Week 24.	at Week 24
Time in remission through Week 52	The duration (in days) in remission to first PMR flare, up to Week 52.	through Week 52
Incidence rate of flare through Week 52	The number of flares and raw incidence rate over the 52-week treatment period.	through Week 52
Change from baseline in PMR activity score and its components 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.	at Weeks 24 and 52
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)	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).	at Weeks 24 and 52

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• EFC18055 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2026
• Primary Completion (Estimated): June 4, 2029
• Study Completion (Estimated): July 16, 2029

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Polymyalgia Rheumatica; sarilumab
• Other Study ID Numbers: EFC18055; 2024-511296-15-00 (Ctis); U1111-1310-5173 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No