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Sarilumab Doses for Early Polymyalgia Rheumatica

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Study Aim

This study aims to evaluate if sarilumab can help achieve and maintain long-term remission in individuals with early relapsing polymyalgia rheumatica over a 52-week period.

What is being tested

Sarilumab

+ Placebo

Drug
Who is being recruted

Connective Tissue Diseases+3

+ Muscular Diseases

+ Musculoskeletal Diseases

Over 50 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: April 2026
See protocol details

Summary

Principal SponsorSanofi
Study ContactTrial Transparency email recommended (Toll free for US & Canada)
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 15, 2026

Actual date on which the first participant was enrolled.

The study aims to find out if the medication sarilumab, given at two different doses, is effective and safe for adults who have early polymyalgia rheumatica (PMR), a condition that causes muscle pain and stiffness. This study is important because it could offer a new treatment option for people with PMR, potentially improving their quality of life. The study involves comparing sarilumab to a placebo, both combined with a 52-week course of prednisone, a common steroid medication used to treat PMR. By exploring these treatment options, the study hopes to address the ongoing need for effective PMR treatments. Participants in the study will be randomly assigned to receive either 150 mg or 200 mg of sarilumab every two weeks or a placebo, along with a gradual reduction of prednisone over 52 weeks. The study will run over multiple visits, starting with a screening visit, followed by the first dose and baseline measurements, and continuing through regular treatment visits. The effectiveness of the treatment will be evaluated by checking for sustained remission, meaning no signs or symptoms of PMR, at the end of the study period. The study will also monitor any potential side effects to ensure the safety of the treatments.

Official TitleA 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
NCT07286214
Principal SponsorSanofi
Study ContactTrial Transparency email recommended (Toll free for US & Canada)
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Connective Tissue DiseasesMuscular DiseasesMusculoskeletal DiseasesPolymyalgia RheumaticaRheumatic DiseasesSkin and Connective Tissue Diseases

Criteria

4 inclusion criteria required to participate
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

8 exclusion criteria prevent from participating
Malignancy

Immunosuppressive therapies including systemic corticosteroids

Patients with uncontrolled diabetes mellitus (HbA1c ≥9%)

Inadequately treated hypothyroidism

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive 200 mg sarilumab q2w with prednisone taper

Group II

Experimental
Participants will receive 150 mg sarilumab q2w with prednisone taper

Group III

Placebo
Participants will receive placebo with prednisone taper

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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