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New drug combo aims to tame painful muscle condition and cut steroid dependence

NCT ID NCT07286214

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding sarilumab (a drug that calms inflammation) to a slow steroid taper can help people with early polymyalgia rheumatica achieve lasting remission. About 300 adults aged 50 and older will receive either sarilumab or a placebo, along with a 52-week prednisone reduction plan. The goal is to see if sarilumab allows more patients to stop steroids without symptoms returning.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

polymyalgia rheumatica

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polymyalgia rheumatica

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Altoona Center for Clinical Research - Duncansville- Site Number : 8400018

    RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • Clinical Research of West Florida - Phase I Unit- Site Number : 8400024

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Denver Arthritis Clinic - Lowry- Site Number : 8400001

    RECRUITING

    Denver, Colorado, 80230, United States

  • Discovery Clinical Research - Plantation- Site Number : 8400091

    RECRUITING

    Plantation, Florida, 33324, United States

  • Florida Research Center- Site Number : 8400084

    RECRUITING

    Miami, Florida, 33174, United States

  • Innovia Research Center- Site Number : 8400029

    RECRUITING

    Miramar, Florida, 33027, United States

  • Inspire Santa Fe Medical Group- Site Number : 8400077

    RECRUITING

    Santa Fe, New Mexico, 87505, United States

  • Investigational Site Number : 1240003

    RECRUITING

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013

    RECRUITING

    Wyomissing, Pennsylvania, 19610, United States

  • TAD Clinical Research - Lufkin- Site Number : 8400069

    RECRUITING

    Lufkin, Texas, 75904, United States

  • Vantage Clinical Trials - Tampa- Site Number : 8400064

    RECRUITING

    Tampa, Florida, 33614, United States

  • Vitalia Medical Research - Margate- Site Number : 8400021

    RECRUITING

    Margate, Florida, 33063, United States

  • West Tennessee Research Institute- Site Number : 8400009

    RECRUITING

    Jackson, Tennessee, 38305, United States

  • Willow Rheumatology and Wellness- Site Number : 8400012

    RECRUITING

    Willowbrook, Illinois, 60527, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.