Taking people in United StatesPhase 3

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Key facts

Who runs it: Sanofi
Where: Aventura, Avondale, Baytown, Bellevue, Charlotte, Clearwater, Covina, Cumming, DeBary, Denton, Denver, Duncansville, Frisco, Gainesville, Glendale, Hagerstown, Houston, Huntington Beach, Jackson, Kalispell, Lufkin, Margate, Miami, Miramar, Murfreesboro, Phoenix, Plantation, Rockville, Saint Paul, Salisbury, San Antonio, Santa Fe, Sarasota, St Louis, Sugar Land, Tampa, Temecula, Thousand Oaks, Tucson, Tustin, West Hills, Willow Grove, Willowbrook, and Wyomissing, United StatesSee the 47 sitesAlso in 9 other countries, 38 sites
Trial code: NCT07286214
EU 2024-511296-15-00
U1111-1310-5173
Status: Recruiting
Phase: Phase 3
People taking part: 300 people, planned
Started: 12 May 2026
Expected to end: 16 Jul 2029
Type of study: Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Sarilumab
Placebo
Record updated: 21 October 2026

Who can take part

Age: 50 years and older
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

Adults ≥50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria
Meet criteria for newly diagnosed PMR (newly diagnosed PMR must have met the EULAR/ACR classification criteria for a first-time diagnosis of PMR within 8 weeks prior to randomization) OR for early relapsing PMR (early relapsing PMR must have met the EULAR/ACR classification criteria prior to initiating treatment for PMR) AND
Have initiated treatment with corticosteroid(s) (CS) for PMR no more than 1 year prior to randomization,
Be on a prednisone dose of at least 7.5 mg/day (or equivalent) and not exceeding 20 mg/day at screening and during the screening period,
Have a history of being treated for at least 8 weeks with prednisone (at a dose of ≥10 mg/day prednisone or equivalent),
Had at least one episode of unequivocal PMR flare while attempting to taper prednisone at a dose that is ≥5 mg/day (or equivalent) within the past 12 weeks prior to screening: (unequivocal symptoms of PMR flare include shoulder and/or hip girdle pain associated with inflammatory stiffness)
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

Who cannot take part

Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia
Immunosuppressive therapies including systemic corticosteroids
Organ transplant recipient; The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial
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
Malignancy
Patients with uncontrolled diabetes mellitus (HbA1c ≥9%)
Diagnosis of Giant Cell Arteritis (GCA)
Inadequately treated hypothyroidism

Where in United States

Also in 9 other countries, 38 sites

Arthritis and Rheumatic Disease Specialties- Site Number : 8400014Aventura, United StatesTaking people
Arizona Arthritis & Rheumatology Research - West Beverly Lane- Site Number : 8400055Avondale, United StatesTaking people
Accurate Clinical Management - Baytown- Site Number : 8400109Baytown, United StatesTaking people
Overlake Arthritis and Osteoporosis Center- Site Number : 8400002Bellevue, United StatesTaking people
Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400005Charlotte, United StatesTaking people
Clinical Research of West Florida - Phase I Unit- Site Number : 8400024Clearwater, United StatesTaking people
Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 8400028Covina, United StatesTaking people
Arthritis & Rheumatology Center Pc- Site Number : 8400038Cumming, United StatesTaking people
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400092DeBary, United StatesTaking people
Lone Star Arthritis & Rheumatology - Denton- Site Number : 8400044Denton, United StatesTaking people
Denver Arthritis Clinic - Lowry- Site Number : 8400001Denver, United StatesTaking people
Altoona Center for Clinical Research - Duncansville- Site Number : 8400018Duncansville, United StatesTaking people
Frisco, TexasHospital not named in the registryTaking people
Arthritis Center of North Georgia - Gainesville- Site Number : 8400102Gainesville, United StatesTaking people
University of Florida Health - Gainesville- Site Number : 8400035Gainesville, United StatesTaking people
Rheumatic Disease Center - Glendale- Site Number : 8400006Glendale, United StatesTaking people
Hagerstown, MarylandHospital not named in the registryTaking people
Prolato Clinical Research Center- Site Number : 8400045Houston, United StatesTaking people
Care Access - Huntington Beach- Site Number : 8400087Huntington Beach, United StatesTaking people
West Tennessee Research Institute- Site Number : 8400009Jackson, United StatesTaking people
Logan Health Research - Glacier View Research Institute - Oncology- Site Number : 8400056Kalispell, United StatesTaking people
TAD Clinical Research - Lufkin- Site Number : 8400069Lufkin, United StatesTaking people
Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400034Margate, United StatesTaking people
Vitalia Medical Research - Margate- Site Number : 8400021Margate, United StatesTaking people
Miami, FloridaHospital not named in the registryTaking people
Florida Research Center- Site Number : 8400084Miami, United StatesTaking people
Innovia Research Center- Site Number : 8400029Miramar, United StatesTaking people
Murfreesboro Medical Clinic - Shores Road- Site Number : 8400040Murfreesboro, United StatesTaking people
Arizona Arthritis & Rheumatology Associates - East Bell Road- Site Number : 8400010Phoenix, United StatesTaking people
Discovery Clinical Research - Plantation- Site Number : 8400091Plantation, United StatesTaking people
Arthritis And Rheumatism Associates- Site Number : 8400083Rockville, United StatesTaking people
HealthPartners Specialty Center- Site Number : 8400094Saint Paul, United StatesTaking people
Digestive Health Associates - Rowan Diagnostic Clinic- Site Number : 8400019Salisbury, United StatesTaking people
Rheumatology Associates Of South Texas- Site Number : 8400050San Antonio, United StatesTaking people
Inspire Santa Fe Medical Group- Site Number : 8400077Santa Fe, United StatesTaking people
Sarasota Arthritis Center- Site Number : 8400073Sarasota, United StatesTaking people
Arthritis Consultants - St. Louis- Site Number : 8400063St Louis, United StatesTaking people
Accurate Clinical Management - Sugar Land- Site Number : 8400061Sugar Land, United StatesTaking people
Vantage Clinical Trials - Tampa- Site Number : 8400064Tampa, United StatesTaking people
Temecula, CaliforniaHospital not named in the registryTaking people
Cohen Medical Centers- Site Number : 8400023Thousand Oaks, United StatesTaking people
Arizona Arthritis & Rheumatology Associates - Tucson- Site Number : 8400039Tucson, United StatesTaking people
Solace Clinical Research - Tustin- Site Number : 8400101Tustin, United StatesTaking people
Comprehensive Rheumatology Center- Site Number : 8400060West Hills, United StatesTaking people
Rheumatology Specialty Center - Willow Grove- Site Number : 8400042Willow Grove, United StatesTaking people
Willow Rheumatology and Wellness- Site Number : 8400012Willowbrook, United StatesTaking people
Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013Wyomissing, United StatesTaking people

About the trial

What the trial wants to find out

This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 3, 3-arm 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.

Read full original descriptionShow less

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 44): Receiving study drug (prednisone taper ends at the end of Week 50), Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.

The 3 groups in the trial

PlaceboPlacebo, for comparison
Participants will receive placebo with prednisone taper
Sarilumab 150 mgTreatment being tested
Participants will receive 150 mg sarilumab q2w with prednisone taper
Treatment: Sarilumab
Sarilumab 200 mgTreatment being tested
Participants will receive 200 mg sarilumab q2w with prednisone taper
Treatment: Sarilumab

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record

Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).

Official 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

Record updated

21 October 2026