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Polymyalgia RheumaticaPhase 3ZIRCONNCT07286214

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

A Phase 3 study testing Sarilumab in people with Polymyalgia Rheumatica, run by Sanofi at 85 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Polymyalgia Rheumatica
What is being tested?
Sarilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
85 sitesin 10 countries
Study dates
12 May 2026to 16 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

85 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

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

800-633-1610 ext. option 6

Contact-US@sanofi.com

85 sites in 10 countries

United States47 sites, 47 recruiting

  • Arthritis and Rheumatic Disease Specialties- Site Number : 8400014

    Aventura, Florida, 33180

    Recruiting

  • Arizona Arthritis & Rheumatology Research - West Beverly Lane- Site Number : 8400055

    Avondale, Arizona, 85392

    Recruiting

  • Accurate Clinical Management - Baytown- Site Number : 8400109

    Baytown, Texas, 77521

    Recruiting

  • Overlake Arthritis and Osteoporosis Center- Site Number : 8400002

    Bellevue, Washington, 98004

    Recruiting

  • Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400005

    Charlotte, North Carolina, 28207

    Recruiting

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

    Clearwater, Florida, 33765

    Recruiting

  • Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 8400028

    Covina, California, 91722

    Recruiting

  • Arthritis & Rheumatology Center Pc- Site Number : 8400038

    Cumming, Georgia, 30040

    Recruiting

  • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400092

    DeBary, Florida, 32713

    Recruiting

  • Lone Star Arthritis & Rheumatology - Denton- Site Number : 8400044

    Denton, Texas, 76205

    Recruiting

  • Denver Arthritis Clinic - Lowry- Site Number : 8400001

    Denver, Colorado, 80230

    Recruiting

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

    Duncansville, Pennsylvania, 16635

    Recruiting

  • Stryde Consulting- Site Number : 8400070

    Frisco, Texas, 75033

    Recruiting

  • University of Florida Health - Gainesville- Site Number : 8400035

    Gainesville, Florida, 32606

    Recruiting

  • Arthritis Center of North Georgia - Gainesville- Site Number : 8400102

    Gainesville, Georgia, 30501

    Recruiting

  • Rheumatic Disease Center - Glendale- Site Number : 8400006

    Glendale, Wisconsin, 53217

    Recruiting

  • Klein and Associates- Site Number : 8400003

    Hagerstown, Maryland, 21740

    Recruiting

  • Prolato Clinical Research Center- Site Number : 8400045

    Houston, Texas, 77054

    Recruiting

  • Care Access - Huntington Beach- Site Number : 8400087

    Huntington Beach, California, 92648

    Recruiting

  • West Tennessee Research Institute- Site Number : 8400009

    Jackson, Tennessee, 38305

    Recruiting

  • Logan Health Research - Glacier View Research Institute - Oncology- Site Number : 8400056

    Kalispell, Montana, 59901

    Recruiting

  • TAD Clinical Research - Lufkin- Site Number : 8400069

    Lufkin, Texas, 75904

    Recruiting

  • Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400034

    Margate, Florida, 33063

    Recruiting

  • Vitalia Medical Research - Margate- Site Number : 8400021

    Margate, Florida, 33063

    Recruiting

  • Rheumwell Comprehensive Rheumatology- Site Number : 8400004

    Miami, Florida, 33143

    Recruiting

  • Florida Research Center- Site Number : 8400084

    Miami, Florida, 33174

    Recruiting

  • Innovia Research Center- Site Number : 8400029

    Miramar, Florida, 33027

    Recruiting

  • Murfreesboro Medical Clinic - Shores Road- Site Number : 8400040

    Murfreesboro, Tennessee, 37128

    Recruiting

  • Arizona Arthritis & Rheumatology Associates - East Bell Road- Site Number : 8400010

    Phoenix, Arizona, 85032

    Recruiting

  • Discovery Clinical Research - Plantation- Site Number : 8400091

    Plantation, Florida, 33324

    Recruiting

  • Arthritis And Rheumatism Associates- Site Number : 8400083

    Rockville, Maryland, 20850

    Recruiting

  • HealthPartners Specialty Center- Site Number : 8400094

    Saint Paul, Minnesota, 55130

    Recruiting

  • Digestive Health Associates - Rowan Diagnostic Clinic- Site Number : 8400019

    Salisbury, North Carolina, 28144

    Recruiting

  • Rheumatology Associates Of South Texas- Site Number : 8400050

    San Antonio, Texas, 78258

    Recruiting

  • Inspire Santa Fe Medical Group- Site Number : 8400077

    Santa Fe, New Mexico, 87505

    Recruiting

  • Sarasota Arthritis Center- Site Number : 8400073

    Sarasota, Florida, 34239

    Recruiting

  • Arthritis Consultants - St. Louis- Site Number : 8400063

    St Louis, Missouri, 63141

    Recruiting

  • Accurate Clinical Management - Sugar Land- Site Number : 8400061

    Sugar Land, Texas, 77479

    Recruiting

  • Vantage Clinical Trials - Tampa- Site Number : 8400064

    Tampa, Florida, 33614

    Recruiting

  • Southland Arthritis- Site Number : 8400047

    Temecula, California, 92592

    Recruiting

  • Cohen Medical Centers- Site Number : 8400023

    Thousand Oaks, California, 91360

    Recruiting

  • Arizona Arthritis & Rheumatology Associates - Tucson- Site Number : 8400039

    Tucson, Arizona, 85704

    Recruiting

  • Solace Clinical Research - Tustin- Site Number : 8400101

    Tustin, California, 92780

    Recruiting

  • Comprehensive Rheumatology Center- Site Number : 8400060

    West Hills, California, 91307

    Recruiting

  • Rheumatology Specialty Center - Willow Grove- Site Number : 8400042

    Willow Grove, Pennsylvania, 19090

    Recruiting

  • Willow Rheumatology and Wellness- Site Number : 8400012

    Willowbrook, Illinois, 60527

    Recruiting

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

    Wyomissing, Pennsylvania, 19610

    Recruiting

Other trials in United States

Spain8 sites, 8 recruiting

  • Investigational Site Number : 7240006

    A Coruña, Galicia [Galicia], 15006

    Recruiting

  • Investigational Site Number : 7240005

    Barcelona, Catalunya [Cataluña], 08035

    Recruiting

  • Investigational Site Number : 7240004

    Madrid, Madrid, Comunidad de, 28046

    Recruiting

  • Investigational Site Number : 7240002

    Madrid, 28041

    Recruiting

  • Investigational Site Number : 7240008

    Málaga, 29010

    Recruiting

  • Investigational Site Number : 7240001

    Sabadell, 08208

    Recruiting

  • Investigational Site Number : 7240009

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

    Recruiting

  • Investigational Site Number : 7240003

    Seville, Andalusia, 41013

    Recruiting

Other trials in Spain

Belgium6 sites, 6 recruiting

  • Investigational Site Number : 0560006

    Bruges, 8000

    Recruiting

  • Investigational Site Number : 0560004

    Brussels, 1070

    Recruiting

  • Investigational Site Number : 0560002

    Genk, 3600

    Recruiting

  • Investigational Site Number : 0560007

    Ghent, 9000

    Recruiting

  • Investigational Site Number : 0560001

    Leuven, 3000

    Recruiting

  • Investigational Site Number : 0560003

    Liège, 4000

    Recruiting

Other trials in Belgium

Germany6 sites, 6 recruiting

  • Investigational Site Number : 2760010

    Berlin, 13125

    Recruiting

  • Investigational Site Number : 2760005

    Freiburg im Breisgau, 79106

    Recruiting

  • Investigational Site Number : 2760003

    Hamburg, 20095

    Recruiting

  • Investigational Site Number : 2760001

    Herne, 44649

    Recruiting

  • Investigational Site Number : 2760012

    Neubrandenburg, 17033

    Recruiting

  • Investigational Site Number : 2760009

    Würzburg, 97080

    Recruiting

Other trials in Germany

Czechia5 sites, 5 recruiting

  • Investigational Site Number : 2030005

    Hlučín, 748 01

    Recruiting

  • Investigational Site Number : 2030004

    Ostrava, 722 00

    Recruiting

  • Investigational Site Number : 2030001

    Prague, 128 00

    Recruiting

  • Investigational Site Number : 2030002

    Uherské Hradiště, 686 01

    Recruiting

  • Investigational Site Number : 2030003

    Zlín, 760 01

    Recruiting

Other trials in Czechia

Netherlands5 sites, 5 recruiting

  • Investigational Site Number : 5280003

    Almelo, 7609 PP

    Recruiting

  • Investigational Site Number : 5280006

    Heerlen, 6419 PC

    Recruiting

  • Investigational Site Number : 5280002

    Leeuwarden, 8934 AD

    Recruiting

  • Investigational Site Number : 5280004

    Rotterdam, 3079 DZ

    Recruiting

  • Investigational Site Number : 5280001

    Venlo, 5912 BL

    Recruiting

Other trials in Netherlands

Austria2 sites, 2 recruiting

  • Investigational Site Number : 0400003

    Graz, 8036

    Recruiting

  • Investigational Site Number : 0400001

    Vienna, 1090

    Recruiting

Other trials in Austria

Canada2 sites, 2 recruiting

  • Investigational Site Number : 1240003

    Sherbrooke, Quebec, J1G 2E8

    Recruiting

  • Investigational Site Number : 1240002

    Trois-Rivières, Quebec, G8Z 1Y2

    Recruiting

Other trials in Canada

France2 sites, 2 recruiting

  • Investigational Site Number : 2500005

    Nantes, 44093

    Recruiting

  • Investigational Site Number : 2500006

    Toulouse, 31059

    Recruiting

Other trials in France

Greece2 sites, 2 recruiting

  • Investigational Site Number : 3000002

    Athens, 115 27

    Recruiting

  • Investigational Site Number : 3000001

    Athens, 124 62

    Recruiting

Other trials in Greece

About this study

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

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.

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.

Being tested
Sarilumab, Placebo
Medical subject headings
Polymyalgia Rheumatica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SarilumabDrug

    Also called Kevzara®

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

  • SarilumabDrug

    Also called Kevzara®

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

  • PlaceboDrug

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

Study groups in NCT07286214
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive placebo with prednisone taper
Receives: Drug: Placebo
Sarilumab 150 mgExperimentalParticipants will receive 150 mg sarilumab q2w with prednisone taper
Receives: Drug: Sarilumab
Sarilumab 200 mgExperimentalParticipants will receive 200 mg sarilumab q2w with prednisone taper
Receives: Drug: Sarilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

    Measured: at Week 52

Secondary outcomes (10)

  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

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

    Measured: at Week 52

  2. Sustained remission at Week 52 (yes/no) in participants with 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).

    Measured: at Week 52

  3. Sustained remission at Week 52 (yes/no) 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).

    Measured: at Week 52

  4. 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).

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

  5. 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.

    Measured: at Week 52

  6. Remission at Week 24

    Achievement of remission at Week 24.

    Measured: at Week 24

  7. Time in remission through Week 52

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

    Measured: through Week 52

  8. Incidence rate of flare through Week 52

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

    Measured: through Week 52

  9. 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.

    Measured: at Weeks 24 and 52

  10. Changes from baseline at Weeks 24 and 52 in the domain scores and 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).

    Measured: at Weeks 24 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start12 May 2026
  3. Primary completion4 Jun 2029 (estimated)
  4. Study completion16 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07286214
Sponsor's protocol ID
EFC18055
Other IDs
2024-511296-15-00, U1111-1310-5173
Acronym
ZIRCON
Status last verified
Oct 2026
First submitted
10 Dec 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sarilumab in people with Polymyalgia Rheumatica, run by Sanofi at 85 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Spain, Belgium, Germany, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07286214.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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