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.
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
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
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- 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
85 sites in 10 countries
United States47 sites, 47 recruiting
- 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
Spain8 sites, 8 recruiting
- 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
Belgium6 sites, 6 recruiting
- 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
Germany6 sites, 6 recruiting
- 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
Czechia5 sites, 5 recruiting
- 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
Netherlands5 sites, 5 recruiting
- 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
Austria2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0400003
Graz, 8036
- Recruiting
Investigational Site Number : 0400001
Vienna, 1090
Canada2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 1240003
Sherbrooke, Quebec, J1G 2E8
- Recruiting
Investigational Site Number : 1240002
Trois-Rivières, Quebec, G8Z 1Y2
France2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2500005
Nantes, 44093
- Recruiting
Investigational Site Number : 2500006
Toulouse, 31059
Greece2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 3000002
Athens, 115 27
- Recruiting
Investigational Site Number : 3000001
Athens, 124 62
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.
- Conditions
- Polymyalgia Rheumatica
- 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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive placebo with prednisone taper Receives: Drug: Placebo |
| Sarilumab 150 mg | Experimental | Participants will receive 150 mg sarilumab q2w with prednisone taper Receives: Drug: Sarilumab |
| Sarilumab 200 mg | Experimental | Participants 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.
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)
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
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
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
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)
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
Remission at Week 24
Achievement of remission at Week 24.
Measured: at Week 24
Time in remission through Week 52
The duration (in days) in remission to first PMR flare, up to Week 52.
Measured: through Week 52
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
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
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.
- First posted16 Dec 2025
- Study start12 May 2026
- Primary completion4 Jun 2029 (estimated)
- Study completion16 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia RheumaticaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
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