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CLINICAL STUDY · NCT07286214

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

RecruitingPhase 4Interventional

Sponsored by Sanofi

Condition
Polymyalgia Rheumatica
Study locations
85 reported sites
Study updated
19 Oct 2026
Source
ClinicalTrials.gov

Overall study status is shown above. Individual hospitals may have a different recruitment status.

THE STUDY

About this study

This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group 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 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.
Full 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

PARTICIPATION

Who may participate

Minimum age
50 Years
Maximum age
Not reported
Sex eligibility
All sexes
Healthy volunteers
Not accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion criteria
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.

NEAR YOU

Study locations worldwide

85 sites

Check the individual site’s status and contact the listed study team for current availability.

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

Recruiting

Wyomissing, Pennsylvania, 19610, United States

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

WHAT IS BEING STUDIED

Treatments and study groups

Interventions

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

Study groups: Sarilumab 200 mg

Other names: Kevzara®

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

Study groups: Sarilumab 150 mg

Other names: Kevzara®

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

Study groups: Placebo

Study groups

PlaceboPlacebo comparator
Participants will receive placebo with prednisone taper

Interventions: Drug: Placebo

Sarilumab 150 mgExperimental
Participants will receive 150 mg sarilumab q2w with prednisone taper

Interventions: Drug: Sarilumab

Sarilumab 200 mgExperimental
Participants will receive 200 mg sarilumab q2w with prednisone taper

Interventions: Drug: Sarilumab

RESEARCH DETAILS

Study design

Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Study model
Parallel
Masking
Quadruple
Enrolment
300 participants · Estimated
Who is masked
Participant, Care provider, Investigator, Outcomes assessor

TIMELINE & MEASURES

Dates and outcomes

Study started
12 May 2026 · Actual
Primary completion
4 Jun 2029 · Estimated
Study completion
16 Jul 2029 · Estimated
First registered
16 Dec 2025 · Actual
Last registry update
19 Oct 2026 · Actual
Status last verified
Oct 2026
Primary outcomes (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).

Time frame: at Week 52

Secondary outcomes (9)

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).

Time frame: at Week 52

Sustained remission at Week 52 (yes/no) in participants with early relapsing PMR, as well as 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).

Time frame: 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).

Time frame: 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.

Time frame: at Week 52

Remission at Week 24

Achievement of remission at Week 24.

Time frame: at Week 24

Time in remission through Week 52

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

Time frame: through Week 52

Incidence rate of flare through Week 52

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

Time frame: 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.

Time frame: at Weeks 24 and 52

Changes from baseline at Weeks 24 and 52 in 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).

Time frame: at Weeks 24 and 52

STUDY TEAM

Sponsor and contacts

Lead sponsor
Sanofi
Sponsor type
Industry
Collaborators
Regeneron Pharmaceuticals
Organisation study ID
EFC18055

Central study contacts

Trial Transparency email recommended (Toll free for US & Canada)ContactPhone: 800-633-1610 ext. option 6Email: Contact-US@sanofi.com

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

FURTHER READING

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.

Related information

Source: ClinicalTrials.gov · Data fetched 20 Oct 2026, 15:52 GMT+0530

Registry data timestamp: 2026-10-19T09:00:04

Registry content is reformatted for readability; original study text is not rewritten. Missing information is labelled “Not reported”. Records are supplied by study sponsors or investigators and can change.

ClinicalTrials.gov does not endorse PharmaBharat. Listing a study does not mean it has been evaluated or approved by a government agency. Information is for research awareness and is not medical advice. Data source terms · Registry disclaimer

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