Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Polymyalgia Rheumatica
In brief
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.
Key facts
- Study ID
- NCT07286214
- Run by
- Sanofi
- People needed
- 300
- Starts
- 2026-05-12
- Expected to finish
- 2029-07-16
- Last updated by the study team
- 2026-06-23
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Denver Arthritis Clinic - Lowry- Site Number : 8400001 — Denver, Colorado, United States (enrolling)
- Clinical Research of West Florida - Phase I Unit- Site Number : 8400024 — Clearwater, Florida, United States (enrolling)
- Vitalia Medical Research - Margate- Site Number : 8400021 — Margate, Florida, United States (enrolling)
- Florida Research Center- Site Number : 8400084 — Miami, Florida, United States (enrolling)
- Innovia Research Center- Site Number : 8400029 — Miramar, Florida, United States (enrolling)
- Discovery Clinical Research - Plantation- Site Number : 8400091 — Plantation, Florida, United States (enrolling)
- Vantage Clinical Trials - Tampa- Site Number : 8400064 — Tampa, Florida, United States (enrolling)
- Willow Rheumatology and Wellness- Site Number : 8400012 — Willowbrook, Illinois, United States (enrolling)
- Inspire Santa Fe Medical Group- Site Number : 8400077 — Santa Fe, New Mexico, United States (enrolling)
- Altoona Center for Clinical Research - Duncansville- Site Number : 8400018 — Duncansville, Pennsylvania, United States (enrolling)
- Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013 — Wyomissing, Pennsylvania, United States (enrolling)
- West Tennessee Research Institute- Site Number : 8400009 — Jackson, Tennessee, United States (enrolling)
- TAD Clinical Research - Lufkin- Site Number : 8400069 — Lufkin, Texas, United States (enrolling)
- Investigational Site Number : 1240003 — Sherbrooke, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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