Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Part of paid clinical trials in Denver, Colorado.

Sponsor
Sanofi
Study ID
NCT07286214
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Polymyalgia Rheumatica

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sarilumab — DRUG
    Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
  • Sarilumab — DRUG
    Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
  • Placebo — DRUG
    Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous

Study Details

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 Dates

Start date
May 12, 2026
Status verified
Jun 2026
Primary completion
Jun 4, 2029
Completion
Jul 16, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants will receive placebo with prednisone taper
  • Experimental: Sarilumab 150 mg
    Participants will receive 150 mg sarilumab q2w with prednisone taper
  • Experimental: Sarilumab 200 mg
    Participants will receive 200 mg sarilumab q2w with prednisone taper

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 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (9)

FacilityCityStateZIPSite coordinators
Denver Arthritis Clinic - Lowry- Site Number : 8400001DenverColorado80230-
Clinical Research of West Florida - Phase I Unit- Site Number : 8400024ClearwaterFlorida33765-
Vitalia Medical Research - Margate- Site Number : 8400021MargateFlorida33063-
Innovia Research Center- Site Number : 8400029MiramarFlorida33027-
Discovery Clinical Research - Plantation- Site Number : 8400091PlantationFlorida33324-
Vantage Clinical Trials - Tampa- Site Number : 8400064TampaFlorida33614-
Willow Rheumatology and Wellness- Site Number : 8400012WillowbrookIllinois60527-
Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013WyomissingPennsylvania19610-
West Tennessee Research Institute- Site Number : 8400009JacksonTennessee38305-

Find similar trials in Denver, CO

By research site
Denver Arthritis Clinic - Lowry· Denver, COClinical Research of West Florida - Phase I Unit· Clearwater, FLVitalia Medical Research - Margate· Margate, FLInnovia Research Center· Miramar, FLDiscovery Clinical Research - Plantation· Plantation, FLVantage Clinical Trials - Tampa· Tampa, FL

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