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RECRUITING Phase 3 ClinicalTrials.gov

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07286214

Registry updated: 2026-10-21
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Description

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.

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

Eligibility criteria

Inclusion Criteria: * 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 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.

Conditions

Polymyalgia Rheumatica

Locations

  • Arizona Arthritis & Rheumatology Research - West Beverly Lane- Site Number : 8400055 — Avondale, Arizona, United States
  • Arizona Arthritis & Rheumatology Associates - East Bell Road- Site Number : 8400010 — Phoenix, Arizona, United States
  • Arizona Arthritis & Rheumatology Associates - Tucson- Site Number : 8400039 — Tucson, Arizona, United States
  • Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 8400028 — Covina, California, United States
  • Care Access - Huntington Beach- Site Number : 8400087 — Huntington Beach, California, United States
  • Southland Arthritis- Site Number : 8400047 — Temecula, California, United States
  • Cohen Medical Centers- Site Number : 8400023 — Thousand Oaks, California, United States
  • Solace Clinical Research - Tustin- Site Number : 8400101 — Tustin, California, United States
  • Comprehensive Rheumatology Center- Site Number : 8400060 — West Hills, California, United States
  • Denver Arthritis Clinic - Lowry- Site Number : 8400001 — Denver, Colorado, United States
  • Arthritis and Rheumatic Disease Specialties- Site Number : 8400014 — Aventura, Florida, United States
  • Clinical Research of West Florida - Phase I Unit- Site Number : 8400024 — Clearwater, Florida, United States
  • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400092 — DeBary, Florida, United States
  • University of Florida Health - Gainesville- Site Number : 8400035 — Gainesville, Florida, United States
  • Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400034 — Margate, Florida, United States
  • Vitalia Medical Research - Margate- Site Number : 8400021 — Margate, Florida, United States
  • Rheumwell Comprehensive Rheumatology- Site Number : 8400004 — Miami, Florida, United States
  • Florida Research Center- Site Number : 8400084 — Miami, Florida, United States
  • Innovia Research Center- Site Number : 8400029 — Miramar, Florida, United States
  • Discovery Clinical Research - Plantation- Site Number : 8400091 — Plantation, Florida, United States
  • Sarasota Arthritis Center- Site Number : 8400073 — Sarasota, Florida, United States
  • Vantage Clinical Trials - Tampa- Site Number : 8400064 — Tampa, Florida, United States
  • Arthritis & Rheumatology Center Pc- Site Number : 8400038 — Cumming, Georgia, United States
  • Arthritis Center of North Georgia - Gainesville- Site Number : 8400102 — Gainesville, Georgia, United States
  • Willow Rheumatology and Wellness- Site Number : 8400012 — Willowbrook, Illinois, United States
  • Klein and Associates- Site Number : 8400003 — Hagerstown, Maryland, United States
  • Arthritis And Rheumatism Associates- Site Number : 8400083 — Rockville, Maryland, United States
  • HealthPartners Specialty Center- Site Number : 8400094 — Saint Paul, Minnesota, United States
  • Arthritis Consultants - St. Louis- Site Number : 8400063 — St Louis, Missouri, United States
  • Logan Health Research - Glacier View Research Institute - Oncology- Site Number : 8400056 — Kalispell, Montana, United States
  • Inspire Santa Fe Medical Group- Site Number : 8400077 — Santa Fe, New Mexico, United States
  • Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400005 — Charlotte, North Carolina, United States
  • Digestive Health Associates - Rowan Diagnostic Clinic- Site Number : 8400019 — Salisbury, North Carolina, United States
  • Altoona Center for Clinical Research - Duncansville- Site Number : 8400018 — Duncansville, Pennsylvania, United States
  • Rheumatology Specialty Center - Willow Grove- Site Number : 8400042 — Willow Grove, Pennsylvania, United States
  • Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013 — Wyomissing, Pennsylvania, United States
  • West Tennessee Research Institute- Site Number : 8400009 — Jackson, Tennessee, United States
  • Murfreesboro Medical Clinic - Shores Road- Site Number : 8400040 — Murfreesboro, Tennessee, United States
  • Accurate Clinical Management - Baytown- Site Number : 8400109 — Baytown, Texas, United States
  • Lone Star Arthritis & Rheumatology - Denton- Site Number : 8400044 — Denton, Texas, United States
  • Stryde Consulting- Site Number : 8400070 — Frisco, Texas, United States
  • Prolato Clinical Research Center- Site Number : 8400045 — Houston, Texas, United States
  • TAD Clinical Research - Lufkin- Site Number : 8400069 — Lufkin, Texas, United States
  • Rheumatology Associates Of South Texas- Site Number : 8400050 — San Antonio, Texas, United States
  • Accurate Clinical Management - Sugar Land- Site Number : 8400061 — Sugar Land, Texas, United States
  • Overlake Arthritis and Osteoporosis Center- Site Number : 8400002 — Bellevue, Washington, United States
  • Rheumatic Disease Center - Glendale- Site Number : 8400006 — Glendale, Wisconsin, United States
  • Investigational Site Number : 0400003 — Graz, Austria
  • Investigational Site Number : 0400001 — Vienna, Austria
  • Investigational Site Number : 0560006 — Bruges, Belgium
  • Investigational Site Number : 0560004 — Brussels, Belgium
  • Investigational Site Number : 0560002 — Genk, Belgium
  • Investigational Site Number : 0560007 — Ghent, Belgium
  • Investigational Site Number : 0560001 — Leuven, Belgium
  • Investigational Site Number : 0560003 — Liège, Belgium
  • Investigational Site Number : 1240003 — Sherbrooke, Quebec, Canada
  • Investigational Site Number : 1240002 — Trois-Rivières, Quebec, Canada
  • Investigational Site Number : 2030005 — Hlučín, Czechia
  • Investigational Site Number : 2030004 — Ostrava, Czechia
  • Investigational Site Number : 2030001 — Prague, Czechia
  • Investigational Site Number : 2030002 — Uherské Hradiště, Czechia
  • Investigational Site Number : 2030003 — Zlín, Czechia
  • Investigational Site Number : 2500005 — Nantes, France
  • Investigational Site Number : 2500006 — Toulouse, France
  • Investigational Site Number : 2760010 — Berlin, Germany
  • Investigational Site Number : 2760005 — Freiburg im Breisgau, Germany
  • Investigational Site Number : 2760003 — Hamburg, Germany
  • Investigational Site Number : 2760001 — Herne, Germany
  • Investigational Site Number : 2760012 — Neubrandenburg, Germany
  • Investigational Site Number : 2760009 — Würzburg, Germany
  • Investigational Site Number : 3000002 — Athens, Greece
  • Investigational Site Number : 3000001 — Athens, Greece
  • Investigational Site Number : 5280003 — Almelo, Netherlands
  • Investigational Site Number : 5280006 — Heerlen, Netherlands
  • Investigational Site Number : 5280002 — Leeuwarden, Netherlands
  • Investigational Site Number : 5280004 — Rotterdam, Netherlands
  • Investigational Site Number : 5280001 — Venlo, Netherlands
  • Investigational Site Number : 7240003 — Seville, Andalusia, Spain
  • Investigational Site Number : 7240005 — Barcelona, Catalunya [Cataluña], Spain
  • Investigational Site Number : 7240006 — A Coruña, Galicia [Galicia], Spain
  • Investigational Site Number : 7240004 — Madrid, Madrid, Comunidad de, Spain
  • Investigational Site Number : 7240009 — San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
  • Investigational Site Number : 7240002 — Madrid, Spain
  • Investigational Site Number : 7240008 — Málaga, Spain
  • Investigational Site Number : 7240001 — Sabadell, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record