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Recruiting Phase 3 Interventional

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

ClinicalTrials.gov ID: NCT07286214

Public ClinicalTrials.gov record NCT07286214. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 11:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07286214
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
300 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
50 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 12, 2026 (Actual)
Primary completion
Jun 4, 2029 (Estimated)
Completion
Jul 16, 2029 (Estimated)
Last update posted
Oct 21, 2026

2026 – 2029

United States locations

U.S. sites
47
U.S. states
17
U.S. cities
45
Facility City State ZIP Site status
Arizona Arthritis & Rheumatology Research - West Beverly Lane- Site Number : 8400055 Avondale Arizona 85392 Recruiting
Arizona Arthritis & Rheumatology Associates - East Bell Road- Site Number : 8400010 Phoenix Arizona 85032 Recruiting
Arizona Arthritis & Rheumatology Associates - Tucson- Site Number : 8400039 Tucson Arizona 85704 Recruiting
Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 8400028 Covina California 91722 Recruiting
Care Access - Huntington Beach- Site Number : 8400087 Huntington Beach California 92648 Recruiting
Southland Arthritis- Site Number : 8400047 Temecula California 92592 Recruiting
Cohen Medical Centers- Site Number : 8400023 Thousand Oaks California 91360 Recruiting
Solace Clinical Research - Tustin- Site Number : 8400101 Tustin California 92780 Recruiting
Comprehensive Rheumatology Center- Site Number : 8400060 West Hills California 91307 Recruiting
Denver Arthritis Clinic - Lowry- Site Number : 8400001 Denver Colorado 80230 Recruiting
Arthritis and Rheumatic Disease Specialties- Site Number : 8400014 Aventura Florida 33180 Recruiting
Clinical Research of West Florida - Phase I Unit- Site Number : 8400024 Clearwater Florida 33765 Recruiting
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400092 DeBary Florida 32713 Recruiting
University of Florida Health - Gainesville- Site Number : 8400035 Gainesville Florida 32606 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
Discovery Clinical Research - Plantation- Site Number : 8400091 Plantation Florida 33324 Recruiting
Sarasota Arthritis Center- Site Number : 8400073 Sarasota Florida 34239 Recruiting
Vantage Clinical Trials - Tampa- Site Number : 8400064 Tampa Florida 33614 Recruiting
Arthritis & Rheumatology Center Pc- Site Number : 8400038 Cumming Georgia 30040 Recruiting
Arthritis Center of North Georgia - Gainesville- Site Number : 8400102 Gainesville Georgia 30501 Recruiting
Willow Rheumatology and Wellness- Site Number : 8400012 Willowbrook Illinois 60527 Recruiting
Klein and Associates- Site Number : 8400003 Hagerstown Maryland 21740 Recruiting
Arthritis And Rheumatism Associates- Site Number : 8400083 Rockville Maryland 20850 Recruiting
HealthPartners Specialty Center- Site Number : 8400094 Saint Paul Minnesota 55130 Recruiting
Arthritis Consultants - St. Louis- Site Number : 8400063 St Louis Missouri 63141 Recruiting
Logan Health Research - Glacier View Research Institute - Oncology- Site Number : 8400056 Kalispell Montana 59901 Recruiting
Inspire Santa Fe Medical Group- Site Number : 8400077 Santa Fe New Mexico 87505 Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400005 Charlotte North Carolina 28207 Recruiting
Digestive Health Associates - Rowan Diagnostic Clinic- Site Number : 8400019 Salisbury North Carolina 28144 Recruiting
Altoona Center for Clinical Research - Duncansville- Site Number : 8400018 Duncansville Pennsylvania 16635 Recruiting
Rheumatology Specialty Center - Willow Grove- Site Number : 8400042 Willow Grove Pennsylvania 19090 Recruiting
Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013 Wyomissing Pennsylvania 19610 Recruiting
West Tennessee Research Institute- Site Number : 8400009 Jackson Tennessee 38305 Recruiting
Murfreesboro Medical Clinic - Shores Road- Site Number : 8400040 Murfreesboro Tennessee 37128 Recruiting
Accurate Clinical Management - Baytown- Site Number : 8400109 Baytown Texas 77521 Recruiting
Lone Star Arthritis & Rheumatology - Denton- Site Number : 8400044 Denton Texas 76205 Recruiting
Stryde Consulting- Site Number : 8400070 Frisco Texas 75033 Recruiting
Prolato Clinical Research Center- Site Number : 8400045 Houston Texas 77054 Recruiting
TAD Clinical Research - Lufkin- Site Number : 8400069 Lufkin Texas 75904 Recruiting
Rheumatology Associates Of South Texas- Site Number : 8400050 San Antonio Texas 78258 Recruiting
Accurate Clinical Management - Sugar Land- Site Number : 8400061 Sugar Land Texas 77479 Recruiting
Overlake Arthritis and Osteoporosis Center- Site Number : 8400002 Bellevue Washington 98004 Recruiting
Rheumatic Disease Center - Glendale- Site Number : 8400006 Glendale Wisconsin 53217 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07286214, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 21, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07286214 live on ClinicalTrials.gov.

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