Recruiting

Sarilumab

Sponsor:

Sanofi

Code:

NCT07286214

Conditions

Polymyalgia Rheumatica

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Sarilumab

Sarilumab

Placebo

Study Details

Brief summary:

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.

Conditions

Polymyalgia Rheumatica

Study ID

NCT07286214

Start date

May 12, 2026

Status verified date

Jun, 2026

Completion date

Jul 16, 2029

Anticipated

Primary completion date

Jun 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Sarilumab

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

Sarilumab

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

Placebo

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

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 and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Denver Arthritis Clinic - Lowry- Site Number : 8400001

Recruiting

Denver, Colorado, United States, 80230

Clinical Research of West Florida - Phase I Unit- Site Number : 8400024

Recruiting

Clearwater, Florida, United States, 33765

Vitalia Medical Research - Margate- Site Number : 8400021

Recruiting

Margate, Florida, United States, 33063

Florida Research Center- Site Number : 8400084

Recruiting

Miami, Florida, United States, 33174

Innovia Research Center- Site Number : 8400029

Recruiting

Miramar, Florida, United States, 33027

Discovery Clinical Research - Plantation- Site Number : 8400091

Recruiting

Plantation, Florida, United States, 33324

Vantage Clinical Trials - Tampa- Site Number : 8400064

Recruiting

Tampa, Florida, United States, 33614

Willow Rheumatology and Wellness- Site Number : 8400012

Recruiting

Willowbrook, Illinois, United States, 60527

Inspire Santa Fe Medical Group- Site Number : 8400077

Recruiting

Santa Fe, New Mexico, United States, 87505

Altoona Center for Clinical Research - Duncansville- Site Number : 8400018

Recruiting

Duncansville, Pennsylvania, United States, 16635

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

Recruiting

Wyomissing, Pennsylvania, United States, 19610

West Tennessee Research Institute- Site Number : 8400009

Recruiting

Jackson, Tennessee, United States, 38305

TAD Clinical Research - Lufkin- Site Number : 8400069

Recruiting

Lufkin, Texas, United States, 75904

Investigational Site Number : 1240003

Recruiting

Sherbrooke, Quebec, Canada, J1G 2E8

More Information

Sponsor

Sanofi

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-06-23.