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NCT07286214PHASE4Recruiting

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Sanofi

Start Date

5/12/2026

Completion Date

7/16/2029

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.

Eligibility Criteria

Age Range: 50 years to No maximum

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.

Interventions

DRUG

Sarilumab

DRUG

Sarilumab

DRUG

Placebo

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Conditions

Polymyalgia Rheumatica

Locations

Denver Arthritis Clinic - Lowry- Site Number : 8400001

Denver, Colorado 80230

United States

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

Clearwater, Florida 33765

United States

Vitalia Medical Research - Margate- Site Number : 8400021

Margate, Florida 33063

United States

Florida Research Center- Site Number : 8400084

Miami, Florida 33174

United States

Innovia Research Center- Site Number : 8400029

Miramar, Florida 33027

United States

Discovery Clinical Research - Plantation- Site Number : 8400091

Plantation, Florida 33324

United States

Vantage Clinical Trials - Tampa- Site Number : 8400064

Tampa, Florida 33614

United States

Willow Rheumatology and Wellness- Site Number : 8400012

Willowbrook, Illinois 60527

United States

Inspire Santa Fe Medical Group- Site Number : 8400077

Santa Fe, New Mexico 87505

United States

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

Duncansville, Pennsylvania 16635

United States

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

Wyomissing, Pennsylvania 19610

United States

West Tennessee Research Institute- Site Number : 8400009

Jackson, Tennessee 38305

United States

TAD Clinical Research - Lufkin- Site Number : 8400069

Lufkin, Texas 75904

United States

Investigational Site Number : 1240003

Sherbrooke, Quebec J1G 2E8

Canada