Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

NCT07286214 | Not Yet Recruiting Phase 4 FDA Drug

• 3 other identifiers: EFC180552024-511296-15-00U1111-1310-5173
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

  No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy).

  at Week 52

Secondary Outcomes (9)

• Sustained remission at Week 52 (yes/no) in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 200 mg q2w with prednisone taper

  at Week 52

• Sustained remission at Week 52 (yes/no) in participants with early relapsing PMR, as well as in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 150 mg q2w with prednisone taper

  at Week 52

• Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), abnormalities in laboratory values, anti-drug antibody

  over the entire study period (up to Week 58)

• Corticosteroid-free remission at Week 52

  at Week 52

• Remission at Week 24

  at Week 24

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo with prednisone taper

Drug: Placebo

Sarilumab 150 mg

EXPERIMENTAL

Participants will receive 150 mg sarilumab q2w with prednisone taper

Drug: Sarilumab

Sarilumab 200 mg

EXPERIMENTAL

Participants will receive 200 mg sarilumab q2w with prednisone taper

Drug: Sarilumab

Interventions

Placebo DRUG

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

Placebo

Sarilumab DRUG

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

Also known as: Kevzara®

Sarilumab 200 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of Giant Cell Arteritis (GCA)
• Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia
• Inadequately treated hypothyroidism
• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

sarilumab

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 16, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): June 4, 2029
• Study Completion (Estimated): July 16, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share