Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Sanofi

Status and phase: Not yet enrolling; Phase 4

Conditions: Polymyalgia Rheumatica

Treatments: Drug: Placebo; Drug: Sarilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07286214

EFC18055

U1111-1310-5173 (Registry Identifier)

2024-511296-15-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive placebo with prednisone taper

Treatment:

Drug: Placebo

Sarilumab 150 mg

Experimental group

Description:

Participants will receive 150 mg sarilumab q2w with prednisone taper

Treatment:

Drug: Sarilumab

Drug: Sarilumab

Sarilumab 200 mg

Experimental group

Description:

Participants will receive 200 mg sarilumab q2w with prednisone taper

Treatment:

Drug: Sarilumab

Drug: Sarilumab