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Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

NCT ID: NCT07286214

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-19

Study Completion Date

2029-07-16

Brief Summary

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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.

Detailed Description

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Conditions

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Polymyalgia Rheumatica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Participants will receive placebo with prednisone taper

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Sarilumab 150 mg

Participants will receive 150 mg sarilumab q2w with prednisone taper

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

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

Sarilumab 200 mg

Participants will receive 200 mg sarilumab q2w with prednisone taper

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

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

Interventions

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Sarilumab

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

Intervention Type DRUG

Sarilumab

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Kevzara® Kevzara®

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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

Role: CONTACT

[email protected]
800-633-1610 ext. option 6

Other Identifiers

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2024-511296-15-00

Identifier Type: CTIS

Identifier Source: secondary_id

U1111-1310-5173

Identifier Type: REGISTRY

Identifier Source: secondary_id

EFC18055

Identifier Type: -

Identifier Source: org_study_id