Sarilumab efficacy and safety in adults with early polymyalgia rheumatica

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2026-06-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-511296-15-00

WHO UTN

U1111-1310-5173

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Dose response, Pharmacokinetic

To demonstrate the superiority in efficacy of sarilumab 200 mg q2w with a 52-week prednisone taper as compared to a 52-week prednisone taper in participants with early relapsing
PMR

Secondary objectives 5

1. To demonstrate the superiority in efficacy of sarilumab 200 mg q2w with a 52-week prednisone taper as compared to a 52-week prednisone taper in all participants (newly diagnosed PMR and early relapsing PMR)
2. To demonstrate the superiority in efficacy of sarilumab 150 mg q2w with a 52-week prednisone taper as compared to a 52-week prednisone taper in participants with early relapsing PMR, as well as in all participants (newly diagnosed PMR and early relapsing PMR)
3. To evaluate the safety (including immunogenicity) and tolerability of each of 2 dose levels of sarilumab with a 52-week prednisone taper as compared to 52-week prednisone taper in all participants (newly diagnosed PMR and early relapsing PMR)
4. To assess the efficacy of each of 2 dose levels of sarilumab with a 52-week prednisone taper as compared to 52-week prednisone taper in all participants (newly diagnosed PMR and early relapsing PMR)
5. To evaluate the effect of sarilumab on participants as measured by PROs

Conditions and MedDRA coding

Musculoskeletal diseases

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adults >50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria
2. 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)
3. Participants must be willing and able to take prednisone of 15 mg/day at randomization
4. 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 8

1. Diagnosis of Giant Cell Arteritis (GCA)
2. Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia
3. Inadequately treated hypothyroidism
4. 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
5. Patients with uncontrolled diabetes mellitus (HbA1c ≥9%
6. Immunosuppressive therapies including systemic corticosteroids
7. Malignancy
8. Organ transplant recipient

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 9

1. 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
2. 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
3. Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), abnormalities in laboratory values, anti-drug antibody
4. Corticosteroid-free remission at Week 52
5. Remission at Week 24
6. Time in remission through Week 52
7. Incidence rate of flare through Week 52
8. Change from baseline in PMR activity score and its components at Weeks 24 and 52
9. Changes from baseline at Weeks 24 and 52 in the physical component summary and mental component summary from Shortform 36-item questionnaire (SF-36v2)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 10

Locations

10 EU/EEA countries · 52 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 120 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications