Health TrialsbyHealthPanel

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

ConditionPolymyalgia Rheumatica
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorSanofi

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sarilumab

    Drug

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

  • Sarilumab

    Drug

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

  • Placebo

    Drug

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

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Sarilumab 150 mgExperimental treatment 1 intervention
Group C: Sarilumab 200 mgExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
at Week 52

Secondary outcomes

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

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

Time frame
at Week 52
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

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

Time frame
at Week 52
3

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

AEs that develop or worsen or became serious during the treatment period (from first dose to 60 days after last dose).

Time frame
over the entire study period (up to Week 58)
4

Corticosteroid-free remission at Week 52

Remission, without receipt of systemic corticosteroids (CS) or rescue treatment within 7 days prior to the assessment time point.

Time frame
at Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
Apply now