Polymyalgia Rheumatica Clinical Trial
Official title:
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in Subjects With Polymyalgia Rheumatica
Sirukumab is a human anti-IL-6 monoclonal antibody that selectively binds to the cytokine
with high affinity that may have therapeutic benefit in the treatment of polymyalgia
rheumatica (PMR) by interrupting multiple pathogenic pathways. Sirukumab inhibits
IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation,
resulting in the inhibition of the biological effect of IL-6. This study will evaluate the
efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in
the treatment of active PMR. The study will be conducted in 2 parts (Part A and Part B) and
consists of the following phases: Screening phase, Part A: 52-week double-blind treatment
phase, Part B: 52-week extension phase with no study drug administration and a 16-week
follow-up phase if applicable.
Approximately 150 subjects with a diagnosis of PMR and active disease within 6 weeks of
baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive
one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone
taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week
52. Subjects completing Part A of the study who are in clinical remission will be eligible to
enter Part B, the 52-week extension phase, designed to investigate the long-term maintenance
of remission and safety following cessation of sirukumab treatment and to assess long-term
corticosteroid use. Subjects will need to have follow-up safety evaluations for at least 16
weeks after receiving the last dose of study drug, applicable for those who have withdrawn
prematurely from the study or who have completed Part A but are not eligible for Part B.
n/a
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