A Phase 2a Study to Evaluate the Effects of Sirukumab in Subjects With Severe Poorly Controlled Asthma
Status:
Withdrawn
Trial end date:
2016-10-04
Target enrollment:
Participant gender:
Summary
Sirukumab is a fully human anti interleukin (IL)-6 immunoglobulin G1-kappa monoclonal
antibody (MAb) which is in development for the treatment of rheumatoid arthritis (RA). The
continuing unmet need in subjects with asthma refractory to corticosteroid therapy and
increased understanding of asthma pathogenesis have stimulated the development of targeted
biologics based on predictive biomarkers. The majority of approaches to date have targeted T
Helper 2 (Th2) cytokines or their downstream effects. Targeting IL-6 in severe asthma
represents an unprecedented approach that has potential to address non-Th2 drivers of severe
asthma. This multicenter, randomized, double-blind (sponsor-unblind), placebo-controlled,
parallel group study will investigate the efficacy of sirukumab compared to placebo in
subjects having uncontrolled severe asthma despite use of high dose inhaled corticosteroid
(ICS) in combination with long-acting Beta-agonist (LABA). The study will employ a variable
treatment period for individual subjects. Dosing will continue every 4 weeks until week 44
(inclusive), or until 24 weeks after the final subject has been randomized, whichever the
sooner. Upon receiving the final dose of study medicine or placebo, subjects will enter a 16
week Follow Up period. Overall, the duration of participation for subjects who complete the
full 44-week treatment period and Follow Up period may be up to 64 weeks. Approximately 175
subjects will be randomized such that 140 evaluable subjects complete the study.