Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma
Status:
Completed
Trial end date:
2019-05-15
Target enrollment:
Participant gender:
Summary
GSK3772847, an anti-interleukin (IL)33 receptor monoclonal antibody, is a novel treatment for
asthma. This is a phase 2a study which aims to evaluate efficacy, safety, tolerability,
pharmacokinetic (PK) and pharmacodynamic (PD) profiles of GSK3772847 in subjects with
moderately severe asthma. The study will be conducted in 4 phases including screening, run-in
phase, treatment phase and follow-up. In treatment phase, eligible subjects will be
randomized to receive either GSK3772847 or placebo administered via intravenous (IV) route
every 4 weeks in addition to open-label background therapy of fluticasone propionate/
salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. During the treatment phase, the
background therapy will be switched to FP 500 mcg for 2 weeks and the dose of FP will be
reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. The
total duration of study will be approximately 33 weeks and approximately 165 subjects with
moderately severe asthma who are maintained on high-dose of inhaled corticosteroids/
Long-Acting Beta-2-Agonists (ICS/LABA) will be randomized.
Phase:
Phase 2
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluticasone Fluticasone Propionate, Salmeterol Xinafoate Drug Combination Salmeterol Xinafoate Xhance