At a glance
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A Randomized, Double-blind, Parallel Group, Multicenter, Stratified Study Evaluating the Efficacy and Safety of Repeat Doses of GSK3772847 Compared With Placebo in Participants With Moderately Severe Asthma
In Brief
A Phase 2 clinical trial evaluating GSK3772847, Placebo, and 2 other interventions for Asthma. Completed, enrolled 165 participants across 64 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
GSK3772847 10 mg/kg will be administered as IV infusion once every 4 weeks to randomized subjects.
Placebo sterile normal saline will be administered as IV infusion once every 4 weeks to randomized subjects.
FP/Sal 500/50 mcg will be administered via inhalation route twice daily to all subjects.
FP 500, 250, 100 or 50 mcg will be administered via inhalation route twice daily to all subjects.