NCT03207243

Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	GSK3772847	GSK3772847 10 mg/kg will be administered as IV infusion once every 4 weeks to randomized subjects.
DRUG	Placebo	Placebo sterile normal saline will be administered as IV infusion once every 4 weeks to randomized subjects.
DRUG	Fluticasone propionate/salmeterol	FP/Sal 500/50 mcg will be administered via inhalation route twice daily to all subjects.
DRUG	Fluticasone propionate	FP 500, 250, 100 or 50 mcg will be administered via inhalation route twice daily to all subjects.

Timeline

• Start date: 2017-09-14
• Primary completion: 2019-02-15
• Completion: 2019-05-15
• First posted: 2017-07-02
• Last updated: 2020-03-02
• Results posted: 2020-03-02

Locations

64 sites across 6 countries: United States, Australia, Canada, Mexico, Russia, Ukraine

Regulatory

• FDA-regulated drug study