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

NCT03207243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2020-03-02

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-14
Primary Completion
2019-02-15
Completion
2019-05-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Mexico
  • Russia
  • Ukraine

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03207243 on ClinicalTrials.gov