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NCT03207243 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Asthma, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
165
Enrollment target
20
Study locations

NCT03207243 is a Phase 2 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 165 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT03207243, a Phase 2 study of Asthma, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
165 participants
Enrollment target
20
Study locations

Study 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 Studied

Asthma

Interventions

  • DRUG Placebo
  • DRUG Fluticasone propionate
  • DRUG GSK3772847
  • DRUG Fluticasone propionate/salmeterol

Study Locations (20)

Florida

  • GSK Investigational Site - Coral Gables
  • GSK Investigational Site - Hialeah
  • GSK Investigational Site - Miami
  • GSK Investigational Site - Miami
  • GSK Investigational Site - Miami
  • GSK Investigational Site - Miami
  • GSK Investigational Site - Miami
  • GSK Investigational Site - Miami
  • GSK Investigational Site - Miami
  • GSK Investigational Site - Winter Park

California

  • GSK Investigational Site - Bakersfield
  • GSK Investigational Site - Long Beach
  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Newport Beach

Alabama

  • GSK Investigational Site - Birmingham
  • GSK Investigational Site - Scottsboro

Connecticut

  • GSK Investigational Site - New Haven

Georgia

  • GSK Investigational Site - Adairsville

Maryland

  • GSK Investigational Site - Baltimore

Michigan

  • GSK Investigational Site - Ann Arbor

Trial Details

FieldValue
Enrollment Target 165 participants
Start Date 2017-09-14
Est. Completion 2019-05-15
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT03207243

The ClinicalTrials.gov registry entry for NCT03207243 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (89% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT03207243 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT03207243 about?

NCT03207243 is a clinical study titled "Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma". 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 st...

What is the current status of trial NCT03207243?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2017-09-14. Estimated completion is 2019-05-15.

What conditions does trial NCT03207243 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT03207243?

The interventions under investigation include: Placebo (DRUG), Fluticasone propionate (DRUG), GSK3772847 (DRUG), Fluticasone propionate/salmeterol (DRUG).

Who is sponsoring clinical trial NCT03207243?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03207243 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.