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218 Participants NeededMy employer runs this trial

GSK5784283 for Nasal Polyps

(PERSISTCRSwNP2 Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: GlaxoSmithKline
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for adults 18 and older with severe chronic rhinosinusitis with nasal polyps (CRSwNP) who have had symptoms for at least a year, significant nasal blockage, and either past sinus surgery or can't have it. Participants must also have used certain steroids in the last year but not recently.

Inclusion Criteria

Endoscopic bilateral NP score consistent with severe CRSwNP assessed by the investigator
Participants must have an elevated SNOT-22 score at screening
I have used daily intranasal steroid treatments for at least 8 weeks.
See 7 more

Exclusion Criteria

Participant considered unfit for the study by physician after medical interview, physical examination, or screening investigation
Known substance or alcohol abuse
Current smokers including e-cigarettes or ex-smokers of 6 months or less
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • GSK5784283

Trial Overview

The study compares GSK5784283 (Felcorekibart), given as an add-on treatment, to a placebo alongside standard care in people with CRSwNP. Participants are randomly assigned to receive either the new drug or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving GSK5784283 + standard of care (SoC)Experimental Treatment2 Interventions
Group II: Participants receiving Placebo + SoCPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

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Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

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