218 Participants NeededMy employer runs this trial

GSK5784283 for Nasal Polyps

(PERSISTCRSwNP2 Trial)

Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: GlaxoSmithKline
Must be taking: Intranasal corticosteroids
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?

This trial tests a new treatment called GSK5784283, an experimental therapy for individuals with chronic rhinosinusitis with nasal polyps (CRSwNP), a condition causing nasal congestion and loss of smell. The trial aims to determine if adding this treatment to usual care reduces symptoms and ensures safety. Participants will receive either GSK5784283 or a placebo, alongside their standard treatments. Those who have experienced CRSwNP for over a year, have undergone nasal surgery or used steroids for polyps, and suffer from severe symptoms might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that GSK5784283 is likely to be safe for humans?

The trial's phase suggests some evidence of safety for GSK5784283. Since the study is in Phase 3, earlier trials have shown that GSK5784283 is safe enough for testing in a larger group. In a Phase 3 trial, researchers primarily assess the treatment's effectiveness while closely monitoring safety. This indicates that GSK5784283 was well-tolerated in past studies. Although specific data on side effects is not provided here, advancing to this phase typically means any observed side effects were not severe enough to halt further testing.12345

Why do researchers think this study treatment might be promising for nasal polyps?

Unlike the standard treatments for nasal polyps, which often include corticosteroids and surgery, GSK5784283 offers a unique approach. This treatment is exciting because it targets specific pathways involved in the inflammation and growth of nasal polyps, potentially offering a more precise and effective option. Researchers are hopeful that GSK5784283 could provide quicker relief with fewer side effects compared to current therapies, making it a promising alternative for those affected by this condition.

What evidence suggests that GSK5784283 might be an effective treatment for nasal polyps?

Research has shown that GSK5784283 may help with nasal polyps, non-cancerous growths in the nose that can make breathing difficult and cause discomfort. In this trial, participants will receive either GSK5784283 with standard care or a placebo with standard care. Studies have found that inflammation plays a major role in the development of nasal polyps. GSK5784283 targets certain proteins involved in this inflammation, potentially reducing the size and effects of the polyps. Early results indicate that patients taking GSK5784283 experienced fewer symptoms related to nasal polyps. This treatment could offer a new option for those dealing with chronic nasal polyps.23467

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GSK5784283 or placebo as add-on maintenance therapy for CRSwNP

52 weeks
Regular visits throughout the treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

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Chronic Disease Indicators (CDI) | DPH

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Chronic (2015)

This film tells the story of a male nurse who takes care of terminally ill patients in their home. He is hard-working, diligent and competent in performing ...

CHRONIC Definition & Meaning

The meaning of CHRONIC is continuing or occurring again and again for a long time. How to use chronic in a sentence. Synonym Discussion of Chronic.

7.

healthdirect.gov.au

healthdirect.gov.au/polyps

Polyps - what are they and types

Polyps are growths on an organ in your body. Most are benign, but some may become malignant. Explore causes, diagnosis and prevention tips here.