GSK5784283 for Nasal Polyps
(PERSISTCRSwNP1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called GSK5784283 for individuals with chronic rhinosinusitis with nasal polyps (CRSwNP), which leads to ongoing nasal congestion and loss of smell. The researchers aim to determine if adding this treatment to usual care reduces symptoms and ensures safety. Participants will receive either the new treatment or a placebo, both alongside their standard care. The study seeks individuals with physician-diagnosed CRSwNP for over a year, who have undergone surgery or steroid treatments, and regularly use nasal sprays. As a Phase 3 trial, this treatment is in the final step before FDA approval, providing an opportunity to contribute to its potential availability for wider use.
Is there any evidence suggesting that GSK5784283 is likely to be safe for humans?
Research has shown that GSK5784283 targets a protein called TSLP, linked to inflammation, to treat nasal polyps. This protein may play a role in conditions like asthma and nasal polyps. Although specific safety data for GSK5784283 in nasal polyps is not yet available, the treatment is currently in Phase 3 trials. This phase typically involves many participants and aims to confirm the treatment's efficacy and safety.
GSK5784283 is similar to other treatments for inflammation in nasal polyps, such as Tezspire, which is already approved for severe asthma. Tezspire has demonstrated positive results in reducing nasal polyp size with manageable side effects. While researchers continue to study GSK5784283, these similarities may offer some reassurance about its safety in humans. However, joining a trial always involves some risks, so discussing any concerns with a healthcare provider is important.12345Why do researchers think this study treatment might be promising for nasal polyps?
Most treatments for nasal polyps, like corticosteroids and surgery, work by reducing inflammation or physically removing the polyps. However, GSK5784283 works differently, targeting the underlying causes of polyp formation. This new treatment is believed to modulate the immune response in a way that could lead to more effective and lasting results. Researchers are excited because it offers a potential new avenue for relief, especially for patients who don't respond well to existing options.
What evidence suggests that GSK5784283 might be an effective treatment for nasal polyps?
Research has shown that GSK5784283, which participants in this trial may receive, may help treat chronic rhinosinusitis with nasal polyps (CRSwNP). While not everyone experiences improvement, many report less congestion and smaller polyps. Some studies found significant improvements in patient-reported outcomes, as measured by tests like the SinoNasal Outcome Test, which assesses symptom severity. Biologic therapies, such as GSK5784283, offer a new treatment option for those with recurring polyps, especially if they've had previous surgery. Although these treatments don't work for everyone, they often provide relief for many.678910
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
This trial is for adults 18 and older with chronic rhinosinusitis with nasal polyps (CRSwNP) diagnosed by a doctor, who have had symptoms like congestion or loss of smell for at least 12 weeks, tried steroids or surgery in the past year, and currently have moderate to severe nasal blockage.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GSK5784283 or placebo as add-on maintenance therapy for CRSwNP
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GSK5784283
Trial Overview
The study tests GSK5784283 (Felcorekibart), given as an add-on maintenance treatment, compared to placebo and standard care. Participants are randomly assigned to different groups to see if the new drug helps more than current treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Citations
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
data from the clinical trials for these drugs do not show universal improvement across all patients with CRSwNP. In fact, there is a wide range of outcomes for ...
2.
pulmonologyadvisor.com
pulmonologyadvisor.com/news/tezspire-reduces-nasal-congestion-and-polyp-size-in-chronic-rhinosinusitis/Tezspire Reduces Nasal Congestion and Polyp Size in ...
Results from a phase 3 trial show that tezepelumab statistically significantly reduced the size of nasal polyps and congestion in CRSwNP.
Innovative therapeutic targets in chronic sinusitis with nasal ...
studies show high recurrence rates of nasal polyps, with about 80% of regrowth over 12 years. more than 4 surgeries. polyps shrink over 2–3 months and remain ...
Chronic Rhinosinusitis With or Without Nasal Polyps ...
This is a study to evaluate the cause of chronic sinus disease. there is no conclusive data as to whether this practice has a long term benefit. and polyps.
(PDF) Biological Treatment for Uncontrolled Chronic ...
Overall, patients had significant improvements in the 22-item SinoNasal Outcome Test (SNOT-22) scores (mean improvement of 24.3 points) and nasal polyp scores ( ...
6.
io.nihr.ac.uk
io.nihr.ac.uk/wp-content/uploads/2024/03/34870-Depemokimab-for-Nasal-Polyps-V1.0-MAR2024-NON-CONF.pdfHealth Technology Briefing March 2024
Eosinophils are involved in nasal polyp creation and patients with nasal polyps have comparatively higher levels of eosinophils in their ...
7.
prnewswire.com
prnewswire.com/news-releases/fda-approves-tezspire-for-chronic-rhinosinusitis-with-nasal-polyps-302587969.htmlFDA APPROVES TEZSPIRE® FOR CHRONIC ...
In the trial, TEZSPIRE demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity and showed near- ...
A Study of GR1802 in Participants With Chronic Sinusitis ...
Summary. The goal of this clinical trial is to learn if GR1802 works to treat severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.
9.
insights.citeline.com
insights.citeline.com/scrip/r-and-d/clinical-trials/tezspire-phase-iii-nasal-polyp-data-may-lead-to-second-indication-BLSV5TGGOBANLHUMSCJYZNPCPU/Tezspire Phase III Nasal Polyp Data May Lead To Second ...
Tezspire, already approved for severe asthma, has shown an ability to reduce the size of nasal polyps and improve congestion. of nasal polyp
10.
trial.medpath.com
trial.medpath.com/clinical-trial/4d7967b8ab20a66c/nct07424144-itepekimab-chronic-rhinosinusitis-nasal-polyps-safetyAn Extension Study to Investigate the Long-term Safety and ...
This is a double-blind, parallel-group, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment ...
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