Could New Research Help People Living With Nasal Polyps?

Could New Research Help People Living With Nasal Polyps?

Advanced ENT & Allergy is participating in a clinical research study evaluating a potential new treatment for adults with chronic rhinosinusitis with nasal polyps (CRSwNP).

The study, called PERSIST CRSwNP-1, is sponsored by GlaxoSmithKline Research & Development Limited, with Kali Gerace, M.D. serving as the Primary Investigator.

The Phase 3 study is evaluating the efficacy and safety of GSK5784283 (felcorekibart) as an add-on maintenance treatment for people with chronic rhinosinusitis with nasal polyps.

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What Is Chronic Rhinosinusitis With Nasal Polyps?

Chronic rhinosinusitis is a long-term condition that causes inflammation of the nose and sinuses. Some people with chronic rhinosinusitis develop nasal polyps, which are soft, noncancerous growths that form inside the nasal passages or sinuses.

Nasal polyps can contribute to symptoms such as:

  • Nasal congestion or blockage
  • Difficulty breathing through the nose
  • Reduced or lost sense of smell
  • Runny nose or postnasal drainage
  • Facial pressure or discomfort
  • Ongoing sinus symptoms

For some people, symptoms can continue despite standard treatments and may affect sleep, daily activities, and quality of life.

About the PERSIST CRSwNP-1 Clinical Study

PERSIST CRSwNP-1 is a Phase 3 clinical study designed to evaluate the efficacy and safety of GSK5784283 (felcorekibart) in participants with chronic rhinosinusitis with nasal polyps.

The study is randomized and double-blind, meaning participants are assigned to study groups by chance and the treatment assignment is not known to participants or the study team during the blinded portion of the study.

Participants will receive either GSK5784283 or placebo, along with standard of care. Researchers will evaluate how participants' nasal polyps and other aspects of their condition change during the study.

The primary outcome includes evaluating changes in the total endoscopic nasal polyp score at Week 52. Researchers will also evaluate other measures related to nasal polyps, treatment needs, and symptoms.

What Is GSK5784283 (Felcorekibart)?

GSK5784283, also known as felcorekibart, is the study medication being evaluated in PERSIST CRSwNP-1.

Because this is a clinical study, researchers are evaluating its efficacy and safety in people with chronic rhinosinusitis with nasal polyps. Participation does not guarantee that the study medication will improve symptoms or provide a personal health benefit.

What Does Participation Involve?

People who participate in the PERSIST CRSwNP-1 study will have regular visits and assessments as part of the clinical research process.

The study team will explain the schedule of visits, study procedures, treatment options, and any potential risks and benefits before participation.

The study is expected to follow participants for approximately one year for the primary outcome assessments, with the overall study expected to continue through 2029.

Your study team can provide more information about what participation would involve and answer questions about the study.

Who May Qualify?

The PERSIST CRSwNP-1 study is designed for adults with chronic rhinosinusitis with nasal polyps.

Clinical studies have specific eligibility requirements, which may include factors related to age, medical history, nasal polyps, previous treatments, and other aspects of your health.

Not everyone who is interested will qualify. The study team will review the eligibility requirements with you and determine whether you may be eligible to participate.

Learn More About the PERSIST CRSwNP-1 Study

If you are living with chronic rhinosinusitis with nasal polyps and are interested in learning more about clinical research, the study team at Advanced ENT & Allergy can provide additional information about PERSIST CRSwNP-1.

Review the study information to learn more about the research, what participation involves, and whether you may qualify.

Interested in Learning More?

If you have chronic rhinosinusitis with nasal polyps and are interested in learning more about the PERSIST CRSwNP-1 study, talk with the study team at Advanced ENT & Allergy.

Primary Investigator:
Kali Gerace, M.D.

Study Sponsor:
GlaxoSmithKline Research & Development Limited

Study Coordinator:
Rhonda Dase
Advanced ENT & Allergy
(502) 399-1885 x 80071
rdase@advancedentandallergy.com 


Study:
A Randomized, Double-blind, Parallel Group Phase 3 Study to Assess the Efficacy and Safety of GSK5784283 (felcorekibart) in Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) (PERSIST CRSwNP-1)

Participation is voluntary, and eligibility will be determined by the study team.

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