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Recruiting Phase 3

A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

NCT07782970 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-09-28
Last updated
2026-10-14

Condition(s) studied

Nasal Polyps

Investigational drug(s) / intervention(s)

GSK5784283 →PlaceboStandard of Care

GSK5784283: GSK5784283 will be administered.

Placebo: Placebo will be administered.

Standard of Care: Standard of Care will be administered.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 years of age and older * Male or eligible female participants * Physician-diagnosed CRSwNP for greater than or equals to (\>=) 12 months before screening. * Have had at least one of the following at Visit 1: * Any documented history of Nasal surgery for the removal of NP (or contraindications/intolerance to Nasal surgery) * Have used at least 3 consecutive days of Systemic corticosteroid (SCS) or 1 intramuscular depot injectable dose (or contraindications/intolerance to SCS) in the previous 12 months (but not in the past 3 months before screening) for the treatment of NP. * Endoscopic bilateral NP score consistent with severe CRSwNP assessed by the investigator. * Symptoms of Chronic rhinosinusitis (CRS) * Presence of symptoms of CRS for at least 12 weeks prior to Visit 1 such as rhinorrhea and/or reduction or loss of smell and * Moderate to severe nasal congestion/blockade/obstruction at Visit 1 based on clinical assessment by the investigator. * Participants must have an elevated SNOT-22 score at screening. * Participants must be on daily treatment with intranasal corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at least the 8 weeks prior to screening. Exclusion Criteria: * As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study. * Have the following conditions:- Cystic fibrosis, Antrochoanal polyps, Nasal cavity tumor (malignant or benign), Fungal rhinosinusitis, Rhinitis medicamentosa, Hyper-eosinophilic syndrome (HES) Eosinophilic granulomatosis with polyangiitis (EGPA) or Churg-Strauss Syndrome or eosinophilic esophagitis, Helminth parasitic infection in the past 6 months unless treated and have responded to therapy. * Female who are pregnant * Known substance or alcohol abuse * Current smokers (including e-cigarettes) or ex-smokers of 6 months or less * Other significant medical conditions (eg immunogenicity, Human immunodeficiency virus \[HIV\], viral hepatitis, tuberculosis \[TB\], cardiac and liver disease) that could impact participants' safety or study outcomes. * Where nasal surgery is contraindicated * Nasal surgery in the past 6 months * Asthma exacerbation in the past 4 weeks.

Primary outcome measure(s)

  • Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52 — Baseline and Week 52
    The NP score evaluated by endoscopy ranges from 0 to 4 in each nostril, with higher score indicating worse status. The total endoscopic NP score is the sum of the right and left nostril scores and ranges from 0 to 8, higher scores indicate worse status.
  • Change from Baseline in mean nasal obstruction score using Verbal Response Scale (VRS) from Week 51 through to Week 52 — Baseline, Weeks 51 to 52 (time - average)
    Participants will be asked to indicate the severity of nasal obstruction at their worst over the last 24 hours using a 4-point VRS ranging from 0 to 3 with higher scores indicating worse status. The average of daily scores will be calculated, and data will be presented for Weeks 51-52.

Trial sites (3)

FacilityCityRegionStatus
GSK Investigational Site Los Angeles California Recruiting
GSK Investigational Site Tulsa Oklahoma Recruiting
GSK Investigational Site San Juan Puerto Rico Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07782970 on ClinicalTrials.gov ↗ ← All trials in the USA