A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Standard of Care: Standard of Care (SoC) 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.
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.
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