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

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)

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

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.