The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
18 years of age and older
Male or eligible female participants
Physician-diagnosed CRSwNP for greater than or equals to (>=) 12 months before screening.
Any documented history of Nasal surgery for the removal of NP (or contraindications/intolerance to Nasal surgery)
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
Parallel
GSK5784283
DrugGSK5784283 will be administered.
Placebo
DrugPlacebo will be administered.
Standard of Care
DrugStandard of Care will be administered.
Change from Baseline in total endoscopic nasal polyps (NP) score at 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
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.
Change from Baseline in mean symptom score for loss of smell using VRS from Week 51 through to Week 52
Participants will be asked to indicate the severity of loss of smell 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.
Change from Baseline in the mean CRSwNP composite symptom score (average of symptom VRS scores for nasal obstruction, rhinorrhea [runny nose], loss of smell, and mucus in throat) from Week 51 through to Week 52
The CRSwNP composite symptom score is used to evaluate the overall severity of symptoms in CRSwNP. The CRSwNP composite symptom score ranges from 0 (No symptoms) to 3 (Severe symptoms), higher score indicates worse overall symptom severity. The average of daily scores will be calculated, and data will be presented for Weeks 51-52.
Change from Baseline in Lund Mackay Computed tomography (LMK CT) score at Week 52
The Lund-Mackay CT score is a standardized radiological scoring system used to assess the severity of chronic rhinosinusitis, including CRSwNP. The LMK CT score ranges from 0 to 24 with higher scores indicating more severe sinus disease.
Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) total score at Week 52
SNOT-22 is a 22-item measure of disease specific quality of life (QoL). SNOT-22 items will be measured using a 6-point rating scale ranging from 0 to 5, higher score indicates worse QoL. The SNOT-22 total score ranges from 0 to 110 with higher scores indicating greater disease impact.
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