This study will evaluate the efficacy and safety of depemokimab (GSK3511294) without concomitant use of Intranasal corticosteroids (INCS) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).
18 years of age and older inclusive, at the time of signing the informed consent
Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) assessed by the investigator
Participants who have had previous nasal surgery for the removal of nasal polyps, have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of nasal polyps, or are medically unsuitable or intolerant to systemic corticosteroid
Participants presenting with severe nasal polyp symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhoea (runny nose) based on clinical assessment by the investigator
As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study
Cystic fibrosis
Antrochoanal polyps
Nasal cavity tumor (malignant or benign)
Single group
Depemokimab
Biological/VaccineParticipants will receive depemokimab.
Percentage of Participants Achieving a One-point or Greater Decrease from Baseline in Total Endoscopic Nasal Polyp (NP) Score Without First Having Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP
The total endoscopic NP score will evaluate the size and extent of nasal polyps via endoscopy. The assessments will be performed using centrally reviewed video recordings of nasal endoscopy. The right and left nostrils will be scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores will be graded based on NP size and will be recorded as the sum of the right and left nostril scores, ranging from 0 (no polyps) to 8 (large polyps), calculated by summing the scores \[0 to 4\] in each nostril, with higher scores indicating worse status.
Change from Baseline in Total Endoscopic NP Score
The total endoscopic NP score will evaluate the size and extent of nasal polyps via endoscopy. The assessments will be performed using centrally reviewed video recordings of nasal endoscopy. The right and left nostrils will be scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores will be graded based on NP size and will be recorded as the sum of the right and left nostril scores, ranging from 0 (no polyps) to 8 (large polyps), calculated by summing the scores \[0 to 4\] in each nostril, with higher scores indicating worse status.
Change from Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale (VRS)
Participants will use a VRS to rate nasal obstruction severity, with scores to be averaged over the specified period to assess treatment impact on nasal obstruction symptoms. Participants will be asked to indicate the severity of nasal obstruction at its worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This will be scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms), with higher scores indicating worse status. The average of daily scores in 4-weekly intervals will be calculated, and data will be presented for Weeks 49-52.
Change from Baseline in Mean Symptom Score for Rhinorrhoea (Runny Nose) Using VRS
Participants will be asked to indicate the severity of rhinorrhoea (runny nose) at its worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This will be scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms), with higher scores indicating worse status. The average of daily scores in 4-weekly intervals will be calculated, and data will be presented for Weeks 49-52.
Change from Baseline in Mean Symptom Score for Loss of Smell Using VRS
Participants will be asked to indicate the severity of loss of smell at its worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This will be scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms), with higher scores indicating worse status. The average of daily scores in 4-weekly intervals will be calculated, and data will be presented for Weeks 49-52.
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