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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Participants will receive depemokimab.
GSK Investigational Site
Ehime, Japan
RECRUITINGGSK Investigational Site
Ehime, Japan
RECRUITINGGSK Investigational Site
Fukui, Japan
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.
Time frame: At Week 52
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.
Time frame: Baseline (Day 1) and Week 52
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.
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GSK Investigational Site
Fukuoka, Japan
RECRUITINGGSK Investigational Site
Gunma, Japan
RECRUITINGGSK Investigational Site
Nagano, Japan
RECRUITINGGSK Investigational Site
Osaka, Japan
RECRUITINGGSK Investigational Site
Saitama, Japan
RECRUITINGGSK Investigational Site
Shiga, Japan
RECRUITINGGSK Investigational Site
Shizuoka, Japan
RECRUITINGTime frame: Baseline (Day 1) and from Week 49 through to Week 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.
Time frame: Baseline (Day 1) and from Week 49 through to Week 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.
Time frame: Baseline (Day 1) and from Week 49 through to Week 52
Change from baseline in Lund Mackay Computerised Tomography (CT) score
The LMK CT scoring system is based on CT imaging of the sinuses, with points to be given for the degree of opacification: 0 = normal, 1 = partial opacification, and 2 = total opacification. These points will be applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinuses on each side (right and left). The osteomeatal complex (OC) will be graded as 0 = not occluded or 2 = occluded. The range for the total LMK CT score will therefore be 0 (normal) to 24 (total opacification) when summed across both sides, with higher scores indicating more severe disease.
Time frame: Baseline (Day 1) and Week 52
Change from Baseline in Sino-nasal Outcome Test (SNOT)-22 Score
The SNOT-22 is a 22-item measure of disease-specific health-related quality of life (HRQoL). Participants will be asked to rate the severity of their condition on each of the 22 items over the previous 2 weeks using a 6-point rating scale of 0-5, including: 0 = Not present/no problem; 1 = Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; and 5 = Problem "as bad as it can be." The scores for each question will be summed to derive the total score, with the SNOT-22 total score ranging from 0 (high quality of life) to 110 (worst quality of life), where higher scores will indicate worse quality of life.
Time frame: Baseline (Day 1) and Week 52