Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps
- Conditions
- Nasal Polyps
- Interventions
- Biological: Depemokimab (GSK3511294)Drug: Placebo
- Registration Number
- NCT05274750
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participants receiving depemokimab (GSK3511294) Depemokimab (GSK3511294) - Participants receiving placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from Baseline in total endoscopic Nasal polyps (NP) score at Week 52 (Scores on a scale) Baseline and at Week 52 NP score is graded based on NP size and recorded as the sum of the right and left nostril scores evaluated by nasal endoscopy. The total endoscopic NP score ranges between 0 (no polyps) to 8 (large polyps); higher scores indicate worse status.
Change from Baseline in mean nasal obstruction score using verbal response scale (VRS) from Weeks 49 to 52 (Scores on a scale) Baseline and from Week 49 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, 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).
- Secondary Outcome Measures
Name Time Method Change from Baseline in mean symptom score for rhinorrhea (runny nose) using VRS (Scores on a scale) Baseline and from Week 49 to Week 52 Participants will be asked to indicate the severity of rhinorrhea (runny nose) at their 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).
Change from Baseline in mean symptom score for loss of smell using VRS (Scores on a scale) Baseline and from Week 49 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, 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).
Change from Baseline in Lund Mackay (LMK) computed tomography (CT) score (Scores on a scale) Baseline and at Week 52 The LMK CT scoring system is based on CT imaging of the sinuses with points given for degree of opacification: 0=normal, 1=partial opacification, 2=total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side (right and left). The osteomeatal complex (OC) is graded as 0 = not occluded, or 2 = occluded deriving a maximum score of 12 per side. The range for the total LMK CT score is therefore 0 (normal) to 24 (total opacification) when summed across both sides.
Change from Baseline in Sino-Nasal Outcome Test (SNOT)-22 total score (Scores on a scale) Baseline and at Week 52 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 (not present/no problem) to -5 (Problem as bad as it can be). The total score range for the SNOT-22 is 0-110, where higher scores indicate greater disease impact.
Change from Baseline in mean nasal obstruction score using VRS from Weeks 21 to 24 (Scores on a scale) Baseline and from Week 21 to Week 24 Participants will be asked to indicate the severity of nasal obstruction at their 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).
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score (Scores on a scale) Baseline and at Week 52 The ACQ-5 is a 5-item questionnaire which enquires about the frequency and/or severity of asthma symptoms over the previous week (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze). Each question is scored from 0 (no impairment/limitation) to 6 (total impairment/ limitation). Higher score indicates more limitations. Impact on asthma control in participants with an ACQ-5 score greater than (\>)0.75 at Baseline will be assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523).
Percentage of participants requiring at least 1 course of systemic corticosteroids or disease-modulating medication for CRSwNP or nasal surgery (actual) during the Week 52 treatment period Up to Week 52 Percentage of participants requiring at least 1 course of systemic corticosteroids or disease-modulating medication for CRSwNP or nasal surgery (actual) during the Week 52 treatment period will be assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523).
Change from Baseline in total endoscopic NP score at Week 26 (Scores on a scale Baseline and at Week 26 NP score is graded based on NP size and recorded as the sum of the right and left nostril scores evaluated by nasal endoscopy. The total endoscopic NP score ranges between 0 (no polyps) to 8 (large polyps); higher scores indicate worse status.
Time to first nasal surgery (actual or entry on waiting list) or disease-modulating medication for Chronic rhinosinusitis with nasal polyps (CRSwNP) up to Week 52 Up to Week 52 Time to first nasal surgery (actual or entry on waiting list) or disease-modulating medication for CRSwNP will be assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523).
Time to first nasal surgery (actual) or disease-modulating medication for CRSwNP up to Week 52 Up to Week 52 Time to first nasal surgery (actual) or disease-modulating medication for CRSwNP will be assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523).
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Wigan, United Kingdom