The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
218
GSK5784283 will be administered.
Placebo will be administered.
Standard of Care (SoC) will be administered.
GSK Investigational Site
Plano, Texas, United States
RECRUITINGChange 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.
Time frame: Baseline and Week 52
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.
Time frame: Baseline, Weeks 51 to 52 (time - average)
Change from Baseline in mean symptoms 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.
Time frame: Baseline, Weeks 51 to 52 (time - average)
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.
Time frame: Baseline, Weeks 51 to 52 (time - average)
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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.
Time frame: Baseline and Week 52
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.
Time frame: Baseline and Week 52
Time to first Nasal surgery decision or disease-modulating medication (DMM) or use of Systemic corticosteroid (SCS) for CRSwNP
Time to first Nasal surgery decision (actual or entry on waiting list) or DMM or use of SCS for CRSwNP (For pooled analysis across studies 300744 and 300745) will be assessed.
Time frame: Up to Week 52
Time to first Nasal surgery decision or DMM
Time to first Nasal surgery decision (actual or entry on waiting list) or DMM (For pooled analysis across studies 300744 and 300745) will be assessed.
Time frame: Up to Week 52
Time to first use of SCS for CRSwNP
Time to first use of SCS for CRSwNP (For pooled analysis across studies 300744 and 300745) will be assessed.
Time frame: Up to Week 52
Change from Baseline in Asthma control questionnaire (5-item version) (ACQ-5) score at Week 52
The ACQ-5 is a five-item questionnaire designed to be self-completed by the participants to assess the most common asthma symptoms. The scores range from 0 to 6. Higher scores indicated more impairment/limitations. Change from Baseline in ACQ-5 score (For pooled analysis across studies 300744 and 300745) will be assessed.
Time frame: Baseline and Week 52