Nasal Polyps
Conditions
Keywords
Chronic rhinosinusitis, Chronic rhinosinusitis with nasal polyps, GSK5784283, Felcorekibart, Nasal polyps, Standard of care, Sinus disease
Brief summary
The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
Interventions
DRUGGSK5784283
GSK5784283 will be administered.
DRUGPlacebo
Placebo will be administered.
DRUGStandard of Care
Standard of Care will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This will be a double-blind study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and older * Male or eligible female participants * Physician-diagnosed CRSwNP for greater than or equals to (\>=) 12 months before screening. * Have had at least one of the following at Visit 1: * Any documented history of Nasal surgery for the removal of NP (or contraindications/intolerance to Nasal surgery) * Have used at least 3 consecutive days of Systemic corticosteroid (SCS) or 1 intramuscular depot injectable dose (or contraindications/intolerance to SCS) in the previous 12 months (but not in the past 3 months before screening) for the treatment of NP. * Endoscopic bilateral NP score consistent with severe CRSwNP assessed by the investigator. * Symptoms of Chronic rhinosinusitis (CRS) * Presence of symptoms of CRS for at least 12 weeks prior to Visit 1 such as rhinorrhea and/or reduction or loss of smell and * Moderate to severe nasal congestion/blockade/obstruction at Visit 1 based on clinical assessment by the investigator. * Participants must have an elevated SNOT-22 score at screening. * Participants must be on daily treatment with intranasal corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at least the 8 weeks prior to screening.
Exclusion criteria
* 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 * Current smokers (including e-cigarettes) or ex-smokers of 6 months or less * Other significant medical conditions (eg immunogenicity, Human immunodeficiency virus \[HIV\], viral hepatitis, tuberculosis \[TB\], cardiac and liver disease) that could impact participants' safety or study outcomes. * Where nasal surgery is contraindicated * Nasal surgery in the past 6 months * Asthma exacerbation in the past 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52 | Baseline and 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 | Baseline, Weeks 51 to 52 (time - average) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in mean symptom score for loss of smell using VRS from Week 51 through to Week 52 | Baseline, Weeks 51 to 52 (time - average) | 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 | Baseline, Weeks 51 to 52 (time - average) | 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 | Baseline and 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 | Baseline and 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 to first Nasal surgery decision or disease-modulating medication (DMM) or use of Systemic corticosteroid (SCS) for CRSwNP | Up to Week 52 | 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 to first Nasal surgery decision or DMM | Up to Week 52 | 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 to first use of SCS for CRSwNP | Up to Week 52 | Time to first use of SCS for CRSwNP (For pooled analysis across studies 300744 and 300745) will be assessed. |
| Change from Baseline in Asthma control questionnaire (5-item version) (ACQ-5) score at Week 52 | Baseline and 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. |
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed