A Phase 3 interventional study of GSK5784283 and Placebo in Nasal Polyps, sponsored by GlaxoSmithKline. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's planned enrollment of 218 is above the median of 60 across 181 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have had at least one of the following at Visit 1:
Symptoms of Chronic rhinosinusitis (CRS)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: GSK5784283 · Drug: Standard of Care
Drug: Placebo · Drug: Standard of Care
GSK5784283 will be administered.
Placebo will be administered.
Standard of Care (SoC) will be administered.
Change 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)
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
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk-studyregister.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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