A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

NCT07782957 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 3007452026-526968-21
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasal Polyps

Keywords

Chronic rhinosinusitis; Chronic rhinosinusitis with nasal polyps; GSK5784283; Felcorekibart; Nasal polyps; Standard of care; Sinus disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Weeks 51 to 52 (time - average)

Secondary Outcomes (8)

• Change from Baseline in mean symptoms score for loss of smell using VRS from Week 51 through to Week 52

  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

  Baseline, Weeks 51 to 52 (time - average)

• Change from Baseline in Lund Mackay Computed tomography (LMK CT) score at Week 52

  Baseline and Week 52

• Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) total score at Week 52

  Baseline and Week 52

• Time to first Nasal surgery decision or disease-modulating medication (DMM) or use of Systemic corticosteroid (SCS) for CRSwNP

  Up to Week 52

Study Arms (2)

Participants receiving GSK5784283 + standard of care (SoC)

EXPERIMENTAL

Drug: GSK5784283; Drug: Standard of Care

Participants receiving Placebo + SoC

PLACEBO COMPARATOR

Drug: Placebo; Drug: Standard of Care

Interventions

GSK5784283 DRUG

GSK5784283 will be administered.

Participants receiving GSK5784283 + standard of care (SoC)

Placebo DRUG

Placebo will be administered.

Participants receiving Placebo + SoC

Standard of Care DRUG

Standard of Care (SoC) will be administered.

Participants receiving GSK5784283 + standard of care (SoC); Participants receiving Placebo + SoC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Nasal Polyps; Paranasal Sinus Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): March 6, 2029
• Study Completion (Estimated): October 30, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.