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

Part of paid clinical trials in Plano, Texas.

Sponsor
GlaxoSmithKline
Study ID
NCT07782957
Phase
PHASE3
Status
Recruiting

Conditions

  • Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GSK5784283 — DRUG
    GSK5784283 will be administered.
  • Placebo — DRUG
    Placebo will be administered.
  • Standard of Care — DRUG
    Standard of Care (SoC) will be administered.

Study Details

The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 3, 2026
Status verified
Sep 2026
Primary completion
Mar 6, 2029
Completion
Oct 30, 2029

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving GSK5784283 + standard of care (SoC)
  • Placebo Comparator: Participants receiving Placebo + SoC

Primary Outcome Measure

Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52 [ Time Frame: Baseline and Week 52 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SitePlanoTexas75075
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Arun Badi (PRINCIPAL_INVESTIGATOR)

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