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Taking people in United StatesPhase 3

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

Key facts

Who runs it
GlaxoSmithKline
Where
Greenville, Plano, and Sherman Oaks, United StatesSee the 3 sitesAlso in 1 other country, 1 site
Status
Recruiting
Phase
Phase 3
People taking part
218 people, planned
Started
3 Sept 2026
Expected to end
30 Oct 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • GSK5784283
  • Placebo
  • Standard of Care
Record updated
9 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Where nasal surgery is contraindicated
  • Nasal surgery in the past 6 months
  • 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
  • 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
  • As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study
  • Female who are pregnant
  • Known substance or alcohol abuse
  • Current smokers (including e-cigarettes) or ex-smokers of 6 months or less
  • Asthma exacerbation in the past 4 weeks

Where in United States

Also in 1 other country, 1 site

  • Greenville, South CarolinaHospital not named in the registryContact: Carole Mercer (principal investigator)Taking people
  • Plano, TexasHospital not named in the registryContact: Arun Badi (principal investigator)Taking people
  • Sherman Oaks, CaliforniaHospital not named in the registryContact: Ashkan Naraghi (principal investigator)Taking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Participants receiving GSK5784283 + standard of care (SoC)Treatment being tested

    Treatment: GSK5784283 and Standard of Care

  • Participants receiving Placebo + SoCPlacebo, for comparison

    Treatment: Placebo and Standard of Care

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Double-blind, Parallel Group Phase 3 Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) (PERSIST CRSwNP-2)
Record updated
9 October 2026