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Clinical trial Recruiting at 4 sites Phase 3 Interventional Ages 18 and up

GSK5784283 as add-on maintenance therapy for nasal polyps in chronic rhinosinusitis

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)

Run by GlaxoSmithKline · NCT07782957 · Data updated 2026-11-12

This study tests whether adding GSK5784283 (Felcorekibart) to standard care helps people with chronic rhinosinusitis with nasal polyps.

More Nasal Polyps trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment218 (estimated)
SponsorGlaxoSmithKline
Industry-sponsored
Locations4 sites (Sherman Oaks, California and 3 other locations)
StatusRecruiting
StartedSeptember 3, 2026
Main results expectedMarch 6, 2029
Study endsOctober 30, 2029
Registry record updatedOctober 9, 2026
Trial IDNCT07782957 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years and older with physician-diagnosed CRSwNP for at least 12 months, with severe nasal polyps and a history of nasal surgery or systemic steroid use, and persistent CRS symptoms.

Probably not a fit

Patients who do not respond to the add-on therapy or who experience intolerable side effects may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial evaluates the efficacy and safety of GSK5784283 as an add-on maintenance therapy for adults with chronic rhinosinusitis with nasal polyps. Participants are randomized to receive either GSK5784283 or placebo along with standard of care. The study targets those with a history of nasal polyps, prior nasal surgery or systemic steroid use, and active nasal symptoms. Outcomes focus on nasal polyp status and symptom control, with safety monitoring as a key component. Locations include investigational sites in California, South Carolina, and Texas under GlaxoSmithKline as lead sponsor.

Why it matters

Potential benefit: If successful, participants may experience improved nasal symptoms and reduced nasal polyps when using GSK5784283.

How similar studies have gone: Previous studies in similar pathways have shown potential benefits; this trial represents a targeted approach in this patient population.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • GSK Investigational Site
    Sherman Oaks, California, United States     Recruiting
  • GSK Investigational Site
    Greenville, South Carolina, United States     Recruiting
  • GSK Investigational Site
    Plano, Texas, United States     Recruiting
  • GSK Investigational Site
    Murdoch, Western Australia, Australia     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.