GSK5784283 as add-on therapy for chronic rhinosinusitis with nasal polyps

Is this trial a fit for you?

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 interventional trial evaluates the efficacy and safety of GSK5784283 as an add-on maintenance therapy for adults with CRSwNP who have a history of nasal polyps for at least 12 months. Participants will receive GSK5784283 or placebo alongside standard of care. The study includes adults with severe endoscopic nasal polyp scores and persistent CRS symptoms, and allows those with prior nasal surgery or recent systemic corticosteroid use. Primary outcomes focus on nasal polyp control and symptom relief, with safety monitoring throughout. Locations include multiple GSK investigational sites in the United States.

Why it matters

Who can join: the full rules

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
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  Louisville, Kentucky, United States Recruiting
• GSK Investigational Site
  Tulsa, Oklahoma, United States Recruiting
• GSK Investigational Site
  Spartanburg, South Carolina, United States Recruiting
• GSK Investigational Site
  Gunma, Japan Recruiting
• GSK Investigational Site
  Nagano, Japan Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

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

• Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis with Nasal Polyps

  This study tests whether metabolic and immune markers in nasal tissue and blood differ between people with nasal polyps and those without, to help understand CRSwNP and find potential diagnostic clues.

  Recruiting Harran University · Sanliurfa, Şanlıurfa · NCT07860411

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

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

  Recruiting at 4 sites Phase 3 GlaxoSmithKline · Sherman Oaks, California and 3 other locations · NCT07782957

• Triamcinolone-loaded nanocapsules after endoscopic nasal surgery

  This trial tests whether a triamcinolone acetonide–loaded nanocapsule spray is better than saline irrigation for healing after endoscopic nasal surgery in adults with chronic rhinosinusitis and nasal polyps.

  Recruiting Phase 2 Deraya University · Minya, Menia Governorate · NCT07714525

• Depemokimab monotherapy for chronic rhinosinusitis with nasal polyps in Japanese adults

  This study tests depemokimab alone (without intranasal corticosteroids) in adults with chronic rhinosinusitis with nasal polyps in Japan.

  Recruiting at 10 sites Phase 4 GlaxoSmithKline · Ehime and 9 other locations · NCT07701967

• Stopping mepolizumab or dupilumab to see if nasal polyps stay in complete remission.

  This trial will test whether adults with well-controlled nasal polyps who have been on mepolizumab or dupilumab can safely stop the biologic and remain symptom-free.

  Recruiting at 6 sites Phase 4 Copenhagen University Hospital, Rigshospitalet · Copenhagen, Region H and 5 other locations · NCT07268313

• Full-house endoscopic sinus surgery with or without nasopharyngeal lymphoid tissue ablation for nasal polyps

  This study will test whether adding nasopharyngeal lymphoid tissue ablation to full-house endoscopic sinus surgery helps adults with nasal polyps have less nasal inflammation and fewer recurrences.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07245329

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.