A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
GlaxoSmithKline · NCT07782970
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 218
- US sites recruiting
- 2
- Study start
- September 28, 2026
- Record last updated
- October 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
Being studied: GSK5784283; Placebo; Standard of Care
Conditions: Nasal Polyps
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
GSK Investigational Site
Los Angeles, CA 90006
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Tulsa, OK 74137
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
Study contacts (from the official record)
- US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
- EU GSK Clinical Trials Call Center · +44 (0) 20 89904466 · GSKClinicalSupportHD@gsk.com