NCT07782957 A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
| NCT ID | NCT07782957 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | GlaxoSmithKline |
| Condition | Nasal Polyps |
| Study Type | INTERVENTIONAL |
| Enrollment | 218 participants |
| Start Date | 2026-09-03 |
| Primary Completion | 2029-03-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 218 participants in total. It began in 2026-09-03 with a primary completion date of 2029-03-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
Eligibility 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.
Contact & Investigator
GSK Clinical Trials
STUDY DIRECTOR
GlaxoSmithKline
Frequently Asked Questions
Who can join the NCT07782957 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nasal Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07782957 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 218 participants.
Is NCT07782957 currently recruiting?
Yes, NCT07782957 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT07782957 trial being conducted?
This trial is being conducted at Sherman Oaks, United States, Greenville, United States, Plano, United States, Murdoch, Australia.
Who is sponsoring the NCT07782957 clinical trial?
NCT07782957 is sponsored by GlaxoSmithKline. The principal investigator is GSK Clinical Trials at GlaxoSmithKline. The trial plans to enroll 218 participants.