NCT07782957 · GlaxoSmithKline
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
(PERSISTCRSwNP2)
What this study is about
The aim of this study is to assess the effectiveness and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
View original scientific description
The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
Interventions
DRUG
GSK5784283
GSK5784283 will be administered.
DRUG
Placebo
Placebo will be administered.
DRUG
Standard of Care
Standard of Care (SoC) will be administered.
Primary outcome measures
Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52
Time frame: Baseline and Week 52
The NP score evaluated by endoscopy ranges from 0 to 4 in each nostril, with higher score indicating worse status. The total endoscopic NP score is the sum of the right and left nostril scores and ranges from 0 to 8, higher scores indicate worse status.
Change from Baseline in mean nasal obstruction score using Verbal Response Scale (VRS) from Week 51 through to Week 52
Time frame: Baseline, Weeks 51 to 52 (time - average)
Participants will be asked to indicate the severity of nasal obstruction at their worst over the last 24 hours using a 4- point VRS ranging from 0 to 3 with higher scores indicating worse status. The average of daily scores will be calculated, and data will be presented for Weeks 51-52.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Sherman Oaks, California
- Greenville, South Carolina
- Plano, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations