Last updated: 08/20/2026 04:31:03
A study to assess the efficacy and safety of GSK5784283 (felcorekibart) compared with placebo in participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)PERSISTCRSwNP2
GSK study ID
300745
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Trial status
Not yet recruiting
Not yet recruiting
Trial overview
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)
Trial 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in mean nasal obstruction score using Verbal Response Scale (VRS) from Week 51 through to Week 52
Timeframe: Baseline, Weeks 51 to 52 (time - average)
Secondary outcomes:
Change from Baseline in mean symptoms score for loss of smell using VRS from Week 51 through to Week 52
Timeframe: Baseline, Weeks 51 to 52 (time - average)
Change from Baseline in the mean CRSwNP composite symptom score (average of symptom VRS scores for nasal obstruction, rhinorrhea [runny nose], loss of smell, and mucus in throat) from Week 51 through to Week 52
Timeframe: Baseline, Weeks 51 to 52 (time - average)
Change from Baseline in Lund Mackay Computed tomography (LMK CT) score at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) total score at Week 52
Timeframe: Baseline and Week 52
Time to first Nasal surgery decision or disease-modulating medication (DMM) or use of Systemic corticosteroid (SCS) for CRSwNP
Timeframe: Up to Week 52
Time to first Nasal surgery decision or DMM
Timeframe: Up to Week 52
Time to first use of SCS for CRSwNP
Timeframe: Up to Week 52
Change from Baseline in Asthma control questionnaire (5-item version) (ACQ-5) score at Week 52
Timeframe: Baseline and Week 52
Interventions:
Drug: GSK5784283
Drug: Placebo
Drug: Standard of Care
Enrollment:
218
Observational study model:
Not applicable
Primary completion date:
2029-06-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Nasal Polyps
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2026 to October 2029
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 18 years of age and older
- Male or eligible female participants
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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: o Any documented history of Nasal surgery for the removal of NP (or contraindications/intolerance to Nasal surgery) o 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) o 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 o 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.
18 years of age and older
Exclusion criteria:
- 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.
As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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