Nasal PolypsPhase 3PERSISTCRSwNP2NCT07782957
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
A Phase 3 study testing GSK5784283 in people with Nasal Polyps, run by GlaxoSmithKline at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- GSK5784283
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 3 Sep 2026to 30 Oct 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- Where nasal surgery is contraindicated
- Nasal surgery in the past 6 months
- Asthma exacerbation in the past 4 weeks.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Greenville, South Carolina, 29607
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Plano, Texas, 75075
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Sherman Oaks, California, 91403
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Australia1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Murdoch, Western Australia, 6150
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
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)
The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
- Conditions
- Nasal Polyps
- Being tested
- GSK5784283, Placebo, Standard of Care
- Keywords
- Chronic rhinosinusitis, Chronic rhinosinusitis with nasal polyps, GSK5784283, Felcorekibart, Nasal polyps, Standard of care, Sinus disease
- Medical subject headings
- Nasal Polyps, Paranasal Sinus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK5784283Drug
GSK5784283 will be administered.
PlaceboDrug
Placebo will be administered.
Standard of CareDrug
Standard of Care (SoC) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving GSK5784283 + standard of care (SoC) | Experimental | Not described Receives: Drug: GSK5784283; Drug: Standard of Care |
| Participants receiving Placebo + SoC | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in total endoscopic nasal polyps (NP) score at 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.
Measured: Baseline and Week 52
Change from Baseline in mean nasal obstruction score using Verbal Response Scale (VRS) from Week 51 through to Week 52
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.
Measured: Baseline, Weeks 51 to 52 (time - average)
Secondary outcomes (8)
Change from Baseline in mean symptoms score for loss of smell using VRS from Week 51 through to Week 52
Participants will be asked to indicate the severity of loss of smell 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.
Measured: 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
The CRSwNP composite symptom score is used to evaluate the overall severity of symptoms in CRSwNP. The CRSwNP composite symptom score ranges from 0 (No symptoms) to 3 (Severe symptoms), higher score indicates worse overall symptom severity. The average of daily scores will be calculated, and data will be presented for Weeks 51-52.
Measured: Baseline, Weeks 51 to 52 (time - average)
Change from Baseline in Lund Mackay Computed tomography (LMK CT) score at Week 52
The Lund-Mackay CT score is a standardized radiological scoring system used to assess the severity of chronic rhinosinusitis, including CRSwNP. The LMK CT score ranges from 0 to 24 with higher scores indicating more severe sinus disease.
Measured: Baseline and Week 52
Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) total score at Week 52
SNOT-22 is a 22-item measure of disease specific quality of life (QoL) SNOT-22 items will be measured using a 6-point rating scale ranging from 0 to 5, higher score indicates worse QoL. The SNOT-22 total score ranges from 0 to 110 with higher scores indicating greater disease impact.
Measured: Baseline and Week 52
Time to first Nasal surgery decision or disease-modulating medication (DMM) or use of Systemic corticosteroid (SCS) for CRSwNP
Time to first Nasal surgery decision (actual or entry on waiting list) or DMM or use of SCS for CRSwNP (For pooled analysis across studies 300744 and 300745) will be assessed.
Measured: Up to Week 52
Time to first Nasal surgery decision or DMM
Time to first Nasal surgery decision (actual or entry on waiting list) or DMM (For pooled analysis across studies 300744 and 300745) will be assessed.
Measured: Up to Week 52
Time to first use of SCS for CRSwNP
Time to first use of SCS for CRSwNP (For pooled analysis across studies 300744 and 300745) will be assessed.
Measured: Up to Week 52
Change from Baseline in Asthma control questionnaire (5-item version) (ACQ-5) score at Week 52
The ACQ-5 is a five-item questionnaire designed to be self-completed by the participants to assess the most common asthma symptoms. The scores range from 0 to 6. Higher scores indicated more impairment/limitations. Change from Baseline in ACQ-5 score (For pooled analysis across studies 300744 and 300745) will be assessed.
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start3 Sep 2026
- Primary completion6 Mar 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782957
- Sponsor's protocol ID
- 300745
- Other IDs
- 2026-526968-21
- Acronym
- PERSISTCRSwNP2
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf