Nasal PolypsPhase 3PERSISTCRSwNP1NCT07782970
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
A Phase 3 study testing GSK5784283 in people with Nasal Polyps, run by GlaxoSmithKline at 8 sites in 3 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
- 8 sitesin 3 countries
- Study dates
- 28 Sep 2026to 30 Oct 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Los Angeles, California, 90006
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
Louisville, Kentucky, 40220
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
Spartanburg, South Carolina, 29303
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
Tulsa, Oklahoma, 74137
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
Japan3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Gunma, 373-8585
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
Nagano, 392-8510
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
Nagano, 395-8505
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
Puerto Rico1 site, 1 recruiting
- Recruiting
GSK Investigational Site
San Juan, 00907
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-1)
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 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 symptom 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 start28 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
- NCT07782970
- Sponsor's protocol ID
- 300744
- Other IDs
- 2026-526966-25
- Acronym
- PERSISTCRSwNP1
- Status last verified
- Nov 2026
- First submitted
- 20 Aug 2026
- Last updated
- 5 Nov 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-1)
- ClinicalTrials.gov ID
- NCT07782970
- Acronym / sponsor ID
- PERSISTCRSwNP1 / 300744
- Conditions
- Nasal Polyps
- Keywords
- Chronic rhinosinusitis, Chronic rhinosinusitis with nasal polyps, GSK5784283, Felcorekibart, Nasal polyps, Standard of care, Sinus disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 6 Mar 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving GSK5784283 + standard of care (SoC) | Experimental | Drug: GSK5784283, Drug: Standard of Care |
| Participants receiving Placebo + SoC | Placebo comparator | Drug: Placebo, Drug: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Endoscopic bilateral NP score consistent with severe CRSwNP assessed by the investigator.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK5784283GSK5784283 will be administered. | Drug | Participants receiving GSK5784283 + standard of care (SoC) |
| PlaceboPlacebo will be administered. | Drug | Participants receiving Placebo + SoC |
| Standard of CareStandard of Care will be administered. | Drug | Participants receiving GSK5784283 + standard of care (SoC), Participants receiving Placebo + SoC |
Primary outcome
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.
8 secondary outcomes
Change from Baseline in mean symptom score for loss of smell using VRS from Week 51 through to Week 52
Time frame: 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
Time frame: Baseline, Weeks 51 to 52 (time - average)
Change from Baseline in Lund Mackay Computed tomography (LMK CT) score at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) total score at Week 52
Time frame: Baseline and Week 52
Time to first Nasal surgery decision or disease-modulating medication (DMM) or use of Systemic corticosteroid (SCS) for CRSwNP
Time frame: Up to Week 52
Time to first Nasal surgery decision or DMM
Time frame: Up to Week 52
Time to first use of SCS for CRSwNP
Time frame: Up to Week 52
Change from Baseline in Asthma control questionnaire (5-item version) (ACQ-5) score at Week 52
Time frame: Baseline and Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GSK Clinical Trials study director
GlaxoSmithKline
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK5784283 in people with Nasal Polyps, run by GlaxoSmithKline at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Japan, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52 (time frame: Baseline and Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.