Pulmonary Disease, Chronic ObstructivePhase 3NCT07780656
A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2)
A Phase 3 study testing GSK5784283 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 8 sites in United States.
Trial summary
The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK5784283
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 624 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Sep 2026to 15 Mar 2030
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or eligible female participants.
- Participants with >=40 to less than or equal to (<=) 80 years of age.
- An eosinophilic phenotype with elevated BEC.
- Moderate to very severe COPD with frequent exacerbations.
- Participants with elevated COPD assessment test (CAT) score.
- Current or former cigarette smokers.
- On triple (Inhaled corticosteroid [ICS]+ Long-acting muscarinic antagonist [LAMA]+ Long-acting beta-agonist [LABA]) or dual inhaled COPD therapy, if ICS is considered not appropriate.
Who cannot join
- Current or prior physician diagnosis of asthma.
- Other clinically significant lung disease.
- Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
- Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.
- Continuous oxygen therapy (more than 16 hours/ day).
- Cor pulmonale resulting in right heart failure and severe pulmonary hypertension.
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- A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).
- Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.
- New York Heart Association class III or IV heart failure.
- Other significant medical conditions that could impact participants' safety or study outcomes.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
GSK Investigational Site
Cape Coral, Florida, 33991
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
Greenacres City, Florida, 33467
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
Miami, Florida, 33144
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
New York, New York, 10026
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
Rapid City, South Dakota, 57702-9208
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
Spokane, Washington, 99218
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
Tampa, Florida, 33607
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
West Point, Utah, 84015
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, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants 40 to 80 Years of Age With Moderate to Very Severe COPD (PERSIST COPD-2)
The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK5784283, Placebo, Standard of care
- Keywords
- Chronic obstructive pulmonary disease, GSK5784283, Eosinophilic phenotype, Felcorekibart, Monoclonal antibody, Thymic Stromal Lymphopoietin
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 plus standard of care | Experimental | Not described Receives: Drug: GSK5784283; Drug: Standard of care |
| Participants receiving matching placebo plus standard of care | 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.
Annualized rate of moderate or severe COPD Exacerbations
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to [>=] 24 hours) or result in death.
Measured: Up to Week 78
Secondary outcomes (5)
Change from Baseline in St. George's respiratory questionnaire (SGRQ) total score
SGRQ total score will be measured using the SGRQ for COPD (SGRQ-C). The SGRQ-C is a 14-item participant questionnaire, designed to measure health impairment by addressing the frequency of respiratory symptoms (questions 1-7) and the participant's current state (questions 8-14). The total score will be calculated on 0-100 rating scale and scores expressed as a percentage of overall impairment. Higher scores indicate greater impairment of health
Measured: Baseline (Day 1) and up to Week 52
Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)
FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometry.
Measured: Baseline (Day 1) and at Week 52
Annualized rate of COPD exacerbations requiring emergency department (ED) visit or hospitalization
Annualized rate of COPD exacerbations requiring ED visit or hospitalization (For pooled analysis across studies 300629 and 300631) will be assessed.
Measured: Up to Week 78
Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening blood eosinophil counts (BEC)
Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening BEC (For pooled analysis across studies 300629 and 300631) will be assessed.
Measured: Up to Week 78
Time to first moderate or severe COPD exacerbation
Time to first moderate or severe exacerbation (For pooled analysis across studies 300629 and 300631) will be assessed.
Measured: Up to Week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start11 Sep 2026
- Primary completion20 Jul 2029 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 624 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
- NCT07780656
- Sponsor's protocol ID
- 300631
- Other IDs
- 2026-526970-17, 2026-526970-17
- Status last verified
- Nov 2026
- First submitted
- 19 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, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants 40 to 80 Years of Age With Moderate to Very Severe COPD (PERSIST COPD-2)
- ClinicalTrials.gov ID
- NCT07780656
- Acronym / sponsor ID
- 300631
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic obstructive pulmonary disease, GSK5784283, Eosinophilic phenotype, Felcorekibart, Monoclonal antibody, Thymic Stromal Lymphopoietin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 20 Jul 2029 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 21 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 study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.
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 plus standard of care | Experimental | Drug: GSK5784283, Drug: Standard of care |
| Participants receiving matching placebo plus standard of care | Placebo comparator | Drug: Placebo, Drug: Standard of care |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or eligible female participants.
- Participants with >=40 to less than or equal to (<=) 80 years of age.
- An eosinophilic phenotype with elevated BEC.
- Moderate to very severe COPD with frequent exacerbations.
- Participants with elevated COPD assessment test (CAT) score.
Key exclusion criteria (10 listed)
- Current or prior physician diagnosis of asthma.
- Other clinically significant lung disease.
- Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
- Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.
- Continuous oxygen therapy (more than 16 hours/ day).
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 plus standard of care |
| PlaceboPlacebo will be administered. | Drug | Participants receiving matching placebo plus standard of care |
| Standard of careStandard of care will be administered. | Drug | Participants receiving GSK5784283 plus standard of care, Participants receiving matching placebo plus standard of care |
Primary outcome
Annualized rate of moderate or severe COPD Exacerbations
Time frame: Up to Week 78
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to [>=] 24 hours) or result in death.
5 secondary outcomes
Change from Baseline in St. George's respiratory questionnaire (SGRQ) total score
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)
Time frame: Baseline (Day 1) and at Week 52
Annualized rate of COPD exacerbations requiring emergency department (ED) visit or hospitalization
Time frame: Up to Week 78
Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening blood eosinophil counts (BEC)
Time frame: Up to Week 78
Time to first moderate or severe COPD exacerbation
Time frame: Up to Week 78
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 1 country: 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 Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 8 sites in United States.
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 7 inclusion and 10 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. 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?
Annualized rate of moderate or severe COPD Exacerbations (time frame: Up to Week 78). 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.