AsthmaPhase 3NCT07780643
A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1)
A Phase 3 study testing GSK5784283 in people with Asthma, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- GSK5784283
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 514 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2026to 11 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF). For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR).
- Participants aged 12 to 80 years at the time of signing the informed consent.
- Male or eligible female participants:
- Female participants:
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Is a Participant of non-childbearing potential (PONCBP) or ii. Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<) 1 percent (%), 28 days prior to the first dose of the study drug, and during the study intervention period and follow-up period for at least 60 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.
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- A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention.
- If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials.
- A documented physician diagnosis of asthma for at least 12 months prior to Visit 1, according to the Global Initiative for Asthma (GINA) 2026 guidelines.
- Evidence of variable airflow obstruction consistent with asthma.
- Documented history of asthma exacerbation within 12 months prior to Visit 1.
- A well-documented requirement for regular treatment with medium or high dose Inhaled corticosteroid (ICS) for at least 3 months prior to screening with or without maintenance oral corticosteroids (OCS).
- At least 1 additional maintenance asthma controller medication is required according to standard practice of care (e.g., Long-acting beta-2 agonist [LABA], Leukotriene receptor antagonists [LTRA], theophylline, Long-acting muscarinic agonists [LAMA], chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to screening.
- Uncontrolled asthma based on ACQ-5 score.
Who cannot join
- Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results.
- 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 (NYHA) class III or IV heart failure.
- Other significant medical conditions that could impact participants' safety or study outcomes.
- History of an unresolved clinically significant infection within 30 days prior to Visit 1.
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- A known immunodeficiency, other than that explained by the use of corticosteroids taken as therapy for asthma.
- Receipt of any marketed or investigational biologic agent or investigational non-biologic agent, prior to Visit 1.
- Use of systemic immunosuppressive medication within 3 months prior to Visit 1 (other than systemic corticosteroid burst or stable maintenance OCS for treatment of asthma).
- Current smokers (tobacco and/or marijuana), current users of vaping products/electronic-cigarettes or participants with a smoking history >=10 pack-years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Miami Lakes, Florida, 33014-2479
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 Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GSK5784283 (Felcorekibart) as an Add-On Therapy in Adults and Adolescents With Uncontrolled Asthma (PERSIST ASTHMA-1)
The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.
- Conditions
- Asthma
- Being tested
- GSK5784283, Placebo, Standard of care
- Keywords
- Asthma, Felcorekibart, GSK5784283, Placebo, Standard of care
- Medical subject headings
- Asthma
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 clinically significant asthma exacerbations
A clinically significant exacerbation is defined as a worsening of asthma symptoms requiring the use of systemic corticosteroids or in-patient hospitalization (that is greater than or equal to [>=] 24 hours) due to asthma.
Measured: Up to Week 52
Secondary outcomes (5)
Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)
FEV1 is defined as the volume of air that can be forced out in first second after taking a deep breath by a person and will be measured by spirometry.
Measured: Baseline and at Week 52
Time to first clinically significant asthma exacerbation
Measured: Up to Week 52
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score
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.
Measured: Baseline and at Week 52
Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) score
The AQLQ is a 32-item self-administered questionnaire designed to measure the impact of asthma on participants daily life. The score ranges from 1.0 to 7.0. Higher scores indicate better quality of life (QoL).
Measured: Baseline and at Week 52
Annualized rate of clinically significant exacerbations requiring emergency department (EmD) visit or hospitalization
Annualized rate of exacerbations requiring EmD visit or hospitalization (For pooled analysis across studies 300742 and 300743) will be assessed.
Measured: Up to Week 52
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 start27 Aug 2026
- Primary completion15 Feb 2029 (estimated)
- Study completion11 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 514 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
- NCT07780643
- Sponsor's protocol ID
- 300742
- Other IDs
- 2026-526964-19
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 25 Sep 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GSK5784283 (Felcorekibart) as an Add-On Therapy in Adults and Adolescents With Uncontrolled Asthma (PERSIST ASTHMA-1)
- ClinicalTrials.gov ID
- NCT07780643
- Acronym / sponsor ID
- 300742
- Conditions
- Asthma
- Keywords
- Asthma, Felcorekibart, GSK5784283, Placebo, Standard of care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 514 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- 15 Feb 2029 (estimated)
- Study completion
- 11 Oct 2029 (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 aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma 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
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF). For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR).
- Participants aged 12 to 80 years at the time of signing the informed consent.
- Male or eligible female participants:
- A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention.
- If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Key exclusion criteria (10 listed)
- Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results.
- 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 (NYHA) class III or IV heart failure.
- Other significant medical conditions that could impact participants' safety or study outcomes.
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 clinically significant asthma exacerbations
Time frame: Up to Week 52
A clinically significant exacerbation is defined as a worsening of asthma symptoms requiring the use of systemic corticosteroids or in-patient hospitalization (that is greater than or equal to [>=] 24 hours) due to asthma.
5 secondary outcomes
Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)
Time frame: Baseline and at Week 52
Time to first clinically significant asthma exacerbation
Time frame: Up to Week 52
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score
Time frame: Baseline and at Week 52
Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) score
Time frame: Baseline and at Week 52
Annualized rate of clinically significant exacerbations requiring emergency department (EmD) visit or hospitalization
Time frame: Up to 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 25 Sep 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
1 site 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 Asthma, run by GlaxoSmithKline at 1 site 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 16 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 clinically significant asthma exacerbations (time frame: Up to Week 52). 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 25 Sep 2026.