GSK5784283 vs placebo for uncontrolled asthma
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)
Run by GlaxoSmithKline · NCT07780643 · Data updated 2026-11-12
This study tests whether GSK5784283 reduces asthma flare-ups more than a placebo in people with uncontrolled asthma.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 80 Years |
| Sex | All |
| Enrollment | 514 (estimated) |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Locations | 1 site (Miami Lakes, Florida) |
| Status | Recruiting |
| Started | August 27, 2026 |
| Main results expected | February 15, 2029 |
| Study ends | October 11, 2029 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07780643 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Individuals aged 12 to 80 with uncontrolled asthma who can provide informed consent (and assent for minors) and who are willing to continue standard asthma care during the study.
✕Probably not a fit
Patients whose asthma does not respond to GSK5784283 or who have safety concerns may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3, randomized, controlled trial compares GSK5784283 to placebo while patients continue standard asthma care. The primary goal is to see if the drug lowers the annual rate of clinically meaningful asthma exacerbations. Participants range from 12 to 80 years old and will provide informed consent; assent is required for minors when applicable. The study is sponsored by GlaxoSmithKline with sites at GSK Investigational Site in Miami Lakes, Florida. Safety and efficacy will be monitored throughout the intervention and follow-up periods.
Why it matters
Potential benefit: If successful, participants may experience fewer asthma flare-ups and better disease control.
How similar studies have gone: Prior studies with similar agents have shown mixed results; this trial aims to provide clearer evidence for efficacy in uncontrolled asthma.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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:
i. 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.
* 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.
Exclusion Criteria:
* 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.
* 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.
Where it's running
-
GSK Investigational Site
Miami Lakes, Florida, United States Recruiting
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.