RecruitingAsthma
A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1)
Eligible age
12–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.
Sponsor: GlaxoSmithKline
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Florida
Miami Lakes
Source: ClinicalTrials.gov · NCT07780643 · last updated 2026-09-25