Asthma study: GSK5784283
Official title A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-2)
ClinicalTrials.gov ID: NCT07782996
What this study is testing
What is GSK5784283?
an investigational medicine being studied as a potential treatment for asthma
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether GSK5784283 (a new medicine) works better than a pretend treatment at lowering asthma attacks.
- Who it's for
- You may be able to join if you have asthma that is not well controlled with current medicines.
- What's involved
- You would take the study medicine or a pretend pill each day. You will visit the clinic for check‑ups and answer questions.
- Time commitment
- The study lasts about a year with several clinic visits.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 80
You may be able to join if
- Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent...
- Participants aged 12 to 80 years at the time of signing the informed consent.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: i.
- A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local...
- If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
You likely can't join if
- Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the...
- History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine...
- 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.
See the full eligibility 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...
- Participants aged 12 to 80 years at the time of signing the informed consent.
- 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.
- 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.
- 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...
- Uncontrolled asthma based on ACQ-5 score.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Tampa, Florida, United States
- Southfield, Michigan, United States
- Albuquerque, New Mexico, United States
- DuBois, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Humble, Texas, United States
- Tomball, Texas, United States
- Gifu, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; Miami, Florida, United States; Miami Lakes, Florida, United States; Tampa, Florida, United States; Southfield, Michigan, United States; Albuquerque, New Mexico, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.