RecruitingPhase 3

A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1)

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether GSK5784283 lowers the number of serious asthma flare-ups compared with a placebo, a treatment with no active drug. It also checks safety. It is for people ages 12 to 80 whose asthma is not well controlled.

The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 12 to 80 years old.
  • Sign a consent form and agree to follow study rules. Those ages 12 to 17 must also have consent from a legally accepted representative.
  • Have a doctor's recorded asthma diagnosis for at least 12 months, with test results showing that airflow changes because of asthma.
  • Have a recorded asthma flare-up within the past 12 months.
  • Have needed regular medium- or high-dose inhaled steroids for at least 3 months. These medicines reduce swelling in the airways.
  • Have used at least one other regular asthma control medicine for at least 3 months.
  • Have poorly controlled asthma based on the ACQ-5 asthma questionnaire.
  • Female participants must not be pregnant or breastfeeding. Those who can become pregnant must have negative pregnancy tests and use highly effective birth control from 28 days before the first dose through at least 60 weeks after the last dose.

Who can't join

  • Have another lung disease or a major medical condition that could affect safety or study results.
  • Have had cancer in the past 5 years, except fully treated non-melanoma skin cancer or very early cancer of the cervix.
  • Have had a heart attack, unstable chest pain, or stroke within 6 months; an unstable heartbeat; or severe heart failure.
  • Have a serious infection that has not cleared within 30 days before the first visit.
  • Have a known weak immune system, unless caused by steroid treatment for asthma.
  • Have received a biologic medicine, a type of treatment made from living sources, or another experimental medicine before the first visit.
  • Have used medicines that weaken the immune system throughout the body within 3 months before the first visit. Short courses or stable daily doses of oral steroids for asthma are allowed.
  • Currently smoke tobacco or marijuana, use vaping products or e-cigarettes, or have smoked at least 10 pack-years—for example, one pack a day for 10 years.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

FL