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

ConditionAsthma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-80
SponsorGlaxoSmithKline

About this trial

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

Eligibility criteria

Qualifiers

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.

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • GSK5784283
  • Placebo
  • Standard of care

Treatment groups

514 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators