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

Conditions: Asthma

Sex: All

Ages: 12 Years – 80 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 514

Sponsor: GlaxoSmithKline

Location: GSK Investigational Site Miami Lakes Florida

Summary

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

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 (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07780643). StuddyBuddy aggregates publicly available trial information.