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)

GlaxoSmithKline

Summary

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

Eligibility

Age range: 12–80 years
Sex: All
Healthy volunteers: No

Detailed 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, a…

Interventions

Drug
GSK5784283
GSK5784283 will be administered.
Drug
Placebo
Placebo will be administered.
Drug
Standard of care
Standard of care will be administered.

Location

GSK Investigational Site
Miami Lakes, Florida
GSKClinicalSupportHD@gsk.com 877-379-3718

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)

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions