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

Sponsor
GlaxoSmithKline
Study ID
NCT07780643
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • GSK5784283 — DRUG
    GSK5784283 will be administered.
  • Placebo — DRUG
    Placebo will be administered.
  • Standard of care — DRUG
    Standard of care will be administered.

Study Details

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

Key Dates

First listed
Aug 21, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Feb 15, 2029
Completion
Oct 11, 2029

Study Design

Enrollment
514 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving GSK5784283 plus standard of care
  • Placebo Comparator: Participants receiving matching placebo plus standard of care

Primary Outcome Measure

Annualized rate of clinically significant asthma exacerbations [ Time Frame: Up to Week 52 ]

Central Contacts

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