A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype
Part of paid clinical trials in Alabaster, Alabama.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT04718103
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- GSK3511294 — BIOLOGICALGSK3511294 was administered using a pre-filled syringe.
- Placebo — BIOLOGICALPlacebo was administered as normal saline using a pre-filled syringe.
Study Details
This study will assess the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive therapy in participants with severe uncontrolled asthma with an eosinophilic phenotype.
Key Dates
- Start date
- Feb 4, 2021
- Status verified
- Nov 2024
- Primary completion
- Apr 11, 2024
- Completion
- Apr 11, 2024
Study Design
- Enrollment
- 397 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: GSK3511294Participants received a 100 milligram (mg) dose of GSK3511294 subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.
- Placebo Comparator: PlaceboParticipants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.
Primary Outcome Measure
Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks [ Time Frame: Up to Week 52 ]
Locations (41)
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