A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype
Overview
- Phase
- Phase 3
- Intervention
- GSK3511294 (Depemokimab)
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 395
- Locations
- 1
- Primary Endpoint
- Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
GSK3511294
Participants received a 100 milligram (mg) dose of GSK3511294 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.
Intervention: GSK3511294 (Depemokimab)
Placebo
Participants received placebo 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.
Intervention: Placebo
Outcomes
Primary Outcomes
Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks
Time Frame: Up to Week 52
Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) \[such as intramuscular (IM), intravenous (IV) or oral\] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.
Secondary Outcomes
- Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52(Baseline (Day 1) and Week 52)
- Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52(Baseline (Day 1) and Week 52)
- Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52(Baseline (Day 1) and Week 52)
- Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52(Baseline to Week 52)
- Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52(Baseline to Week 52)
- Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks(Up to Week 52)