A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multi-center Study to Evaluate the Efficacy and Safety of GB001 as Maintenance Therapy in Adult Subjects With Moderate to Severe Asthma
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Asthma
- Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
- Enrollment
- 481
- Locations
- 115
- Primary Endpoint
- Proportion of Participants Who Experience Worsening of Asthma by Week 24
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Placebo once per day (QD) for 24 weeks
Intervention: Placebo
GB001 20 mg
GB001 20 mg QD for 24 weeks
Intervention: GB001
GB001 40 mg
GB001 40 mg QD for 24 weeks
Intervention: GB001
GB001 60 mg
GB001 60 mg QD for 24 weeks
Intervention: GB001
Outcomes
Primary Outcomes
Proportion of Participants Who Experience Worsening of Asthma by Week 24
Time Frame: up to Week 24
Proportion of participants who experience worsening of asthma by Week 24 as defined by at least 1 of the following: * On 2 consecutive days, morning (AM) peak expiratory flow (PEF) ≤ 75% of mean AM PEF measured over the last 7 days of the Run-in * Forced expiratory volume in 1 second (FEV1) \< 80% of baseline * Increase in rescue medication use of ≥ 6 puffs/day on 2 consecutive days compared to mean use over the last 7 days of the Run-in * Increase in Asthma Control Questionnaire 5 (ACQ-5; see Outcome Measure 2 for description) score of ≥ 0.5 compared to baseline * The occurrence of a severe asthma exacerbation (asthma attack) defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.
Secondary Outcomes
- Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)(Baseline, Week 24)
- Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score(Baseline, Week 24)
- Annualized Rate of Severe Asthma Exacerbations(up to Week 24)
- Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)(Baseline, Week 24)
- Time to First Asthma Worsening(up to Week 24)
- Change From Baseline to Week 24 in Post-Bronchodilator FEV1(Baseline, Week 24)
- Percentage of Participants With a Treatment-Emergent Adverse Event (AE)(From first dose of study treatment through Week 28)