Phase 2
N=480
GB001 in Adult Subjects With Moderate to Severe Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03683576 ↗Enrolled (actual)
480
Serious AEs
5.4%
Results posted
Aug 2021
Primary outcome: Primary: Proportion of Participants Who Experience Worsening of Asthma by Week 24 — 0.658; 0.567; 0.568; 0.557 proportion of participants — p=0.1425
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GB001 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Who Experience Worsening of Asthma by Week 24 |
0.658; 0.567; 0.568; 0.557 | 0.1425 |
| SECONDARY Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score |
-0.89; -1.04; -1.04; -1.08 | 0.1647 |
| SECONDARY Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) |
0.105; 0.121; 0.146; 0.180 | 0.7718 |
| SECONDARY Time to First Asthma Worsening |
10.57; 17.43; 17.57; 19.86 | 0.0466 sig |
| SECONDARY Annualized Rate of Severe Asthma Exacerbations |
0.933; 0.744; 0.698; 0.829 | 0.3382 |
| SECONDARY Change From Baseline to Week 24 in Post-Bronchodilator FEV1 |
0.012; -0.011; 0.047; 0.091 | 0.6645 |
| SECONDARY Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF) |
8.993; 15.115; 22.941; 14.581 | 0.3957 |
| SECONDARY Percentage of Participants With a Treatment-Emergent Adverse Event (AE) |
65.8; 65.8; 69.5; 68.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- A diagnosis of asthma by a physician at least 12 months before Screening Visit.
- Treated with medium or high dose inhaled corticosteroid (ICS) plus additional controller for at least 12 months prior to Screening Visit. Subjects must maintain a stable ICS dose regimen during the 4 weeks prior to the Screening Visit.
- Forced Expiratory Volume in 1 second (FEV1) of ≤ 85% of predicted normal
- Demonstrated reversibility of at least 12% in FEV1
- Evidence of uncontrolled asthma
- Eosinophilic asthma
- No changes in ICS dose and compliant with standard of care asthma therapy during run-in period.
Exclusion Criteria
- Current smokers (any substance)
- Serious co-morbidities
- Fridericia's correction QT factor (QTcF) ≥450 msec (male) or ≥470 msec (female)
- Use of other investigational drugs within 30 days, or within 5 half-lives, whichever is longer, prior to Screening Visit
- Regular use of systemic corticosteroids or immunosuppressive treatments or monoclonal antibodies for asthma
- Pregnant or breastfeeding
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03683576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.