GB001 in Adult Subjects With Moderate to Severe Asthma

• Status: Completed
• Trial end date: 2020-08-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

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.