GB001 in Adult Subjects With Moderate to Severe Asthma

Gossamer Bio

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: GB001

Study type: Interventional

Funder types: Industry

Identifiers

NCT03683576

GB001-2001

Details and patient eligibility

About

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.

Enrollment: 481 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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481 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo once per day (QD) for 24 weeks

Treatment:

Drug: Placebo

GB001 20 mg

Experimental group

Description:

GB001 20 mg QD for 24 weeks

Treatment:

Drug: GB001

GB001 40 mg

Experimental group

Description:

GB001 40 mg QD for 24 weeks

Treatment:

Drug: GB001

GB001 60 mg

Experimental group

Description:

GB001 60 mg QD for 24 weeks

Treatment:

Drug: GB001