GB001 in Adult Subjects With Moderate to Severe Asthma



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 74
Updated:2/17/2019
Start Date:October 22, 2018
End Date:July 31, 2020
Contact:Gossamer Bio, Inc
Email:ClinicalTrials@gossamerbio.com
Phone:1 866-668-4083

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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

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.


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.

- FEV1 of 50-85% 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 SOC asthma therapy during run-in period.

Exclusion Criteria

- Current smokers

- QTcF (Fridericia) ≥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

- Pregnant or breastfeeding

- Serious co-morbidities

- Regular use of systemic corticosteroids or immunosuppressive treatments or monoclonal
antibodies for asthma

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
33
sites
221 East 23rd
Panama City, Florida 32405
850-785-6550
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Abingdon, Virginia 24210
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Birmingham, Alabama 35209
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Charlotte, North Carolina 28207
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Charlotte, North Carolina 28277
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Cincinnati, Ohio 45231
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Colorado Springs, Colorado 80909
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Corsicana, Texas 75110
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Los Angeles, CA
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Marietta, Georgia 30060
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Medford, Oregon 97504
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Minneapolis, Minnesota 55402
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Napa, California 94558
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Ocean City, New Jersey 07712
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Oklahoma City, OK
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Orangeburg, South Carolina 29118
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3604 Wathen's Crossing
Owensboro, Kentucky 42301
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Pittsburgh, Pennsylvania 15241
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Riverside, California 92506
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Antonio, Texas 78229
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Stockbridge, Georgia 30281
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Stockton, California 95207
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2713 West Virginia Avenue
Tampa, Florida 33607
(813) 873-8102
Clinical Research Trials of Florida, Inc (CRTFI) is located across of St Joseph Hospital the...
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Toronto, Ontario
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Warwick, Rhode Island 02886
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Winston-Salem, North Carolina 27157
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Wyomissing, Pennsylvania 19610
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