GB001 in Adult Subjects With Moderate to Severe Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT03683576

Run by

GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

People needed

481

Starts

2018-10-22

Expected to finish

2020-08-18

Last updated by the study team

2021-09-16

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Banner University of Arizona Medical Center — Tucson, Arizona, United States
• California Allergy and Asthma Medical Group — Los Angeles, California, United States
• Southern California Institute for Respiratory Diseases, Inc. — Los Angeles, California, United States
• North Bay Clinical Trials, Inc — Napa, California, United States
• Allergy, Asthma & Sinus Consultants, Inc — Riverside, California, United States
• Integrated Research of Inland, Inc. — Riverside, California, United States
• Allergy & Asthma Medical Group and Research Center, A P.C. — San Diego, California, United States
• Allergy and Asthma Associates of Santa Clara Valley Research Center — San Jose, California, United States
• Bensch Clinical Research LLC — Stockton, California, United States
• Pulmonary Associates — Colorado Springs, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Central Florida Pulmonary Group, PA — Altamonte Springs, Florida, United States
• Central Florida Pulmonary Group, PA — Orlando, Florida, United States
• Emerald Coast Research Associates — Panama City, Florida, United States
• Allergy and Asthma Diagnostic Treatment Center — Tallahassee, Florida, United States
• Clinical Research Trials of Florida, Inc. — Tampa, Florida, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Atlanta Allergy & Asthma Clinic, PA, — Marietta, Georgia, United States
• Atlanta Allergy & Asthma Clinic, PA — Stockbridge, Georgia, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Allergy & Asthma Specialists, PSC — Owensboro, Kentucky, United States
• John Hopkins Asthma and Allergy Center — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Clinical Research Center of Albama, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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