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 |
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.
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
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Mission Viejo, California 92691
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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2713 West Virginia Avenue
Tampa, Florida 33607
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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