Trials / Completed
CompletedNCT03683576
GB001 in Adult Subjects With Moderate to Severe Asthma
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 481 (actual)
- Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GB001 | film-coated oral tablet |
| DRUG | Placebo | film-coated oral tablet |
Timeline
- Start date
- 2018-10-22
- Primary completion
- 2020-07-23
- Completion
- 2020-08-18
- First posted
- 2018-09-25
- Last updated
- 2021-09-16
- Results posted
- 2021-08-23
Locations
117 sites across 11 countries: United States, Austria, Belgium, Canada, Czechia, France, Germany, Poland, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03683576. Inclusion in this directory is not an endorsement.