At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 481 enrolled
Drug / intervention
GB001 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.·interventional·Posted Sep 25, 2018·Updated Sep 16, 2021
In Brief
A Phase 2 clinical trial evaluating GB001 and Placebo for Asthma. Completed, enrolled 481 participants across 117 sites in 11 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustria, Belgium, Canada, Czechia, France, Germany, Poland, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartOct 2018
Primary CompletionJul 2020
Study CompletionAug 2020
TodayJul 2026
First PostedSep 25, 2018
Enrollment StartOct 22, 2018
Primary CompletionJul 23, 2020
Study CompletionAug 18, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.8 years ago
Interventions
GB001drug
film-coated oral tablet
Placebodrug
film-coated oral tablet