GB001 in Adult Subjects With Moderate to Severe Asthma
- Registration Number
- NCT03683576
- Lead Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 481
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo once per day (QD) for 24 weeks GB001 40 mg GB001 GB001 40 mg QD for 24 weeks GB001 60 mg GB001 GB001 60 mg QD for 24 weeks GB001 20 mg GB001 GB001 20 mg QD for 24 weeks
- Primary Outcome Measures
Name Time Method Proportion of Participants Who Experience Worsening of Asthma by Week 24 up to Week 24 Proportion of participants who experience worsening of asthma by Week 24 as defined by at least 1 of the following:
* On 2 consecutive days, morning (AM) peak expiratory flow (PEF) ≤ 75% of mean AM PEF measured over the last 7 days of the Run-in
* Forced expiratory volume in 1 second (FEV1) \< 80% of baseline
* Increase in rescue medication use of ≥ 6 puffs/day on 2 consecutive days compared to mean use over the last 7 days of the Run-in
* Increase in Asthma Control Questionnaire 5 (ACQ-5; see Outcome Measure 2 for description) score of ≥ 0.5 compared to baseline
* The occurrence of a severe asthma exacerbation (asthma attack) defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF) Baseline, Week 24 AM PEF was measured by participants using an electronic diary.
Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score Baseline, Week 24 The ACQ-5 is a 5-item questionnaire which has been developed as a measure of the participant's asthma control that can be quickly and easily completed. The questions are designed to be self-completed by the participant. The 5 questions enquire about the frequency and/or severity of symptoms in the prior week (nocturnal awakening, activity limitation, shortness of breath, wheeze). The response options for each of these questions consists of a zero (no impairment/limitation) to 6 (total impairment/limitation) scale.
Annualized Rate of Severe Asthma Exacerbations up to Week 24 A severe asthma exacerbation is defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.
Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Baseline, Week 24 Pre-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Time to First Asthma Worsening up to Week 24 Time to first asthma worsening is defined as the time from the date of the first dose of study treatment to the first date that any of the components of asthma worsening endpoint is met. See Outcome Measure 1 for the definition of asthma worsening.
Change From Baseline to Week 24 in Post-Bronchodilator FEV1 Baseline, Week 24 Post-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Percentage of Participants With a Treatment-Emergent Adverse Event (AE) From first dose of study treatment through Week 28 An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to study treatment. Abnormal laboratory test results or other safety assessments, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator were to be reported as AEs.
Trial Locations
- Locations (115)
Clinical Research Center of Albama, LLC
🇺🇸Birmingham, Alabama, United States
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
Scroll for more (105 remaining)Clinical Research Center of Albama, LLC🇺🇸Birmingham, Alabama, United States