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GB001 in Adult Subjects With Moderate to Severe Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683576
Recruitment Status : Completed
First Posted : September 25, 2018
Results First Posted : August 23, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Gossamer Bio Inc. ( GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. )

Tracking Information
First Submitted Date  ICMJE September 11, 2018
First Posted Date  ICMJE September 25, 2018
Results First Submitted Date  ICMJE July 23, 2021
Results First Posted Date  ICMJE August 23, 2021
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE October 22, 2018
Actual Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2021)
Proportion of Participants Who Experience Worsening of Asthma by Week 24 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
Number of participants out of the total experiencing asthma worsening as assessed by changes in peak expiratory flow, FEV1, rescue medication use, and ACQ-5 score, and the occurrence of severe asthma exacerbations. [ Time Frame: 24 weeks ]
Asthma worsening is defined as at least one of the following: peak expiratory flow less than or equal to 75 percent of baseline; forced expiratory volume in 1 second (FEV1) less than 80 percent of baseline; increase in rescue medication use of greater than or equal to 6 puffs per day compared to baseline; increase in Asthma Control Questionnaire (ACQ-5) score of greater than or equal to 0.5 compared to baseline; or the occurrence of a severe asthma exacerbation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2021)
  • Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score [ Time Frame: 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.
  • Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, Week 24 ]
    Pre-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
  • Time to First Asthma Worsening [ Time Frame: 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.
  • Annualized Rate of Severe Asthma Exacerbations [ Time Frame: 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 Post-Bronchodilator FEV1 [ Time Frame: Baseline, Week 24 ]
    Post-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
  • Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF) [ Time Frame: Baseline, Week 24 ]
    AM PEF was measured by participants using an electronic diary.
  • Percentage of Participants With a Treatment-Emergent Adverse Event (AE) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GB001 in Adult Subjects With Moderate to Severe Asthma
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: GB001
    film-coated oral tablet
  • Drug: Placebo
    film-coated oral tablet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo once per day (QD) for 24 weeks
    Intervention: Drug: Placebo
  • Experimental: GB001 20 mg
    GB001 20 mg QD for 24 weeks
    Intervention: Drug: GB001
  • Experimental: GB001 40 mg
    GB001 40 mg QD for 24 weeks
    Intervention: Drug: GB001
  • Experimental: GB001 60 mg
    GB001 60 mg QD for 24 weeks
    Intervention: Drug: GB001
Publications * Ortega H, Fitzgerald M, Raghupathi K, Tompkins CA, Shen J, Dittrich K, Pattwell C, Singh D. A phase 2 study to evaluate the safety, efficacy and pharmacokinetics of DP2 antagonist GB001 and to explore biomarkers of airway inflammation in mild-to-moderate asthma. Clin Exp Allergy. 2020 Feb;50(2):189-197. doi: 10.1111/cea.13524. Epub 2019 Nov 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2020)
481
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2018)
480
Actual Study Completion Date  ICMJE August 18, 2020
Actual Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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.

Exclusion Criteria

  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czechia,   France,   Germany,   Poland,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03683576
Other Study ID Numbers  ICMJE GB001-2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gossamer Bio Inc. ( GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. )
Study Sponsor  ICMJE GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gossamer Bio Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP