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GB001 in Adult Subjects With Moderate to Severe Asthma

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ClinicalTrials.gov Identifier: NCT03683576
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : June 12, 2019
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
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE October 22, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03683576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • ACQ-5 Score [ Time Frame: 24 weeks ]
    Change from baseline in ACQ-5 score
  • Pre-bronchodilator FEV1 [ Time Frame: 24 weeks ]
    Change from baseline in pre-bronchodilator FEV1
  • Asthma worsening [ Time Frame: 24 weeks ]
    Time to first asthma worsening
  • Post-bronchodilator FEV1 [ Time Frame: 24 weeks ]
    Change from baseline in post-bronchodilator FEV1
  • AM peak expiratory flow [ Time Frame: 24 weeks ]
    Change from baseline in AM peak expiratory flow
  • Incidence of Treatment Emergent Adverse Events [ Time Frame: 28 weeks ]
    To evaluate the safety and tolerability of GB001 as compared to placebo looking at only those adverse events that start on or after the first dose of the study drug or placebo respectively
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
    GB001 dose daily
  • Drug: Placebo Oral Tablet
    Placebo dose daily
Study Arms  ICMJE
  • Experimental: GB001 Dose 1 daily
    Intervention: Drug: GB001
  • Experimental: GB001 Dose 2 daily
    Intervention: Drug: GB001
  • Experimental: GB001 Dose 3 daily
    Intervention: Drug: GB001
  • Placebo Comparator: Placebo daily
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2018)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date June 30, 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.
  • 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 SOC asthma therapy during run-in period.

Exclusion Criteria

  • Current smokers (any substance)
  • 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

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: Gossamer Bio, Inc 1 866-668-4083 ClinicalTrials@gossamerbio.com
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czechia,   France,   Germany,   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 June 2019

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