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GB001 in Adult Subjects With Moderate to Severe Asthma

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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. )

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: GB001 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 481 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 22, 2018
Actual Primary Completion Date : July 23, 2020
Actual Study Completion Date : August 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo once per day (QD) for 24 weeks
Drug: Placebo
film-coated oral tablet

Experimental: GB001 20 mg
GB001 20 mg QD for 24 weeks
Drug: GB001
film-coated oral tablet

Experimental: GB001 40 mg
GB001 40 mg QD for 24 weeks
Drug: GB001
film-coated oral tablet

Experimental: GB001 60 mg
GB001 60 mg QD for 24 weeks
Drug: GB001
film-coated oral tablet




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683576


Locations
Show Show 117 study locations
Sponsors and Collaborators
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
  Study Documents (Full-Text)

Documents provided by Gossamer Bio Inc. ( GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. ):
Study Protocol  [PDF] April 16, 2020
Statistical Analysis Plan  [PDF] April 11, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier: NCT03683576    
Other Study ID Numbers: GB001-2001
First Posted: September 25, 2018    Key Record Dates
Results First Posted: August 23, 2021
Last Update Posted: September 16, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gossamer Bio Inc. ( GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. ):
GB001
eosinophilic asthma
moderate asthma
severe asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases