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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. )

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 Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 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
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: GB001 Dose 1 daily Drug: GB001
GB001 dose daily

Experimental: GB001 Dose 2 daily Drug: GB001
GB001 dose daily

Experimental: GB001 Dose 3 daily Drug: GB001
GB001 dose daily

Placebo Comparator: Placebo daily Drug: Placebo Oral Tablet
Placebo dose daily




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. ACQ-5 Score [ Time Frame: 24 weeks ]
    Change from baseline in ACQ-5 score

  2. Pre-bronchodilator FEV1 [ Time Frame: 24 weeks ]
    Change from baseline in pre-bronchodilator FEV1

  3. Asthma worsening [ Time Frame: 24 weeks ]
    Time to first asthma worsening

  4. Post-bronchodilator FEV1 [ Time Frame: 24 weeks ]
    Change from baseline in post-bronchodilator FEV1

  5. AM peak expiratory flow [ Time Frame: 24 weeks ]
    Change from baseline in AM peak expiratory flow

  6. 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



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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.
  • 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


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


Contacts
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Contact: Gossamer Bio, Inc 1 866-668-4083 ClinicalTrials@gossamerbio.com

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Sponsors and Collaborators
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

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Responsible Party: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier: NCT03683576     History of Changes
Other Study ID Numbers: GB001-2001
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
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