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Completed

NCT Number: NCT03683576

GB001 in Adult Subjects With Moderate to Severe Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Eosinophilia Hematologic Diseases Hemic and Lymphatic Diseases Hypereosinophilic Syndrome Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders Lung Diseases Lung Diseases, Obstructive Pulmonary Eosinophilia Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ordination Dr. Robert Voves, Feldbach, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GB001

Drug

film-coated oral tablet

Placebo

Drug

film-coated oral tablet

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2018
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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