GB001 in Adult Subjects With Moderate to Severe Asthma

August 20, 2021 updated by: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

481

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldbach, Austria, 8330
        • Ordination Dr. Robert Voves
      • Salzburg, Austria
        • SALK University Hospital Salzburg, State Hospital Salzburg
      • Vienna, Austria
        • Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog
  • Belgium
      • Bruxelles, Belgium
        • UCL Saint-Luc - Pneumology Department
      • Erpent, Belgium
        • Pneumocare SPRL
      • Gent, Belgium
        • UZ Gent - Department of Respiratory Medicine
      • Montigny-le-Tilleul, Belgium
        • CHU de Charleroi - Site André Vésale
  • Canada
      • Montréal, Canada
        • Centre integre universitaire de sante et de services sociaux du Nord-de-I'lle-de-Montreal - Hopital du Sacre-Coeur de Montreal
      • Montréal, Canada
        • Dr. Jamie Del Carpio's Clinic
      • Toronto, Canada
        • Inspirational Research Limited
      • Trois-Rivières, Canada
        • C. I. C Mauricie Inc.
      • Vancouver, Canada
        • The Lung Centre, Vancouver General Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5T 3A9
        • Inspiration Research Limited
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Departement de pneumologie
      • Montreal, Quebec, Canada, H3G 1L5
        • Allergiste & Immunologue - Clinic/Outpatient Facility
  • Czechia
      • Brno, Czechia
        • St. Anne's University Hospital Brno, Institute of Clinical Immunology and Allergology
      • Hradec Kralove, Czechia
        • University Hospital Hradec Kralove, Institute of Clinical Immunology and Allergollogy
      • Jindrichuv Hradec, Czechia, 37701
        • MediTrial s.r.o.
      • Karlovy Vary, Czechia, 36017
        • PNEUMO-KV s.r.o.
      • Kralupy nad Vltavou, Czechia, 27801
        • Pulmonary Outpatient Clinic - Dr. Otakar Hokynar
      • Olomouc, Czechia, 779 00
        • University Hospital Olomouc, Department of Allergology and Clinical Immunology
      • Praha 4, Czechia
        • Medicon a.s.
      • Rokycany, Czechia, 33722
        • Pulmonary Outpatient Clinic Rokycany s.r.o.
      • Tábor, Czechia, 39002
        • Outpatient Allergology and Neurology Clinic Kasmed Ltd.
  • France
      • Lyon, France
        • La Croix Rousse Hospital
      • Nantes, France
        • Nord G&R Laennec Hospital
      • Pringy, France
        • Centre Hospitalier Annecy Genevois
      • Strasbourg, France, 67091
        • NOUVEL HOPITAL CIVIL - New Civil Hospital
  • Germany
      • Berlin, Germany, 10717
        • RCMS Dr. Linhoff
      • Berlin, Germany, 10969
        • Pneumologisches Studienzentrum Margrafenstrasse
      • Berlin, Germany, 12159
        • Institut fuer Allergie - und Asthmaforschung
      • Berlin, Germany
        • Pneumologische Praxis am Schloss
      • Frankfurt am Main, Germany, 60596
        • IKF Pneumologie GmbH & Co. KG
      • Hannover, Germany, 30173
        • Pneumologicum im Suedstadtforum
      • Koblenz, Germany, 56068
        • Schmid
      • Leipzig, Germany, 04275
        • BAG Prof. Hoheisel/Dr. A. Bonitz
      • Leipzig, Germany
        • Pneumologische Praxis PD Dr. med.
      • Luebeck, Germany, 23552
        • KLB Gesundheitsforschung Luebeck GmbH
      • Mainz, Germany
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V
  • Poland
      • Białystok, Poland
        • Centrum Medycyny Oddechowej Mroz sp. j.
      • Kraków, Poland
        • Malopolskie Centrum Alergologii
      • Kraków, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ)
      • Ostrowiec Świętokrzyski, Poland
        • Ostrowieckie Centrum Medyczne
      • Proszowice, Poland
        • SPZOZ Proszowice
      • Sucha Beskidzka, Poland
        • Gabinet Lekarski Zenon Bukowczan
      • Wrocław, Poland
        • ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy Marek Jutel
      • Wrocław, Poland
        • Centrum Medyczne Melita Medical
      • Wrocław, Poland
        • NZOZ Lekarze Specjalisci
      • Łódź, Poland
        • SPZOZ Uniwersytecki Szpital Kliniczny nr 1
  • Spain
      • Alicante, Spain, 03004
        • Instituto de Ciencias Médicas
      • Barcelona, Spain
        • Hospital Clinic de Barcelona
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Valencia, Spain, 46017
        • Hospital Universitario Doctor Peset
    • A Coruna
      • Santiago De Compostela, A Coruna, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
  • Ukraine
      • Dnipro, Ukraine, 49006
        • Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council
      • Dnipro, Ukraine, 49102
        • Public Institution "City Clinical Hospital #4" under Dnipro City Council
      • Ivano-Frankivsk, Ukraine, 76018
        • Ivano-Frankivsk Central City Clinical Hospital
      • Kharkiv, Ukraine
        • Public Non-Profit Enterprise: City Clinical Hospital #13 under Kharkiv City Council
      • Kyiv, Ukraine, 03680
        • State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"
      • Kyiv, Ukraine
        • State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"
      • Zaporizhia, Ukraine, 69035
        • Public Institution: City Clinical Hospital #6
      • Zaporizhia, Ukraine, 69104
        • Public Non-Profit Enterprise City Hospital #1 under Zaporizhia City Council
      • Zhytomyr, Ukraine, 10002
        • Public Enterprise "Hospital #1" under Zhytomyr City Council
  • United Kingdom
      • Birmingham, United Kingdom
        • Birmingham Heartlands Hospital
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Glasgow, United Kingdom
        • Glasgow Clinical Research Facility, Glasgow Royal Infirmary
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital
      • Southampton, United Kingdom
        • University Hospital Southampton
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Clinical Research Center of Albama, LLC
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Banner University of Arizona Medical Center
    • California
      • Los Angeles, California, United States, 90048
        • Southern California Institute for Respiratory Diseases, Inc.
      • Los Angeles, California, United States, 90025
        • California Allergy and Asthma Medical Group
      • Napa, California, United States, 94558
        • North Bay Clinical Trials, Inc
      • Riverside, California, United States, 92506
        • Allergy, Asthma & Sinus Consultants, Inc
      • Riverside, California, United States, 92506
        • Integrated Research of Inland, Inc.
      • San Diego, California, United States, 92123
        • Allergy & Asthma Medical Group and Research Center, A P.C.
      • San Jose, California, United States, 95117
        • Allergy and Asthma Associates of Santa Clara Valley Research Center
      • Stockton, California, United States, 95207
        • Bensch Clinical Research LLC
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Pulmonary Associates
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale New Haven Hospital
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Central Florida Pulmonary Group, PA
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group, PA
      • Panama City, Florida, United States, 32405
        • Emerald Coast Research Associates
      • Tallahassee, Florida, United States, 32308
        • Allergy and Asthma Diagnostic Treatment Center
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
      • Marietta, Georgia, United States, 30060
        • Atlanta Allergy & Asthma Clinic, PA,
      • Stockbridge, Georgia, United States, 30281
        • Atlanta Allergy & Asthma Clinic, PA
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Allergy & Asthma Specialists, PSC
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • John Hopkins Asthma and Allergy Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medicine
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute, Inc.
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University School of Medicine
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Atlantic Research Center, LLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Clinical Research of Charlotte
      • Charlotte, North Carolina, United States, 28207
        • American Health Research
      • Winston-Salem, North Carolina, United States, 27104
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Bernstein Clinical Research Center, LLC
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73131
        • Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
    • Oregon
      • Medford, Oregon, United States, 97504
        • Crisor, LLC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy and Clinical Immunology Associates
      • Wyomissing, Pennsylvania, United States, 19610
        • Berks Schuylkill Respiratory Specialists, Ltd.
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • AAPRI Clinical Research Institute
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Clinical Research of Rock Hill
    • Texas
      • Corsicana, Texas, United States, 75110
        • Corsicana Medical Research, LLC
      • El Paso, Texas, United States, 79903
        • Western Sky Medical Research
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78229
        • Allergy and Asthma Research Center, PA
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Pulmonary Research of Abingdon, LLC
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research & Innovation
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-9988
        • University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 24
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.
Baseline, Week 24
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.
up to Week 24
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.
up to Week 24
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.
Baseline, Week 24
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.
Baseline, Week 24
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.
From first dose of study treatment through Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 22, 2018

Primary Completion (ACTUAL)

July 23, 2020

Study Completion (ACTUAL)

August 18, 2020

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (ACTUAL)

September 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB001-2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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