GB001 in Adult Subjects With Moderate to Severe Asthma
- Registration Number
- NCT03683576
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 481
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo once per day (QD) for 24 weeks GB001 40 mg GB001 GB001 40 mg QD for 24 weeks GB001 60 mg GB001 GB001 60 mg QD for 24 weeks GB001 20 mg GB001 GB001 20 mg QD for 24 weeks
- Primary Outcome Measures
Name Time Method Proportion of Participants Who Experience Worsening of Asthma by Week 24 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
Name Time Method Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF) Baseline, Week 24 AM PEF was measured by participants using an electronic diary.
Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score 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.
Annualized Rate of Severe Asthma Exacerbations 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.
Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Baseline, Week 24 Pre-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Time to First Asthma Worsening 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.
Change From Baseline to Week 24 in Post-Bronchodilator FEV1 Baseline, Week 24 Post-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Percentage of Participants With a Treatment-Emergent Adverse Event (AE) 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.
Trial Locations
- Locations (115)
Allergy, Asthma & Sinus Consultants, Inc
🇺🇸Riverside, California, United States
Integrated Research of Inland, Inc.
🇺🇸Riverside, California, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Allergy and Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Bernstein Clinical Research Center, LLC
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ)
🇵🇱Kraków, Poland
Pulmonary Associates
🇺🇸Colorado Springs, Colorado, United States
University of Michigan Medicine
🇺🇸Ann Arbor, Michigan, United States
Clinical Research Center of Albama, LLC
🇺🇸Birmingham, Alabama, United States
Central Florida Pulmonary Group, PA
🇺🇸Orlando, Florida, United States
Clinical Research Institute, Inc.
🇺🇸Minneapolis, Minnesota, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Allergy and Asthma Research Center, PA
🇺🇸San Antonio, Texas, United States
Banner University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
California Allergy and Asthma Medical Group
🇺🇸Los Angeles, California, United States
North Bay Clinical Trials, Inc
🇺🇸Napa, California, United States
Southern California Institute for Respiratory Diseases, Inc.
🇺🇸Los Angeles, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Allergy & Asthma Medical Group and Research Center, A P.C.
🇺🇸San Diego, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
🇺🇸San Jose, California, United States
Bensch Clinical Research LLC
🇺🇸Stockton, California, United States
Emerald Coast Research Associates
🇺🇸Panama City, Florida, United States
Clinical Research Trials of Florida, Inc.
🇺🇸Tampa, Florida, United States
Allergy and Asthma Diagnostic Treatment Center
🇺🇸Tallahassee, Florida, United States
Atlanta Allergy & Asthma Clinic, PA
🇺🇸Stockbridge, Georgia, United States
Atlanta Allergy & Asthma Clinic, PA,
🇺🇸Marietta, Georgia, United States
Allergy & Asthma Specialists, PSC
🇺🇸Owensboro, Kentucky, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
John Hopkins Asthma and Allergy Center
🇺🇸Baltimore, Maryland, United States
Atlantic Research Center, LLC
🇺🇸Ocean City, New Jersey, United States
American Health Research
🇺🇸Charlotte, North Carolina, United States
Clinical Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
Crisor, LLC
🇺🇸Medford, Oregon, United States
Berks Schuylkill Respiratory Specialists, Ltd.
🇺🇸Wyomissing, Pennsylvania, United States
AAPRI Clinical Research Institute
🇺🇸Warwick, Rhode Island, United States
Corsicana Medical Research, LLC
🇺🇸Corsicana, Texas, United States
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research of Rock Hill
🇺🇸Rock Hill, South Carolina, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
MultiCare Institute for Research & Innovation
🇺🇸Tacoma, Washington, United States
Pulmonary Research of Abingdon, LLC
🇺🇸Abingdon, Virginia, United States
Ordination Dr. Robert Voves
🇦🇹Feldbach, Austria
University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research
🇺🇸Madison, Wisconsin, United States
Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog
🇦🇹Vienna, Austria
SALK University Hospital Salzburg, State Hospital Salzburg
🇦🇹Salzburg, Austria
Pneumocare sprl
🇧🇪Erpent, Belgium
UZ Gent - Department of Respiratory Medicine
🇧🇪Gent, Belgium
CHU de Charleroi - Site André Vésale
🇧🇪Montigny-le-Tilleul, Belgium
Inspiration Research Limited
🇨🇦Toronto, Ontario, Canada
CHUM - Departement de pneumologie
🇨🇦Montreal, Quebec, 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
🇨🇦Montréal, Canada
Inspirational Research Limited
🇨🇦Toronto, Canada
C. I. C Mauricie Inc.
🇨🇦Trois-Rivières, Canada
NOUVEL HOPITAL CIVIL - New Civil Hospital
🇫🇷Strasbourg, France
The Lung Centre, Vancouver General Hospital
🇨🇦Vancouver, Canada
MediTrial s.r.o.
🇨🇿Jindrichuv Hradec, Czechia
St. Anne's University Hospital Brno, Institute of Clinical Immunology and Allergology
🇨🇿Brno, Czechia
University Hospital Hradec Kralove, Institute of Clinical Immunology and Allergollogy
🇨🇿Hradec Kralove, Czechia
PNEUMO-KV s.r.o.
🇨🇿Karlovy Vary, Czechia
Pulmonary Outpatient Clinic - Dr. Otakar Hokynar
🇨🇿Kralupy nad Vltavou, Czechia
Pulmonary Outpatient Clinic Rokycany s.r.o.
🇨🇿Rokycany, Czechia
University Hospital Olomouc, Department of Allergology and Clinical Immunology
🇨🇿Olomouc, Czechia
Centre Hospitalier Annecy Genevois
🇫🇷Pringy, France
Nord G&R Laennec Hospital
🇫🇷Nantes, France
Outpatient Allergology and Neurology Clinic Kasmed Ltd.
🇨🇿Tábor, Czechia
Medicon a.s.
🇨🇿Praha 4, Czechia
La Croix Rousse Hospital
🇫🇷Lyon, France
Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V
🇩🇪Homburg, Saarland, Germany
RCMS Dr. Linhoff
🇩🇪Berlin, Germany
IKF Pneumologie GmbH & Co. KG
🇩🇪Frankfurt am Main, Germany
Pneumologisches Studienzentrum Margrafenstrasse
🇩🇪Berlin, Germany
Institut fuer Allergie - und Asthmaforschung
🇩🇪Berlin, Germany
Pneumologische Praxis am Schloss
🇩🇪Berlin, Germany
KLB Gesundheitsforschung Luebeck GmbH
🇩🇪Luebeck, Germany
Pneumologicum im Suedstadtforum
🇩🇪Hannover, Germany
Schmid
🇩🇪Koblenz, Germany
Pneumologische Praxis PD Dr. med.
🇩🇪Leipzig, Germany
BAG Prof. Hoheisel/Dr. A. Bonitz
🇩🇪Leipzig, Germany
Malopolskie Centrum Alergologii
🇵🇱Kraków, Poland
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital
🇩🇪Mainz, Germany
Centrum Medycyny Oddechowej Mroz sp. j.
🇵🇱Białystok, Poland
Ostrowieckie Centrum Medyczne
🇵🇱Ostrowiec Świętokrzyski, Poland
Gabinet Lekarski Zenon Bukowczan
🇵🇱Sucha Beskidzka, Poland
SPZOZ Proszowice
🇵🇱Proszowice, Poland
ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy Marek Jutel
🇵🇱Wrocław, Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1
🇵🇱Łódź, Poland
Centrum Medyczne Melita Medical
🇵🇱Wrocław, Poland
Hospital Clinico Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, A Coruna, Spain
Instituto de Ciencias Medicas
🇪🇸Alicante, Spain
NZOZ Lekarze Specjalisci
🇵🇱Wrocław, Poland
Hospital Universitario de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Ivano-Frankivsk Central City Clinical Hospital
🇺🇦Ivano-Frankivsk, Ukraine
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Public Institution "City Clinical Hospital #4" under Dnipro City Council
🇺🇦Dnipro, Ukraine
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council
🇺🇦Dnipro, Ukraine
Public Non-Profit Enterprise: City Clinical Hospital #13 under Kharkiv City Council
🇺🇦Kharkiv, Ukraine
State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"
🇺🇦Kyiv, Ukraine
Public Institution: City Clinical Hospital #6
🇺🇦Zaporizhia, Ukraine
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Public Non-Profit Enterprise City Hospital #1 under Zaporizhia City Council
🇺🇦Zaporizhia, Ukraine
Public Enterprise "Hospital #1" under Zhytomyr City Council
🇺🇦Zhytomyr, Ukraine
Glasgow Clinical Research Facility, Glasgow Royal Infirmary
🇬🇧Glasgow, United Kingdom
University Hospital Southampton
🇬🇧Southampton, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Allergiste & Immunologue - Clinic/Outpatient Facility
🇨🇦Montreal, Quebec, Canada
UCL Saint-Luc - Pneumology Department
🇧🇪Bruxelles, Belgium
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom