Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
481 participants
INTERVENTIONAL
2018-10-22
2020-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo once per day (QD) for 24 weeks
Placebo
film-coated oral tablet
GB001 20 mg
GB001 20 mg QD for 24 weeks
GB001
film-coated oral tablet
GB001 40 mg
GB001 40 mg QD for 24 weeks
GB001
film-coated oral tablet
GB001 60 mg
GB001 60 mg QD for 24 weeks
GB001
film-coated oral tablet
Interventions
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GB001
film-coated oral tablet
Placebo
film-coated oral tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
No
Sponsors
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GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Center of Albama, LLC
Birmingham, Alabama, United States
Banner University of Arizona Medical Center
Tucson, Arizona, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
Southern California Institute for Respiratory Diseases, Inc.
Los Angeles, California, United States
North Bay Clinical Trials, Inc
Napa, California, United States
Allergy, Asthma & Sinus Consultants, Inc
Riverside, California, United States
Integrated Research of Inland, Inc.
Riverside, California, 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
Pulmonary Associates
Colorado Springs, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Central Florida Pulmonary Group, PA
Altamonte Springs, Florida, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
Emerald Coast Research Associates
Panama City, Florida, United States
Allergy and Asthma Diagnostic Treatment Center
Tallahassee, Florida, United States
Clinical Research Trials of Florida, Inc.
Tampa, Florida, United States
The Emory Clinic
Atlanta, Georgia, United States
Atlanta Allergy & Asthma Clinic, PA,
Marietta, Georgia, United States
Atlanta Allergy & Asthma Clinic, PA
Stockbridge, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, United States
John Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Medicine
Ann Arbor, Michigan, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, 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
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
Oklahoma City, Oklahoma, United States
Crisor, LLC
Medford, Oregon, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Berks Schuylkill Respiratory Specialists, Ltd.
Wyomissing, Pennsylvania, United States
AAPRI Clinical Research Institute
Warwick, Rhode Island, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Corsicana Medical Research, LLC
Corsicana, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Allergy and Asthma Research Center, PA
San Antonio, Texas, United States
Pulmonary Research of Abingdon, LLC
Abingdon, Virginia, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research
Madison, Wisconsin, United States
Ordination Dr. Robert Voves
Feldbach, , Austria
SALK University Hospital Salzburg, State Hospital Salzburg
Salzburg, , Austria
Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog
Vienna, , Austria
UCL Saint-Luc - Pneumology Department
Brussels, , Belgium
Pneumocare sprl
Erpent, , Belgium
UZ Gent - Department of Respiratory Medicine
Ghent, , Belgium
CHU de Charleroi - Site André Vésale
Montigny-le-Tilleul, , Belgium
Inspiration Research Limited
Toronto, Ontario, Canada
CHUM - Departement de pneumologie
Montreal, Quebec, Canada
Allergiste & Immunologue - Clinic/Outpatient Facility
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
Montreal, , Canada
Dr. Jamie Del Carpio's Clinic
Montreal, , Canada
Inspirational Research Limited
Toronto, , Canada
C. I. C Mauricie Inc.
Trois-Rivières, , Canada
The Lung Centre, Vancouver General Hospital
Vancouver, , Canada
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 Králové, , Czechia
MediTrial s.r.o.
Jindřichův Hradec, , Czechia
PNEUMO-KV s.r.o.
Karlovy Vary, , Czechia
Pulmonary Outpatient Clinic - Dr. Otakar Hokynar
Kralupy nad Vltavou, , Czechia
University Hospital Olomouc, Department of Allergology and Clinical Immunology
Olomouc, , Czechia
Medicon a.s.
Prague, , Czechia
Pulmonary Outpatient Clinic Rokycany s.r.o.
Rokycany, , Czechia
Outpatient Allergology and Neurology Clinic Kasmed Ltd.
Tábor, , Czechia
La Croix Rousse Hospital
Lyon, , France
Nord G&R Laennec Hospital
Nantes, , France
Centre Hospitalier Annecy Genevois
Pringy, , France
NOUVEL HOPITAL CIVIL - New Civil Hospital
Strasbourg, , France
Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V
Homburg, Saarland, Germany
RCMS Dr. Linhoff
Berlin, , Germany
Pneumologisches Studienzentrum Margrafenstrasse
Berlin, , Germany
Institut fuer Allergie - und Asthmaforschung
Berlin, , Germany
Pneumologische Praxis am Schloss
Berlin, , Germany
IKF Pneumologie GmbH & Co. KG
Frankfurt am Main, , Germany
Pneumologicum im Suedstadtforum
Hanover, , Germany
Schmid
Koblenz, , Germany
BAG Prof. Hoheisel/Dr. A. Bonitz
Leipzig, , Germany
Pneumologische Praxis PD Dr. med.
Leipzig, , Germany
KLB Gesundheitsforschung Luebeck GmbH
Lübeck, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital
Mainz, , Germany
Centrum Medycyny Oddechowej Mroz sp. j.
Bialystok, , Poland
Malopolskie Centrum Alergologii
Krakow, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ)
Krakow, , Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1
Lodz, , Poland
Ostrowieckie Centrum Medyczne
Ostrowiec Świętokrzyski, , Poland
SPZOZ Proszowice
Proszowice, , Poland
Gabinet Lekarski Zenon Bukowczan
Sucha Beskidzka, , Poland
ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy Marek Jutel
Wroclaw, , Poland
Centrum Medyczne Melita Medical
Wroclaw, , Poland
NZOZ Lekarze Specjalisci
Wroclaw, , Poland
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Instituto de Ciencias Medicas
Alicante, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council
Dnipro, , Ukraine
Public Institution "City Clinical Hospital #4" under Dnipro City Council
Dnipro, , Ukraine
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk, , 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
State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"
Kyiv, , Ukraine
Public Institution: City Clinical Hospital #6
Zaporizhia, , Ukraine
Public Non-Profit Enterprise City Hospital #1 under Zaporizhia City Council
Zaporizhia, , Ukraine
Public Enterprise "Hospital #1" under Zhytomyr City Council
Zhytomyr, , Ukraine
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Glasgow Clinical Research Facility, Glasgow Royal Infirmary
Glasgow, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Countries
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References
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Moss MH, Lugogo NL, Castro M, Hanania NA, Ludwig-Sengpiel A, Saralaya D, Dobek R, Ojanguren I, Vyshnyvetskyy I, Bruey JM, Osterhout R, Tompkins CA, Dittrich K, Raghupathi K, Ortega H; LEDA Investigators. Results of a Phase 2b Trial With GB001, a Prostaglandin D2 Receptor 2 Antagonist, in Moderate to Severe Eosinophilic Asthma. Chest. 2022 Aug;162(2):297-308. doi: 10.1016/j.chest.2022.02.038. Epub 2022 Mar 3.
Ortega H, Fitzgerald M, Raghupathi K, Tompkins CA, Shen J, Dittrich K, Pattwell C, Singh D. A phase 2 study to evaluate the safety, efficacy and pharmacokinetics of DP2 antagonist GB001 and to explore biomarkers of airway inflammation in mild-to-moderate asthma. Clin Exp Allergy. 2020 Feb;50(2):189-197. doi: 10.1111/cea.13524. Epub 2019 Nov 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GB001-2001
Identifier Type: -
Identifier Source: org_study_id
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