GB001 in Adult Subjects With Moderate to Severe Asthma
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
1 other identifier
interventional
481
11 countries
117
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Oct 2018
Typical duration for phase_2 asthma
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedStudy Start
First participant enrolled
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2020
CompletedResults Posted
Study results publicly available
August 23, 2021
CompletedSeptember 16, 2021
August 1, 2021
1.8 years
September 11, 2018
July 23, 2021
August 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Who Experience Worsening of Asthma by 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 Outcomes (7)
Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score
Baseline, Week 24
Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Baseline, Week 24
Time to First Asthma Worsening
up to Week 24
Annualized Rate of Severe Asthma Exacerbations
up to Week 24
Change From Baseline to Week 24 in Post-Bronchodilator FEV1
Baseline, Week 24
- +2 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo once per day (QD) for 24 weeks
GB001 20 mg
EXPERIMENTALGB001 20 mg QD for 24 weeks
GB001 40 mg
EXPERIMENTALGB001 40 mg QD for 24 weeks
GB001 60 mg
EXPERIMENTALGB001 60 mg QD for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (117)
Clinical Research Center of Albama, LLC
Birmingham, Alabama, 35209, United States
Banner University of Arizona Medical Center
Tucson, Arizona, 85724, United States
California Allergy and Asthma Medical Group
Los Angeles, California, 90025, United States
Southern California Institute for Respiratory Diseases, Inc.
Los Angeles, California, 90048, United States
North Bay Clinical Trials, Inc
Napa, California, 94558, United States
Allergy, Asthma & Sinus Consultants, Inc
Riverside, California, 92506, United States
Integrated Research of Inland, Inc.
Riverside, California, 92506, United States
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, 92123, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117, United States
Bensch Clinical Research LLC
Stockton, California, 95207, United States
Pulmonary Associates
Colorado Springs, Colorado, 80909, United States
Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
Central Florida Pulmonary Group, PA
Altamonte Springs, Florida, 32701, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803, United States
Emerald Coast Research Associates
Panama City, Florida, 32405, United States
Allergy and Asthma Diagnostic Treatment Center
Tallahassee, Florida, 32308, United States
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Atlanta Allergy & Asthma Clinic, PA,
Marietta, Georgia, 30060, United States
Atlanta Allergy & Asthma Clinic, PA
Stockbridge, Georgia, 30281, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, 42301, United States
John Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Washington University School of Medicine
St Louis, Missouri, 63108, United States
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712, United States
American Health Research
Charlotte, North Carolina, 28207, United States
Clinical Research of Charlotte
Charlotte, North Carolina, 28277, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27104, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
Oklahoma City, Oklahoma, 73131, United States
Crisor, LLC
Medford, Oregon, 97504, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
Berks Schuylkill Respiratory Specialists, Ltd.
Wyomissing, Pennsylvania, 19610, United States
AAPRI Clinical Research Institute
Warwick, Rhode Island, 02886, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732, United States
Corsicana Medical Research, LLC
Corsicana, Texas, 75110, United States
Western Sky Medical Research
El Paso, Texas, 79903, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Allergy and Asthma Research Center, PA
San Antonio, Texas, 78229, United States
Pulmonary Research of Abingdon, LLC
Abingdon, Virginia, 24210, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405, United States
University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research
Madison, Wisconsin, 53792-9988, United States
Ordination Dr. Robert Voves
Feldbach, 8330, 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, M5T 3A9, Canada
CHUM - Departement de pneumologie
Montreal, Quebec, H2X 3E4, Canada
Allergiste & Immunologue - Clinic/Outpatient Facility
Montreal, Quebec, H3G 1L5, 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, 37701, Czechia
PNEUMO-KV s.r.o.
Karlovy Vary, 36017, Czechia
Pulmonary Outpatient Clinic - Dr. Otakar Hokynar
Kralupy nad Vltavou, 27801, Czechia
University Hospital Olomouc, Department of Allergology and Clinical Immunology
Olomouc, 779 00, Czechia
Medicon a.s.
Prague, Czechia
Pulmonary Outpatient Clinic Rokycany s.r.o.
Rokycany, 33722, Czechia
Outpatient Allergology and Neurology Clinic Kasmed Ltd.
Tábor, 39002, 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, 67091, France
Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V
Homburg, Saarland, 66421, Germany
RCMS Dr. Linhoff
Berlin, 10717, Germany
Pneumologisches Studienzentrum Margrafenstrasse
Berlin, 10969, Germany
Institut fuer Allergie - und Asthmaforschung
Berlin, 12159, Germany
Pneumologische Praxis am Schloss
Berlin, Germany
IKF Pneumologie GmbH & Co. KG
Frankfurt am Main, 60596, Germany
Pneumologicum im Suedstadtforum
Hanover, 30173, Germany
Schmid
Koblenz, 56068, Germany
BAG Prof. Hoheisel/Dr. A. Bonitz
Leipzig, 04275, Germany
Pneumologische Praxis PD Dr. med.
Leipzig, Germany
KLB Gesundheitsforschung Luebeck GmbH
Lübeck, 23552, 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, 15706, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Instituto de Ciencias Medicas
Alicante, 03004, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council
Dnipro, 49006, Ukraine
Public Institution "City Clinical Hospital #4" under Dnipro City Council
Dnipro, 49102, Ukraine
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk, 76018, 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, 03680, Ukraine
State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"
Kyiv, Ukraine
Public Institution: City Clinical Hospital #6
Zaporizhia, 69035, Ukraine
Public Non-Profit Enterprise City Hospital #1 under Zaporizhia City Council
Zaporizhia, 69104, Ukraine
Public Enterprise "Hospital #1" under Zhytomyr City Council
Zhytomyr, 10002, 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
Related Publications (2)
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.
PMID: 35248549DERIVEDOrtega 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.
PMID: 31659803DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gossamer Study Director
- Organization
- GB001, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2018
First Posted
September 25, 2018
Study Start
October 22, 2018
Primary Completion
July 23, 2020
Study Completion
August 18, 2020
Last Updated
September 16, 2021
Results First Posted
August 23, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share