Clinical trial NCT03683576: GB001 in Adult Subjects With Moderate to Severe Asthma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: GB001
eosinophilic asthma
moderate asthma
severe asthma
Lead sponsor: Gossamer Bio Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-25
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Participants Who Experience Worsening of Asthma by Week 24
timeFrame: up to Week 24
Secondary outcomes:
measure: Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score
timeFrame: Baseline, Week 24
measure: Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, Week 24
measure: Time to First Asthma Worsening
timeFrame: up to Week 24
measure: Annualized Rate of Severe Asthma Exacerbations
timeFrame: up to Week 24
measure: Change From Baseline to Week 24 in Post-Bronchodilator FEV1
timeFrame: Baseline, Week 24
measure: Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)
timeFrame: Baseline, Week 24
measure: Percentage of Participants With a Treatment-Emergent Adverse Event (AE)
timeFrame: From first dose of study treatment through Week 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Albama, LLC
state: Alabama
city: Tucson
country: United States
facility: Banner University of Arizona Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: Los Angeles
country: United States
facility: Southern California Institute for Respiratory Diseases, Inc.
state: California
city: Napa
country: United States
facility: North Bay Clinical Trials, Inc
state: California
city: Riverside
country: United States
facility: Allergy, Asthma & Sinus Consultants, Inc
state: California
city: Riverside
country: United States
facility: Integrated Research of Inland, Inc.
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center, A P.C.
state: California
city: San Jose
country: United States
facility: Allergy and Asthma Associates of Santa Clara Valley Research Center
state: California
city: Stockton
country: United States
facility: Bensch Clinical Research LLC
state: California
city: Colorado Springs
country: United States
facility: Pulmonary Associates
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Altamonte Springs
country: United States
facility: Central Florida Pulmonary Group, PA
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, PA
state: Florida
city: Panama City
country: United States
facility: Emerald Coast Research Associates
state: Florida
city: Tallahassee
country: United States
facility: Allergy and Asthma Diagnostic Treatment Center
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc.
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Marietta
country: United States
facility: Atlanta Allergy & Asthma Clinic, PA,
state: Georgia
city: Stockbridge
country: United States
facility: Atlanta Allergy & Asthma Clinic, PA
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Owensboro
country: United States
facility: Allergy & Asthma Specialists, PSC
state: Kentucky
city: Baltimore
country: United States
facility: John Hopkins Asthma and Allergy Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medicine
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Ocean City
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Charlotte
country: United States
facility: Clinical Research of Charlotte
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
state: Oklahoma
city: Medford
country: United States
facility: Crisor, LLC
state: Oregon
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Schuylkill Respiratory Specialists, Ltd.
state: Pennsylvania
city: Warwick
country: United States
facility: AAPRI Clinical Research Institute
state: Rhode Island
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Corsicana
country: United States
facility: Corsicana Medical Research, LLC
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Allergy and Asthma Research Center, PA
state: Texas
city: Abingdon
country: United States
facility: Pulmonary Research of Abingdon, LLC
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research
state: Wisconsin
city: Feldbach
country: Austria
facility: Ordination Dr. Robert Voves
city: Salzburg
country: Austria
facility: SALK University Hospital Salzburg, State Hospital Salzburg
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog
city: Bruxelles
country: Belgium
facility: UCL Saint-Luc - Pneumology Department
city: Erpent
country: Belgium
facility: Pneumocare sprl
city: Gent
country: Belgium
facility: UZ Gent - Department of Respiratory Medicine
city: Montigny-le-Tilleul
country: Belgium
facility: CHU de Charleroi - Site André Vésale
city: Toronto
country: Canada
facility: Inspiration Research Limited
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Departement de pneumologie
state: Quebec
city: Montreal
country: Canada
facility: Allergiste & Immunologue - Clinic/Outpatient Facility
state: Quebec
city: Montréal
country: Canada
facility: Centre integre universitaire de sante et de services sociaux du Nord-de-I'lle-de-Montreal - Hopital du Sacre-Coeur de Montreal
city: Montréal
country: Canada
facility: Dr. Jamie Del Carpio's Clinic
city: Toronto
country: Canada
facility: Inspirational Research Limited
city: Trois-Rivières
country: Canada
facility: C. I. C Mauricie Inc.
city: Vancouver
country: Canada
facility: The Lung Centre, Vancouver General Hospital
city: Brno
country: Czechia
facility: St. Anne's University Hospital Brno, Institute of Clinical Immunology and Allergology
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove, Institute of Clinical Immunology and Allergollogy
city: Jindrichuv Hradec
country: Czechia
facility: MediTrial s.r.o.
city: Karlovy Vary
country: Czechia
facility: PNEUMO-KV s.r.o.
city: Kralupy nad Vltavou
country: Czechia
facility: Pulmonary Outpatient Clinic - Dr. Otakar Hokynar
city: Olomouc
country: Czechia
facility: University Hospital Olomouc, Department of Allergology and Clinical Immunology
city: Praha 4
country: Czechia
facility: Medicon a.s.
city: Rokycany
country: Czechia
facility: Pulmonary Outpatient Clinic Rokycany s.r.o.
city: Tábor
country: Czechia
facility: Outpatient Allergology and Neurology Clinic Kasmed Ltd.
city: Lyon
country: France
facility: La Croix Rousse Hospital
city: Nantes
country: France
facility: Nord G&R Laennec Hospital
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Strasbourg
country: France
facility: NOUVEL HOPITAL CIVIL - New Civil Hospital
city: Homburg
country: Germany
facility: Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V
state: Saarland
city: Berlin
country: Germany
facility: RCMS Dr. Linhoff
city: Berlin
country: Germany
facility: Pneumologisches Studienzentrum Margrafenstrasse
city: Berlin
country: Germany
facility: Institut fuer Allergie - und Asthmaforschung
city: Berlin
country: Germany
facility: Pneumologische Praxis am Schloss
city: Frankfurt am Main
country: Germany
facility: IKF Pneumologie GmbH & Co. KG
city: Hannover
country: Germany
facility: Pneumologicum im Suedstadtforum
city: Koblenz
country: Germany
facility: Schmid
city: Leipzig
country: Germany
facility: BAG Prof. Hoheisel/Dr. A. Bonitz
city: Leipzig
country: Germany
facility: Pneumologische Praxis PD Dr. med.
city: Luebeck
country: Germany
facility: KLB Gesundheitsforschung Luebeck GmbH
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital
city: Białystok
country: Poland
facility: Centrum Medycyny Oddechowej Mroz sp. j.
city: Kraków
country: Poland
facility: Malopolskie Centrum Alergologii
city: Kraków
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ)
city: Ostrowiec Świętokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne
city: Proszowice
country: Poland
facility: SPZOZ Proszowice
city: Sucha Beskidzka
country: Poland
facility: Gabinet Lekarski Zenon Bukowczan
city: Wrocław
country: Poland
facility: ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy Marek Jutel
city: Wrocław
country: Poland
facility: Centrum Medyczne Melita Medical
city: Wrocław
country: Poland
facility: NZOZ Lekarze Specjalisci
city: Łódź
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: A Coruna
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Alicante
country: Spain
facility: Instituto de Ciencias Medicas
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Dnipro
country: Ukraine
facility: Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council
city: Dnipro
country: Ukraine
facility: Public Institution "City Clinical Hospital #4" under Dnipro City Council
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Central City Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Public Non-Profit Enterprise: City Clinical Hospital #13 under Kharkiv City Council
city: Kyiv
country: Ukraine
facility: State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"
city: Kyiv
country: Ukraine
facility: State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"
city: Zaporizhia
country: Ukraine
facility: Public Institution: City Clinical Hospital #6
city: Zaporizhia
country: Ukraine
facility: Public Non-Profit Enterprise City Hospital #1 under Zaporizhia City Council
city: Zhytomyr
country: Ukraine
facility: Public Enterprise "Hospital #1" under Zhytomyr City Council
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Glasgow Clinical Research Facility, Glasgow Royal Infirmary
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
References:
citation: 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.
citation: 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.