GB001 in Adult Subjects With Moderate to Severe Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683576
• Other study ID #: GB001-2001
• Status: Completed
• Phase: Phase 2
• Start date: October 22, 2018
• Est. completion date: August 18, 2020

Study information

• Verified date: August 2021
• Source: Gossamer Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: August 18, 2020
• Est. primary completion date: July 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• GB001
film-coated oral tablet
• Placebo
film-coated oral tablet

Locations

Country	Name	City	State
Austria	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
Belgium	UCL Saint-Luc - Pneumology Department	Bruxelles
Belgium	Pneumocare sprl	Erpent
Belgium	UZ Gent - Department of Respiratory Medicine	Gent
Belgium	CHU de Charleroi - Site André Vésale	Montigny-le-Tilleul
Canada	Allergiste & Immunologue - Clinic/Outpatient Facility	Montreal	Quebec
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	Inspiration Research Limited	Toronto	Ontario
Canada	Inspirational Research Limited	Toronto
Canada	C. I. C Mauricie Inc.	Trois-Rivières
Canada	The Lung Centre, Vancouver General Hospital	Vancouver
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	MediTrial s.r.o.	Jindrichuv 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.	Praha 4
Czechia	Pulmonary Outpatient Clinic Rokycany s.r.o.	Rokycany
Czechia	Outpatient Allergology and Neurology Clinic Kasmed Ltd.	Tábor
France	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
Germany	Institut fuer Allergie - und Asthmaforschung	Berlin
Germany	Pneumologische Praxis am Schloss	Berlin
Germany	Pneumologisches Studienzentrum Margrafenstrasse	Berlin
Germany	RCMS Dr. Linhoff	Berlin
Germany	IKF Pneumologie GmbH & Co. KG	Frankfurt am Main
Germany	Pneumologicum im Suedstadtforum	Hannover
Germany	Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V	Homburg	Saarland
Germany	Schmid	Koblenz
Germany	BAG Prof. Hoheisel/Dr. A. Bonitz	Leipzig
Germany	Pneumologische Praxis PD Dr. med.	Leipzig
Germany	KLB Gesundheitsforschung Luebeck GmbH	Luebeck
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital	Mainz
Poland	Centrum Medycyny Oddechowej Mroz sp. j.	Bialystok
Poland	Malopolskie Centrum Alergologii	Kraków
Poland	Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ)	Kraków
Poland	SPZOZ Uniwersytecki Szpital Kliniczny nr 1	Lódz
Poland	Ostrowieckie Centrum Medyczne	Ostrowiec Swietokrzyski
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
Spain	Instituto de Ciencias Medicas	Alicante
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Clinico Universitario de Santiago de Compostela	Santiago De Compostela	A Coruna
Spain	Hospital Universitario Doctor Peset	Valencia
Ukraine	Public Institution "City Clinical Hospital #4" under Dnipro City Council	Dnipro
Ukraine	Public Institution: Dnipro Clinical Association of Urgent Medical Care 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
United Kingdom	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 States	Pulmonary Research of Abingdon, LLC	Abingdon	Virginia
United States	Central Florida Pulmonary Group, PA	Altamonte Springs	Florida
United States	University of Michigan Medicine	Ann Arbor	Michigan
United States	The Emory Clinic	Atlanta	Georgia
United States	John Hopkins Asthma and Allergy Center	Baltimore	Maryland
United States	Clinical Research Center of Albama, LLC	Birmingham	Alabama
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	American Health Research	Charlotte	North Carolina
United States	Clinical Research of Charlotte	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Pulmonary Associates	Colorado Springs	Colorado
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	California Allergy and Asthma Medical Group	Los Angeles	California
United States	Southern California Institute for Respiratory Diseases, Inc.	Los Angeles	California
United States	University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research	Madison	Wisconsin
United States	Atlanta Allergy & Asthma Clinic, PA,	Marietta	Georgia
United States	Crisor, LLC	Medford	Oregon
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	North Bay Clinical Trials, Inc	Napa	California
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Atlantic Research Center, LLC	Ocean City	New Jersey
United States	Oklahoma Institute of Allergy & Asthma Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Central Florida Pulmonary Group, PA	Orlando	Florida
United States	Allergy & Asthma Specialists, PSC	Owensboro	Kentucky
United States	Emerald Coast Research Associates	Panama City	Florida
United States	Allergy and Clinical Immunology Associates	Pittsburgh	Pennsylvania
United States	Allergy, Asthma & Sinus Consultants, Inc	Riverside	California
United States	Integrated Research of Inland, Inc.	Riverside	California
United States	Clinical Research of Rock Hill	Rock Hill	South Carolina
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Allergy and Asthma Research Center, PA	San Antonio	Texas
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	Atlanta Allergy & Asthma Clinic, PA	Stockbridge	Georgia
United States	Bensch Clinical Research LLC	Stockton	California
United States	MultiCare Institute for Research & Innovation	Tacoma	Washington
United States	Allergy and Asthma Diagnostic Treatment Center	Tallahassee	Florida
United States	Clinical Research Trials of Florida, Inc.	Tampa	Florida
United States	Banner University of Arizona Medical Center	Tucson	Arizona
United States	AAPRI Clinical Research Institute	Warwick	Rhode Island
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	Berks Schuylkill Respiratory Specialists, Ltd.	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Poland,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score	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
Secondary	Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Pre-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.	Baseline, Week 24
Secondary	Time to First Asthma Worsening	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
Secondary	Annualized Rate of Severe Asthma Exacerbations	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
Secondary	Change From Baseline to Week 24 in Post-Bronchodilator FEV1	Post-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.	Baseline, Week 24
Secondary	Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)	AM PEF was measured by participants using an electronic diary.	Baseline, Week 24
Secondary	Percentage of Participants With a Treatment-Emergent Adverse Event (AE)	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