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GB001 in Adult Subjects With Moderate to Severe Asthma

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ClinicalTrials.gov Identifier: NCT03683576
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Gossamer Bio Inc. ( 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: GB001 Drug: Placebo Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: GB001 Dose 1 daily Drug: GB001
GB001 dose daily

Experimental: GB001 Dose 2 daily Drug: GB001
GB001 dose daily

Experimental: GB001 Dose 3 daily Drug: GB001
GB001 dose daily

Placebo Comparator: Placebo daily Drug: Placebo Oral Tablet
Placebo dose daily




Primary Outcome Measures :
  1. Number of participants out of the total experiencing asthma worsening as assessed by changes in peak expiratory flow, FEV1, rescue medication use, and ACQ-5 score, and the occurrence of severe asthma exacerbations. [ Time Frame: 24 weeks ]
    Asthma worsening is defined as at least one of the following: peak expiratory flow less than or equal to 75 percent of baseline; forced expiratory volume in 1 second (FEV1) less than 80 percent of baseline; increase in rescue medication use of greater than or equal to 6 puffs per day compared to baseline; increase in Asthma Control Questionnaire (ACQ-5) score of greater than or equal to 0.5 compared to baseline; or the occurrence of a severe asthma exacerbation.


Secondary Outcome Measures :
  1. ACQ-5 Score [ Time Frame: 24 weeks ]
    Change from baseline in ACQ-5 score

  2. Pre-bronchodilator FEV1 [ Time Frame: 24 weeks ]
    Change from baseline in pre-bronchodilator FEV1

  3. Asthma worsening [ Time Frame: 24 weeks ]
    Time to first asthma worsening

  4. Post-bronchodilator FEV1 [ Time Frame: 24 weeks ]
    Change from baseline in post-bronchodilator FEV1

  5. AM peak expiratory flow [ Time Frame: 24 weeks ]
    Change from baseline in AM peak expiratory flow

  6. Incidence of Treatment Emergent Adverse Events [ Time Frame: 28 weeks ]
    To evaluate the safety and tolerability of GB001 as compared to placebo looking at only those adverse events that start on or after the first dose of the study drug or placebo respectively



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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 SOC asthma therapy during run-in period.

Exclusion Criteria

  • Current smokers (any substance)
  • QTcF (Fridericia) ≥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
  • Pregnant or breastfeeding
  • Serious co-morbidities
  • Regular use of systemic corticosteroids or immunosuppressive treatments or monoclonal antibodies for asthma

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683576


Contacts
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Contact: Gossamer Bio, Inc 1 866-668-4083 ClinicalTrials@gossamerbio.com

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Locations
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United States, Alabama
Clinical Research Center of Albama, LLC Recruiting
Birmingham, Alabama, United States, 35209
United States, California
California Allergy and Asthma Medical Group Recruiting
Los Angeles, California, United States, 90025
Southern California Institute for Respiratory Diseases, Inc. Recruiting
Los Angeles, California, United States, 90048
Allergy & Asthma Associates of Southern California dba Southern California Research Recruiting
Mission Viejo, California, United States, 92691
North Bay Clinical Trials, Inc Recruiting
Napa, California, United States, 94558
Allergy, Asthma & Sinus Consultants, Inc Recruiting
Riverside, California, United States, 92506
Integrated Research of Inland, Inc. Recruiting
Riverside, California, United States, 92506
Allergy and Asthma Associates of Santa Clara Valley Research Center Recruiting
San Jose, California, United States, 95117
Bensch Clinical Research LLC Recruiting
Stockton, California, United States, 95207
United States, Colorado
Pulmonary Associates Recruiting
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06519
United States, Florida
Emerald Coast Research Associates Recruiting
Panama City, Florida, United States, 32405
Allergy and Asthma Diagnostic Treatment Center Recruiting
Tallahassee, Florida, United States, 32308
Clinical Research Trials of Florida, Inc. Recruiting
Tampa, Florida, United States, 33607
United States, Georgia
Atlanta Allergy & Asthma Clinic, PA Recruiting
Marietta, Georgia, United States, 30060
Atlanta Allergy & Asthma Clinic, PA Recruiting
Stockbridge, Georgia, United States, 30281
United States, Idaho
Treasure Valley Medical Research Recruiting
Boise, Idaho, United States, 83706
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Kentucky
Allergy & Asthma Specialists, PSC Recruiting
Owensboro, Kentucky, United States, 42301
United States, Michigan
University of Michigan Medicine Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Clinical Research Institute, Inc. Recruiting
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
United States, New Jersey
Atlantic Research Center, LLC Recruiting
Ocean City, New Jersey, United States, 07712
United States, North Carolina
American Health Research Recruiting
Charlotte, North Carolina, United States, 28207
Clinical Research of Charlotte Recruiting
Charlotte, North Carolina, United States, 28277
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Bernstein Clinical Research Center, LLC Recruiting
Cincinnati, Ohio, United States, 45231
United States, Oklahoma
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC Recruiting
Oklahoma City, Oklahoma, United States, 73131
United States, Oregon
Crisor, LLC Recruiting
Medford, Oregon, United States, 97504
United States, Pennsylvania
Allergy and Clinical Immunology Associates Recruiting
Pittsburgh, Pennsylvania, United States, 15241
Pediatric Alliance, P.C., Division of Allergy, Asthma & Immunology Recruiting
Wexford, Pennsylvania, United States, 15090
Berks Schuylkill Respiratory Specialists, Ltd. Recruiting
Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
AAPRI Clinical Research Institute Recruiting
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Carolina Research Recruiting
Orangeburg, South Carolina, United States, 29118
United States, Texas
Cosicana Medical Research, LLC Recruiting
Corsicana, Texas, United States, 75110
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Allergy and Asthma Research Center, PA Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
Pulmonary Research of Abingdon, LLC Recruiting
Abingdon, Virginia, United States, 24210
United States, Washington
MultiCare Institute for Research & Innovation Recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research Recruiting
Madison, Wisconsin, United States, 53792-9988
Austria
Ordination Dr. Robert Voves Recruiting
Feldbach, Austria, 8330
Kepler University Hospital GmbH, Med Campus III, Department of Pneumology Recruiting
Linz, Austria
SALK University Hospital Salzburg, State Hospital Salzburg Recruiting
Salzburg, Austria
Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog Recruiting
Vienna, Austria
Belgium
UCL Saint-Luc - Pneumology Department Recruiting
Bruxelles, Belgium
Pneumocare sprl Recruiting
Erpent, Belgium
UZ Gent - Department of Respiratory Medicine Recruiting
Gent, Belgium
CHU de Charleroi - Site André Vésale Recruiting
Montigny-le-Tilleul, Belgium
Canada, Ontario
Inspiration Research Limited Recruiting
Toronto, Ontario, Canada, M5T 3A9
Canada, Quebec
Allergiste & Immunologue - Clinic/Outpatient Facility Recruiting
Montreal, Quebec, Canada, H3G 1L5
C.I.C. Mauricie Inc. Recruiting
Trois-Rivières, Quebec, Canada, G8T 7A1
Canada
The Lung Centre, Vancouver General Hospital Recruiting
Vancouver, Canada
Czechia
St. Anne's University Hospital Brno, Institute of Clinical Immunology and Allergology Recruiting
Brno, Czechia
University Hospital Hradec Kralove, Institute of Clinical Immunology and Allergollogy Recruiting
Hradec Kralove, Czechia
MediTrial s.r.o. Recruiting
Jindrichuv Hradec, Czechia, 37701
PNEUMO-KV s.r.o. Recruiting
Karlovy Vary, Czechia, 36017
Pulmonary Outpatient Clinic - Dr. Otakar Hokynar Recruiting
Kralupy nad Vltavou, Czechia, 27801
Medicon a.s. Recruiting
Praha 4, Czechia
Pulmonary Outpatient Clinic Rokycany s.r.o. Recruiting
Rokycany, Czechia, 33722
Outpatient Allergology and Neurology Clinic Kasmed Ltd. Recruiting
Tábor, Czechia, 39002
France
La Croix Rousse Hospital Recruiting
Lyon, France
Nord G&R Laennec Hospital Recruiting
Nantes, France
Bichat-Claude Bernard Hospital Recruiting
Paris, France
CIC of pneumology, Francois Magendie Center - Haut-Leveque Hospital Recruiting
Pessac, France
Centre Hospitalier Annecy Genevois Recruiting
Pringy, France
Germany
RCMS Dr. Linhoff Recruiting
Berlin, Germany, 10717
Institut fuer Allergie - und Asthmaforschung Recruiting
Berlin, Germany, 12159
IKF Pneumologie GmbH & Co. KG Recruiting
Frankfurt am Main, Germany, 60596
Pneumologicum im Suedstadtforum Recruiting
Hannover, Germany, 30173
Schmid Recruiting
Koblenz, Germany, 56068
BAG Prof. Hoheisel/Dr. A. Bonitz Recruiting
Leipzig, Germany, 04275
KLB Gesundheitsforschung Luebeck GmbH Recruiting
Luebeck, Germany, 23552
Spain
Hospital Clinico Universitario de Santiago de Compostela Recruiting
Santiago De Compostela, A Coruna, Spain, 15706
Hospital Universitario de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Universitario Fundacion Alcorcon Recruiting
Alcorcon, Madrid, Spain, 28922
Instituto de Ciencias Medicas Recruiting
Alicante, Spain, 03004
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain
Hospital Universitario Doctor Peset Recruiting
Valencia, Spain, 46017
Hospital Universitari I Politecnic La Fe Recruiting
Valencia, Spain
Ukraine
Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council Recruiting
Dnipro, Ukraine, 49006
Public Non-Profit Enterprise: City Clinical Hospital #13 under Kharkiv City Council Recruiting
Kharkiv, Ukraine
State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU" Recruiting
Kyiv, Ukraine, 03680
State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU" Recruiting
Kyiv, Ukraine
Public Institution: City Clinical Hospital #6 Recruiting
Zaporizhia, Ukraine, 69035
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom
Bradford Royal Infirmary Recruiting
Bradford, United Kingdom
Glasgow Clinical Research Facility, Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom
University Hospital Southampton Recruiting
Southampton, United Kingdom
Sponsors and Collaborators
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

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Responsible Party: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier: NCT03683576     History of Changes
Other Study ID Numbers: GB001-2001
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gossamer Bio Inc. ( GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. ):
GB001
eosinophilic asthma
moderate asthma
severe asthma

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases