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NCT03683576 | COMPLETED | Asthma


GB001 in Adult Subjects With Moderate to Severe Asthma
Sponsor:

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

Asthma

Intervention/treatment

GB001

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 481 participants
Masking : DOUBLE
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 : 2018-10-22
Estimated Primary Completion Date : 2020-07-23
Estimated Study Completion Date : 2020-08-18

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 74 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

  • GB001 in Adult Subjects With Moderate to Severe Asthma

    Location Details

    NCT03683576


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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations


    Not yet recruiting

    United States, alabama

    Clinical Research Center of Albama, LLC

    Birmingham, alabama, United States, 35209

    Not yet recruiting

    United States, Arizona

    Banner University of Arizona Medical Center

    Tucson, arizona, United States, 85724

    Not yet recruiting

    United States, California

    California Allergy and Asthma Medical Group

    Los Angeles, California, United States, 90025

    Not yet recruiting

    United States, California

    Southern California Institute for Respiratory Diseases, Inc.

    Los Angeles, California, United States, 90048

    Not yet recruiting

    United States, California

    North Bay Clinical Trials, Inc

    Napa, California, United States, 94558

    Not yet recruiting

    United States, California

    Allergy, Asthma & Sinus Consultants, Inc

    Riverside, California, United States, 92506

    Not yet recruiting

    United States, California

    Integrated Research of Inland, Inc.

    Riverside, California, United States, 92506

    Not yet recruiting

    United States, California

    Allergy & Asthma Medical Group and Research Center, A P.C.

    San Diego, California, United States, 92123

    Not yet recruiting

    United States, California

    Allergy and Asthma Associates of Santa Clara Valley Research Center

    San Jose, California, United States, 95117

    Not yet recruiting

    United States, California

    Bensch Clinical Research LLC

    Stockton, California, United States, 95207

    Not yet recruiting

    United States, Colorado

    Pulmonary Associates

    Colorado Springs, Colorado, United States, 80909

    Not yet recruiting

    United States, Connecticut

    Yale New Haven Hospital

    New Haven, Connecticut, United States, 06519

    Not yet recruiting

    United States, Florida

    Central Florida Pulmonary Group, PA

    Altamonte Springs, florida, United States, 32701

    Not yet recruiting

    United States, Florida

    Central Florida Pulmonary Group, PA

    Orlando, florida, United States, 32803

    Not yet recruiting

    United States, Florida

    Emerald Coast Research Associates

    Panama City, florida, United States, 32405

    Not yet recruiting

    United States, Florida

    Allergy and Asthma Diagnostic Treatment Center

    Tallahassee, florida, United States, 32308

    Not yet recruiting

    United States, Florida

    Clinical Research Trials of Florida, Inc.

    Tampa, florida, United States, 33607

    Not yet recruiting

    United States, Georgia

    The Emory Clinic

    Atlanta, Georgia, United States, 30322

    Not yet recruiting

    United States, Georgia

    Atlanta Allergy & Asthma Clinic, PA,

    Marietta, Georgia, United States, 30060

    Not yet recruiting

    United States, Georgia

    Atlanta Allergy & Asthma Clinic, PA

    Stockbridge, Georgia, United States, 30281

    Not yet recruiting

    United States, Idaho

    Treasure Valley Medical Research

    Boise, Idaho, United States, 83706

    Not yet recruiting

    United States, Illinois

    Rush University Medical Center

    Chicago, Illinois, United States, 60612

    Not yet recruiting

    United States, Kentucky

    Allergy & Asthma Specialists, PSC

    Owensboro, Kentucky, United States, 42301

    Not yet recruiting

    United States, Maryland

    John Hopkins Asthma and Allergy Center

    Baltimore, Maryland, United States, 21224

    Not yet recruiting

    United States, Massachusetts

    Brigham and Women's Hospital

    Boston, Massachusetts, United States, 02115

    Not yet recruiting

    United States, road cancer

    University of Michigan Medicine

    Ann Arbor, road cancer, United States, 48109

    Not yet recruiting

    United States, Minnesota

    Clinical Research Institute, Inc.

    Minneapolis, Minnesota, United States, 55402

    Not yet recruiting

    United States, Missouri

    Washington University School of Medicine

    St. Louis, Missouri, United States, 63108

    Not yet recruiting

    United States, New Jersey

    Atlantic Research Center, LLC

    Ocean City, New Jersey, United States, 07712

    Not yet recruiting

    United States, North Carolina

    American Health Research

    Charlotte, North Carolina, United States, 28207

    Not yet recruiting

    United States, North Carolina

    Clinical Research of Charlotte

    Charlotte, North Carolina, United States, 28277

    Not yet recruiting

    United States, North Carolina

    Wake Forest Baptist Health

    Winston-Salem, North Carolina, United States, 27104

    Not yet recruiting

    United States, Ohio

    Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, United States, 45231

    Not yet recruiting

    United States, Ohio

    Cleveland Clinic

    Cleveland, Ohio, United States, 44195

    Not yet recruiting

    United States, Oklahoma

    Oklahoma Institute of Allergy & Asthma Clinical Research, LLC

    Oklahoma City, Oklahoma, United States, 73131

    Not yet recruiting

    United States, Oregon

    Crisor, LLC

    Medford, Oregon, United States, 97504

    Not yet recruiting

    United States, Pennsylvania

    Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, United States, 15241

    Not yet recruiting

    United States, Pennsylvania

    Berks Schuylkill Respiratory Specialists, Ltd.

    Wyomissing, Pennsylvania, United States, 19610

    Not yet recruiting

    United States, Rhode Island

    AAPRI Clinical Research Institute

    Warwick, Rhode Island, United States, 02886

    Not yet recruiting

    United States, South Carolina

    Clinical Research of Rock Hill

    Rock Hill, South Carolina, United States, 29732

    Not yet recruiting

    United States, Texas

    Corsicana Medical Research, LLC

    Corsicana, Texas, United States, 75110

    Not yet recruiting

    United States, Texas

    Western Sky Medical Research

    El Paso, Texas, United States, 79903

    Not yet recruiting

    United States, Texas

    Baylor College of Medicine

    Houston, Texas, United States, 77030

    Not yet recruiting

    United States, Texas

    Allergy and Asthma Research Center, PA

    Saint Anthony, Texas, United States, 78229

    Not yet recruiting

    United States, Virginia

    Pulmonary Research of Abingdon, LLC

    Abingdon, Virginia, United States, 24210

    Not yet recruiting

    United States, Washington

    MultiCare Institute for Research & Innovation

    tacoma, Washington, United States, 98405

    Not yet recruiting

    United States, Wisconsin

    University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

    Madison, Wisconsin, United States, 53792-9988

    Not yet recruiting

    Austria,

    Ordination Dr. Robert Voves

    Feldbach, Austria, 8330

    Not yet recruiting

    Austria,

    SALK University Hospital Salzburg, State Hospital Salzburg

    Salzburg, Austria,

    Not yet recruiting

    Austria,

    Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog

    Vienna, Austria,

    Not yet recruiting

    Belgium,

    UCL Saint-Luc - Pneumology Department

    Bruxelles, Belgium,

    Not yet recruiting

    Belgium,

    Pneumocare sprl

    Erpent, Belgium,

    Not yet recruiting

    Belgium,

    UZ Gent - Department of Respiratory Medicine

    Gent, Belgium,

    Not yet recruiting

    Belgium,

    Charleroi University Hospital - André Vésale Site

    Montigny-le-Tilleul, Belgium,

    Not yet recruiting

    Canada, Ontario

    Inspiration Research Limited

    Toronto, Ontario, Canada, His brain is disobedient

    Not yet recruiting

    Canada, Quebec

    CHUM - Department of pneumology

    Montreal, Quebec, Canada, H2X 3E4

    Not yet recruiting

    Canada, Quebec

    Allergiste & Immunologue - Clinic/Outpatient Facility

    Montreal, Quebec, Canada, H3G 1L5

    Not yet recruiting

    Canada,

    Integrated university health and social services center of Nord-de-I'lle-de-Montreal - Hopital du Sacre-Coeur de Montreal

    Montréal, Canada,

    Not yet recruiting

    Canada,

    Dr. Jamie Del Carpio's Clinic

    Montréal, Canada,

    Not yet recruiting

    Canada,

    Inspirational Research Limited

    Toronto, Canada,

    Not yet recruiting

    Canada,

    C. I. C Mauricie Inc.

    Trois-Rivières, Canada,

    Not yet recruiting

    Canada,

    The Lung Centre, Vancouver General Hospital

    Vancouver, Canada,

    Not yet recruiting

    Czechia,

    St. Anne's University Hospital Brno, Institute of Clinical Immunology and Allergology

    Brno, Czechia,

    Not yet recruiting

    Czechia,

    University Hospital Hradec Kralove, Institute of Clinical Immunology and Allergollogy

    Hradec Kralove, Czechia,

    Not yet recruiting

    Czechia,

    MediTrial s.r.o.

    jindrichuv hradek, Czechia, 37701

    Not yet recruiting

    Czechia,

    TIRE-KV s.r.o.

    Karlovy Vary, Czechia, 36017

    Not yet recruiting

    Czechia,

    Pulmonary Patient Clinic - Dr. Atyaka Chakinar

    Kralupy nad Vltava, Czechia, 27801

    Not yet recruiting

    Czechia,

    University Hospital Olomouc, Department of Allergology and Clinical Immunology

    Olomouc, Czechia, 779 00

    Not yet recruiting

    Czechia,

    Medicon a.s.

    Prague 4, Czechia,

    Not yet recruiting

    Czechia,

    Pulmonary Outpatient Clinic Rokycany s.r.o.

    Rokycans, Czechia, 33722

    Not yet recruiting

    Czechia,

    Outpatient Allergology and Neurology Clinic Kasmed Ltd.

    Camp, Czechia, 39002

    Not yet recruiting

    France,

    La Croix Rousse Hospital

    Lyon, France,

    Not yet recruiting

    France,

    Nord G&R Laennec Hospital

    Nantes, France,

    Not yet recruiting

    France,

    Annecy Geneva Hospital Center

    Pringy, France,

    Not yet recruiting

    France,

    NOUVEL HOPITAL CIVIL - New Civil Hospital

    Strasbourg, France, 67091

    Not yet recruiting

    Germany, Saarland

    Saarland University Hospital, Department of Internal Medicine V

    Homburg, Saarland, Germany, 66421

    Not yet recruiting

    Germany,

    RCMS Dr. Linhoff

    Berlin, Germany, 10717

    Not yet recruiting

    Germany,

    Pneumological Study Center Margrafenstrasse

    Berlin, Germany, 10969

    Not yet recruiting

    Germany,

    Institute for Allergy and Asthma Research

    Berlin, Germany, 12159

    Not yet recruiting

    Germany,

    Pneumology practice at the castle

    Berlin, Germany,

    Not yet recruiting

    Germany,

    IKF Pneumologie GmbH & Co. KG

    Frankfurt am Main, Germany, 60596

    Not yet recruiting

    Germany,

    Pneumologicum im Suedstadtforum

    Hannover, Germany, 30173

    Not yet recruiting

    Germany,

    Schmid

    Koblenz, Germany, 56068

    Not yet recruiting

    Germany,

    BAG Prof. Hoheisel/Dr. A. Bonitz

    Leipzig, Germany, 04275

    Not yet recruiting

    Germany,

    Pulmonological practice PD Dr. med.

    Leipzig, Germany,

    Not yet recruiting

    Germany,

    KLB Health Research Luebeck GmbH

    Luebeck, Germany, 23552

    Not yet recruiting

    Germany,

    University Medicine of the Johannes Gutenberg University Mainz - Hospital

    Mainz, Germany,

    Not yet recruiting

    Poland,

    Mroz Respiratory Medicine Center sp. j.

    Białystok, Poland,

    Not yet recruiting

    Poland,

    Malopolska Allergology Center

    Cracow, Poland,

    Not yet recruiting

    Poland,

    Private Health Care Facility (NZOZ)

    Cracow, Poland,

    Not yet recruiting

    Poland,

    Ostrowiec Medical Center

    Ostrowiec Świętokrzyski, Poland,

    Not yet recruiting

    Poland,

    SPZOZ Proszowice

    Proszowice, Poland,

    Not yet recruiting

    Poland,

    Zenon Bukowczan Medical Office

    Sucha Beskidzka, Poland,

    Not yet recruiting

    Poland,

    ALL-MED - Specialized Medical Care - Medical Research Institute Marek Jutel

    Wrocław, Poland,

    Not yet recruiting

    Poland,

    Melita Medical Center

    Wrocław, Poland,

    Not yet recruiting

    Poland,

    NZOZ Specialist Doctors

    Wrocław, Poland,

    Not yet recruiting

    Poland,

    SPZOZ University Clinical Hospital No. 1

    Łódź, Poland,

    Not yet recruiting

    Spain, The Crown

    University Clinical Hospital of Santiago de Compostela

    Santiago de Compostela, A Coruna, Spain, 15706

    Not yet recruiting

    Spain, Barcelona

    Bellvitge University Hospital

    L'Hospitalet de Llobregat, Barcelona, Spain, 08907

    Not yet recruiting

    Spain,

    Institute of Medical Sciences

    Alicante, Spain, 03004

    Not yet recruiting

    Spain,

    Hospital Clinic of Barcelona

    Barcelona, Spain,

    Not yet recruiting

    Spain,

    Vall d'Hebron University Hospital

    Barcelona, Spain,

    Not yet recruiting

    Spain,

    Doctor Peset University Hospital

    Valencia, Spain, 46017

    Not yet recruiting

    Ukraine,

    Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council

    Dnipro, Ukraine, 49006

    Not yet recruiting

    Ukraine,

    Public Institution "City Clinical Hospital #4" under Dnipro City Council

    Dnipro, Ukraine, 49102

    Not yet recruiting

    Ukraine,

    Ivano-Frankivsk Central City Clinical Hospital

    Ivano-Frankivsk, Ukraine, 76018

    Not yet recruiting

    Ukraine,

    Public Non-Profit Enterprise: City Clinical Hospital #13 under Kharkiv City Council

    Kharkiv, Ukraine,

    Not yet recruiting

    Ukraine,

    State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"

    Kyiv, Ukraine, 03680

    Not yet recruiting

    Ukraine,

    State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"

    Kyiv, Ukraine,

    Not yet recruiting

    Ukraine,

    Public Institution: City Clinical Hospital #6

    Zaporozhye, Ukraine, 69035

    Not yet recruiting

    Ukraine,

    Public Non-Profit Enterprise City Hospital #1 under Zaporizhia City Council

    Zaporozhye, Ukraine, 69104

    Not yet recruiting

    Ukraine,

    Public Enterprise "Hospital #1" under Zhytomyr City Council

    Zhytomyr, Ukraine, 10002

    Not yet recruiting

    United Kingdom,

    Birmingham Heartlands Hospital

    Birmingham, United Kingdom,

    Not yet recruiting

    United Kingdom,

    Bradford Royal Infirmary

    Bradford, United Kingdom,

    Not yet recruiting

    United Kingdom,

    Glasgow Clinical Research Facility, Glasgow Royal Infirmary

    Glasgow, United Kingdom,

    Not yet recruiting

    United Kingdom,

    Royal Liverpool University Hospital

    Liverpool, United Kingdom,

    Not yet recruiting

    United Kingdom,

    University Hospital Southampton

    Southampton, United Kingdom,

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