GB001 in Adult Participants With Chronic Rhinosinusitis
NCT ID: NCT03956862
Last Updated: 2021-08-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
97 participants
INTERVENTIONAL
2019-05-16
2020-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GB001
GB001 40 mg once per day (QD) for 16 weeks
GB001
film-coated oral tablet
Placebo
Placebo QD for 16 weeks
Placebo
film-coated oral tablet
Interventions
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GB001
film-coated oral tablet
Placebo
film-coated oral tablet
Eligibility Criteria
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Inclusion Criteria
* Treated with stable intranasal corticosteroid (INCS) for at least 2 months prior to Screening Visit
* Presence of at least 2 nasal symptoms: nasal blockage/ obstruction/congestion or nasal discharge or facial pain/pressure or reduction/loss of smell
* Women of childbearing potential must use an acceptable method of contraception
Exclusion Criteria
* Asthma or chronic obstructive pulmonary disease (COPD) patients that are current smokers
* Use of other investigational drugs within 30 days, or within 5 half-lives, whichever is longer, prior to Screening Visit
* Pregnant or breastfeeding
* Pre-existing clinically important co-morbidities
* Regular use of systemic corticosteroids or immunosuppressive treatments
18 Years
75 Years
ALL
No
Sponsors
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GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
INDUSTRY
Responsible Party
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Locations
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Banner University of Arizona Medical Center
Tucson, Arizona, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
Roseville, California, United States
Bensch Clinical Research LLC
Stockton, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
ChicagoENT
Chicago, Illinois, United States
Iowa Head & Neck, PC
Des Moines, Iowa, United States
Kentuckiana Ear, Nose, and Throat
Louisville, Kentucky, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Tandem Clinical Research LLC
Marrero, Louisiana, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Nebraska Medical Research Institute, Inc.
Bellevue, Nebraska, United States
BreatheAmerica Albuquerque
Albuquerque, New Mexico, United States
Northwell Health at ENT and Allergy Associates
New Hyde Park, New York, United States
Northwell Health at ENT and Allergy Associates
New York, New York, United States
University of Rochester Medicine Otolaryngology
Rochester, New York, United States
Northwell Health at ENT and Allergy Associates
White Plains, New York, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Specialty Physician Associates
Bethlehem, Pennsylvania, United States
Thomas Jefferson University Department of Otolaryngology
Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Department of Otolaryngology
Charleston, South Carolina, United States
AARA Research Center
Dallas, Texas, United States
Memorial Hermann Medical Plaza
Houston, Texas, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Advanced Otolaryngology, P.C. DBA Richmond Ear, Nose and Throat
Richmond, Virginia, United States
University Hospital Hradec Kralove, Department of Otorhinolaryngology and Head and Neck Surgery
Hradec Králové, , Czechia
ENT Outpatient Clinic Pavel Navratil
Olomouc, , Czechia
Medicon a.s.
Prague, , Czechia
Pulmonary Outpatient Clinic Rokycany s.r.o.
Rokycany, , Czechia
Public Non-Profit Enterprise "Clinical Hospital of Emergency Medical Care" under Dnipro City Council
Dnipro, , Ukraine
Public Non-Profit Enterprise under KRC "Regional Clinical Specialized Center for Radiation Protection of the Public"
Kharkiv, , Ukraine
State Institution "O.S. Kolomiychenko Institute of Otolaryngology of National Academy of Medical Sciences of Ukraine"
Kyiv, , Ukraine
Municipal Non-commercial Enterprise "Ternopil Municipal City Hospital #2"
Ternopil, , Ukraine
Public Non-Profit Enterprise "City Hospital #3" under Zaporizhia City Council
Zaporizhia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-001682-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GB001-2101
Identifier Type: -
Identifier Source: org_study_id
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