Clinical trial NCT03956862: GB001 in Adult Participants With Chronic Rhinosinusitis
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Effect of GB001 in Patients With Chronic Rhinosinusitis With or Without Nasal Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Keywords: GB001
Gossamer Bio
Gossamer
Nasal Polyposis
CRSwNP
CRSsNP
Lead sponsor: Gossamer Bio Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-21
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without nasal polyposis (NP).


Eligibility criteria: Inclusion Criteria:

* A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic rhinosinusitis without nasal polyps (CRSsNP) by a physician at least 12 weeks before Screening Visit
* 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:

* Sino-Nasal Outcome Test-22 (SNOT-22) score \< 20 at screening
* 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

Other protocol-defined inclusion/exclusion criteria will apply.

Primary outcomes:
measure: Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline to Week 16 in Lund-Mackay Score
timeFrame: Baseline, Week 16
measure: Change From Baseline to Week 16 in Nasal Polyp Score (NPS)
timeFrame: Baseline, Week 16
measure: Time to First Response in NPS
timeFrame: up to Week 16
measure: Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score
timeFrame: Baseline, Week 16
measure: Change From Baseline to Week 16 in AM Total Symptom Score (TSS)
timeFrame: Baseline, Week 16
measure: Change From Baseline to Week 16 in University of Pennsylvania Smell Identification Test (UPSIT) Score
timeFrame: Baseline, Week 16
measure: Time to First Chronic Rhinosinusitis (CRS) Exacerbation
timeFrame: up to Week 16
measure: Percentage of Participants With a Treatment-Emergent Adverse Event (AE)
timeFrame: From first dose of study drug through Week 20
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University of Arizona Medical Center
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Roseville
country: United States
facility: Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
state: California
city: Stockton
country: United States
facility: Bensch Clinical Research LLC
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: ChicagoENT
state: Illinois
city: Des Moines
country: United States
facility: Iowa Head & Neck, PC
state: Iowa
city: Louisville
country: United States
facility: Kentuckiana Ear, Nose, and Throat
state: Kentucky
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research LLC
state: Louisiana
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Bellevue
country: United States
facility: Nebraska Medical Research Institute, Inc.
state: Nebraska
city: Albuquerque
country: United States
facility: BreatheAmerica Albuquerque
state: New Mexico
city: New Hyde Park
country: United States
facility: Northwell Health at ENT and Allergy Associates
state: New York
city: New York
country: United States
facility: Northwell Health at ENT and Allergy Associates
state: New York
city: Rochester
country: United States
facility: University of Rochester Medicine Otolaryngology
state: New York
city: White Plains
country: United States
facility: Northwell Health at ENT and Allergy Associates
state: New York
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Bethlehem
country: United States
facility: Specialty Physician Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Department of Otolaryngology
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, Department of Otolaryngology
state: South Carolina
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Medical Plaza
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Richmond
country: United States
facility: Advanced Otolaryngology, P.C. DBA Richmond Ear, Nose and Throat
state: Virginia
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove, Department of Otorhinolaryngology and Head and Neck Surgery
city: Olomouc
country: Czechia
facility: ENT Outpatient Clinic Pavel Navratil
city: Praha 4
country: Czechia
facility: Medicon a.s.
city: Rokycany
country: Czechia
facility: Pulmonary Outpatient Clinic Rokycany s.r.o.
city: Dnipro
country: Ukraine
facility: Public Non-Profit Enterprise "Clinical Hospital of Emergency Medical Care" under Dnipro City Council
city: Kharkiv
country: Ukraine
facility: Public Non-Profit Enterprise under KRC "Regional Clinical Specialized Center for Radiation Protection of the Public"
city: Kyiv
country: Ukraine
facility: State Institution "O.S. Kolomiychenko Institute of Otolaryngology of National Academy of Medical Sciences of Ukraine"
city: Ternopil'
country: Ukraine
facility: Municipal Non-commercial Enterprise "Ternopil Municipal City Hospital #2"
city: Zaporizhia
country: Ukraine
facility: Public Non-Profit Enterprise "City Hospital #3" under Zaporizhia City Council
Study officials:
References: