Back to resultsGB001 in Adult Participants With Chronic Rhinosinusitis
Primary Purpose
Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GB001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) focused on measuring GB001, Gossamer Bio, Gossamer, Nasal Polyposis, CRSwNP, CRSsNP
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.
Sites / Locations
- Banner University of Arizona Medical Center
- NEA Baptist Clinic
- Cedars-Sinai Medical Center
- Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
- Bensch Clinical Research LLC
- Yale School of Medicine
- Emory University
- Rush University Medical Center
- ChicagoENT
- Iowa Head & Neck, PC
- Kentuckiana Ear, Nose, and Throat
- Advanced ENT and Allergy
- Tandem Clinical Research LLC
- Chesapeake Clinical Research, Inc.
- Brigham and Women's Hospital
- Nebraska Medical Research Institute, Inc.
- BreatheAmerica Albuquerque
- Northwell Health at ENT and Allergy Associates
- Northwell Health at ENT and Allergy Associates
- University of Rochester Medicine Otolaryngology
- Northwell Health at ENT and Allergy Associates
- Vital Prospects Clinical Research Institute, P.C.
- Specialty Physician Associates
- Thomas Jefferson University Department of Otolaryngology
- Medical University of South Carolina, Department of Otolaryngology
- AARA Research Center
- Memorial Hermann Medical Plaza
- Eastern Virginia Medical School
- Advanced Otolaryngology, P.C. DBA Richmond Ear, Nose and Throat
- University Hospital Hradec Kralove, Department of Otorhinolaryngology and Head and Neck Surgery
- ENT Outpatient Clinic Pavel Navratil
- Medicon a.s.
- Pulmonary Outpatient Clinic Rokycany s.r.o.
- Public Non-Profit Enterprise "Clinical Hospital of Emergency Medical Care" under Dnipro City Council
- Public Non-Profit Enterprise under KRC "Regional Clinical Specialized Center for Radiation Protection of the Public"
- State Institution "O.S. Kolomiychenko Institute of Otolaryngology of National Academy of Medical Sciences of Ukraine"
- Municipal Non-commercial Enterprise "Ternopil Municipal City Hospital #2"
- Public Non-Profit Enterprise "City Hospital #3" under Zaporizhia City Council
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GB001
Placebo
Arm Description
GB001 40 mg once per day (QD) for 16 weeks
Placebo QD for 16 weeks
Outcomes
Primary Outcome Measures
Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score
The SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis (CRS) on quality of life and utilizes a 2-week recall period. It is a 22-item outcome measure on a 5-point category scale applicable to sinonasal conditions and surgical treatments. The total scores range from 0 to 110 with higher total scores implying greater impact of CRS on quality of life.
Secondary Outcome Measures
Change From Baseline to Week 16 in Lund-Mackay Score
Lund-Mackay scores are based on centralized imaging data assessments and are scored by blinded central reading at the imaging core laboratory. The Lund-Mackay system is based on localization with points given for degree of opacification: 0=normal, 1=partial opacification, 2=total opacification. These points are then applied to each sinus (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus) on each side. The osteomeatal complex on each side is graded as 0=not occluded, or 2=occluded. The maximum score is 12 per side, for a total score ranging from 0 to 24.
Change From Baseline to Week 16 in Nasal Polyp Score (NPS)
The bilateral endoscopic NPS is the sum of the right and left nostril scores, as evaluated by means of blinded, centrally read nasal endoscopy and ranges from 0 to 8. NP is graded based on polyp size: 0 = No polyps, 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = Polyps reaching below the lower border of the middle turbinate, 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = Large polyps causing complete obstruction of the inferior nasal cavity.
Time to First Response in NPS
Response was defined as ≥ 1-point improvement from baseline.
The bilateral endoscopic NPS is the sum of the right and left nostril scores, as evaluated by means of blinded, centrally read nasal endoscopy and ranges from 0-8. NP is graded based on polyp size: 0 = No polyps, 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = Polyps reaching below the lower border of the middle turbinate, 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = Large polyps causing complete obstruction of the inferior nasal cavity.
Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score
AM NC score was assessed using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms).
Change From Baseline to Week 16 in AM Total Symptom Score (TSS)
AM TSS is the sum of the scores from the 4 AM symptom categories (congestion and/or obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of sense of smell) and ranges from 0-12. Each symptom category was assessed using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms).
Change From Baseline to Week 16 in University of Pennsylvania Smell Identification Test (UPSIT) Score
The UPSIT test consists of four booklets, each containing 10 odorants with one odorant per page. The test-time is about 15 minutes. The stimuli are embedded in 10-50 μm diameter plastic microcapsules on brown strips at the bottom of each page. Above each odorant strip is a multiple-choice question with four alternative words to describe the odor. The participant is asked to release the odorant by rubbing the brown-strip with the tip of a pencil and to indicate which of 4 words best describes the odor. An UPSIT result is scored from 0 to 40 where a higher score indicates better olfaction.
Time to First Chronic Rhinosinusitis (CRS) Exacerbation
Chronic rhinosinusitis exacerbation is defined as deterioration of CRS symptoms requiring treatment with an antibiotic, an anti-inflammatory drug, or a symptom reliever; an Emergency Department visit; or hospitalization.
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 drug. 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.
Full Information
NCT ID
NCT03956862
First Posted
May 17, 2019
Last Updated
August 19, 2021
Sponsor
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03956862
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
July 9, 2020 (Actual)
Study Completion Date
August 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Keywords
GB001, Gossamer Bio, Gossamer, Nasal Polyposis, CRSwNP, CRSsNP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GB001
Arm Type
Experimental
Arm Description
GB001 40 mg once per day (QD) for 16 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo QD for 16 weeks
Intervention Type
Drug
Intervention Name(s)
GB001
Intervention Description
film-coated oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
film-coated oral tablet
Primary Outcome Measure Information:
Title
Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score
Description
The SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis (CRS) on quality of life and utilizes a 2-week recall period. It is a 22-item outcome measure on a 5-point category scale applicable to sinonasal conditions and surgical treatments. The total scores range from 0 to 110 with higher total scores implying greater impact of CRS on quality of life.
Time Frame
Baseline, Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 16 in Lund-Mackay Score
Description
Lund-Mackay scores are based on centralized imaging data assessments and are scored by blinded central reading at the imaging core laboratory. The Lund-Mackay system is based on localization with points given for degree of opacification: 0=normal, 1=partial opacification, 2=total opacification. These points are then applied to each sinus (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus) on each side. The osteomeatal complex on each side is graded as 0=not occluded, or 2=occluded. The maximum score is 12 per side, for a total score ranging from 0 to 24.
Time Frame
Baseline, Week 16
Title
Change From Baseline to Week 16 in Nasal Polyp Score (NPS)
Description
The bilateral endoscopic NPS is the sum of the right and left nostril scores, as evaluated by means of blinded, centrally read nasal endoscopy and ranges from 0 to 8. NP is graded based on polyp size: 0 = No polyps, 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = Polyps reaching below the lower border of the middle turbinate, 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = Large polyps causing complete obstruction of the inferior nasal cavity.
Time Frame
Baseline, Week 16
Title
Time to First Response in NPS
Description
Response was defined as ≥ 1-point improvement from baseline.
The bilateral endoscopic NPS is the sum of the right and left nostril scores, as evaluated by means of blinded, centrally read nasal endoscopy and ranges from 0-8. NP is graded based on polyp size: 0 = No polyps, 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = Polyps reaching below the lower border of the middle turbinate, 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = Large polyps causing complete obstruction of the inferior nasal cavity.
Time Frame
up to Week 16
Title
Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score
Description
AM NC score was assessed using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms).
Time Frame
Baseline, Week 16
Title
Change From Baseline to Week 16 in AM Total Symptom Score (TSS)
Description
AM TSS is the sum of the scores from the 4 AM symptom categories (congestion and/or obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of sense of smell) and ranges from 0-12. Each symptom category was assessed using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms).
Time Frame
Baseline, Week 16
Title
Change From Baseline to Week 16 in University of Pennsylvania Smell Identification Test (UPSIT) Score
Description
The UPSIT test consists of four booklets, each containing 10 odorants with one odorant per page. The test-time is about 15 minutes. The stimuli are embedded in 10-50 μm diameter plastic microcapsules on brown strips at the bottom of each page. Above each odorant strip is a multiple-choice question with four alternative words to describe the odor. The participant is asked to release the odorant by rubbing the brown-strip with the tip of a pencil and to indicate which of 4 words best describes the odor. An UPSIT result is scored from 0 to 40 where a higher score indicates better olfaction.
Time Frame
Baseline, Week 16
Title
Time to First Chronic Rhinosinusitis (CRS) Exacerbation
Description
Chronic rhinosinusitis exacerbation is defined as deterioration of CRS symptoms requiring treatment with an antibiotic, an anti-inflammatory drug, or a symptom reliever; an Emergency Department visit; or hospitalization.
Time Frame
up to Week 16
Title
Percentage of Participants With a Treatment-Emergent Adverse Event (AE)
Description
An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to study drug. 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.
Time Frame
From first dose of study drug through Week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Banner University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Bensch Clinical Research LLC
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
ChicagoENT
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Iowa Head & Neck, PC
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50312
Country
United States
Facility Name
Kentuckiana Ear, Nose, and Throat
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Advanced ENT and Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tandem Clinical Research LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Nebraska Medical Research Institute, Inc.
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
BreatheAmerica Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Northwell Health at ENT and Allergy Associates
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Northwell Health at ENT and Allergy Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester Medicine Otolaryngology
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Northwell Health at ENT and Allergy Associates
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, P.C.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Specialty Physician Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Thomas Jefferson University Department of Otolaryngology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina, Department of Otolaryngology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Memorial Hermann Medical Plaza
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Advanced Otolaryngology, P.C. DBA Richmond Ear, Nose and Throat
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
University Hospital Hradec Kralove, Department of Otorhinolaryngology and Head and Neck Surgery
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Facility Name
ENT Outpatient Clinic Pavel Navratil
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Medicon a.s.
City
Praha 4
ZIP/Postal Code
14046
Country
Czechia
Facility Name
Pulmonary Outpatient Clinic Rokycany s.r.o.
City
Rokycany
ZIP/Postal Code
33722
Country
Czechia
Facility Name
Public Non-Profit Enterprise "Clinical Hospital of Emergency Medical Care" under Dnipro City Council
City
Dnipro
ZIP/Postal Code
49006
Country
Ukraine
Facility Name
Public Non-Profit Enterprise under KRC "Regional Clinical Specialized Center for Radiation Protection of the Public"
City
Kharkiv
ZIP/Postal Code
61166
Country
Ukraine
Facility Name
State Institution "O.S. Kolomiychenko Institute of Otolaryngology of National Academy of Medical Sciences of Ukraine"
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Municipal Non-commercial Enterprise "Ternopil Municipal City Hospital #2"
City
Ternopil'
ZIP/Postal Code
46023
Country
Ukraine
Facility Name
Public Non-Profit Enterprise "City Hospital #3" under Zaporizhia City Council
City
Zaporizhia
ZIP/Postal Code
69032
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GB001 in Adult Participants With Chronic Rhinosinusitis
We'll reach out to this number within 24 hrs