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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001682-33 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GB001 | Experimental | GB001 40 mg once per day (QD) for 16 weeks |
|
| Placebo | Placebo Comparator | Placebo QD for 16 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB001 | Drug | film-coated oral tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria will apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University of Arizona Medical Center | Tucson | Arizona | 85724 | United States | ||
| NEA Baptist Clinic |
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The study included a run-in period, during which eligibility for randomization was determined. 192 participants entered the run-in period, 97 of whom were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo once per day (QD) for 16 weeks |
| FG001 | GB001 | GB001 40 mg QD for 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2020 | Jul 6, 2021 |
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| Drug |
film-coated oral tablet |
|
| Baseline, Week 16 |
| 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. | Baseline, Week 16 |
| 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. | up to Week 16 |
| 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). | Baseline, Week 16 |
| 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). | Baseline, Week 16 |
| 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. | Baseline, Week 16 |
| 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. | up to Week 16 |
| 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. | From first dose of study drug through Week 20 |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Sacramento Ear Nose and Throat Surgical and Medical Group, Inc. | Roseville | California | 95661 | United States |
| Bensch Clinical Research LLC | Stockton | California | 95207 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06519 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| ChicagoENT | Chicago | Illinois | 60657 | United States |
| Iowa Head & Neck, PC | Des Moines | Iowa | 50312 | United States |
| Kentuckiana Ear, Nose, and Throat | Louisville | Kentucky | 40205 | United States |
| Advanced ENT and Allergy | Louisville | Kentucky | 40207 | United States |
| Tandem Clinical Research LLC | Marrero | Louisiana | 70072 | United States |
| Chesapeake Clinical Research, Inc. | White Marsh | Maryland | 21162 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Nebraska Medical Research Institute, Inc. | Bellevue | Nebraska | 68123 | United States |
| BreatheAmerica Albuquerque | Albuquerque | New Mexico | 87109 | United States |
| Northwell Health at ENT and Allergy Associates | New Hyde Park | New York | 11042 | United States |
| Northwell Health at ENT and Allergy Associates | New York | New York | 10016 | United States |
| University of Rochester Medicine Otolaryngology | Rochester | New York | 14618 | United States |
| Northwell Health at ENT and Allergy Associates | White Plains | New York | 10605 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| Specialty Physician Associates | Bethlehem | Pennsylvania | 18017 | United States |
| Thomas Jefferson University Department of Otolaryngology | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina, Department of Otolaryngology | Charleston | South Carolina | 29425 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Memorial Hermann Medical Plaza | Houston | Texas | 77030 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| Advanced Otolaryngology, P.C. DBA Richmond Ear, Nose and Throat | Richmond | Virginia | 23235 | United States |
| University Hospital Hradec Kralove, Department of Otorhinolaryngology and Head and Neck Surgery | Hradec Králové | 50005 | Czechia |
| ENT Outpatient Clinic Pavel Navratil | Olomouc | 77900 | Czechia |
| Medicon a.s. | Prague | 14046 | Czechia |
| Pulmonary Outpatient Clinic Rokycany s.r.o. | Rokycany | 33722 | Czechia |
| Public Non-Profit Enterprise "Clinical Hospital of Emergency Medical Care" under Dnipro City Council | Dnipro | 49006 | Ukraine |
| Public Non-Profit Enterprise under KRC "Regional Clinical Specialized Center for Radiation Protection of the Public" | Kharkiv | 61166 | Ukraine |
| State Institution "O.S. Kolomiychenko Institute of Otolaryngology of National Academy of Medical Sciences of Ukraine" | Kyiv | 03680 | Ukraine |
| Municipal Non-commercial Enterprise "Ternopil Municipal City Hospital #2" | Ternopil | 46023 | Ukraine |
| Public Non-Profit Enterprise "City Hospital #3" under Zaporizhia City Council | Zaporizhia | 69032 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo QD for 16 weeks |
| BG001 | GB001 | GB001 40 mg QD for 16 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat (ITT) population: all participants who were randomized and received at least 1 dose of study treatment. Participants with a baseline and a post-baseline value. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 16 |
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| Secondary | 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. | ITT population: all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 16 |
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| Secondary | 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. | ITT population: all participants who were randomized and received at least 1 dose of study treatment. Participants with nasal polyps with a baseline value. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 16 |
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| Secondary | 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. | ITT population: all participants who were randomized and received at least 1 dose of study treatment. Participants with nasal polyps. | Posted | Median | 95% Confidence Interval | weeks | up to Week 16 |
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| Secondary | 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). | ITT population: all participants who were randomized and received at least 1 dose of study treatment. Participants with a baseline value. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 16 |
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| Secondary | 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). | ITT population: all participants who were randomized and received at least 1 dose of study treatment. Participants with a baseline value. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 16 |
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| Secondary | 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. | ITT population: all participants who were randomized and received at least 1 dose of study treatment. Participants with a baseline value. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 16 |
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| Secondary | 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. | ITT population: all participants who were randomized and received at least 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | weeks | up to Week 16 |
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| Secondary | 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. | Safety Population: all participants who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | From first dose of study drug through Week 20 |
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From first dose of study drug through Week 20
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo QD for 16 weeks | 0 | 50 | 0 | 50 | 10 | 50 |
| EG001 | GB001 | GB001 40 mg QD for 16 weeks | 0 | 47 | 1 | 47 | 12 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endometriosis | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GB001, Inc. Study Director | GB001, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | 1-866-668-4083 | ClinicalTrials@gossamerbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2020 | Jul 6, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Black or African American |
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| Asian |
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| Hispanic or Latino |
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