GB001 in Adult Participants With Chronic Rhinosinusitis
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
- Interventions
- Drug: Placebo
- Registration Number
- NCT03956862
- Lead Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo QD for 16 weeks GB001 GB001 GB001 40 mg once per day (QD) for 16 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score Baseline, Week 16 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
Name Time Method Change From Baseline to Week 16 in Lund-Mackay Score Baseline, Week 16 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 to First Response in NPS up to Week 16 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 to First Chronic Rhinosinusitis (CRS) Exacerbation up to Week 16 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.
Change From Baseline to Week 16 in AM Total Symptom Score (TSS) Baseline, Week 16 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 Baseline, Week 16 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.
Percentage of Participants With a Treatment-Emergent Adverse Event (AE) From first dose of study drug through Week 20 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.
Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score Baseline, Week 16 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 Nasal Polyp Score (NPS) Baseline, Week 16 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.
Trial Locations
- Locations (36)
Emory University
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Iowa Head & Neck, PC
🇺🇸Des Moines, Iowa, 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
ChicagoENT
🇺🇸Chicago, Illinois, United States
Kentuckiana Ear, Nose, and Throat
🇺🇸Louisville, Kentucky, United States
BreatheAmerica Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Northwell Health at ENT and Allergy Associates
🇺🇸White Plains, New York, United States
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
🇺🇸Roseville, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Bensch Clinical Research LLC
🇺🇸Stockton, California, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
University of Rochester Medicine Otolaryngology
🇺🇸Rochester, New York, United States
Specialty Physician Associates
🇺🇸Bethlehem, Pennsylvania, United States
Thomas Jefferson University Department of Otolaryngology
🇺🇸Philadelphia, Pennsylvania, United States
AARA Research Center
🇺🇸Dallas, Texas, United States
Memorial Hermann Medical Plaza
🇺🇸Houston, Texas, 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
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
Municipal Non-commercial Enterprise "Ternopil Municipal City Hospital #2"
🇺🇦Ternopil', Ukraine
Medicon a.s.
🇨🇿Praha 4, Czechia
Public Non-Profit Enterprise "City Hospital #3" under Zaporizhia City Council
🇺🇦Zaporizhia, Ukraine
Public Non-Profit Enterprise under KRC "Regional Clinical Specialized Center for Radiation Protection of the Public"
🇺🇦Kharkiv, Ukraine
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Banner University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
State Institution "O.S. Kolomiychenko Institute of Otolaryngology of National Academy of Medical Sciences of Ukraine"
🇺🇦Kyiv, Ukraine
Medical University of South Carolina, Department of Otolaryngology
🇺🇸Charleston, South Carolina, United States