GB001 in Adult Participants With Chronic Rhinosinusitis

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956862
• Other study ID #: GB001-2101
• Secondary ID: 2019-001682-33
• Status: Completed
• Phase: Phase 2
• Start date: May 16, 2019
• Est. completion date: August 5, 2020

Study information

• Verified date: August 2021
• Source: Gossamer Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 5, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
• Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Drug:
• GB001
film-coated oral tablet
• Placebo
film-coated oral tablet

Locations

Country	Name	City	State
Czechia	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.	Praha 4
Czechia	Pulmonary Outpatient Clinic Rokycany s.r.o.	Rokycany
Ukraine	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
United States	BreatheAmerica Albuquerque	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	Nebraska Medical Research Institute, Inc.	Bellevue	Nebraska
United States	Specialty Physician Associates	Bethlehem	Pennsylvania
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina, Department of Otolaryngology	Charleston	South Carolina
United States	ChicagoENT	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	AARA Research Center	Dallas	Texas
United States	Iowa Head & Neck, PC	Des Moines	Iowa
United States	Memorial Hermann Medical Plaza	Houston	Texas
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	Kentuckiana Ear, Nose, and Throat	Louisville	Kentucky
United States	Tandem Clinical Research LLC	Marrero	Louisiana
United States	Yale School of Medicine	New Haven	Connecticut
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	Eastern Virginia Medical School	Norfolk	Virginia
United States	Thomas Jefferson University Department of Otolaryngology	Philadelphia	Pennsylvania
United States	Advanced Otolaryngology, P.C. DBA Richmond Ear, Nose and Throat	Richmond	Virginia
United States	University of Rochester Medicine Otolaryngology	Rochester	New York
United States	Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.	Roseville	California
United States	Bensch Clinical Research LLC	Stockton	California
United States	Banner University of Arizona Medical Center	Tucson	Arizona
United States	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma
United States	Chesapeake Clinical Research, Inc.	White Marsh	Maryland
United States	Northwell Health at ENT and Allergy Associates	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, Week 16
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.	Baseline, Week 16
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.	Baseline, Week 16
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.	up to Week 16
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).	Baseline, Week 16
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).	Baseline, Week 16
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.	Baseline, Week 16
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.	up to Week 16
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.	From first dose of study drug through Week 20