GB001 in Adult Participants With Chronic Rhinosinusitis

NCT03956862 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: GB001-21012019-001682-33
• Study Type: interventional
• Target: 97
• Locations: 3 countries
• Sites: 38

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).

Conditions

Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP); Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Keywords

GB001; Gossamer Bio; Gossamer; Nasal Polyposis; CRSwNP; CRSsNP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change From Baseline to Week 16 in Lund-Mackay Score

  Baseline, Week 16

• Change From Baseline to Week 16 in Nasal Polyp Score (NPS)

  Baseline, Week 16

• Time to First Response in NPS

  up to Week 16

• Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score

  Baseline, Week 16

• Change From Baseline to Week 16 in AM Total Symptom Score (TSS)

  Baseline, Week 16

Study Arms (2)

GB001

EXPERIMENTAL

GB001 40 mg once per day (QD) for 16 weeks

Drug: GB001

Placebo

PLACEBO COMPARATOR

Placebo QD for 16 weeks

Drug: Placebo

Interventions

GB001 DRUG

film-coated oral tablet

GB001

Placebo DRUG

film-coated oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.: lead

Study Sites (38)

Banner University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.

Roseville, California, 95661, United States

Location

Bensch Clinical Research LLC

Stockton, California, 95207, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

ChicagoENT

Chicago, Illinois, 60657, United States

Location

Iowa Head & Neck, PC

Des Moines, Iowa, 50312, United States

Location

Kentuckiana Ear, Nose, and Throat

Louisville, Kentucky, 40205, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40207, United States

Location

Tandem Clinical Research LLC

Marrero, Louisiana, 70072, United States

Location

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, 21162, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Nebraska Medical Research Institute, Inc.

Bellevue, Nebraska, 68123, United States

Location

BreatheAmerica Albuquerque

Albuquerque, New Mexico, 87109, United States

Location

Northwell Health at ENT and Allergy Associates

New Hyde Park, New York, 11042, United States

Location

Northwell Health at ENT and Allergy Associates

New York, New York, 10016, United States

Location

University of Rochester Medicine Otolaryngology

Rochester, New York, 14618, United States

Location

Northwell Health at ENT and Allergy Associates

White Plains, New York, 10605, United States

Location

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136, United States

Location

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

Location

Thomas Jefferson University Department of Otolaryngology

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina, Department of Otolaryngology

Charleston, South Carolina, 29425, United States

Location

AARA Research Center

Dallas, Texas, 75231, United States

Location

Memorial Hermann Medical Plaza

Houston, Texas, 77030, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Advanced Otolaryngology, P.C. DBA Richmond Ear, Nose and Throat

Richmond, Virginia, 23235, United States

Location

University Hospital Hradec Kralove, Department of Otorhinolaryngology and Head and Neck Surgery

Hradec Králové, 50005, Czechia

Location

ENT Outpatient Clinic Pavel Navratil

Olomouc, 77900, Czechia

Location

Medicon a.s.

Prague, 14046, Czechia

Location

Pulmonary Outpatient Clinic Rokycany s.r.o.

Rokycany, 33722, Czechia

Location

Public Non-Profit Enterprise "Clinical Hospital of Emergency Medical Care" under Dnipro City Council

Dnipro, 49006, Ukraine

Location

Public Non-Profit Enterprise under KRC "Regional Clinical Specialized Center for Radiation Protection of the Public"

Kharkiv, 61166, Ukraine

Location

State Institution "O.S. Kolomiychenko Institute of Otolaryngology of National Academy of Medical Sciences of Ukraine"

Kyiv, 03680, Ukraine

Location

Municipal Non-commercial Enterprise "Ternopil Municipal City Hospital #2"

Ternopil, 46023, Ukraine

Location

Public Non-Profit Enterprise "City Hospital #3" under Zaporizhia City Council

Zaporizhia, 69032, Ukraine

Location

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GB001, Inc. Study Director
• Organization: GB001, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

ClinicalTrials@gossamerbio.com

1-866-668-4083

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: May 16, 2019
• Primary Completion: July 9, 2020
• Study Completion: August 5, 2020
• Last Updated: August 23, 2021
• Results First Posted: July 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

UA (5); US (29); CZ (4)