GB001 in Adult Participants With Chronic Rhinosinusitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

In brief

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).

Key facts

Study ID

NCT03956862

Run by

GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

People needed

97

Starts

2019-05-16

Expected to finish

2020-08-05

Last updated by the study team

2021-08-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Other protocol-defined inclusion/exclusion criteria will apply.

Where it is running

• Banner University of Arizona Medical Center — Tucson, Arizona, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Sacramento Ear Nose and Throat Surgical and Medical Group, Inc. — Roseville, California, United States
• Bensch Clinical Research LLC — Stockton, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• ChicagoENT — Chicago, Illinois, United States
• Iowa Head & Neck, PC — Des Moines, Iowa, United States
• Kentuckiana Ear, Nose, and Throat — Louisville, Kentucky, 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
• BreatheAmerica Albuquerque — Albuquerque, New Mexico, 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
• University of Rochester Medicine Otolaryngology — Rochester, New York, United States
• Northwell Health at ENT and Allergy Associates — White Plains, New York, United States
• Vital Prospects Clinical Research Institute, P.C. — Tulsa, Oklahoma, United States
• Specialty Physician Associates — Bethlehem, Pennsylvania, United States
• Thomas Jefferson University Department of Otolaryngology — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina, Department of Otolaryngology — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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