Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GB001
GB001 40 mg once per day (QD) for 16 weeks
  • Drug: GB001
    film-coated oral tablet
Placebo Comparator
Placebo
Placebo QD for 16 weeks
  • Drug: Placebo
    film-coated oral tablet

More Details

Status
Completed
Sponsor
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.