GB001 in Adult Participants With Chronic Rhinosinusitis

• Status: Completed
• Trial end date: 2020-08-05
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.