GB001 in Adult Participants With Chronic Rhinosinusitis

Gossamer Bio

Status and phase: Completed; Phase 2

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

Treatments: Drug: GB001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03956862

2019-001682-33 (EudraCT Number)

GB001-2101

Details and patient eligibility

About

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).

Enrollment: 97 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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97 participants in 2 patient groups, including a placebo group

GB001

Experimental group

Description:

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

Treatment:

Drug: GB001

Placebo

Placebo Comparator group

Description:

Placebo QD for 16 weeks

Treatment:

Drug: Placebo