A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Effect of GB001 in Patients With Chronic Rhinosinusitis With or Without Nasal Polyps

GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.36 sites in 3 countries97 target enrollmentMay 16, 2019

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

InterventionsGB001 Placebo

DrugsGB001 Placebo

Overview

Phase: Phase 2
Intervention: GB001
Conditions: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Sponsor: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
Enrollment: 97
Locations: 36
Primary Endpoint: Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 16, 2019

End Date

August 5, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

GB001

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

Intervention: GB001

Placebo

Placebo QD for 16 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score

Time Frame: Baseline, Week 16

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.

Secondary Outcomes

Change From Baseline to Week 16 in Lund-Mackay Score(Baseline, Week 16)
Time to First Response in NPS(up to Week 16)
Time to First Chronic Rhinosinusitis (CRS) Exacerbation(up to Week 16)
Change From Baseline to Week 16 in AM Total Symptom Score (TSS)(Baseline, Week 16)
Change From Baseline to Week 16 in University of Pennsylvania Smell Identification Test (UPSIT) Score(Baseline, Week 16)
Percentage of Participants With a Treatment-Emergent Adverse Event (AE)(From first dose of study drug through Week 20)
Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score(Baseline, Week 16)
Change From Baseline to Week 16 in Nasal Polyp Score (NPS)(Baseline, Week 16)