GB001 in Adult Participants With Chronic Rhinosinusitis
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
- Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental GB001 |
GB001 40 mg once per day (QD) for 16 weeks |
|
Placebo Comparator Placebo |
Placebo QD for 16 weeks |
|
More Details
- Status
- Completed
- Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.