Phase 2
N=97
GB001 in Adult Participants With Chronic Rhinosinusitis
Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) · Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Bottom Line
View on ClinicalTrials.gov: NCT03956862 ↗Enrolled (actual)
97
Serious AEs
1.0%
Results posted
Jul 2021
Primary outcome: Primary: Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score — -18.1; -18.3 score on a scale — p=0.9499
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GB001 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score |
-18.1; -18.3 | 0.9499 |
| SECONDARY Change From Baseline to Week 16 in Lund-Mackay Score |
-0.6; -0.9 | 0.6778 |
| SECONDARY Change From Baseline to Week 16 in Nasal Polyp Score (NPS) |
-0.8; -0.7 | 0.7914 |
| SECONDARY Time to First Response in NPS |
16.43; 16.14 | 0.8916 |
| SECONDARY Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score |
-0.733; -0.543 | 0.1635 |
| SECONDARY Change From Baseline to Week 16 in AM Total Symptom Score (TSS) |
-2.499; -1.867 | 0.1742 |
| SECONDARY Change From Baseline to Week 16 in University of Pennsylvania Smell Identification Test (UPSIT) Score |
1.5; 2.3 | 0.4851 |
| SECONDARY Time to First Chronic Rhinosinusitis (CRS) Exacerbation |
NA; NA | 0.3898 |
| SECONDARY Percentage of Participants With a Treatment-Emergent Adverse Event (AE) |
36.0; 44.7 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT03956862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.