Trials / Completed
CompletedNCT03956862
GB001 in Adult Participants With Chronic Rhinosinusitis
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 97 (actual)
- Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GB001 | film-coated oral tablet |
| DRUG | Placebo | film-coated oral tablet |
Timeline
- Start date
- 2019-05-16
- Primary completion
- 2020-07-09
- Completion
- 2020-08-05
- First posted
- 2019-05-21
- Last updated
- 2021-08-23
- Results posted
- 2021-07-30
Locations
38 sites across 3 countries: United States, Czechia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03956862. Inclusion in this directory is not an endorsement.