At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 97 enrolled
Drug / intervention
GB001 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.·interventional·Posted May 21, 2019·Updated Aug 23, 2021
In Brief
A Phase 2 clinical trial evaluating GB001 and Placebo for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) and Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). Completed, enrolled 97 participants across 38 sites in 3 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Rhinosinusitis Without Nasal Polyps (CRSsNP), Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
CountriesCzechia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartMay 2019
First PostedMay 2019
Primary CompletionJul 2020
Study CompletionAug 2020
TodayJul 2026
First PostedMay 21, 2019
Enrollment StartMay 16, 2019
Primary CompletionJul 9, 2020
Study CompletionAug 5, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.1 years ago
Interventions
GB001drug
film-coated oral tablet
Placebodrug
film-coated oral tablet