Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03956862 | GB001 in Adult Participants With Chronic Rhinosinusitis | PHASE2 | COMPLETED | 97 | — | — | May 16, 2019 | Aug 5, 2020 | Aug 23, 2021 | 38 | United States, Czechia +1 |
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.
| Arm | Type | Description |
|---|---|---|
| GB001 | EXPERIMENTAL | GB001 40 mg once per day (QD) for 16 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo QD for 16 weeks |
| Name | Type | Description |
|---|---|---|
| GB001 | DRUG | film-coated oral tablet |
| Placebo | DRUG | film-coated oral tablet |
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 Visi...