Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GB001 · 2 trials · 3 indications
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.
Proportion of participants who experience worsening of asthma by Week 24 as defined by at least 1 of the following: * On 2 consecutive days, morning (AM) peak expiratory flow (PEF) ≤ 75% of mean AM PEF measured over the last 7 days of the Run-in * Forced expiratory volume in 1 second (FEV1) \< 80% of baseline * Increase in rescue medication use of ≥ 6 puffs/day on 2 consecutive days compared to mean use over the last 7 days of the Run-in * Increase in Asthma Control Questionnaire 5 (ACQ-5; see Outcome Measure 2 for description) score of ≥ 0.5 compared to baseline * The occurrence of a severe asthma exacerbation (asthma attack) defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.
| Arm | Type | Description |
|---|---|---|
| GB001 | EXPERIMENTAL | GB001 40 mg once per day (QD) for 16 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo QD for 16 weeks |
| GB001 20 mg | EXPERIMENTAL | GB001 20 mg QD for 24 weeks |
| GB001 40 mg | EXPERIMENTAL | GB001 40 mg QD for 24 weeks |
| GB001 60 mg | EXPERIMENTAL | GB001 60 mg QD for 24 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...