Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GB-0895 · 3 trials · 3 indications
The annual exacerbation rate is based on clinically significant (CS) exacerbations reported by the investigator in the electronic case (eCRF) over 52 weeks for subjects on GB-0895 as compared to placebo.
| Arm | Type | Description |
|---|---|---|
| GB-0895 | EXPERIMENTAL | GB-0895 Subcutaneous (SC) injection |
| Placebo | PLACEBO_COMPARATOR | Placebo Subcutaneous (SC) injection |
| Part A: Single Ascending Dose (SAD) (asthma participants) | EXPERIMENTAL | randomized 3:1 active:placebo |
| Part B: Multiple Ascending Dose (MAD) (asthma participants) | EXPERIMENTAL | randomized 3:1 active:placebo |
| Part C: Single Dose (COPD participants) | EXPERIMENTAL | randomized 3:1 active:placebo |
| Name | Type | Description |
|---|---|---|
| GB-0895 | DRUG | Study Drug |
| Placebo | DRUG | Placebo |
| GB-0895 (SC) | BIOLOGICAL | Single subcutaneous dose of GB-0895 |
| Placebo (SC) | DRUG | Single subcutaneous dose of placebo |
1. Adults and adolescents ≥ 12 and ≤ 80 years of age. 2. Documented physician diagnosis of asthma for ≥ 2 years. 3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1...