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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03927157 | Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma | PHASE3 | COMPLETED | 405 | — | — | Jun 14, 2019 | Aug 13, 2024 | Jul 1, 2025 | 72 | China, Philippines +1 |
| NCT03347279 | Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma | PHASE3 | COMPLETED | 1,061 | — | — | Nov 23, 2017 | Nov 12, 2020 | Nov 26, 2021 | 289 | United States, Argentina +16 |
The annual exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks
The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)
The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. This analysis is based on subjects with baseline eosinophils \< 300 cells/uL
| Arm | Type | Description |
|---|---|---|
| Tezepelumab | EXPERIMENTAL | Tezepelumab: Tezepelumab subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Placebo: Placebo subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Experimental: Tezepelumab | BIOLOGICAL | Tezepelumab subcutaneous injection |
| Placebo | OTHER | Placebo subcutaneous injection |
Inclusion Criteria: * Age. 18-80 * Documented physician-diagnosed asthma for at least 12 months * Participants who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 6 months. * Documented treatment with a total daily dose of either medium or...