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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06750289 | Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment | PHASE3 | RECRUITING | 400 | — | — | Mar 28, 2025 | Nov 3, 2028 | May 13, 2026 | 160 | United States, Bulgaria +11 |
To assess asthma exacerbation rate.
| Arm | Type | Description |
|---|---|---|
| Medium-dose ICS-LABA + benralizumab | ACTIVE_COMPARATOR | Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks. |
| High-dose ICS-LABA + placebo | ACTIVE_COMPARATOR | Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks. |
| Name | Type | Description |
|---|---|---|
| ICS-LABA | COMBINATION_PRODUCT | ICS-LABA inhalation |
| benralizumab | COMBINATION_PRODUCT | Benralizumab. SC injection. |
| Placebo for Benralizumab | COMBINATION_PRODUCT | Placebo for Benralizumab (aka, "placebo"). SC injection. |
Inclusion Criteria: * Written informed consent * Participant must be 12 to 75 years of age * Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (\> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 mon...