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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05288504 | A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma. | PHASE2 | COMPLETED | 91 | — | — | Feb 24, 2022 | May 11, 2023 | Sep 5, 2024 | 24 | United States |
Percentage of patients who experience any of the following asthma related events: * ≥6 additional reliever puffs of Short-Acting Beta-Agonist (compared to baseline) in a 24-hour period on 2 consecutive days or, * increase in inhaled corticosteroid dose ≥4 times than the dose at baseline or, * a decrease in peak flow of 30% or more (compared to baseline) on 2 consecutive days of treatment, or * an asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or * a hospitalization or emergency room visit because of an asthma exacerbation
| Arm | Type | Description |
|---|---|---|
| AVTX-002 | EXPERIMENTAL | Approximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study. |
| Placebo | PLACEBO_COMPARATOR | Approximately 40 subjects will receive placebo sourced as normal saline three times during the study. |
| Name | Type | Description |
|---|---|---|
| AVTX-002 | DRUG | Dose of 600 mg administered subcutaneously three times during the study. |
| Placebo | DRUG | Placebo sourced as normal saline administered subcutaneously three times during the study. |
Inclusion Criteria: * Documented non-eosinophilic asthma diagnosis (\<300 eosinophils/μL). * Symptoms consistent with a diagnosis of asthma that is poorly controlled as determined by an ACQ score ≥ 1.5. * Poorly controlled asthma despite the use of a Long-Acting Beta-Agonists and Inhaled Corticoste...