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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05251259 | Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma | PHASE2 | COMPLETED | 670 | — | — | Jan 27, 2022 | Jan 7, 2026 | Jan 14, 2026 | 234 | United States, Argentina +18 |
The clinical efficacy of Atuliflapon Dose A will be assessed by calculating a Hazard Ratio between the treatment arms, Atuliflapon Dose A vs. placebo, in a selected population (based on biomarker level). CompEx Asthma, a novel composite endpoint for exacerbations, captures asthma-worsening episodes based on a combination of diary events (worsening in daily peak expiratory flow (PEF), asthma symptoms and reliever medication use) plus severe asthma exacerbation events.
| Arm | Type | Description |
|---|---|---|
| Lead-in PK cohort (Atuliflapon) | EXPERIMENTAL | Randomised participants will receive Atuliflapon in Lead-in PK period of the study. |
| Lead-in PK cohort (Placebo) | PLACEBO_COMPARATOR | Randomised participants will receive matching placebo to Atuliflapon in Lead-in PK cohort of the study. |
| Part 1 (Atuliflapon) | EXPERIMENTAL | Randomised participants will receive Atuliflapon in Part 1 of the study. |
| Part 1 (Placebo) | PLACEBO_COMPARATOR | Randomised participants will receive matching placebo to Atuliflapon in Part 1 of the study. |
| Name | Type | Description |
|---|---|---|
| Atuliflapon | DRUG | Randomised participants will receive Atuliflapon |
| Placebo | DRUG | Randomised participants will receive matching placebo to Atuliflapon. |
Inclusion Criteria Lead-in PK Cohort: * 18 to 55 years of age inclusive at the time of signing the informed consent at screening Visit 1. * Bodyweight 50 to 120 kg (inclusive) and BMI 18 to 32 kg/m\^2 (inclusive) at screening Visit 1. * Documented asthma diagnosis ≥12 months prior to screening Vis...