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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05101187 | Olorofim Aspergillus Infection Study | PHASE3 | ACTIVE NOT_RECRUITING | 225 | — | — | Mar 31, 2022 | Nov 1, 2026 | Jan 6, 2026 | 140 | United States, Australia +18 |
To compare all-cause mortality (ACM) at Day 42 following treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in the intent-to-treat (ITT) population of patients with Invasive Fungal Disease (IFD) caused by proven Invasive Aspergillosis (IA) at any site or probable lower respiratory tract disease (LRTD) Aspergillus species (invasive aspergillosis, IA).
| Arm | Type | Description |
|---|---|---|
| Olorofim | ACTIVE_COMPARATOR | Olorofim versus AmBisome followed by Standard of Care (SOC) |
| AmBisome | ACTIVE_COMPARATOR | Olorofim versus AmBisome followed by Standard of Care (SOC) |
| Name | Type | Description |
|---|---|---|
| Olorofim | DRUG | Loading Dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 Maintenance Dose: 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 84 (± 7 days) |
| AmBisome® | DRUG | Initial course of at least 10 days of AmBisome® administered daily at a dose of 3 mg/kg by IV infusion over a 30- to 60-minute period or according to local guidelines Administration of SOC will follow international, national, or local guidelines and product labelling. |
Inclusion Criteria: 1. Male and female patients ages over 18 years and weighing more than 30 kg 2. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study and where the duration of specific therapy for this episode of IA has been ≤ 28 days. For ...