Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ELA026 · 2 trials · 2 indications
Incidence of adverse events (AEs) including dose-limiting toxicities (DLTs), serious adverse events (SAEs), deaths, AEs leading to withdrawal from study
Incidence of DLTs and treatment emergent adverse events (TEAEs), including serious adverse advents (SAEs)
| Arm | Type | Description |
|---|---|---|
| Part 1 ELA026 | EXPERIMENTAL | Cohort 1: Single dose escalation up to 3.0 mg/kg IV or SC. Cohort 2: priming dose: 0.1 mg/kg IV on Day 1; 0.3 mg/kg IV on Day 2 - 4, followed by weekly maintenance doses of 1 mg/kg IV/SC from Day 8 to Day 81. Cohort 3: priming dose: 0.1 mg/kg IV on Day 1; 0.3 mg/kg IV on Days 2 - 4, followed by twice weekly maintenance doses of 0.5 mg/kg IV/SC from Day 8 to Day 81. |
| Part 2 ELA026 | EXPERIMENTAL | Cohort A and Cohort B: priming dose: 0.1 mg/kg IV/SC on Day 1; loading dose 0.3 mg/kg IV/SC on Days 2 - 4, followed by twice weekly maintenance doses of 0.5 mg/kg (IV/SC) from Day 8 to Day 81. |
| Level 0 Arm | EXPERIMENTAL | Starting dose level |
| Level -1 Arm | EXPERIMENTAL | Dose level below Starting Dose Level |
| Level +1 Arm | EXPERIMENTAL | Dose level above Starting Dose Level |
| Name | Type | Description |
|---|---|---|
| ELA026 | DRUG | Multiple doses of ELA026 |
Key Inclusion Criteria for Part 1: 1. ≥12 years at the time of HLH diagnosis (Cohort 1). 2. ≥6 years at the time of HLH diagnosis (Cohort 2-3). 3. Treatment naïve or relapsed/refractory (Cohorts 1 and 2). 4. Treatment naïve or early refractory (Cohort 3). 5. Participant with sHLH confirmed criteria...