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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04691570 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA) | PHASE2 | COMPLETED | 6 | — | — | Nov 10, 2021 | Jan 17, 2023 | Jan 19, 2024 | 1 | United States |
Number of participants with TEAEs, defined as any adverse event with an onset on or after the day of infusion through 16 weeks after the infusion
Change in hemoglobin, lactate dehydrogenase, bilirubin, reticulocyte count and haptoglobin from baseline
| Arm | Type | Description |
|---|---|---|
| ANX005 | EXPERIMENTAL | Participants will receive two once-weekly doses of ANX005 at specific time points |
| Name | Type | Description |
|---|---|---|
| ANX005 | DRUG | ANX005 is provided as a solution for IV infusion |
Inclusion Criteria: * Male or non-pregnant, non-lactating female ≥18 years of age (no maximum age). * Diagnosis of wAIHA at least 3 months prior to screening with a direct antiglobulin test (DAT) ≥1 positive for immunoglobulin G (IgG)±C3, or a diagnosis of mixed autoimmune hemolytic anemia (AIHA) t...