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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05972967 | Safety and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria Patients With a Sub-optimal Response to Ravulizumab | PHASE2 | COMPLETED | 12 | — | — | Mar 27, 2023 | Oct 10, 2024 | Oct 1, 2025 | 5 | Germany, Greece +2 |
| NCT05889299 | Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria | PHASE1 | COMPLETED | 15 | — | — | Dec 9, 2022 | Nov 3, 2025 | May 11, 2026 | 1 | Ukraine |
Number and % of participants with Treatment-emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0, including abnormalities in laboratory measures, ECGs and physical examinations
Number and % of participants with Treatment-emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0, including abnormalities in laboratory measures, ECGs and physical examinations.
| Arm | Type | Description |
|---|---|---|
| 3 mg/kg IV OMS906 with Ravulizumab IV | EXPERIMENTAL | Up to 6 doses of 3 mg/kg at 8-week intervals. All patients will receive 3 doses of OMS906 of 3 mg/kg Intravenous (IV) at 8-week intervals. Clinical responders at Week 24 will receive an additional 3 doses of OMS906 only at 8-week intervals at 5 mg/kg (monotherapy). Incomplete responders may receive an additional 3 doses of OMS906 with ravulizumab at 8-week intervals. Non responders will not receive additional OMS906. |
| 5 mg/kg IV OMS906 with Ravulizumab IV | EXPERIMENTAL | Up to 6 doses of 5 mg/kg at 8-week intervals. All patients will receive 3 doses of OMS906 of 5 mg/kg Intravenous (IV) at 8-week intervals. Clinical responders at Week 24 will receive an additional 3 doses of OMS906 only at 8-week intervals (monotherapy). Incomplete responders may receive an additional 3 doses of OMS906 with ravulizumab at 8-week intervals. Non responders will not receive additional OMS906. |
| OMS906 study drug administration in three phases | EXPERIMENTAL | 1. 5 mg/kg SC administered every 4 weeks (Q4W), 2. 5 mg/kg IV administered once followed by administration of additional doses of 5 mg/kg IV at the occurrence of protocol-defined subclinical breakthrough hemolysis, and 3.) 8 mg/kg IV every 8 weeks (Q8W) on a fixed-dosing (FD) schedule |
| Name | Type | Description |
|---|---|---|
| OMS906 | BIOLOGICAL | Biological: OMS906 |
Inclusion Criteria: 1. Confirmed diagnosis of PNH by flow cytometry with PNH clone size of \> 10% red blood cells (RBCs) and/or granulocytes. 2. Male or female adults 18 years and older. 3. Completed informed consent procedures. 4. In relation to ravulizumab treatment prescribed in accordance with ...