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Ravulizumab OBDS · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Ravulizumab SC Treatment Group | EXPERIMENTAL | In the Randomized Treatment Period, participants will receive an IV loading dose of ravulizumab on Day 1 followed by SC maintenance doses of ravulizumab administered via the ravulizumab OBDS on Day 15 and every week (qw) thereafter for a total of 10 weeks of study treatment. In the Extension Period, ravulizumab SC will be administered via the ravulizumab OBDS from Day 71 qw through Day 1274. |
| Ravulizumab IV Treatment Group | ACTIVE_COMPARATOR | In the Randomized Treatment Period, participants will receive an IV loading dose of ravulizumab on Day 1 followed by IV maintenance doses of ravulizumab on Day 15. In the Extension Period, ravulizumab SC will be administered via the ravulizumab OBDS from Day 71 qw through Day 1274. |
| Name | Type | Description |
|---|---|---|
| Ravulizumab OBDS | COMBINATION_PRODUCT | The ravulizumab OBDS is a biological-device combination product consisting of a prefilled cartridge containing ravulizumab SC and an on-body injector. |
| Ravulizumab | BIOLOGICAL | Administered by IV infusion. Ravulizumab IV doses will be based on participant body weight. |
Inclusion Criteria: * Male or female ≥18 years of age * Treated with eculizumab for PNH for at least 3 months prior to Day 1 * LDH level ≤1.5 × upper limit of normal (ULN) at screening * PNH diagnosis confirmed by documented high-sensitivity flow cytometry. * Documented meningococcal vaccination no...
Ravulizumab OBDS is an investigational on-body delivery system formulation of ravulizumab, a monoclonal antibody developed by AstraZeneca PLC (ticker AZN) for paroxysmal nocturnal hemoglobinuria. It is designed to deliver the drug subcutaneously and is in Phase 3 clinical development.
Ravulizumab OBDS is being developed for the treatment of paroxysmal nocturnal hemoglobinuria, a rare blood disorder. It is intended as a subcutaneous formulation of ravulizumab for adults with PNH who are currently treated with eculizumab, based on the completed Phase 3 trial NCT03748823.
Ravulizumab OBDS targets complement protein C5. It is a monoclonal antibody that acts as a C5 inhibitor, blocking C5 cleavage and thereby reducing complement-mediated destruction of red blood cells in paroxysmal nocturnal hemoglobinuria.
Ravulizumab OBDS is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this subcutaneous on-body delivery system formulation of ravulizumab.
Ravulizumab OBDS is in Phase 3 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 3 trial NCT03748823 has been completed.
Ravulizumab OBDS has been studied in the Phase 3 trial NCT03748823, titled Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab. This completed trial enrolled 139 adults across multiple countries.