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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 used for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. It is an investigational small molecule being studied in adults with PNH who are currently treated with eculizumab. The drug is in Phase 3 clinical development and is not yet approved.
Ravulizumab OBDS is developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with paroxysmal nocturnal hemoglobinuria.
Ravulizumab OBDS is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 3 trial has been completed, evaluating the drug in adults with paroxysmal nocturnal hemoglobinuria.
Ravulizumab OBDS has one completed Phase 3 trial, identified as NCT03748823. This trial compared subcutaneous administration of ravulizumab to intravenous administration in adults with paroxysmal nocturnal hemoglobinuria who were currently treated with eculizumab. The trial enrolled 139 participants across multiple countries.
No, Ravulizumab OBDS is not the same as eculizumab. The clinical trial NCT03748823 specifically studied ravulizumab in patients with paroxysmal nocturnal hemoglobinuria who were already being treated with eculizumab, indicating they are distinct drugs. Ravulizumab is being developed as a potential alternative treatment.