Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BAY1213790 (Osocimab), Osocimab
BAY1213790 · 3 trials · 6 indications
Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table. Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis. Descriptive time to composite of treatment emergent major and CRNMB events \[in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines\] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.
Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table. Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis. An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.
DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
CRNM bleeding: Clinically Relevant Non-Major bleeding
| Arm | Type | Description |
|---|---|---|
| BAY1213790 low dose | EXPERIMENTAL | Participants will receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg until the end of the extension treatment period. |
| Placebo low dose | PLACEBO_COMPARATOR | Placebo will be administered subcutaneously in the same manner as Osocimab. |
| BAY1213790 high dose | EXPERIMENTAL | Participants will receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg until the end of the extension treatment period. |
| Placebo high dose | EXPERIMENTAL | Placebo will be administered subcutaneously in the same manner as Osocimab. |
| Enoxaparin | ACTIVE_COMPARATOR | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed. |
| Apixaban | ACTIVE_COMPARATOR | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed. |
| BAY1213790 0.3 mg/kg (post-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery. |
| BAY1213790 0.6 mg/kg (post-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery. |
| BAY1213790 1.2 mg/kg (post-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery. |
| BAY1213790 1.8 mg/kg (post-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery. |
| BAY1213790 0.3 mg/kg (pre-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery. |
| BAY1213790 1.8 mg/kg (pre-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery. |
| Dose 1 of BAY1213790 | EXPERIMENTAL | Single intravenous infusion BAY1213790 (Dose 1) |
| Dose 2 of BAY1213790 | EXPERIMENTAL | Single intravenous infusion BAY1213790 (Dose 2) |
| Placebo | PLACEBO_COMPARATOR | Single intravenous infusion placebo |
| Name | Type | Description |
|---|---|---|
| BAY1213790 (Osocimab) | DRUG | Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses. |
| Placebo | DRUG | Subcutaneous administration in the same manner as Osocimab. |
| Enoxaparin | DRUG | 40 mg enoxaparin administered as subcutaneous injection once daily |
| Apixaban | DRUG | 2.5 mg apixaban administered as tablet orally twice daily |
| BAY1213790 | DRUG | Single dose of BAY1213790 administered as intravenous infusion |
| 0.9% sodium chloride solution | DRUG | Single intravenous infusion of Placebo (0.9% sodium chloride solution) |
Inclusion Criteria: * Participants must be at least 18 years of age * Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator * Body weight of at least 50 kg * Male and/o...
BAY1213790 is an investigational monoclonal antibody developed by Bayer AG under the name osocimab. It is being studied for the prevention of thromboembolic events in patients with end-stage renal disease on hemodialysis and in patients undergoing total knee arthroplasty. It is in Phase 2 clinical development.
BAY1213790 is being studied for prevention of thromboembolic events in patients with end-stage renal disease requiring regular hemodialysis or hemodiafiltration, and for prevention of venous thromboembolism in patients undergoing total knee arthroplasty. These are the indications explored in its completed clinical trials.
BAY1213790 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the clinical studies of the drug, including the Phase 2 hemodialysis study and the Phase 2 total knee arthroplasty study.
BAY1213790 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Its completed trials include a Phase 2 study in kidney failure patients on hemodialysis and a Phase 2 study in total knee arthroplasty, plus a Phase 1 pilot study in renal dialysis.
BAY1213790 has been studied in NCT04523220, a completed Phase 2 trial of low and high doses in adults with kidney failure requiring regular hemodialysis, and NCT03276143, a completed Phase 2 trial in patients undergoing total knee arthroplasty. A completed Phase 1 pilot study, NCT03787368, enrolled 55 patients with renal dialysis.
Yes, BAY1213790 is also known as osocimab. Osocimab is the international nonproprietary name used for the same monoclonal antibody, so searches for either name refer to the same Bayer AG investigational drug candidate.