drugset / Trial / NCT05156710
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objectives: * Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR * Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: * To assess the overall efficacy of BIVV020 in prevention or treatment of AMR * To characterize the safety and tolerability of BIVV020 in kidney transplant participants * To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants * To evaluate the immunogenicity of BIVV020
Timeline
- Start
- 2022-06-09
- Primary completion
- 2025-10-21
- Completion
- 2026-10-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Riliprubart | Monoclonal antibody | — | Intravenous |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | Intravenous |
| Background | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | — | Intravenous |
| Background | Mycophenolate Sodium | Unknown | — | Oral |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Tacrolimus | Small molecule | — | Oral |