Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BIVV020 (SAR445088)
BIVV020 · 2 trials · 2 indications
Defined as the proportion of participants meeting at least one of the following criteria: * Biopsy-proven active AMR as per Banff Criteria 2019 as per central pathology assessment, * Graft loss.
Defined as the proportion of participants with post-treatment biopsy not fulfilling active AMR diagnosis criteria as per Banff Criteria 2019 as per central pathology assessment.
Number of participants with adverse events (AEs)
| Arm | Type | Description |
|---|---|---|
| BIVV020 with Standard of Care (SOC) Cohort A | EXPERIMENTAL | Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate. |
| BIVV020 with Standard of Care (SOC) Cohort B | EXPERIMENTAL | Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab. |
| Standard of Care (SOC) Cohort B | OTHER | SOC includes plasmapheresis, IVIg, corticosteroids, rituximab. |
| BIVV020 IV | EXPERIMENTAL | Single administration dose 1, plus two optional doses of BIVV020 administered intravenously. |
| Name | Type | Description |
|---|---|---|
| BIVV020 (SAR445088) | DRUG | Pharmaceutical Form: Solution for injection Route of Administration: Intravenous |
| Intravenous immunoglobulin (IVIg) | DRUG | Pharmaceutical Form: Solution for injection Route of Administration: Intravenous |
| Rituximab or biosimilar | DRUG | Pharmaceutical Form: Solution for injection Route of Administration: Intravenous |
| Antithymocyte globulin (ATG) | DRUG | Pharmaceutical Form: Solution for injection Route of Administration: Intravenous |
| Tacrolimus | DRUG | Pharmaceutical Form: Tablet Route of Administration: Oral |
| Mycophenolate | DRUG | Pharmaceutical Form: Tablet Route of Administration: Oral |
| Corticosteroids | DRUG | Pharmaceutical Form: Vary Route of Administration: Vary |
| BIVV020 | DRUG | Pharmaceutical form:solution for injection Route of administration: intravenous |
Inclusion Criteria: -Participant intended to receive SOC therapy per Investigator's judgment and local practice. Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor. Cohort B: Participants who are kidney transplant recipients dia...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Actinium Pharmaceuticals, Inc. (Delaware) | ATNM | 1 | PHASE2/PHASE3 | 131I-apamistamab, Allogeneic Hematopoietic Stem Cell Transplant |
BIVV020 is an investigational small molecule being developed by Sanofi for transplant rejection and autoimmune haemolytic anaemia. It is being studied in cold agglutinin disease, a form of autoimmune haemolytic anaemia, and in the prevention and treatment of antibody-mediated rejection in transplant patients.
BIVV020 targets the complement system, specifically the C1s protein, which is part of the classical complement pathway. By inhibiting C1s, BIVV020 aims to reduce complement-mediated destruction of red blood cells in cold agglutinin disease and antibody-mediated tissue damage in transplant rejection.
BIVV020 is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is also known as SAR445088.
BIVV020 is in clinical development. A Phase 1 study in cold agglutinin disease has been completed, and a Phase 2 study in antibody-mediated rejection is active but not recruiting. BIVV020 is not yet approved and remains investigational.
BIVV020 has been studied in two clinical trials. NCT04269551 was a completed Phase 1 safety and tolerability study in adults with cold agglutinin disease. NCT05156710 is an active Phase 2 study of BIVV020 (SAR445088) in the prevention and treatment of antibody-mediated rejection.
Yes, BIVV020 is also known as SAR445088. Both names refer to the same investigational drug developed by Sanofi.