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, Fludarabine, Cyclophosphamide, Allogeneic Hematopoietic Stem Cell Transplant |
BIVV020 is an investigational small molecule being developed by Sanofi for autoimmune haemolytic anaemia and transplant rejection. It is being studied in adults with cold agglutinin disease, a form of autoimmune haemolytic anaemia, and for 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 autoimmune haemolytic anaemia and antibody-mediated tissue damage in transplant rejection.
BIVV020 is developed by Sanofi, a multinational pharmaceutical company traded on the NASDAQ under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety, tolerability, and efficacy of BIVV020 in autoimmune haemolytic anaemia and transplant rejection.
BIVV020 is in Phase 1 and Phase 2 clinical development. A Phase 1 trial in cold agglutinin disease has been completed, and a Phase 2 trial in antibody-mediated rejection is active but not recruiting. BIVV020 is investigational and has not been approved by regulatory authorities.
BIVV020 has two clinical trials. NCT04269551 is a completed Phase 1 safety and tolerability study in adults with cold agglutinin disease, enrolling 12 participants. NCT05156710 is an active Phase 2 study in prevention and treatment of antibody-mediated rejection, enrolling 48 participants across multiple countries.
Yes, BIVV020 is also known as SAR445088. The drug is referred to by both names in clinical trials and scientific literature. Researchers and investors may encounter either name when reviewing Sanofi's development programs for this investigational therapy.