BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
Condition(s) studied
Investigational drug(s) / intervention(s)
BIVV020 (SAR445088): Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Intravenous immunoglobulin (IVIg): Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Rituximab or biosimilar: Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Antithymocyte globulin (ATG): Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Tacrolimus: Pharmaceutical Form: Tablet Route of Administration: Oral
Mycophenolate: Pharmaceutical Form: Tablet Route of Administration: Oral
Corticosteroids: Pharmaceutical Form: Vary Route of Administration: Vary
Study 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
Eligibility
Primary outcome measure(s)
- Cohort A: Treatment failure rate — Up to Week 49
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. - Cohort B: AMR resolution rate — Up to Week 49
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.
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| Cedars-Sinai Medical Center- Site Number : 8400100 | Los Angeles | California | |
| University of California Los Angeles Medical Center- Site Number : 8400103 | Los Angeles | California | |
| University of California San Francisco - Parnassus Heights- Site Number : 8400001 | San Francisco | California | |
| Massachusetts General Hospital- Site Number : 8400007 | Boston | Massachusetts | |
| Brigham & Women's Hospital- Site Number : 8400004 | Boston | Massachusetts | |
| NYU Langone Medical Center- Site Number : 8400102 | New York | New York | |
| University of Wisconsin Hospitals and Clinics- Site Number : 8400003 | Madison | Wisconsin | |
| Investigational Site Number : 1240101 | Vancouver | British Columbia | |
| Investigational Site Number : 1240001 | Vancouver | British Columbia | |
| Investigational Site Number : 1240002 | London | Ontario | |
| Investigational Site Number : 1240003 | Montreal | Quebec | |
| Investigational Site Number : 2500007 | Bordeaux | France | |
| Investigational Site Number : 2500002 | Créteil | France | |
| Investigational Site Number : 2500001 | Paris | France | |
| Investigational Site Number : 2500005 | Toulouse | France | |
| Investigational Site Number : 2760002 | Berlin | Germany | |
| Investigational Site Number : 2760004 | Essen | Germany | |
| Investigational Site Number : 2760001 | Munich | Germany | |
| Investigational Site Number : 3800004 | Bologna | Emilia-Romagna | |
| Investigational Site Number : 3800002 | Rome | Lazio | |
| Investigational Site Number : 3800001 | Brescia | Lombardy | |
| Investigational Site Number : 3800003 | Milan | Milano | |
| Investigational Site Number : 7240004 | Barcelona | Barcelona [Barcelona] | |
| Investigational Site Number : 7240003 | Madrid | Madrid, Comunidad de | |
| Investigational Site Number : 7240002 | Madrid | Madrid, Comunidad de | |
| Investigational Site Number : 7520001 | Huddinge | Sweden | |
| Investigational Site Number : 7520002 | Uppsala | Sweden |
More Sanofi trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05156710 on ClinicalTrials.gov ↗ ← All trials in Italy