BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 9, 2022

Primary Completion Date

October 27, 2025

Study Completion Date

November 17, 2026

Conditions
Transplant Rejection
Interventions
DRUG

BIVV020 (SAR445088)

Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

DRUG

Intravenous immunoglobulin (IVIg)

Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

DRUG

Rituximab or biosimilar

Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

DRUG

Antithymocyte globulin (ATG)

Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

DRUG

Tacrolimus

Pharmaceutical Form: Tablet Route of Administration: Oral

DRUG

Mycophenolate

Pharmaceutical Form: Tablet Route of Administration: Oral

DRUG

Corticosteroids

Pharmaceutical Form: Vary Route of Administration: Vary

Trial Locations (27)

10016

NYU Langone Medical Center- Site Number : 8400102, New York

13353

Investigational Site Number : 2760002, Berlin

20162

Investigational Site Number : 3800003, Milan

25123

Investigational Site Number : 3800001, Brescia

28041

Investigational Site Number : 7240003, Madrid

28046

Investigational Site Number : 7240002, Madrid

31059

Investigational Site Number : 2500005, Toulouse

33076

Investigational Site Number : 2500007, Bordeaux

40138

Investigational Site Number : 3800004, Bologna

45147

Investigational Site Number : 2760004, Essen

53792

University of Wisconsin Hospitals and Clinics- Site Number : 8400003, Madison

75010

Investigational Site Number : 2500001, Paris

81675

Investigational Site Number : 2760001, Munich

90048

Cedars-Sinai Medical Center- Site Number : 8400100, Los Angeles

90095

University of California Los Angeles Medical Center- Site Number : 8400103, Los Angeles

94010

Investigational Site Number : 2500002, Créteil

94143

University of California San Francisco - Parnassus Heights- Site Number : 8400001, San Francisco

02114

Massachusetts General Hospital- Site Number : 8400007, Boston

02115

Brigham & Women's Hospital- Site Number : 8400004, Boston

V5Z 1M9

Investigational Site Number : 1240101, Vancouver

V6Z 1Y6

Investigational Site Number : 1240001, Vancouver

N6A 5A5

Investigational Site Number : 1240002, London

H4A 3J1

Investigational Site Number : 1240003, Montreal

00168

Investigational Site Number : 3800002, Rome

08035

Investigational Site Number : 7240004, Barcelona

141 57

Investigational Site Number : 7520001, Huddinge

751 85

Investigational Site Number : 7520002, Uppsala

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT05156710 - BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR) | Biotech Hunter | Biotech Hunter