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

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NCT05156710

Sponsored by Sanofi (industry) · SNY — their whole pipeline →.

Phase

Phase 2

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

48actual

Sites

Countries

Canada, France, Germany +4

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2022-06-09

actual

When the study began enrolling

Primary completion

2025-10-21

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2026-10-26

estimated

The whole study's end, after follow-up

First posted

2021-12-14

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-02-24

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Transplant Rejection

Interventions

Drug: BIVV020 (SAR445088)
Drug: Intravenous immunoglobulin (IVIg)
Drug: Rituximab or biosimilar
Drug: Antithymocyte globulin (ATG)
Drug: Tacrolimus
Drug: Mycophenolate
Drug: Corticosteroids

Primary outcomes

what the primary-completion date above is the date OF

Cohort A: Treatment failure rate

measured Up to Week 49

Cohort B: AMR resolution rate

measured Up to Week 49

Publications

PMID 35332298 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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