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

NCT05156710 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-02-24

No results posted yet for this 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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2025-10-21
Completion
2026-10-26
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05156710 on ClinicalTrials.gov