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Active, not recruiting Phase 2

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

NCT05156710 · tracked via the Priya Life Science Italy tracker
Sponsor
Phase
Phase 2
Started
2022-06-09
Last updated
2026-08-21

Condition(s) studied

Transplant Rejection

Investigational drug(s) / intervention(s)

BIVV020 (SAR445088) →Intravenous immunoglobulin (IVIg) →Rituximab or biosimilar →Antithymocyte globulin (ATG) →Tacrolimus →MycophenolateCorticosteroids

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 diagnosed with active AMR. * BMI ≤ 40 kg/m2. * Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant). * Contraceptive use by men during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant). Exclusion Criteria: * Participants who are ABO incompatible with their donors. * Participants with known active ongoing infection as per below: 1. Positive HIV. 2. Positive HBV. 3. HCV with detectable HCV RNA. 4. Within 4 weeks of first study intervention: any serious infection, or any active bacterial infection, or any other infection which is clinically significant in the option of the Investigator, unless it can be confirmed that infection was cleared at least 3 days prior to first study intervention. * History of active tuberculosis (TB) regardless of treatment. * Participants with clinical diagnosis of systemic lupus erythematosus (SLE). * Prior treatment with complement system inhibitor within 5 times the half-life. * Current enrollment in any other clinical study where the last investigational study treatment administration was within 5 half-lives from study intervention initiation. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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)

FacilityCityRegionStatus
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
Official registry record

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