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

Study on Prevention and Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

Not Recruiting
18 years or above
All
Phase 2
48 participants needed

Study Overview

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

Study Details

Up to approximately 2 years

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Transplant Rejection
  • Age: 18 years or above
  • Gender: All

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.

The purpose of this study is to investigate the effectiveness of an investigational medication in preventing and treating antibody-mediated rejection (AMR) in kidney transplant patients. Participants will be involved in the study for up to approximately 2 years. This study aims to evaluate the investigational medication's ability to prevent AMR in patients receiving a kidney transplant and to treat those who already have active AMR.

Participants in the study will undergo various procedures, including receiving the investigational medication and standard of care therapy. The study will assess the safety and tolerability of the investigational medication, as well as its pharmacokinetic profile, which means how the drug is absorbed, distributed, metabolized, and excreted in the body. Additionally, the study will evaluate the immune response to the investigational medication.

  • Who can participate: Adults with chronic kidney disease receiving a kidney transplant or those diagnosed with active AMR can participate. Key factors include a BMI of 40 kg/m2 or less and adherence to contraceptive guidelines for both men and women during and after treatment.
  • Study details: Participants will receive an investigational medication along with standard of care therapy. The study will monitor participants to assess the medication's safety, tolerability, and pharmacokinetics.
  • Study timelines: The study will last up to approximately 2 years.
Updated on 26 Feb 2026. Study ID: NCT05156710