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

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: Between 18 Years - 75 Years
  • 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 to whom they are sensitized, and/or required
        desensitization prior to transplantation.
        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).
          -  18-75 years old at the time of consent.
        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 infection
                  requiring antibiotic treatment against an identified or suspected bacterial
                  pathogen.
          -  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.

Updated on 21 Mar 2024. Study ID: NCT05156710

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