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

Investigational Medication in Prevention and Treatment of Immune Rejection in Kidney Transplant Patients

Recruiting
18 years - 75 years
All
Phase 2
54 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 - 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.

This study investigates the use of an investigational medication in preventing and treating antibody-mediated rejection (AMR) in kidney transplant patients. The study includes two arms: Cohort A focuses on preventing AMR in patients who are sensitized to their donor, while Cohort B focuses on treating patients with active AMR.

Participants in the study will receive either the investigational medication or standard of care treatments. The study will evaluate the medication's effectiveness, safety, and how it is processed in the body. Participants will also be monitored for any immune response to the medication. The study aims to provide insights into the medication's potential benefits for kidney transplant recipients.

  • Who can participate: Individuals aged 18 to 75 years who are either scheduled to receive a kidney transplant from a sensitized donor or have been diagnosed with active antibody-mediated rejection can participate. Key eligibility criteria include a BMI of 40 kg/m2 or less and adherence to contraceptive guidelines. Participants must not have certain infections or conditions like systemic lupus erythematosus.
  • Study details: Participants will be assigned to receive either the investigational medication or standard care. The study will involve monitoring the safety and effectiveness of the treatment, including any immune response. Participants will need to follow specific contraceptive guidelines during and after the study.
  • Study timelines: The study will last up to approximately 2 years.
Updated on 04 Apr 2025. Study ID: NCT05156710

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