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
Description
Up to approximately 2 years
Eligibility
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.