BIVV020 in Prevention and Treatment of Antibody-mediated Rejection (AMR)
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.
Updated on
04 Apr 2025.
Study ID: NCT05156710