BIVV020 in Prevention and Treatment of Antibody-mediated Rejection (AMR)
Recruiting
18-75 years
All
Phase
2
54 participants needed
3 Locations
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
12 Dec 2024.
Study ID: NCT05156710
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