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

• Status: Not yet recruiting
• Trial end date: 2025-04-09
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Antibodies; Antilymphocyte Serum; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Rituximab; Tacrolimus

Criteria

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.