Open Actively Recruiting

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

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Brief 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
Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
75 Years

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:
    • Positive HIV.
    • Positive HBV.
    • HCV with detectable HCV RNA.
    • 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.

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Protocol No.
22-001952
Category
Genitourinary Disorders
Immune System/Transplant Related Disorders
Contact
NAKUL DATTA
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05156710
For detailed technical eligibility, visit ClinicalTrials.gov.