BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sanofi
Study ID
NCT05156710
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BIVV020 (SAR445088) — DRUG
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Intravenous immunoglobulin (IVIg) — DRUG
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Rituximab or biosimilar — DRUG
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Antithymocyte globulin (ATG) — DRUG
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Tacrolimus — DRUG
    Pharmaceutical Form: Tablet Route of Administration: Oral
  • Mycophenolate — DRUG
    Pharmaceutical Form: Tablet Route of Administration: Oral
  • Corticosteroids — DRUG
    Pharmaceutical Form: Vary Route of Administration: Vary

Study Details

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

Key Dates

Start date
Jun 9, 2022
Status verified
Feb 2026
Primary completion
Oct 21, 2025
Completion
Oct 26, 2026

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BIVV020 with Standard of Care (SOC) Cohort A
    Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate.
  • Experimental: BIVV020 with Standard of Care (SOC) Cohort B
    Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab.
  • Other: Standard of Care (SOC) Cohort B
    SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.

Primary Outcome Measure

Cohort A: Treatment failure rate [ Time Frame: Up to Week 49 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center- Site Number : 8400100Los AngelesCalifornia90048-
University of California Los Angeles Medical Center- Site Number : 8400103Los AngelesCalifornia90095-
University of California San Francisco - Parnassus Heights- Site Number : 8400001San FranciscoCalifornia94143-
Brigham & Women's Hospital- Site Number : 8400004BostonMassachusetts02115-
Massachusetts General Hospital- Site Number : 8400007BostonMassachusetts02114-
NYU Langone Medical Center- Site Number : 8400102New YorkNew York10016-
University of Wisconsin Hospitals and Clinics- Site Number : 8400003MadisonWisconsin53792-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of California Los Angeles Medical Center· Los Angeles, CAUniversity of California San Francisco - Parnassus Heights· San Francisco, CABrigham & Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MANYU Langone Medical Center· New York, NY