Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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. 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).

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 any active bacterial infection, or any other infection which is clinically significant in the option of the Investigator, unless it can be confirmed that infection was cleared at least 3 days prior to first study intervention. - 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Randomization for Cohort B only

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BIVV020 with Standard of Care (SOC) Cohort A
Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate.
  • Drug: BIVV020 (SAR445088)
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Drug: Antithymocyte globulin (ATG)
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Drug: Tacrolimus
    Pharmaceutical Form: Tablet Route of Administration: Oral
  • Drug: Mycophenolate
    Pharmaceutical Form: Tablet Route of Administration: Oral
Experimental
BIVV020 with Standard of Care (SOC) Cohort B
Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab.
  • Drug: BIVV020 (SAR445088)
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Drug: Intravenous immunoglobulin (IVIg)
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Drug: Rituximab or biosimilar
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Drug: Corticosteroids
    Pharmaceutical Form: Vary Route of Administration: Vary
Other
Standard of Care (SOC) Cohort B
SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.
  • Drug: Intravenous immunoglobulin (IVIg)
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Drug: Rituximab or biosimilar
    Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
  • Drug: Corticosteroids
    Pharmaceutical Form: Vary Route of Administration: Vary

Recruiting Locations

Massachusetts General Hospital Site Number : 8400007
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)
800-633-1610
Contact-US@sanofi.com

Detailed Description

Up to approximately 2 years

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.