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

NCT05156710 | Active Not Recruiting Phase 2 FDA Drug

• 4 other identifiers: ACT17012U1111-1267-26122023-509936-252021-000010-41
• Study Type: interventional
• Target: 48
• Locations: 7 countries
• Sites: 27

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

Conditions

Transplant Rejection

Outcome Measures

Primary Outcomes (2)

• Cohort A: Treatment failure rate

  Defined as the proportion of participants meeting at least one of the following criteria: * Biopsy-proven active AMR as per Banff Criteria 2019 as per central pathology assessment, * Graft loss.

  Up to Week 49

• Cohort B: AMR resolution rate

  Defined as the proportion of participants with post-treatment biopsy not fulfilling active AMR diagnosis criteria as per Banff Criteria 2019 as per central pathology assessment.

  Up to Week 49

Secondary Outcomes (11)

• Cohort A: Treatment failure rate per local assessment using Banff criteria 2019

  Up to Week 49

• Cohort B: AMR resolution rate per local assessment using Banff criteria 2019

  Up to Week 49

• Change in renal function from baseline per central laboratory assessment of estimated glomerular filtration rate (eGFR) from serum creatinine using Modification of Diet in Renal Disease equation (MDRD)

  Up to 22 weeks after end of treatment period

• Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio

  Up to 22 weeks after end of treatment period

• Change in allograft histopathology Banff score

  Up to Week 49

Study Arms (3)

BIVV020 with Standard of Care (SOC) Cohort A

EXPERIMENTAL

Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate.

Drug: BIVV020 (SAR445088); Drug: Antithymocyte globulin (ATG); Drug: Tacrolimus; Drug: Mycophenolate

BIVV020 with Standard of Care (SOC) Cohort B

EXPERIMENTAL

Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab.

Drug: BIVV020 (SAR445088); Drug: Intravenous immunoglobulin (IVIg); Drug: Rituximab or biosimilar; Drug: Corticosteroids

Standard of Care (SOC) Cohort B

OTHER

SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.

Drug: Intravenous immunoglobulin (IVIg); Drug: Rituximab or biosimilar; Drug: Corticosteroids

Interventions

BIVV020 (SAR445088) DRUG

Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

BIVV020 with Standard of Care (SOC) Cohort A; BIVV020 with Standard of Care (SOC) Cohort B

Intravenous immunoglobulin (IVIg) DRUG

Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

BIVV020 with Standard of Care (SOC) Cohort B; Standard of Care (SOC) Cohort B

Rituximab or biosimilar DRUG

Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

BIVV020 with Standard of Care (SOC) Cohort B; Standard of Care (SOC) Cohort B

Antithymocyte globulin (ATG) DRUG

Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

BIVV020 with Standard of Care (SOC) Cohort A

Tacrolimus DRUG

Pharmaceutical Form: Tablet Route of Administration: Oral

BIVV020 with Standard of Care (SOC) Cohort A

Mycophenolate DRUG

Pharmaceutical Form: Tablet Route of Administration: Oral

BIVV020 with Standard of Care (SOC) Cohort A

Corticosteroids DRUG

Pharmaceutical Form: Vary Route of Administration: Vary

BIVV020 with Standard of Care (SOC) Cohort B; Standard of Care (SOC) Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (27)

Cedars-Sinai Medical Center- Site Number : 8400100

Los Angeles, California, 90048, United States

Location

University of California Los Angeles Medical Center- Site Number : 8400103

Los Angeles, California, 90095, United States

Location

University of California San Francisco - Parnassus Heights- Site Number : 8400001

San Francisco, California, 94143, United States

Location

Massachusetts General Hospital- Site Number : 8400007

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital- Site Number : 8400004

Boston, Massachusetts, 02115, United States

Location

NYU Langone Medical Center- Site Number : 8400102

New York, New York, 10016, United States

Location

University of Wisconsin Hospitals and Clinics- Site Number : 8400003

Madison, Wisconsin, 53792, United States

Location

Investigational Site Number : 1240101

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Investigational Site Number : 1240001

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Investigational Site Number : 1240002

London, Ontario, N6A 5A5, Canada

Location

Investigational Site Number : 1240003

Montreal, Quebec, H4A 3J1, Canada

Location

Investigational Site Number : 2500007

Bordeaux, 33076, France

Location

Investigational Site Number : 2500002

Créteil, 94010, France

Location

Investigational Site Number : 2500001

Paris, 75010, France

Location

Investigational Site Number : 2500005

Toulouse, 31059, France

Location

Investigational Site Number : 2760002

Berlin, 13353, Germany

Location

Investigational Site Number : 2760004

Essen, 45147, Germany

Location

Investigational Site Number : 2760001

Munich, 81675, Germany

Location

Investigational Site Number : 3800004

Bologna, Emilia-Romagna, 40138, Italy

Location

Investigational Site Number : 3800002

Rome, Lazio, 00168, Italy

Location

Investigational Site Number : 3800001

Brescia, Lombardy, 25123, Italy

Location

Investigational Site Number : 3800003

Milan, Milano, 20162, Italy

Location

Investigational Site Number : 7240004

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Investigational Site Number : 7240003

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Investigational Site Number : 7240002

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Investigational Site Number : 7520001

Huddinge, 141 57, Sweden

Location

Investigational Site Number : 7520002

Uppsala, 751 85, Sweden

Location

Related Publications (1)

• Karpman D, Bekassy Z, Grunenwald A, Roumenina LT. A role for complement blockade in kidney transplantation. Cell Mol Immunol. 2022 Jul;19(7):755-757. doi: 10.1038/s41423-022-00854-5. Epub 2022 Mar 24. No abstract available.

  PMID: 35332298 DERIVED

Related Links

• ACT17012 kidney transplant - antibody-mediated rejection website
• ACT17012 Plain Language Results Summary

MeSH Terms

Interventions

Immunoglobulins, Intravenous; Rituximab; Biosimilar Pharmaceuticals; Antilymphocyte Serum; Tacrolimus; Mycophenolic Acid; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Biological Products; Complex Mixtures; Immune Sera; Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization for Cohort B only
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 14, 2021
• Study Start: June 9, 2022
• Primary Completion: October 21, 2025
• Study Completion (Estimated): October 26, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (4); DE (3); SE (2); FR (4); US (7); IT (4); ES (3)