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

Sanofi

Status and phase: Active, not recruiting; Phase 2

Conditions: Transplant Rejection

Treatments: Drug: Tacrolimus; Drug: Corticosteroids; Drug: Mycophenolate; Drug: BIVV020 (SAR445088); Drug: Intravenous immunoglobulin (IVIg); Drug: Rituximab or biosimilar; Drug: Antithymocyte globulin (ATG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05156710

U1111-1267-2612 (Registry Identifier)

2021-000010-41 (EudraCT Number)

2023-509936-25 (Registry Identifier)

2023-509936-25-00 (Registry Identifier)

ACT17012

Details and patient eligibility

About

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

Full description

Up to approximately 2 years

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

BIVV020 with Standard of Care (SOC) Cohort A

Experimental group

Description:

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

Treatment:

Drug: Antithymocyte globulin (ATG)

Drug: BIVV020 (SAR445088)

Drug: Mycophenolate

Drug: Tacrolimus

BIVV020 with Standard of Care (SOC) Cohort B

Experimental group

Description:

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

Treatment:

Drug: Rituximab or biosimilar

Drug: Intravenous immunoglobulin (IVIg)

Drug: BIVV020 (SAR445088)

Drug: Corticosteroids

Standard of Care (SOC) Cohort B

Other group

Description:

SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.

Treatment:

Drug: Rituximab or biosimilar

Drug: Intravenous immunoglobulin (IVIg)

Drug: Corticosteroids