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

Transplant Rejection Clinical Trial

Official title:

A Multi-cohort, Randomized, Phase 2, Open-label Study to Assess the Preliminary Efficacy, Safety, and Pharmacokinetics of BIVV020 for Prevention and Treatment of Antibody-mediated Rejection in Adult Kidney Transplant Recipients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156710
• Other study ID #: ACT17012
• Secondary ID: U1111-1267-26122
• Status: Recruiting
• Phase: Phase 2
• Start date: June 9, 2022
• Est. completion date: December 3, 2026

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Up to approximately 2 years

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 3, 2026
• Est. primary completion date: November 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Transplant Rejection

Intervention

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

Locations

Country	Name	City	State
Canada	Investigational Site Number : 1240002	London	Ontario
Canada	Investigational Site Number : 1240003	Montreal	Quebec
Canada	Investigational Site Number : 1240001	Vancouver	British Columbia
Canada	Investigational Site Number : 1240101	Vancouver	British Columbia
France	Investigational Site Number : 2500007	Bordeaux
France	Investigational Site Number : 2500002	Creteil
France	Investigational Site Number : 2500001	Paris
France	Investigational Site Number : 2500005	Toulouse
Germany	Investigational Site Number : 2760002	Berlin
Germany	Investigational Site Number : 2760004	Essen
Germany	Investigational Site Number : 2760001	München
Italy	Investigational Site Number : 3800004	Bologna	Emilia-Romagna
Italy	Investigational Site Number : 3800001	Brescia	Lombardia
Italy	Investigational Site Number : 3800003	Milano
Italy	Investigational Site Number : 3800002	Roma	Lazio
Spain	Investigational Site Number : 7240004	Barcelona	Barcelona [Barcelona]
Spain	Investigational Site Number : 7240002	Madrid	Madrid, Comunidad De
Spain	Investigational Site Number : 7240003	Madrid	Madrid, Comunidad De
Spain	Investigational Site Number : 7240001	Madrid / Madrid	Madrid, Comunidad De
Sweden	Investigational Site Number : 7520001	Huddinge
Sweden	Investigational Site Number : 7520002	Uppsala
United States	Brigham & Women's Hospital Site Number : 8400004	Boston	Massachusetts
United States	Massachusetts General Hospital Site Number : 8400007	Boston	Massachusetts
United States	Cedars-Sinai Medical Center Site Number : 8400100	Los Angeles	California
United States	University of California Los Angeles (UCLA) - Ronald Reagan UCLA Medical Center Site Number : 8400103	Los Angeles	California
United States	University Of Wisconsin Hospital And Clinics Site Number : 8400003	Madison	Wisconsin
United States	NYU Langone Medical Center Site Number : 8400102	New York	New York
United States	University of California San Francisco Site Number : 8400001	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Cohort A: Treatment failure rate per local assessment using Banff criteria 2019		Up to Week 49
Secondary	Cohort B: AMR resolution rate per local assessment using Banff criteria 2019		Up to Week 49
Secondary	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
Secondary	Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio		Up to 22 weeks after end of treatment period
Secondary	Change in allograft histopathology Banff score		Up to Week 49
Secondary	Graft survival as predicted by iBOX		Up to Week 49
Secondary	Assessment of adverse events (AEs)	Number of participants with treatment emergent adverse events (TEAEs)/ serious adverse events (SAES), laboratory abnormalities	Up to end of study, up to approximately 2 years
Secondary	Change in systemic lupus erythematosus (SLE) panel		Up to 22 weeks after end of treatment period
Secondary	Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin	Cmin is defined as the minimum concentration after injection	Up to 22 weeks after end of treatment period
Secondary	Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC	AUC is defined as the area under plasma concentration versus time curve	Up to 22 weeks after end of treatment period
Secondary	Number of participants with anti-BIVV020 antibodies	Number of participants developed drug-induced ADAs	Up to 22 weeks after end of treatment period

External Links

•   ACT17012 kidney transplant - antibody-mediated rejection website