BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)
- Conditions
- Transplant Rejection
- Interventions
- Drug: BIVV020 (SAR445088)Drug: Antithymocyte globulin (ATG)Drug: Corticosteroids
- Registration Number
- NCT05156710
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Up to approximately 2 years
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 48
-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).
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Participants who are ABO incompatible with their donors.
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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).
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Prior treatment with complement system inhibitor within 5 times the half-life.
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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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIVV020 with Standard of Care (SOC) Cohort B Rituximab or biosimilar Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab. BIVV020 with Standard of Care (SOC) Cohort A BIVV020 (SAR445088) Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate. Standard of Care (SOC) Cohort B Corticosteroids SOC includes plasmapheresis, IVIg, corticosteroids, rituximab. BIVV020 with Standard of Care (SOC) Cohort A Antithymocyte globulin (ATG) Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate. BIVV020 with Standard of Care (SOC) Cohort A Tacrolimus Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate. BIVV020 with Standard of Care (SOC) Cohort B BIVV020 (SAR445088) Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab. BIVV020 with Standard of Care (SOC) Cohort B Corticosteroids Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab. Standard of Care (SOC) Cohort B Rituximab or biosimilar SOC includes plasmapheresis, IVIg, corticosteroids, rituximab. BIVV020 with Standard of Care (SOC) Cohort A Mycophenolate Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate. BIVV020 with Standard of Care (SOC) Cohort B Intravenous immunoglobulin (IVIg) Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab. Standard of Care (SOC) Cohort B Intravenous immunoglobulin (IVIg) SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.
- Primary Outcome Measures
Name Time Method Cohort B: AMR resolution rate Up to Week 49 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.
Cohort A: Treatment failure rate Up to Week 49 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.
- Secondary Outcome Measures
Name Time Method Cohort A: Treatment failure rate per local assessment using Banff criteria 2019 Up to Week 49 Graft survival as predicted by iBOX 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 allograft histopathology Banff score Up to Week 49 Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC Up to 22 weeks after end of treatment period AUC is defined as the area under plasma concentration versus time curve
Change in systemic lupus erythematosus (SLE) panel Up to 22 weeks after end of treatment period 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 using protein: creatinine ratio Up to 22 weeks after end of treatment period Number of participants with anti-BIVV020 antibodies Up to 22 weeks after end of treatment period Number of participants developed drug-induced ADAs
Assessment of adverse events (AEs) Up to end of study, up to approximately 2 years Number of participants with treatment emergent adverse events (TEAEs)/ serious adverse events (SAES), laboratory abnormalities
Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin Up to 22 weeks after end of treatment period Cmin is defined as the minimum concentration after injection
Trial Locations
- Locations (27)
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 Medical Center- Site Number : 8400103
🇺🇸Los Angeles, California, United States
University of California San Francisco - Parnassus Heights- Site Number : 8400001
🇺🇸San Francisco, California, United States
Brigham & Women's Hospital- Site Number : 8400004
🇺🇸Boston, Massachusetts, United States
NYU Langone Medical Center- Site Number : 8400102
🇺🇸New York, New York, United States
University of Wisconsin Hospitals and Clinics- Site Number : 8400003
🇺🇸Madison, Wisconsin, United States
Investigational Site Number : 1240101
🇨🇦Vancouver, British Columbia, Canada
Investigational Site Number : 1240001
🇨🇦Vancouver, British Columbia, Canada
Investigational Site Number : 1240002
🇨🇦London, Ontario, Canada
Investigational Site Number : 1240003
🇨🇦Montreal, Quebec, Canada
Investigational Site Number : 2500007
🇫🇷Bordeaux, France
Investigational Site Number : 2500002
🇫🇷Créteil, France
Investigational Site Number : 2500001
🇫🇷Paris, France
Investigational Site Number : 2500005
🇫🇷Toulouse, France
Investigational Site Number : 2760002
🇩🇪Berlin, Germany
Investigational Site Number : 2760004
🇩🇪Essen, Germany
Investigational Site Number : 2760001
🇩🇪Munich, Germany
Investigational Site Number : 3800004
🇮🇹Bologna, Emilia-Romagna, Italy
Investigational Site Number : 3800002
🇮🇹Rome, Lazio, Italy
Investigational Site Number : 3800001
🇮🇹Brescia, Lombardia, Italy
Investigational Site Number : 3800003
🇮🇹Milan, Milano, Italy
Investigational Site Number : 7240004
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240003
🇪🇸Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240002
🇪🇸Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7520001
🇸🇪Huddinge, Sweden
Investigational Site Number : 7520002
🇸🇪Uppsala, Sweden