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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05156710




Registration number
NCT05156710
Ethics application status
Date submitted
18/11/2021
Date registered
14/12/2021
Date last updated
15/12/2023

Titles & IDs
Public title
BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)
Scientific 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.
Secondary ID [1] 0 0
U1111-1267-2612
Secondary ID [2] 0 0
ACT17012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transplant Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIVV020 (SAR445088)
Treatment: Drugs - Intravenous immunoglobulin (IVIg)
Treatment: Drugs - Rituximab or biosimilar
Treatment: Drugs - Antithymocyte globulin (ATG)
Treatment: Drugs - Tacrolimus
Treatment: Drugs - Mycophenolate
Treatment: Drugs - Corticosteroids

Experimental: BIVV020 with Standard of Care (SOC) Cohort A - Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate.

Experimental: BIVV020 with Standard of Care (SOC) Cohort B - Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab.

Other: Standard of Care (SOC) Cohort B - SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.


Treatment: Drugs: BIVV020 (SAR445088)
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

Treatment: Drugs: Intravenous immunoglobulin (IVIg)
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

Treatment: Drugs: Rituximab or biosimilar
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

Treatment: Drugs: Antithymocyte globulin (ATG)
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous

Treatment: Drugs: Tacrolimus
Pharmaceutical Form: Tablet Route of Administration: Oral

Treatment: Drugs: Mycophenolate
Pharmaceutical Form: Tablet Route of Administration: Oral

Treatment: Drugs: Corticosteroids
Pharmaceutical Form: Vary Route of Administration: Vary
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort A: Treatment failure rate
Timepoint [1] 0 0
Up to Week 49
Primary outcome [2] 0 0
Cohort B: AMR resolution rate
Timepoint [2] 0 0
Up to Week 49
Secondary outcome [1] 0 0
Cohort A: Treatment failure rate per local assessment using Banff criteria 2019
Timepoint [1] 0 0
Up to Week 49
Secondary outcome [2] 0 0
Cohort B: AMR resolution rate per local assessment using Banff criteria 2019
Timepoint [2] 0 0
Up to Week 49
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Up to 22 weeks after end of treatment period
Secondary outcome [4] 0 0
Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio
Timepoint [4] 0 0
Up to 22 weeks after end of treatment period
Secondary outcome [5] 0 0
Change in allograft histopathology Banff score
Timepoint [5] 0 0
Up to Week 49
Secondary outcome [6] 0 0
Graft survival as predicted by iBOX
Timepoint [6] 0 0
Up to Week 49
Secondary outcome [7] 0 0
Assessment of adverse events (AEs)
Timepoint [7] 0 0
Up to end of study, up to approximately 2 years
Secondary outcome [8] 0 0
Change in systemic lupus erythematosus (SLE) panel
Timepoint [8] 0 0
Up to 22 weeks after end of treatment period
Secondary outcome [9] 0 0
Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin
Timepoint [9] 0 0
Up to 22 weeks after end of treatment period
Secondary outcome [10] 0 0
Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC
Timepoint [10] 0 0
Up to 22 weeks after end of treatment period
Secondary outcome [11] 0 0
Number of participants with anti-BIVV020 antibodies
Timepoint [11] 0 0
Up to 22 weeks after end of treatment period

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/12/2026
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Investigational Site Number : 0360003 - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Wisconsin
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
France
State/province [7] 0 0
Bordeaux
Country [8] 0 0
France
State/province [8] 0 0
Creteil
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Suresnes
Country [11] 0 0
France
State/province [11] 0 0
Toulouse
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Essen
Country [14] 0 0
Germany
State/province [14] 0 0
München
Country [15] 0 0
Italy
State/province [15] 0 0
Emilia-Romagna
Country [16] 0 0
Italy
State/province [16] 0 0
Lazio
Country [17] 0 0
Italy
State/province [17] 0 0
Lombardia
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona [Barcelona]
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid, Comunidad De
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Sweden
State/province [22] 0 0
Huddinge
Country [23] 0 0
Sweden
State/province [23] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05156710
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05156710