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

Last updated: January 9, 2025
Sponsor: Sanofi
Overall Status: Active - Not Recruiting

Phase

2

Condition

Transplant Rejection

Treatment

Rituximab

BIVV020 (SAR445088)

BIVV020

Clinical Study ID

NCT05156710
ACT17012
U1111-1267-2612
2021-000010-41
2023-509936-25-00
2023-509936-25
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 weeksafter the last administration of IMP (BIVV020 + SOC arm participant) or lasttreatment period visit (SOC arm participant).

  • Contraceptive use by men during the treatment period, and for at least 49 weeksafter the last administration of IMP (BIVV020 + SOC arm participant) or lasttreatment period visit (SOC arm participant).

Exclusion

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 anyactive bacterial infection, or any other infection which is clinicallysignificant in the option of the Investigator, unless it can be confirmed thatinfection 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 studytreatment 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

Total Participants: 48
Treatment Group(s): 9
Primary Treatment: Rituximab
Phase: 2
Study Start date:
June 09, 2022
Estimated Completion Date:
November 17, 2026

Study Description

Up to approximately 2 years

Connect with a study center

  • Investigational Site Number : 0360003

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Investigational Site Number :0360003

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Investigational Site Number : 1240001

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

  • Investigational Site Number : 1240101

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Investigational Site Number :1240001

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Active - Recruiting

  • Investigational Site Number :1240101

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240002

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Investigational Site Number : 1240003

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Investigational Site Number :1240003

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Investigational Site Number : 2500007

    Bordeaux, 33076
    France

    Site Not Available

  • Investigational Site Number :2500007

    Bordeaux, 33000
    France

    Active - Recruiting

  • Investigational Site Number : 2500002

    Creteil, 94000
    France

    Site Not Available

  • Investigational Site Number :2500002

    Creteil, 94000
    France

    Active - Recruiting

  • Investigational Site Number : 2500002

    Créteil, 94010
    France

    Site Not Available

  • Investigational Site Number : 2500001

    Paris, 75010
    France

    Site Not Available

  • Investigational Site Number :2500001

    Paris, 75010
    France

    Active - Recruiting

  • Investigational Site Number : 2500004

    Suresnes, 92150
    France

    Site Not Available

  • Investigational Site Number :2500004

    Suresnes, 92150
    France

    Active - Recruiting

  • Investigational Site Number : 2500005

    Toulouse, 31059
    France

    Site Not Available

  • Investigational Site Number :2500005

    Toulouse, 31059
    France

    Active - Recruiting

  • Investigational Site Number : 2760002

    Berlin, 13353
    Germany

    Site Not Available

  • Investigational Site Number :2760002

    Berlin, 13353
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760004

    Essen, 45147
    Germany

    Site Not Available

  • Investigational Site Number :2760004

    Essen, 45122
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760001

    Munich, 81675
    Germany

    Site Not Available

  • Investigational Site Number : 2760001

    München, 81675
    Germany

    Site Not Available

  • Investigational Site Number :2760001

    München, 81675
    Germany

    Active - Recruiting

  • Investigational Site Number : 3800004

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • Investigational Site Number :3800004

    Bologna, Emilia-Romagna 40138
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800002

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Investigational Site Number : 3800002

    Rome, Lazio 00168
    Italy

    Site Not Available

  • Investigational Site Number : 3800001

    Brescia, Lombardia 25123
    Italy

    Site Not Available

  • Investigational Site Number :3800001

    Brescia, Lombardia 25123
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800003

    Milan, Milano 20162
    Italy

    Site Not Available

  • Investigational Site Number : 3800003

    Milano, 20126
    Italy

    Site Not Available

  • Investigational Site Number :3800003

    Milano, 20126
    Italy

    Active - Recruiting

  • Investigational Site Number : 7240004

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Investigational Site Number :7240004

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240001

    Madrid, Madrid, Comunidad De 28007
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240002

    Madrid, Madrid, Comunidad De 28046
    Spain

    Site Not Available

  • Investigational Site Number : 7240003

    Madrid, Madrid, Comunidad De 28041
    Spain

    Site Not Available

  • Investigational Site Number :7240002

    Madrid, Madrid, Comunidad De 28046
    Spain

    Active - Recruiting

  • Investigational Site Number :7240003

    Madrid, Madrid, Comunidad De 28041
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240001

    Madrid / Madrid, Madrid, Comunidad De 28007
    Spain

    Site Not Available

  • Investigational Site Number :7240001

    Madrid / Madrid, Madrid, Comunidad De 28007
    Spain

    Active - Recruiting

  • Investigational Site Number : 7520001

    Huddinge, 141 57
    Sweden

    Site Not Available

  • Investigational Site Number :7520001

    Huddinge,
    Sweden

    Active - Recruiting

  • Investigational Site Number : 7520002

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Investigational Site Number :7520002

    Uppsala, 751 85
    Sweden

    Active - Recruiting

  • Cedars-Sinai Medical Center Site Number : 8400100

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center- Site Number : 8400100

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California Los Angeles (UCLA) - Ronald Reagan UCLA Medical Center Site Number : 8400103

    Los Angeles, California 90095
    United States

    Active - Recruiting

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

    Los Angeles, California 90095
    United States

    Site Not Available

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

    San Francisco, California 94143
    United States

    Site Not Available

  • University of California San Francisco Site Number : 8400001

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Brigham & Women's Hospital Site Number : 8400004

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Brigham & Women's Hospital- Site Number : 8400004

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham & Women's Hospital-Site Number:8400004

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Harvard Medical School - Massachusetts General Hospital (MGH) - Medical Practice Evaluation Center (MPEC)- Site Number : 8400007

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital Site Number : 8400007

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital- Site Number : 8400007

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital-Site Number:8400007

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • NYU Langone Medical Center Site Number : 8400102

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Medical Center- Site Number : 8400102

    New York, New York 10016
    United States

    Site Not Available

  • University Of Wisconsin Hospital And Clinics Site Number : 8400003

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • University Of Wisconsin Hospital And Clinics-Site Number:8400003

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • University of Wisconsin Hospitals and Clinics- Site Number : 8400003

    Madison, Wisconsin 53792
    United States

    Site Not Available

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