BIVV020 (SAR445088) in prevention and treatment of antibody-mediated rejection (AMR)

Phase 1

Recruiting

• Conditions: Transplant Rejection; MedDRA version: 21.1Level: PTClassification code: 10044439Term: Transplant rejection Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-509936-25-00
• Lead Sponsor: Sanofi-Aventis Recherche & Developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 55

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)., 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: a)Positive HIV. b)Positive HBV. c)HCV with detectable HCV RNA. d)Within 4 weeks of first study intervention: any serious infection, or any active bacterial infection i, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified