Active — Not RecruitingPhase 2

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

United States48 participantsStarted 2022-06-09

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓Participant intended to receive SOC therapy per Investigator's judgment and local practice.

Exclusion criteria

✕. 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.

What they're measuring

Cohort A: Treatment failure rate

Timeframe: Up to Week 49

Cohort B: AMR resolution rate

Timeframe: Up to Week 49

Trial details

NCT IDNCT05156710

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-21

View on ClinicalTrials.gov More Transplant Rejection trials