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NCT05156710 · ClinicalTrials.gov registry record · Phase 2
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
A Phase 2 study of Transplant Rejection, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT05156710: Active Phase 2 study of Transplant Rejection, sponsored by Sanofi.
NCT05156710 is a Phase 2 study of Transplant Rejection that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05156710, a Phase 2 study of Transplant Rejection, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG Antithymocyte globulin (ATG)
- DRUG BIVV020 (SAR445088)
- DRUG Intravenous immunoglobulin (IVIg)
- DRUG Rituximab or biosimilar
Study Locations (20)
Other
- Investigational Site Number : 2500007 - Bordeaux
- Investigational Site Number : 2500002 - Créteil
- Investigational Site Number : 2500001 - Paris
- Investigational Site Number : 2500005 - Toulouse
- Investigational Site Number : 2760002 - Berlin
- Investigational Site Number : 2760004 - Essen
- Investigational Site Number : 2760001 - Munich
California
- Cedars-Sinai Medical Center- Site Number : 8400100 - Los Angeles
- University of California Los Angeles Medical Center- Site Number : 8400103 - Los Angeles
- University of California San Francisco - Parnassus Heights- Site Number : 8400001 - San Francisco
Massachusetts
- Massachusetts General Hospital- Site Number : 8400007 - Boston
- Brigham & Women's Hospital- Site Number : 8400004 - Boston
British Columbia
- Investigational Site Number : 1240101 - Vancouver
- Investigational Site Number : 1240001 - Vancouver
New York
- NYU Langone Medical Center- Site Number : 8400102 - New York
Wisconsin
- University of Wisconsin Hospitals and Clinics- Site Number : 8400003 - Madison
Ontario
- Investigational Site Number : 1240002 - London
Quebec
- Investigational Site Number : 1240003 - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2026-10-26 |
| Phase | Phase 2 |
What the registry record for NCT05156710 still lists
NCT05156710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Transplant Rejection appearing as the primary indexed condition, and to 5 interventions - of which Tacrolimus is the first listed.
NCT05156710 names 20 study sites across 10 states, led by Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05156710 about?
NCT05156710 is a clinical study titled "BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)". 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 ...
What is the current status of trial NCT05156710?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2022-06-09. Estimated completion is 2026-10-26.
What conditions does trial NCT05156710 study?
This clinical trial studies the following conditions: Transplant Rejection.
What interventions are being tested in trial NCT05156710?
The interventions under investigation include: Tacrolimus (DRUG), Antithymocyte globulin (ATG) (DRUG), BIVV020 (SAR445088) (DRUG), Intravenous immunoglobulin (IVIg) (DRUG), Rituximab or biosimilar (DRUG).
Who is sponsoring clinical trial NCT05156710?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05156710 being conducted?
This trial has 20 study locations across California, Massachusetts, New York, Wisconsin, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05156710's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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