Trials / Active Not Recruiting
Active Not RecruitingNCT05156710
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
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.
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Up to approximately 2 years
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIVV020 (SAR445088) | Pharmaceutical Form: Solution for injection Route of Administration: Intravenous |
| DRUG | Intravenous immunoglobulin (IVIg) | Pharmaceutical Form: Solution for injection Route of Administration: Intravenous |
| DRUG | Rituximab or biosimilar | Pharmaceutical Form: Solution for injection Route of Administration: Intravenous |
| DRUG | Antithymocyte globulin (ATG) | Pharmaceutical Form: Solution for injection Route of Administration: Intravenous |
| DRUG | Tacrolimus | Pharmaceutical Form: Tablet Route of Administration: Oral |
| DRUG | Mycophenolate | Pharmaceutical Form: Tablet Route of Administration: Oral |
| DRUG | Corticosteroids | Pharmaceutical Form: Vary Route of Administration: Vary |
Timeline
- Start date
- 2022-06-09
- Primary completion
- 2025-10-21
- Completion
- 2026-10-26
- First posted
- 2021-12-14
- Last updated
- 2026-02-24
Locations
27 sites across 7 countries: United States, Canada, France, Germany, Italy, Spain, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05156710. Inclusion in this directory is not an endorsement.