drugset / Trial / NCT03781414
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
RandomizedParallel-groupOpen-labelTreatment
Summary
This was a multicenter, open-label, active-controlled study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 maintenance doses in de novo liver transplant recipients.
Timeline
- Start
- 2019-10-07
- Primary completion
- 2023-04-20
- Completion
- 2023-04-20
Outcome
Outcome not reported
Stopped: “The study was terminated following less favorable efficacy by Iscalimab (CFZ533) in liver transplant patients compared to tacrolimus.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | iscalimab | Monoclonal antibody | 300 mg | Intravenous |
| Subject | iscalimab | Monoclonal antibody | 600 mg | Intravenous |
| Comparator | Mycophenolate Mofetil | Small molecule | — | — |
| Comparator | Tacrolimus | Small molecule | — | — |