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

A 12-month, Open-label, Multicenter, Randomized, Safety, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Two Regimens of Anti-CD40 Monoclonal Antibody, CFZ533 vs. Standard of Care Control, in Adult de Novo Liver Transplant Recipients With a 12-month Additionalr Follow-up and a Long-term Extension (CONTRAIL I)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study was designed as a randomized, 36-month clinical trial comprised of: * A screening period (up to 2 months) starting from informed consent, screening visit, and including successful liver transplantation (LTx). * A run-in treatment period following successful transplantation that ended on the day of randomization or randomization failure, at Day 8 (with visit window of +/- 2 days) post-LTx. * The primary treatment period (Treatment Period 1) starting at randomization Day 8 +/- 2 post-LTx up to Month 12 followed by a 12-month follow-up treatment period (Treatment Period 2) until Month 24. * The long-term extension period (Treatment Period 3) starting post Month 24 until the end of the study (EOS). * A minimum 12-week safety follow-up period for all patients after EOS. The study was terminated following less favorable efficacy by Iscalimab (CFZ533) in liver transplant patients compared to tacrolimus.

Conditions

• Liver Transplant Rejection

Interventions

Type	Name	Description
BIOLOGICAL	CFZ533	Comparison with standard of care immunosuppression
DRUG	Tacrolimus - MMF - corticosteroids	Standard of care immunosuppresive regimen

Timeline

• Start date: 2019-10-07
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2018-12-19
• Last updated: 2025-05-16
• Results posted: 2024-07-03

Locations

29 sites across 10 countries: United States, Argentina, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Spain

Regulatory

• FDA-regulated drug study