Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title: A Three-year, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability in Patients With Active Lupus Nephritis

Status Terminated

Clinical Trial Summary

The purpose is to provide treatment with secukinumab delivered subcutaneously (s.c.) via pre-filled syringe (PFS) for participants who complete study treatment until the Week 104 of the core study CAIN457Q12301 and to obtain long term efficacy, safety and tolerability data

Clinical Trial Description

This study is an up to three-year open-label extension study to the core study CAIN457Q12301 (a two-year, phase III study that enrolled participants aged 18 to 75 years with active Lupus Nephritis). The aim is to provide treatment with secukinumab delivered subcutaneously (s.c.) via pre-filled syringe (PFS) for participants who complete study treatment until the Week 104 of the core study and opt to continue in to the extension study and to obtain further long-term efficacy, safety and tolerability information. All subjects will receive 300 mg secukinumab s.c. every 4 weeks. Background SoC will consist of maintenance therapy with mycophenolic acid (MPA) and oral corticosteroids at the minimal dose required by the participant's status to maintain response. Participants who the investigator believes will continue to receive benefit from treatment may also have post-trial access until secukinumab is available for LN following product launch/subsequent reimbursement (where applicable), or treatment discontinuation, or the benefit-risk profile is no longer positive. ;

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

• NCT number: NCT05232864
• Study type: Interventional
• Source: Novartis
• Status: Terminated
• Phase: Phase 3
• Start date: August 22, 2022
• Completion date: August 23, 2023