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

• Status: Not yet recruiting
• Trial end date: 2029-01-08
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Key Inclusion criteria

• Participant must have both participated in core study and completed the entire treatment period up to and including Week 104 of the core study CAIN457Q12301.

• Participant must be deemed by the investigator to benefit from secukinumab therapy.

• Signed informed consent must be obtained prior to participation in the study

Key Exclusion criteria

• Any participant taking other concomitant biologic immunomodulating agent(s) except secukinumab.

• Pregnant or nursing (lactating) women

• Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the entire study or longer if required by locally approved prescribing information