Long-Term Safety Study of Secukinumab for Patients Who Completed a Previous Novartis Secukinumab Trial Open-Label Treatment for Autoimmune and Inflammatory Conditions

What this Trial Is About

This trial focuses on participants with autoimmune or inflammatory conditions who have previously taken part in a Novartis secukinumab study. It aims to evaluate the long-term safety of continuing secukinumab treatment in those who the investigator judges will benefit and who cannot obtain the marketed secukinumab formulation. The study is an open-label extension phase 4 trial sponsored by Novartis Pharmaceuticals. Participants will receive secukinumab injections under the skin at doses of 75 mg, 150 mg, or 300 mg every four weeks, depending on their dose in the prior trial. For those who had intravenous secukinumab, the starting dose will be 300 mg subcutaneously. Dosing may be adjusted based on clinical need and investigator judgment. Pediatric dosing will not exceed the maximum dose evaluated for their weight group in the previous trial. During the study, participants will be monitored for up to two years to assess safety, focusing on adverse events and serious adverse events. They will have regular assessments including communication with investigators and follow study requirements. The total study duration extends up to April 2030, with ongoing evaluation to ensure participants continue to benefit from treatment while monitoring for any risks.

Secukinumab Open Label Roll-over Extension Protocol