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

Phase 3 Terminated 31 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this open-label extension study was to provide treatment with secukinumab for subjects who completed core study treatment in Study CAIN457Q12301 (NCT04181762), and to obtain further data on long-term efficacy, safety and tolerability of secukinunab in patients with active lupus nephritis (LN).

Timeline

Start: 2022-08-22
Primary completion: 2023-08-23
Completion: 2023-08-23

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped: “Study terminated by sponsor based on a futility analysis of the core study CAIN457Q12301”

paper In the extension study, the results were not interpretable, owing to the low patient number included in the data analysis (n = 31). PMID 41092316 ↗

Publications

Zhao MH, Cons Molina F, Aroca G, Tektonidou MG, Mathur A, Tangadpalli R, Sun R, Martin R, Pellet P, Ngoc Phuong Huynh T. Secukinumab in active lupus nephritis: results from a phase III randomized, placebo-controlled study (SELUNE) and an open-label extension study. Rheumatology (Oxford). 2026 Jan 8;65(1):keaf536. doi: 10.1093/rheumatology/keaf536.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Secukinumab	Monoclonal antibody	300 mg	Subcutaneous