Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

Summary

This was a pivotal, randomized, double-blind, placebo-controlled trial evaluating at Week 52 the efficacy and safety of secukinumab versus placebo in patients with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features) also receiving background standard of care therapy (SoC).

Timeline

Start

2020-07-07

Primary completion

2023-09-13

Completion

2023-09-13

Outcome

Missed primary endpoint

Stopped: “Study terminated by sponsor due to futility analysis”

registry analysis (superiority test); Secukinumab 300 mg vs Placebo; p = 0.0662; Mean Difference (Final Values) -12.7 (95% CI -26.3 to 0.9); Regression, Logistic NCT04181762 ↗

paper Secukinumab did not demonstrate superior efficacy over placebo in patients with active LN. 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.
• Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.

Drugs

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

Indications