A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis (SELUNE)

  • End date
    Jan 8, 2026
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 23 October 2022
glomerular filtration rate
urinary sediment


The purpose of this trial is to evaluate the efficacy and safety of subcutaneous secukinumab 300 mg compared to placebo, in combination with standard of care therapy (SoC), in subjects with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features).

Condition Lupus Nephritis
Treatment Secukinumab
Clinical Study IdentifierNCT04181762
SponsorNovartis Pharmaceuticals
Last Modified on23 October 2022


Yes No Not Sure

Inclusion Criteria

Adult male and female subjects aged 18 - 75 years old at the time of Baseline
Confirmed diagnosis of
SLE as defined by the American College of Rheumatology (ACR), OR
LN as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies
Active lupus nephritis
International Society of Neurology/Renal Pathology Society (ISN/RPS) Class III or IV LN [excluding III (C), IV-S (C) and IV-G (C)]; subjects are permitted to have co-existing Class V
UPCR ≥1 at Screening
Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m2
Active urinary sediment

Exclusion Criteria

Severe renal impairment and subjects requiring dialysis dialysis within the previous 12 months before Screening
Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE)
Cyclophosphamide (CYC) use (i.v. or oral) or more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the month prior to Baseline
Active ongoing inflammatory diseases
Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor
Ongoing infections or malignant process
Pregnant or lactating women
Other inclusion and exclusion criteria may apply
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