SELUNE

Description

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).

Is there compensation for this trial? Yes

Am I Eligible or this trial?

Below is the detailed inclusion and exclusion detail for the the trial. Some of these you may know and other we may need to test in order to determine if you are a good fit for the trial. If you are not sure, please fill out the form to the left and one of our researchers will call you to assist in determining this and answering any additional questions.

Inclusion Criteria:

  • Adult aged 18 - 75 years old

  • 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

  • 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.

 

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