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

About

Brief Summary

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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
75 Years

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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Study Stats
Protocol No.
21-000586
Category
Rheumatology
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04181762
For detailed technical eligibility, visit ClinicalTrials.gov.