Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC… (NCT04181762) | Clinical Trial Compass
TerminatedPhase 3
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
Stopped: Study terminated by sponsor due to futility analysis
United States275 participantsStarted 2020-07-07
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adult male and female subjects aged 18 - 75 years old at the time of Baseline.
✓. Confirmed diagnosis of:
✓. Active lupus nephritis, as defined by meeting the 4 following criteria:
✓. Subjects must have currently been on MPA, or willing to initiate SoC induction therapy for LN according to the institutional practices using MPA or low-dose CYC in addition to corticosteroids. For guidance, see published guidelines such as by (Bertsias et al 2012, Hahn et al 2012).
✓. Subjects must had been treated with anti-malarials (e.g. hydroxychloroquine), unless contra-indicated, and the dose had been stable for at least 10 days prior to Randomization.
✓. Able to provide signed informed consent.
Exclusion criteria
✕. Severe renal impairment as defined by i.) Stage 4 CKD, or ii.) presence of oliguria (defined as a documented urine volume \< 400 mL/24 h), or iii.) ESRD required dialysis or transplantation.
✕. Known intolerance/hypersensitivity to MPA, or oral corticosteroids, or any component of the study drug(s).
What they're measuring
1
Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52
✕. Subjects received any other biologic immunomodulatory therapy within 6 months prior to Screening, excluding belimumab where 3 months were acceptable.
✕. Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor.
✕. Subjects received any investigational drug within 1 month or five times the half-life of enrollment, whichever was longer.
✕. Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the 12 weeks prior to Baseline.
✕. Treatment with a systemic calcineurin inhibitor (e.g. cyclosporine, tacrolimus) within 12 weeks prior to Baseline
✕. CYC use (i.v. or oral) within the month prior to Baseline.