Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active… (NCT02547922) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
United States147 participantsStarted 2015-11-04
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 18 through 70 years at the time of screening
✓. Fulfils at least 4 of the 11 criteria of the revised 1982 ACR classification criteria for SLE, at least one of which must be:
✓. Positive antinuclear antibody (ANA) test (1:40 or higher) or
✓. Elevated anti-dsDNA antibodies at screening (reported as equivocal or positive results), as per the centrallaboratory; or
✓. Anti-Smith antibody at screening elevated to above normal (ie, positive or equivocal results) as per the central laboratory
✓. Class III (±Class V) or Class IV (±Class V) LN according to the World Health Organisation (WHO) or 2003 ISN/RPS classification based on a renal biopsy obtained within 12 weeks prior to signing the ICF or during the screening period:
✓. Urine protein to creatinine ratio \>1 gm/gm (113.17 mg/mmol), obtained on a 24-hour urine collection at screening
✕. Receipt of any investigational product (small molecule or biologic) or commercially available biologic agent within four weeks or 5 half lives prior to signing of the ICF, whichever is greater
✕. Pure Class V membranous LN on a renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period
✕. Known intolerance to ≤1.0 gm/day of MMF
What they're measuring
1
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR)
✕. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6 month period after enrolment
✕. Subjects, who at the time of signing the ICF, received any of the following immunosuppressive therapies after their qualifying biopsy
✕. Oral corticosteroids \>0.5 mg/kg/day for more than 8 weeks or
✕. Oral or IV pulse methylprednisolone \>3.0 gm (cumulative dose) or
✕. IV cyclophosphamide \>2 pulses of high-dose (≥0.5 gm/m2) or \>4 doses of low dose (500 mg every 2 weeks) or