Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
This study tests a new drug called iptacopan (LNP023) combined with standard lupus kidney disease treatments to see if it can help reduce kidney inflammation and damage. Lupus nephritis is a serious kidney complication that occurs in some people with lupus, where the immune system attacks the kidneys.
Key Objective:The trial is testing whether iptacopan can improve kidney function and reduce proteinuria (protein loss in urine) in people with active lupus nephritis.
Who to Consider:People with active lupus nephritis (classes III-IV or V) who are already receiving standard lupus treatments should consider enrolling if they continue to have signs of active kidney disease.
Trial Parameters
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Brief Summary
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
Eligibility Criteria
Inclusion Criteria: Unequivocally positive ANA test result and/or a positive anti dsDNA at screening Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis. Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS. eGFR ≥ 30 ml/min/1.73 m2 Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections Vaccination against Haemophilus influenzae infection Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study. First presentation or flare of lupus nephritis. Exclusion Criteria: Indu