Overview
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.
Description
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
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:
Induction treatment with cyclophosphamide within 3 months of planned treatment for this
study; treatment with calcineurin inhibitors within the previous 3 months prior to
screening Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50%
decline in eGFR within 3 months prior to screening.
Renal biopsy presenting with interstitial fibrosis/tubular atrophy (IF/TA) or
glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such
that it precludes likely response to immunosuppressive therapy.
Participants being treated with systemic corticosteroids (>5 mg/day prednisone or
equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel
disease.
Participants being treated with systemic corticosteroids for SLE or LN will be excluded if
they have taken more than an average of 10 mg/day prednisone (or equivalent) in the
previous 4 weeks and more than an average of 20 mg/day in the previous 1 week Receipt of
more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative
dose) within 2 weeks prior to enrollment (and at enrollment)
Other protocol-defined inclusion/exclusion criteria may apply