Study 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. 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.
Interventions
Iptacopan (part 1)
Iptacopan (part 2)
Iptacopan + placebo
Placebo + standard of care
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:
Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization.
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 15 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 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
Novartis Investigative Site
Recruiting
Shenyang,Liaoning,110004,China
Novartis Investigative Site
Recruiting
Wuhan,Hubei,430022,China
Novartis Investigative Site
Recruiting
Nanning,Guangxi,530022,China
Novartis Investigative Site
Recruiting
Shenzhen,518036,China
Novartis Investigative Site
Recruiting
Cologne,North Rhine-Westphalia,51109,Germany
Novartis Investigative Site
Recruiting
Mainz,55131,Germany
Novartis Investigative Site
Recruiting
Vila Nova de Gaia,4434 502,Portugal
FDI Clinical Research
Recruiting
San Juan,00927,Puerto Rico
Jose Cangiano
Novartis Investigative Site
Recruiting
Madrid,28040,Spain
Novartis Investigative Site
Recruiting
Ciudad Real,13005,Spain
Novartis Investigative Site
Recruiting
Madrid,28034,Spain
Novartis Investigative Site
Recruiting
Bursa,Nilufer,16059,Turkey (Türkiye)
Virginia Commonwealth University
Recruiting
Richmond,Virginia,23298,United States
Jason Kidd
Ronald Reagan UCLA Medical Center
Recruiting
Los Angeles,California,90095,United States
Lama Abdelnour
Rana Nikbakht Malvajerdi
Loma Linda University
Recruiting
San Bernardino,California,92408,United States
Sayna Norouzi
Gema Castaneda Duenas
University of Colorado Denver
Recruiting
Aurora,Colorado,80045,United States
Amber Podoll
Elizabeth Wagner
Cleveland Clinic Foundation
Recruiting
Cleveland,Ohio,44195,United States
Sarah Cleveland
Laura Ferreira-Provenzano
Royal Research Corp
Recruiting
Hollywood,Florida,33021,United States
Elio Torres
Mayo Clinic Jacksonville
Recruiting
Jacksonville,Florida,32224,United States
Nabeel Aslam
Florida Kidney Physicians
Recruiting
Riverview,Florida,33578,United States
Amit Johnsingh
Jamie Coney
Yvette Martinez
Marc Richards
Prolato Clinical Research Center
Recruiting
Houston,Texas,77054,United States
Biruh Workeneh
Temple University
Recruiting
Philadelphia,Pennsylvania,19140,United States
Iris Lee
Stony Brook Internists PC
Recruiting
East Setauket,New York,11733,United States
Sobia Khan
Melissa Espinoza
Brigham and Womens Hosp Harvard Med School
Recruiting
Boston,Massachusetts,02115,United States
Valentina Castro
Finnian McCausland
Ochsner Health System
Recruiting
New Orleans,Louisiana,70121,United States
Ivo Lukitsch
Wichita Community Clcl Onco Program
Recruiting
Wichita,Kansas,67214,United States
Wissam Saliba
Worldwide Contacts
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