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
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Rosario,Santa Fe,2000,Argentina
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San Luis,5700,Argentina
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Santa Fe,S3000epv,Argentina
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Salvador,BA,40150 150,Brazil
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Belo Horizonte,MG,30150-221,Brazil
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Juiz de Fora,MG,36010 570,Brazil
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Sao Paulo,SP,05403 000,Brazil
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Barretos,Sao Paulo,14784 400,Brazil
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Sao Paulo,SP,01308-050,Brazil
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Shenyang,Liaoning,110003,China
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Yinchuan,Ningxia,100039,China
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Shenzhen,518036,China
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Beijing,100034,China
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Wuhan,430022,China
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Nanning,Guangxi,530021,China
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Bogota,Cundinamarca,111411,Colombia
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Bucaramanga,Santander,0001,Colombia
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Barranquilla,080020,Colombia
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Monteria,230004,Colombia
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Nantes Cedex 1,44093,France
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Paris,75015,France
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Strasbourg Cedex,67091,France
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Marseille,13385,France
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Braunschweig,Niedersachsen,38126,Germany
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Koeln,Nordrhein-Westfalen,51109,Germany
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Ludwigshafen,67063,Germany
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Berlin,13353,Germany
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Mainz,55131,Germany
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Muenchen,81377,Germany
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Pokfulam,Hong Kong
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Debrecen,4032,Hungary
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Budapest,H-1083,Hungary
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Szeged,6720,Hungary
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Kozhikode,Kerala,673008,India
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New Delhi,110029,India
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Vellore,Tamil Nadu,632 004,India
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Hyderabad,Telangana,500082,India
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Lucknow,Uttar Pradesh,226014,India
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Jerusalem,9112001,Israel
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Ramat Gan,52621,Israel
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Kuantan,Pahang,25100,Malaysia
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Taiping,Perak,34000,Malaysia
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Selangor Darul Ehsan,68100,Malaysia
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Merida,Yucatan,97070,Mexico
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Veracruz,91900,Mexico
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Tampico,Tamaulipas,89440,Mexico
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Aguascalientes,20230,Mexico
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Iloilo,5000,Philippines
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Quezon,1102,Philippines
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Makati,Metro Manila,1218,Philippines
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Vila Nova De Gaia,4434 502,Portugal
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Carnaxide,Lisboa,2799 523,Portugal
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Coimbra,3000 075,Portugal
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Lisboa,1649 035,Portugal
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Porto,4200 319,Portugal
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Singapore,S308433,Singapore
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Ciudad Real,13005,Spain
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Sevilla,Andalucia,41009,Spain
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Madrid,28034,Spain
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Barcelona,Catalunya,08036,Spain
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Madrid,28040,Spain
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Puerto De Sagunto,Comunidad Valenciana,46520,Spain
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Istanbul,34093,Turkey
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Ankara,Cankaya,06800,Turkey
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Ankara,06500,Turkey
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Mersin,33110,Turkey
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Talas Kayseri,38039,Turkey
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Bursa,Gorukle,16059,Turkey
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Cambridge,Cb2 0qq,United Kingdom
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Leicester,Le5 4pw,United Kingdom
Wichita Community Clcl Onco Program
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Wichita,Kansas,67214,United States
Wissam Saliba
Temple University
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Philadelphia,Pennsylvania,19140,United States
Iris Lee
Mayo Clinic Jacksonville
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Jacksonville,Florida,32224,United States
Nabeel Aslam
Brigham and Womens Hosp Harvard Med School
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Boston,Massachusetts,02115,United States
Katherine Curtis
Finnian McCausland
Prolato Clinical Research Center
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Houston,Texas,77054,United States
Biruh Workeneh
Ronald Reagan UCLA Medical Center
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Los Angeles,California,90095,United States
Lama Abdelnour
Kaiser Permanente Fontana
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Fontana,California,92335,United States
Steve Lee
Nephrology Associates Of Central FL
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Orlando,Florida,32806,United States
Arvind Madan
Mayo Clinic Rochester
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Rochester,Minnesota,55905,United States
Alexandria Ramirez
Evamaria Anvari
Virginia Commonwealth University
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Richmond,Virginia,23298,United States
Jason Kidd
Olive View UCLA Medical Center
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Sylmar,California,91342,United States
Phuong-Chi Pham
Ochsner Health System
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New Orleans,Louisiana,70121,United States
Ivo Lukitsch
University of Colorado Denver
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Aurora,Colorado,80045,United States
Amber Podoll
Allegheny Health Network
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Pittsburgh,Pennsylvania,15212,United States
Swati Arora
Florida Kidney Physicians
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Riverview,Florida,33578,United States
Amit Johnsingh
Marc Richards
University of Nebraska Medical Center
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Omaha,Nebraska,68198,United States
Prasanth Ravipati
Johns Hopkins Hospital
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Baltimore,Maryland,21287,United States
Mohamed G Atta
Dallas Nephrology Associates
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Dallas,Texas,75204,United States
Ankit Mehta
Esmeralda Martinez
Loma Linda University
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Loma Linda,California,92354,United States
Brenda Delgado
Sayna Norouzi
Nep Assoc of Northern Illinois
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Hinsdale,Illinois,60521,United States
William Whittier
Stony Brook Internists PC
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East Setauket,New York,11733,United States
Sobia Khan
Worldwide Contacts
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