Phase
Condition
Lupus Nephritis
Cutaneous Lupus Erythematosus
Systemic Lupus Erythematosus
Treatment
Placebo + standard of care
Iptacopan (part 1)
Iptacopan (part 2)
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Rosario, Santa Fe Province 2000
ArgentinaSite Not Available
Novartis Investigative Site
Rosario 3838583, Santa Fe Province 3836276 2000
ArgentinaSite Not Available
Novartis Investigative Site
San Luis, 5700
ArgentinaSite Not Available
Novartis Investigative Site
San Luis 3837056, 5700
ArgentinaSite Not Available
Novartis Investigative Site
Santa Fe, S3000EPV
ArgentinaSite Not Available
Novartis Investigative Site
Santa Fe 3836277, S3000EPV
ArgentinaSite Not Available
Novartis Investigative Site
Belo Horizonte, Minas Gerais 30150-221
BrazilCompleted
Novartis Investigative Site
Juiz de Fora, Minas Gerais 36010 570
BrazilSite Not Available
Novartis Investigative Site
Belo Horizonte 3470127, Minas Gerais 3457153 30150-221
BrazilSite Not Available
Novartis Investigative Site
Juiz de Fora 3459505, Minas Gerais 3457153 36010 570
BrazilSite Not Available
Novartis Investigative Site
Sao Paulo, SP 01308-050
BrazilSite Not Available
Novartis Investigative Site
Barretos, São Paulo 14784 400
BrazilSite Not Available
Novartis Investigative Site
São Paulo, São Paulo 01308-050
BrazilSite Not Available
Novartis Investigative Site
Barretos 3470451, São Paulo 3448433 14784 400
BrazilSite Not Available
Novartis Investigative Site
São Paulo 3448439, São Paulo 3448433 04038-002
BrazilSite Not Available
Novartis Investigative Site
Salvador, 40323-010
BrazilSite Not Available
Novartis Investigative Site
Salvador 3450554, 40323-010
BrazilSite Not Available
Novartis Investigative Site
Nanning, Guangxi 530022
ChinaActive - Recruiting
Novartis Investigative Site
Nanning 1799869, Guangxi 1809867 530022
ChinaSite Not Available
Novartis Investigative Site
Wuhan, Hubei 430022
ChinaActive - Recruiting
Novartis Investigative Site
Wuhan 1791247, Hubei 1806949 430022
ChinaSite Not Available
Novartis Investigative Site
Shenyang, Liaoning 110004
ChinaActive - Recruiting
Novartis Investigative Site
Shenyang 2034937, Liaoning 2036115 110004
ChinaSite Not Available
Novartis Investigative Site
Yinchuan, Ningxia 750004
ChinaSite Not Available
Novartis Investigative Site
Yinchuan 1786657, Ningxia 1799355 750004
ChinaSite Not Available
Novartis Investigative Site
Beijing, 100034
ChinaSite Not Available
Novartis Investigative Site
Beijing 1816670, 100034
ChinaSite Not Available
Novartis Investigative Site
Shenzhen, 518036
ChinaActive - Recruiting
Novartis Investigative Site
Shenzhen 1795565, 518036
ChinaSite Not Available
Novartis Investigative Site
Barranquilla, Atlántico 080020
ColombiaSite Not Available
Novartis Investigative Site
Barranquilla 3689147, Atlántico 3689436 080020
ColombiaSite Not Available
Novartis Investigative Site
Bogota, Cundinamarca 111411
ColombiaSite Not Available
Novartis Investigative Site
Bucaramanga, Santander Department 680003
ColombiaSite Not Available
Novartis Investigative Site
Bucaramanga 3688465, Santander Department 3668578 680003
ColombiaSite Not Available
Novartis Investigative Site
Monteria, 230004
ColombiaSite Not Available
Novartis Investigative Site
Montería, 230004
ColombiaSite Not Available
Novartis Investigative Site
Montería 3674453, 230004
ColombiaSite Not Available
Novartis Investigative Site
Marseille, 13005
FranceCompleted
Novartis Investigative Site
Marseille 2995469, 13005
FranceSite Not Available
Novartis Investigative Site
Nantes, 44093
FranceActive - Recruiting
Novartis Investigative Site
Nantes 2990969, 44093
FranceSite Not Available
Novartis Investigative Site
Nantes Cedex 1, 44093
FranceSite Not Available
Novartis Investigative Site
Paris, 75015
FranceSite Not Available
Novartis Investigative Site
Paris 2988507, 75015
FranceSite Not Available
Novartis Investigative Site
Strasbourg, 67091
FranceSite Not Available
Novartis Investigative Site
Strasbourg 2973783, 67091
FranceSite Not Available
Novartis Investigative Site
Strasbourg Cedex, 67091
FranceSite Not Available
Novartis Investigative Site
Munich, Bavaria 81377
GermanySite Not Available
Novartis Investigative Site
Munich 2867714, Bavaria 2951839 81377
GermanySite Not Available
Novartis Investigative Site
Ludwigshafen, Germany 67063
GermanySite Not Available
Novartis Investigative Site
Ludwigshafen 2875377, Germany 67063
GermanySite Not Available
Novartis Investigative Site
Frankfurt am Main, Hesse 60590
GermanySite Not Available
Novartis Investigative Site
Frankfurt am Main 2925533, Hesse 2905330 60590
GermanySite Not Available
Novartis Investigative Site
Braunschweig, Lower Saxony 38126
GermanyActive - Recruiting
Novartis Investigative Site
Braunschweig 2945024, Lower Saxony 2862926 38126
GermanySite Not Available
Novartis Investigative Site
Koeln, Nordrhein-Westfalen 51109
GermanySite Not Available
Novartis Investigative Site
Cologne, North Rhine-Westphalia 51109
GermanyActive - Recruiting
Novartis Investigative Site
Cologne 2886242, North Rhine-Westphalia 2861876 51109
GermanySite Not Available
Novartis Investigative Site
Berlin, 13353
GermanySite Not Available
Novartis Investigative Site
Berlin 2950159, 13353
GermanySite Not Available
Novartis Investigative Site
Frankfurt, 60590
GermanySite Not Available
Novartis Investigative Site
Mainz, 55131
GermanyActive - Recruiting
Novartis Investigative Site
Mainz 2874225, 55131
GermanySite Not Available
Novartis Investigative Site
Muenchen, 81377
GermanySite Not Available
Novartis Investigative Site
Hong Kong, Hong Kong 999077
Hong KongSite Not Available
Novartis Investigative Site
Hong Kong 1819729, Hong Kong 999077
Hong KongSite Not Available
Novartis Investigative Site
Pokfulam, 999077
Hong KongSite Not Available
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye 4032
HungarySite Not Available
Novartis Investigative Site
Debrecen 721472, Hajdu Bihar Megye 4032
HungarySite Not Available
Novartis Investigative Site
Budapest, H-1083
HungarySite Not Available
Novartis Investigative Site
Budapest 3054643, H-1083
HungarySite Not Available
Novartis Investigative Site
Szeged, 6725
HungarySite Not Available
Novartis Investigative Site
Szeged 715429, 6725
HungarySite Not Available
Novartis Investigative Site
Ahmedabad, Gujarat 380015
IndiaSite Not Available
Novartis Investigative Site
Ahmedabad 1279233, Gujarat 1270770 380015
IndiaSite Not Available
Novartis Investigative Site
Kozhikode, Kerala 673008
IndiaActive - Recruiting
Novartis Investigative Site
Kozhikode 1265873, Kerala 1267254 673008
IndiaSite Not Available
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi 110029
IndiaActive - Recruiting
Novartis Investigative Site
New Delhi 1261481, National Capital Territory of Delhi 1273293 110029
IndiaSite Not Available
Novartis Investigative Site
Vellore, Tamil Nadu 632 004
IndiaSite Not Available
Novartis Investigative Site
Vellore 1253286, Tamil Nadu 1255053 632 004
IndiaSite Not Available
Novartis Investigative Site
Hyderabad, Telangana 500082
IndiaActive - Recruiting
Novartis Investigative Site
Hyderabad 1269843, Telangana 1254788 500082
IndiaSite Not Available
Novartis Investigative Site
Lucknow, Uttar Pradesh 226014
IndiaActive - Recruiting
Novartis Investigative Site
Lucknow 1264733, Uttar Pradesh 1253626 226014
IndiaSite Not Available
Novartis Investigative Site
Puducherry, 607402
IndiaSite Not Available
Novartis Investigative Site
Puducherry 1259425, 607402
IndiaSite Not Available
Novartis Investigative Site
Ashkelon, 7830604
IsraelSite Not Available
Novartis Investigative Site
Ashkelon 295620, 7830604
IsraelSite Not Available
Novartis Investigative Site
Jerusalem, 9112001
IsraelSite Not Available
Novartis Investigative Site
Jerusalem 281184, 9112001
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan, 5265601
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan 293788, 5265601
IsraelSite Not Available
Novartis Investigative Site
Kuantan, Pahang 25100
MalaysiaActive - Recruiting
Novartis Investigative Site
Kuantan 1735227, Pahang 1733042 25100
MalaysiaSite Not Available
Novartis Investigative Site
Taiping, Perak 34000
MalaysiaActive - Recruiting
Novartis Investigative Site
Taiping 1734586, Perak 1733041 34000
MalaysiaSite Not Available
Novartis Investigative Site
Selangor Darul Ehsan, 68100
MalaysiaActive - Recruiting
Novartis Investigative Site
Tampico, Tamaulipas 89440
MexicoSite Not Available
Novartis Investigative Site
Tampico 3516355, Tamaulipas 3516391 89440
MexicoSite Not Available
Novartis Investigative Site
Merida, Yucatan 97070
MexicoSite Not Available
Novartis Investigative Site
Mérida, Yucatán 97070
MexicoSite Not Available
Novartis Investigative Site
Mérida 3523349, Yucatán 3514211 97070
MexicoSite Not Available
Novartis Investigative Site
Aguascalientes, 20230
MexicoCompleted
Novartis Investigative Site
Aguascalientes 4019233, 20230
MexicoSite Not Available
Novartis Investigative Site
Veracruz, 91900
MexicoSite Not Available
Novartis Investigative Site
Veracruz 3514783, 91900
MexicoSite Not Available
Novartis Investigative Site
Makati, Metro Manila 1218
PhilippinesSite Not Available
Novartis Investigative Site
Makati City, National Capital Region 1218
PhilippinesActive - Recruiting
Novartis Investigative Site
Makati City 1703417, National Capital Region 7521311 1218
PhilippinesSite Not Available
Novartis Investigative Site
Iloilo, 5000
PhilippinesSite Not Available
Novartis Investigative Site
Iloilo City, 5000
PhilippinesSite Not Available
Novartis Investigative Site
Iloilo City 1711005, 5000
PhilippinesSite Not Available
Novartis Investigative Site
Quezon, 1102
PhilippinesActive - Recruiting
Novartis Investigative Site
Quezon 1692214, 1102
PhilippinesSite Not Available
Novartis Investigative Site
Carnaxide - Linda-A-Velha, Lisboa 2790-134
PortugalSite Not Available
Novartis Investigative Site
Carnaxide, 2799-523
PortugalSite Not Available
Novartis Investigative Site
Carnaxide 2270157, 2799-523
PortugalSite Not Available
Novartis Investigative Site
Coimbra, 3004-561
PortugalSite Not Available
Novartis Investigative Site
Coimbra 2740637, 3004-561
PortugalSite Not Available
Novartis Investigative Site
Lisboa, 1649 035
PortugalSite Not Available
Novartis Investigative Site
Lisbon, 1649-035
PortugalSite Not Available
Novartis Investigative Site
Lisbon 2267057, 1649-035
PortugalSite Not Available
Novartis Investigative Site
Porto, 4200 319
PortugalSite Not Available
Novartis Investigative Site
Porto 2735943, 4200 319
PortugalSite Not Available
Novartis Investigative Site
Vila Nova de Gaia, 4434 502
PortugalActive - Recruiting
Novartis Investigative Site
Vila Nova de Gaia 2732544, 4434 502
PortugalSite Not Available
FDI Clinical Research
San Juan, 00927
Puerto RicoActive - Recruiting
Novartis Investigative Site
San Juan, 00927
Puerto RicoActive - Recruiting
FDI Clinical Research
San Juan 4568127, 00927
Puerto RicoSite Not Available
Novartis Investigative Site
Singapore, Singapore S308433
SingaporeActive - Recruiting
Novartis Investigative Site
Singapore 1880252, Singapore S308433
SingaporeSite Not Available
Novartis Investigative Site
Sevilla, Andalucia 41009
SpainSite Not Available
Novartis Investigative Site
Port de Sagunt, Valencia 46520
SpainSite Not Available
Novartis Investigative Site
Puerto De Sagunto, Valencia 46520
SpainSite Not Available
Novartis Investigative Site
Port de Sagunt 2518210, Valencia 2593113 46520
SpainSite Not Available
Novartis Investigative Site
Barcelona, 08036
SpainSite Not Available
Novartis Investigative Site
Barcelona 3128760, 08036
SpainSite Not Available
Novartis Investigative Site
Ciudad Real, 13005
SpainActive - Recruiting
Novartis Investigative Site
Ciudad Real 2519402, 13005
SpainSite Not Available
Novartis Investigative Site
Madrid, 28040
SpainActive - Recruiting
Novartis Investigative Site
Madrid 3117735, 28040
SpainSite Not Available
Novartis Investigative Site
Seville, 41009
SpainSite Not Available
Novartis Investigative Site
Seville 2510911, 41009
SpainSite Not Available
Novartis Investigative Site
Ankara, Cankaya 06800
TurkeySite Not Available
Novartis Investigative Site
Bursa, Gorukle 16059
TurkeySite Not Available
Novartis Investigative Site
Istanbul, 34093
TurkeySite Not Available
Novartis Investigative Site
Mersin, 33110
TurkeySite Not Available
Novartis Investigative Site
Talas / Kayseri, 38039
TurkeySite Not Available
Novartis Investigative Site
Talas Kayseri, 38039
TurkeySite Not Available
Novartis Investigative Site
Ankara, Bilkent-Cankaya 06800
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Ankara 323786, Bilkent-Cankaya 06800
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Istanbul, Fatih 34093
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Istanbul 745044, Fatih 34093
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Kayseri, Melikgazi 38039
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Kayseri 308464, Melikgazi 38039
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Bursa, Nilufer 16059
Turkey (Türkiye)Active - Recruiting
Novartis Investigative Site
Bursa 750269, Nilufer 16059
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Mersin, Yenisehir 33110
Turkey (Türkiye)Completed
Novartis Investigative Site
Mersin 304531, Yenisehir 33110
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Cambridge, CB2 0QQ
United KingdomSite Not Available
Novartis Investigative Site
Cambridge 2653941, CB2 0QQ
United KingdomSite Not Available
Novartis Investigative Site
Leicester, LE5 4PW
United KingdomSite Not Available
Novartis Investigative Site
Leicester 2644668, LE5 4PW
United KingdomSite Not Available
AKDHC Medical Research ServicesLLC
Phoenix, Arizona 85016
United StatesSite Not Available
Novartis Investigative Site
Phoenix, Arizona 85016
United StatesActive - Recruiting
AKDHC Medical Research ServicesLLC
Phoenix 5308655, Arizona 5551752 85016
United StatesSite Not Available
Kaiser Permanente Fontana
Fontana, California 92335
United StatesSite Not Available
Univ Calif Irvine
Irvine, California 92697
United StatesSite Not Available
Loma Linda University
Loma Linda, California 92354
United StatesSite Not Available
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United StatesActive - Recruiting
Loma Linda University
San Bernardino, California 92408
United StatesSite Not Available
Olive View UCLA Medical Center
Sylmar, California 91342
United StatesSite Not Available
Kaiser Permanente Fontana
Fontana 5349755, California 5332921 92335
United StatesSite Not Available
Univ Calif Irvine
Irvine 5359777, California 5332921 92697
United StatesSite Not Available
Loma Linda University
Loma Linda 5367696, California 5332921 92354
United StatesSite Not Available
Ronald Reagan UCLA Medical Center
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Loma Linda University
San Bernardino 5391710, California 5332921 92408
United StatesSite Not Available
Olive View UCLA Medical Center
Sylmar 5400784, California 5332921 91342
United StatesSite Not Available
University of Colorado Denver
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado Denver
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Royal Research Corp
Hollywood, Florida 33021
United StatesActive - Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United StatesActive - Recruiting
Nephrology Associates Of Central FL
Orlando, Florida 32806
United StatesSite Not Available
Florida Kidney Physicians
Riverview, Florida 33578
United StatesActive - Recruiting
Royal Research Corp
Hollywood 4158928, Florida 4155751 33021
United StatesSite Not Available
Mayo Clinic Jacksonville
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Nephrology Associates Of Central FL
Orlando 4167147, Florida 4155751 32806
United StatesSite Not Available
Florida Kidney Physicians
Riverview 4170156, Florida 4155751 33578
United StatesSite Not Available
Nep Assoc of Northern Illinois
Hinsdale, Illinois 60521
United StatesSite Not Available
Novartis Investigative Site
Hinsdale, Illinois 60521
United StatesActive - Recruiting
Nep Assoc of Northern Illinois
Hinsdale 4896012, Illinois 4896861 60521
United StatesSite Not Available
Wichita Community Clcl Onco Program
Wichita, Kansas 67214
United StatesActive - Recruiting
Wichita Community Clcl Onco Program
Wichita 4281730, Kansas 4273857 67214
United StatesSite Not Available
Ochsner Health System
New Orleans, Louisiana 70121
United StatesActive - Recruiting
Ochsner Health System
New Orleans 4335045, Louisiana 4331987 70121
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Novartis Investigative Site
Baltimore, Maryland 21287
United StatesActive - Recruiting
Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts 02115
United StatesActive - Recruiting
Brigham and Womens Hosp Harvard Med School
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
United StatesSite Not Available
Stony Brook Internists PC
East Setauket, New York 11733
United StatesActive - Recruiting
Stony Brook Internists PC
East Setauket 5116060, New York 5128638 11733
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesActive - Recruiting
Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
Temple University
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Temple University
Philadelphia 4560349, Pennsylvania 6254927 19140
United StatesSite Not Available
Allegheny Health Network
Pittsburgh 5206379, Pennsylvania 6254927 15212
United StatesSite Not Available
Dallas Nephrology Associates
Dallas, Texas 75204
United StatesSite Not Available
Prolato Clinical Research Center
Houston, Texas 77054
United StatesActive - Recruiting
Dallas Nephrology Associates
Dallas 4684888, Texas 4736286 75204
United StatesSite Not Available
Prolato Clinical Research Center
Houston 4699066, Texas 4736286 77054
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesActive - Recruiting
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23298
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.