Phase
Condition
Lupus Nephritis
Kidney Disease
Nephritis
Treatment
Placebo + standard of care
Iptacopan (part 1)
Iptacopan (part 2)
Clinical Study ID
Ages > 18 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 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
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Sao Paulo, SP 05403 000
BrazilActive - Recruiting
Novartis Investigative Site
Beijing, 100034
ChinaActive - Recruiting
Novartis Investigative Site
Wuhan, 430022
ChinaActive - Recruiting
Novartis Investigative Site
Marseille, 13385
FranceActive - Recruiting
Novartis Investigative Site
Nantes Cedex 1, 44093
FranceActive - Recruiting
Novartis Investigative Site
Paris, 75015
FranceActive - Recruiting
Novartis Investigative Site
Strasbourg Cedex, 67091
FranceActive - Recruiting
Novartis Investigative Site
Berlin, 13353
GermanyActive - Recruiting
Novartis Investigative Site
Frankfurt, 60590
GermanyActive - Recruiting
Novartis Investigative Site
Muenchen, 81377
GermanyActive - Recruiting
Novartis Investigative Site
Pokfulam,
Hong KongActive - Recruiting
Novartis Investigative Site
Debrecen, 4032
HungaryActive - Recruiting
Novartis Investigative Site
Vellore, Tamil Nadu 632004
IndiaActive - Recruiting
Novartis Investigative Site
New Delhi, 110029
IndiaActive - Recruiting
Novartis Investigative Site
Puducherry, 607403
IndiaActive - Recruiting
Novartis Investigative Site
Ashkelon, 78278
IsraelActive - Recruiting
Novartis Investigative Site
Jerusalem, 9112001
IsraelActive - Recruiting
Novartis Investigative Site
Ramat Gan, 52621
IsraelActive - Recruiting
Novartis Investigative Site
Kuantan, Pahang 25100
MalaysiaActive - Recruiting
Novartis Investigative Site
Taiping, Perak 34000
MalaysiaActive - Recruiting
Novartis Investigative Site
Selangor Darul Ehsan, 68100
MalaysiaActive - Recruiting
Novartis Investigative Site
Tampico, Tamaulipas 8944
MexicoActive - Recruiting
Novartis Investigative Site
Merida, Yucatan 97070
MexicoActive - Recruiting
Novartis Investigative Site
Veracruz, 91900
MexicoActive - Recruiting
Novartis Investigative Site
Carnaxide - Linda-A-Velha, Lisboa 2790-134
PortugalActive - Recruiting
Novartis Investigative Site
Lisboa, 1600190
PortugalActive - Recruiting
Novartis Investigative Site
Vila Nova de Gaia, 4434 502
PortugalActive - Recruiting
Novartis Investigative Site
San Juan, 00927
Puerto RicoActive - Recruiting
Novartis Investigative Site
Singapore, 308433
SingaporeActive - Recruiting
Novartis Investigative Site
Sevilla, Andalucia 41009
SpainActive - Recruiting
Novartis Investigative Site
Madrid, 28040
SpainActive - Recruiting
Novartis Investigative Site
Bursa, Gorukle 16059
TurkeyActive - Recruiting
Novartis Investigative Site
Ankara, 06560
TurkeyActive - Recruiting
Novartis Investigative Site
Istanbul, 34093
TurkeyActive - Recruiting
Novartis Investigative Site
Talas / Kayseri, 38039
TurkeyActive - Recruiting
Novartis Investigative Site
Phoenix, Arizona 85016
United StatesActive - Recruiting
Novartis Investigative Site
Hinsdale, Illinois 60521
United StatesActive - Recruiting
Novartis Investigative Site
Baltimore, Maryland 21287
United StatesActive - Recruiting
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