Study Description
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.)
ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in
combination with SoC, in adult participants with active LN This trial will evaluate the efficacy, safety, and tolerability of subcutaneous (s.c.)
ianalumab given every 4 weeks (q4w) or ianalumab given every 12 weeks (q12w) compared to
placebo, in combination with SoC, in adult participants with active LN (ISN/RPS class
III, IV active glomerulonephritis with or without co-existing class V features, or pure
class V membranous). using the 2003 International Society for Nephrology (ISN)/Renal
Pathology Society (RPS) criteria).
Interventions
ianalumab s.c. q12w
ianalumab s.c. q4w
placebo s.c.
Eligibility Criteria
Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following
criteria:
- Adult male and female participants aged 18 years or older at the time of screening
- Weigh at least 35 kg at screening
- Have a confirmed clinical diagnosis of SLE according to European League Against
Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus
(SLE) classification criteria
- Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at
screening visit based on central or local laboratory result
- Active LN at screening, as defined by meeting the 3 following criteria:
- Renal biopsy within 6 months prior to screening period indicating ISN/RPS class III
or IV active glomerulonephritis with or without co-existing class V features, or
pure class V membranous LN. If no biopsy was performed within 6 months prior to
screening period, a biopsy will need to be performed during the screening period
after having met all other inclusion/exclusion criteria.
- UPCR ≥ 1.0 g/g on 24h urine collection at Screening
- eGFR ≥ 25mL/min/1.73 m2. Participants with eGFR < 30 mL/min/1.73 m2 require renal
biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli
- Newly diagnosed participants as well as pre-treated LN participants (including
refractory cases) can be included, as long as they are currently on, or willing to
initiate SoC induction therapy for LN using MPA
- Induction therapy, as defined by treatment including both high dose
corticosteroids and MPA, should be initiated prior to or on day of
randomization
- Anti-malarial treatment at stable dosing prior to randomization is strongly
recommended, in the absence of contraindications
- Participants on azathioprine treatment at Screening must be switched to MPA
prior to randomization
- Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day
up to 3000 mg cumulative dose) or equivalent for treatment of current episode of
active LN within 60 days prior randomization. Participant who cannot take the pulse
i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/day (max 80mg/day)
oral predniso(lo)ne.
- Able to communicate well with the Investigator to understand and comply with the
requirements of the study
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this
study:
- Severe renal impairment as defined by i.) presence of oliguria (defined as a
documented urine volume <400 mL/24 hrs) or ii.) End-Stage Renal Disease (ESRD)
requiring dialysis or transplantation
- Sclerosis in > 50% of glomeruli on renal biopsy
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30
days or until the expected pharmacodynamic effect has returned to baseline. Use of
certain Traditional Chinese Medicines
- Prior use of ianalumab (ever); or prior use other B cell depleting therapy within 36
weeks prior to randomization or if therapy was administered < 36 weeks prior to
randomization, B cell count less than the lower limit of normal or patient's own
baseline value prior to having received an earlier B cell-depleting therapy
- Prior treatment with any of the following within 12 weeks prior to randomization
- Belimumab, telitacicept, abatacept, TNF-α mAb, immunoglobulins (i.v./s.c.)
plasmapheresis
- Any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin
inhibitors, JAK inhibitors or other kinase inhibitors)
- Thalidomide treatment and/or methotrexate
- Combination of DMARDs
- Imidazole derivative (e.g., azathioprine, mizoribine) must be discontinued prior to
starting treatment with MPA
- Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within
12 weeks prior to randomization
- History of major organ transplant or hematopoietic stem cell/bone marrow transplant
or are due to receive transplantation
- Any one of the following laboratory values at screening:
- Hemoglobin levels < 8.0 g/dL (< 5 mmol/L), or < 7.0 g/dL (< 4.3 mmol/L) if
related to participant's SLE such as in active hemolytic anaemia
- Platelet count < 25 x 1000/µL
- Absolute neutrophil count (ANC) < 0.8 x 1000/µL
- Active viral, bacterial or other infections requiring intravenous or intramuscular
treatment for clinically significant infection or history of recurrent clinically
significant infection which in the opinion of the investigator will place the
participant at risk for participation.
- History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any
component of the study drug(s) or its excipients
- Receipt of live/attenuated vaccine within a 4-week period prior to randomization
- History of primary or secondary immunodeficiency, including a positive HIV test
result
- History of malignancy of any organ system (other than localized basal cell carcinoma
or squamous cell carcinoma of the skin or or in-situ cervical cancer), treated or
untreated, within the past 5 years, regardless of whether there is evidence of local
recurrence or metastases
- Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes),
psychiatric or additional physical condition that the Investigator feels may
jeopardize the participants in case of participation in this study
- Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for
hepatitis B surface antigen (HBsAg) excludes the participant
- Evidence of active tuberculosis (TB) infection (after anti-TB treatment,
participants with history of TB may become eligible according to national local
guidelines)
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
during dosing and for 6 months after stopping of investigational medication
- Sexually active male participants, who do not agree to use barrier protection during
intercourse with women of child-bearing potential while taking study treatment
Other protocol -defined Inclusion/Exclusion may apply.
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Buenos Aire,1426,Argentina
Novartis Investigative Site
Recruiting
Tucuman,4000,Argentina
Novartis Investigative Site
Recruiting
Caba,Buenos Aires,C1056abj,Argentina
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Bs As,Buenos Aires,C1015abo,Argentina
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Bs As,Buenos Aires,C1119acn,Argentina
Novartis Investigative Site
Recruiting
La Plata,Buenos Aires,B1900awt,Argentina
Novartis Investigative Site
Recruiting
Juiz de Fora,MG,36010 570,Brazil
Novartis Investigative Site
Recruiting
Pernambuco,Recife,50740-900,Brazil
Novartis Investigative Site
Recruiting
Porto Alegre,RS,90020-090,Brazil
Novartis Investigative Site
Recruiting
Salvador,BA,40150 150,Brazil
Novartis Investigative Site
Recruiting
Porto Alegre,RS,90035-003,Brazil
Novartis Investigative Site
Recruiting
Vitoria,ES,29055 450,Brazil
Novartis Investigative Site
Recruiting
Santo Andre,SP,09090-790,Brazil
Novartis Investigative Site
Recruiting
Sao Luis,Maranhao,65020-600,Brazil
Novartis Investigative Site
Recruiting
Salvador,40301-155,Brazil
Novartis Investigative Site
Recruiting
Belo Horizonte,MG,30150-221,Brazil
Novartis Investigative Site
Recruiting
Vancouver,British Columbia,V5z 1l7,Canada
Novartis Investigative Site
Recruiting
London,Ontario,N6a 5w9,Canada
Novartis Investigative Site
Recruiting
Montreal,Quebec,H1t 2m4,Canada
Novartis Investigative Site
Recruiting
Sherbrooke,Quebec,J1g 2e8,Canada
Novartis Investigative Site
Recruiting
Santiago,RM,7500922,Chile
Novartis Investigative Site
Recruiting
Temuco,4790084,Chile
Novartis Investigative Site
Recruiting
Liuzhou,Guangxi,545005,China
Novartis Investigative Site
Recruiting
Shanghai,200080,China
Novartis Investigative Site
Recruiting
Guang Zhou,Guangdong,510120,China
Novartis Investigative Site
Recruiting
Xian,Shanxi,710004,China
Novartis Investigative Site
Recruiting
Haikou,Hainan,570311,China
Novartis Investigative Site
Recruiting
Shanghai,200127,China
Novartis Investigative Site
Recruiting
Guangzhou,Guangdong,510000,China
Novartis Investigative Site
Recruiting
Chengdu,Sichuan,610041,China
Novartis Investigative Site
Recruiting
Changsha,Hunan,410008,China
Novartis Investigative Site
Recruiting
Wuhan,430022,China
Novartis Investigative Site
Recruiting
Guang Zhou,510080,China
Novartis Investigative Site
Recruiting
Chongqing,400038,China
Novartis Investigative Site
Recruiting
Nanjing,Jiangsu,210029,China
Novartis Investigative Site
Recruiting
Nanchang,Jiangxi,330006,China
Novartis Investigative Site
Recruiting
Zhejiang,315016,China
Novartis Investigative Site
Recruiting
Shantou,Guangdong,515041,China
Novartis Investigative Site
Recruiting
Shenyang,Liaoning,110003,China
Novartis Investigative Site
Recruiting
Shenzhen,Guangdong,518020,China
Novartis Investigative Site
Recruiting
Guangzhou,510280,China
Novartis Investigative Site
Recruiting
Binzhou,Shandong,256603,China
Novartis Investigative Site
Recruiting
Shenzhen,Guangdong,518037,China
Novartis Investigative Site
Recruiting
Shanghai,200040,China
Novartis Investigative Site
Recruiting
Hefei,Anhui,230022,China
Novartis Investigative Site
Recruiting
Linyi,Shandong,276000,China
Novartis Investigative Site
Recruiting
Barranquilla,080020,Colombia
Novartis Investigative Site
Recruiting
Medellin,Antioquia,050001,Colombia
Novartis Investigative Site
Recruiting
Bogota,Cundinamarca,110111,Colombia
Novartis Investigative Site
Recruiting
Olomouc,CZE,779 00,Czechia
Novartis Investigative Site
Recruiting
Praha 2,128 50,Czechia
Novartis Investigative Site
Recruiting
Tallinn,10117,Estonia
Novartis Investigative Site
Recruiting
Tallinn,10138,Estonia
Novartis Investigative Site
Recruiting
Bordeaux Cedex,33076,France
Novartis Investigative Site
Recruiting
Grenoble,38043,France
Novartis Investigative Site
Recruiting
Lyon,69003,France
Novartis Investigative Site
Recruiting
Marseille,13385,France
Novartis Investigative Site
Recruiting
Poitiers,86021,France
Novartis Investigative Site
Recruiting
Angers Cedex 9,49933,France
Novartis Investigative Site
Recruiting
Besancon Cedex,25030,France
Novartis Investigative Site
Recruiting
Bochum,44791,Germany
Novartis Investigative Site
Recruiting
Muenster,48149,Germany
Novartis Investigative Site
Recruiting
Aachen,52074,Germany
Novartis Investigative Site
Recruiting
Guatemala City,01011,Guatemala
Novartis Investigative Site
Recruiting
Guatemala,01010,Guatemala
Novartis Investigative Site
Recruiting
Quetzaltenango,9001,Guatemala
Novartis Investigative Site
Recruiting
Kwun Tong,Kowloon,Hong Kong
Novartis Investigative Site
Recruiting
Tuen Mun,999077,Hong Kong
Novartis Investigative Site
Recruiting
Budapest,H-1032,Hungary
Novartis Investigative Site
Recruiting
Budapest,H-1097,Hungary
Novartis Investigative Site
Recruiting
Debrecen,4032,Hungary
Novartis Investigative Site
Recruiting
Kaposvar,7400,Hungary
Novartis Investigative Site
Recruiting
Lucknow,Uttar Pradesh,226014,India
Novartis Investigative Site
Recruiting
Chandigarh,160 012,India
Novartis Investigative Site
Recruiting
Bangalore,Karnataka,560 079,India
Novartis Investigative Site
Recruiting
Secunderabad,Telangana,500003,India
Novartis Investigative Site
Recruiting
Pavia,PV,27100,Italy
Novartis Investigative Site
Recruiting
Roma,RM,00168,Italy
Novartis Investigative Site
Recruiting
Torino,TO,10154,Italy
Novartis Investigative Site
Recruiting
Cagliari,CA,09134,Italy
Novartis Investigative Site
Recruiting
Udine,UD,33100,Italy
Novartis Investigative Site
Recruiting
Foggia,FG,71122,Italy
Novartis Investigative Site
Recruiting
Napoli,80131,Italy
Novartis Investigative Site
Recruiting
Firenze,FI,50134,Italy
Novartis Investigative Site
Recruiting
Milano,MI,20132,Italy
Novartis Investigative Site
Recruiting
Seoul,05030,Korea, Republic of
Novartis Investigative Site
Recruiting
Daejeon,Korea,35015,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,05505,Korea, Republic of
Novartis Investigative Site
Recruiting
Busan,602 715,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,06591,Korea, Republic of
Novartis Investigative Site
Recruiting
Daegu,705 718,Korea, Republic of
Novartis Investigative Site
Recruiting
Gwangju,61469,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,03722,Korea, Republic of
Novartis Investigative Site
Recruiting
Bundang Gu,Gyeonggi Do,13620,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,04763,Korea, Republic of
Novartis Investigative Site
Recruiting
Suwon si,Gyeonggi Do,16499,Korea, Republic of
Novartis Investigative Site
Recruiting
Kaunas,LTU,Lt 50161,Lithuania
Novartis Investigative Site
Recruiting
Vilnius,Lt-08661,Lithuania
Novartis Investigative Site
Recruiting
Kuala Terengganu,Terengganu,20400,Malaysia
Novartis Investigative Site
Recruiting
Kuala Lumpur,Wilayah Persekutuan,50586,Malaysia
Novartis Investigative Site
Recruiting
Sibu,Sarawak,96000,Malaysia
Novartis Investigative Site
Recruiting
Leon,Guanajuato,37160,Mexico
Novartis Investigative Site
Recruiting
Monterrey,Nuevo Leon,64440,Mexico
Novartis Investigative Site
Recruiting
Oaxaca,68020,Mexico
Novartis Investigative Site
Recruiting
Queretaro,76070,Mexico
Novartis Investigative Site
Recruiting
Bucharest,022328,Romania
Novartis Investigative Site
Recruiting
Cluj Napoca,400006,Romania
Novartis Investigative Site
Recruiting
Timisoara,300736,Romania
Novartis Investigative Site
Recruiting
Oradea,Jud Bihor,410619,Romania
Novartis Investigative Site
Recruiting
Singapore,169608,Singapore
Novartis Investigative Site
Recruiting
Singapore,S308433,Singapore
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08035,Spain
Novartis Investigative Site
Recruiting
Madrid,28041,Spain
Novartis Investigative Site
Recruiting
Valencia,Comunidad Valenciana,46017,Spain
Novartis Investigative Site
Recruiting
Madrid,280796,Spain
Novartis Investigative Site
Recruiting
Santiago De Compostela,Galicia,15706,Spain
Novartis Investigative Site
Recruiting
Pamplona,Navarra,31008,Spain
Novartis Investigative Site
Recruiting
Vigo,Pontevedra,36200,Spain
Novartis Investigative Site
Recruiting
La Laguna,Santa Cruz De Tenerife,38320,Spain
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08003,Spain
Novartis Investigative Site
Recruiting
Madrid,28040,Spain
Novartis Investigative Site
Recruiting
Kaohsiung,83301,Taiwan
Novartis Investigative Site
Recruiting
Taichung,40447,Taiwan
Novartis Investigative Site
Recruiting
Taichung,407219,Taiwan
Novartis Investigative Site
Recruiting
Taipei,11217,Taiwan
Novartis Investigative Site
Recruiting
Songkhla,Hat Yai,90110,Thailand
Novartis Investigative Site
Recruiting
Bangkok,10330,Thailand
Novartis Investigative Site
Recruiting
Bangkok,10400,Thailand
Novartis Investigative Site
Recruiting
Bangkok,10700,Thailand
Novartis Investigative Site
Recruiting
Chiang Mai,50200,Thailand
Novartis Investigative Site
Recruiting
London,Se1 9rt,United Kingdom
Novartis Investigative Site
Recruiting
Bradford,West Yorkshire,Bd9 6rj,United Kingdom
Wayne State University
Recruiting
Detroit,Michigan,48201,United States
Yahya Osman
Univ of Pennsylvania Medical Center
Recruiting
Philadelphia,Pennsylvania,19104,United States
Marleny Montero
Gaia Coppock
Baylor Scott and White Research
Recruiting
Temple,Texas,76502,United States
Mohanram Narayanan
Kaiser Permanente
Recruiting
San Diego,California,92111,United States
Hui Xue
Emory University School of Medicine
Recruiting
Atlanta,Georgia,30303,United States
S Sam Lim
Circuit Clinical
Recruiting
Orchard Park,New York,14127,United States
Isha Gupta
NY Nephrology
Recruiting
Clifton Park,New York,12065,United States
Frank Cortazar
University of California LA
Recruiting
Los Angeles,California,90095,United States
Maureen McMahon
Univ of Nevada School of Med
Recruiting
Las Vegas,Nevada,89102,United States
Katherin Mendez
Walter Winn Chatham
Univof Texas Southwestern Med Cntr
Recruiting
Dallas,Texas,75235,United States
David Karp
Northern Assoc of Northern VA
Recruiting
Fairfax,Virginia,22033,United States
Gregory Wang
Mayo Clinic Jacksonville
Recruiting
Jacksonville,Florida,32224,United States
Nabeel Aslam
Brookview Hills Research Assoc
Recruiting
Winston-Salem,North Carolina,27103,United States
Nicholas McLean
Liberty Research Center
Recruiting
Dallas,Texas,75230,United States
Irfan Agha
VA NM Healthcare System
Recruiting
Albuquerque,New Mexico,87108,United States
Kavitha Ganta
University of Texas Medical Branch
Recruiting
Galveston,Texas,77555-0144,United States
Tina Kochar
Fides Clinical Research
Recruiting
Atlanta,Georgia,30342,United States
Elizabeth Nguyen
University of California Irvine
Recruiting
Orange,California,92868,United States
Kelly Acero
Sheetal Desai
Hospital for Special Surgery
Recruiting
New York,New York,10021,United States
Kyriakos Kirou
University Of Alabama
Recruiting
Birmingham,Alabama,35294,United States
Jane Vines
Jose Mosquera Rubio
University of Kansas Hospital
Recruiting
Kansas City,Kansas,66160,United States
Kelly Liang
University Of Cincinnati
Recruiting
Cincinnati,Ohio,45267,United States
Manish Anand
Uni of Texas Health Science Center
Recruiting
San Antonio,Texas,78284,United States
Agustin Escalante
James J Peters VA Medical Center
Recruiting
Bronx,New York,10468,United States
Kelly Steed
Uni Wisconsin School Med Pub Health
Recruiting
Madison,Wisconsin,53792,United States
Tripti Singh
Parris and Associates Rheumatology
Recruiting
Lawrenceville,Georgia,30044,United States
Glenn Parris
UC Davis School of Medicine
Recruiting
Sacramento,California,95817,United States
Annie Trinh
Nasim Wiegley
University Of Miami
Recruiting
Miami,Florida,33136,United States
Maria Fernanda Carpintero
Northwell Health
Recruiting
New York,New York,10028,United States
Richard Furie
Wallace Rheumatic Study Center
Recruiting
Los Angeles,California,90048,United States
Carla Martinez
Daniel Wallace
UMC New Orleans
Recruiting
New Orleans,Louisiana,70112,United States
Jasmine McGary
Stephen Lindsey
Novartis Investigative Site
Recruiting
Hanoi,100000,Vietnam
Novartis Investigative Site
Recruiting
Ho Chi Minh,700000,Vietnam
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.