Phase
Condition
Lupus
Musculoskeletal Diseases
Cutaneous Lupus Erythematosus
Treatment
ianalumab
placebo
Clinical Study ID
Ages 12-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female participants aged 12 years or older at the time of screening, orlimited to 18 years or older in European Economic Area countries and other countrieswhere inclusion of participants below 18 years is not allowed.
Diagnosis of systemic lupus erythematosus meeting the 2019 European League AgainstRheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteriaat least 6 months prior to screening.
Elevated serum titers at screening of anti-nuclear antibodies ≥ 1:80 as determinedby a central laboratory with a SLE-typical fluorescence pattern.
Currently receiving CS and/or anti-malarial treatment and/or anotherdisease-modifying antirheumatic drug (DMARD) as specified in the protocol.
SLEDAI-2K criteria at screening: SLEDAI-2K score ≥ 6 points, excluding pointsattributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome"
BILAG-2004 disease activity level at screening of at least 1 of the following:
BILAG-2004 level 'A' disease in ≥ 1 organ system, Or
BILAG-2004 level 'B' disease in ≥ 2 organ systems
Weigh at least 35 kg at screening
Exclusion
Exclusion Criteria:
Prior treatment with ianalumab
History of receiving following treatment I) high dose CS, calcineurin inhibitors,JAK or other kinase inhibitors or other DMARD (except as listed in inclusioncriteria) administered within 12 weeks prior to screening II) cyclophosphamide orbiologics such as immunoglobulins (intravenous or s.c.), plasmapheresis, anti-type Iinterferon receptor biologic agents, anti-CD40 agents, CTLA4-Fc Ig or B-cellactivating factor (BAFF)-targeting agents administered within 24 weeks prior toscreening; belimumab administered within 12 weeks prior to screening. III) any Bcell-depleting therapies, other than ianalumab administered within 36 weeks prior torandomization or as long as B cell count is less than the lower limit of normal orbaseline value prior to receipt of B cell-depleting therapy (whichever is lower).IV) Traditional Chinese medicines administered within 30 days prior to randomization
Active viral, bacterial or other infections requiring intravenous or intramusculartreatment for clinically significant infection
Chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
Evidence of active tuberculosis infection
History of primary or secondary immunodeficiency, including a positive humanimmunodeficiency virus (HIV) test result at screening
Any one of the following abnormal laboratory values prior to randomization:
Platelets < 25000/ mm^3 (< 25 x 10^3/ μL)
Hemoglobin (Hgb) < 8.0 g/dL (< 5 mmol/L), or < 7.0 g/dL (< 4.3 mmol/L) ifrelated to participant's SLE such as in active hemolytic anaemia
Absolute neutrophil count (ANC) (< 0.8 x 10^3/ μL)
Severe organ dysfunction or life-threatening disease at screening
Presence of severe lupus kidney disease as defined by proteinuria above 2 g/day orequivalent using spot urine protein creatinine ratio, or serum creatinine greaterthan 2.0 mg/dL (176.84 µmol/L), or requiring immune-suppressive induction ormaintenance treatment at screening
Receipt of live/attenuated vaccine within a 4-week period before first dosing
Any uncontrolled, co-existing serious disease, which in the opinion of theinvestigator will place the participant at risk for participation or interfere withevaluation for SLE-related symptoms
Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent orchronic treatment with systemic CS
History of malignancy of any organ system other than localized basal cell carcinomaof the skin or in situ cervical cancer
Pregnant or nursing (lactating) women.
Women of child-bearing potential (WOCBP), defined as all women physiologicallycapable of becoming pregnant, unless they are using highly effective methods ofcontraception while on study treatment and for 6 months after stopping ofinvestigational drug.
Any surgical, medical, psychiatric or additional physical condition that mayjeopardize participation in this study
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires C1015ABO
ArgentinaActive - Recruiting
Novartis Investigative Site
La Plata, Buenos Aires B1900AWT
ArgentinaActive - Recruiting
Novartis Investigative Site
San Miguel, Buenos Aires 1663
ArgentinaActive - Recruiting
Novartis Investigative Site
San Miguel de Tucuman, Tucuman T4000CBC
ArgentinaActive - Recruiting
Novartis Investigative Site
Buenos Aires, C1430EGF
ArgentinaActive - Recruiting
Novartis Investigative Site
Tucuman, 4000
ArgentinaActive - Recruiting
Novartis Investigative Site
Maroochydore, Queensland 4558
AustraliaActive - Recruiting
Novartis Investigative Site
Victoria Park, Western Australia 6100
AustraliaSite Not Available
Novartis Investigative Site
St Leonards, 2065
AustraliaActive - Recruiting
Novartis Investigative Site
Valdivia, Los Rios 5110683
ChileActive - Recruiting
Novartis Investigative Site
Santiago, RM 7500588
ChileActive - Recruiting
Novartis Investigative Site
Concepcion, 6740
ChileActive - Recruiting
Novartis Investigative Site
Medellin, Antioquia 050001
ColombiaActive - Recruiting
Novartis Investigative Site
Barranquilla, Atlantico 080002
ColombiaActive - Recruiting
Novartis Investigative Site
Bucaramanga, Santander 0001
ColombiaActive - Recruiting
Novartis Investigative Site
Cali, Valle Del Cauca 760046
ColombiaActive - Recruiting
Novartis Investigative Site
Bogota, 111611
ColombiaActive - Recruiting
Novartis Investigative Site
Cundinamarca, 111121
ColombiaActive - Recruiting
Novartis Investigative Site
Angers Cedex 9, 49933
FranceActive - Recruiting
Novartis Investigative Site
Grenoble, 38043
FranceActive - Recruiting
Novartis Investigative Site
Montpellier Cedex 5, 34295
FranceActive - Recruiting
Novartis Investigative Site
Paris, 75014
FranceActive - Recruiting
Novartis Investigative Site
Paris 13, 75651
FranceActive - Recruiting
Novartis Investigative Site
Paris Cedex 13, 75651
FranceSite Not Available
Novartis Investigative Site
Toulouse, 31400
FranceActive - Recruiting
Novartis Investigative Site
Toulouse 4, 31054
FranceActive - Recruiting
Novartis Investigative Site
Tours, 37044
FranceActive - Recruiting
Novartis Investigative Site
Aachen, 52074
GermanyActive - Recruiting
Novartis Investigative Site
Berlin, 13353
GermanyActive - Recruiting
Novartis Investigative Site
Erlangen, 91056
GermanyActive - Recruiting
Novartis Investigative Site
Freiburg, 79106
GermanyActive - Recruiting
Novartis Investigative Site
Herne, 44649
GermanyActive - Recruiting
Novartis Investigative Site
Koeln, 50937
GermanyActive - Recruiting
Novartis Investigative Site
Leipzig, 04103
GermanyActive - Recruiting
Novartis Investigative Site
Mainz, 55131
GermanyActive - Recruiting
Novartis Investigative Site
Ahmedabad, Gujarat 380015
IndiaActive - Recruiting
Novartis Investigative Site
Kozhikode, Kerala 673008
IndiaActive - Recruiting
Novartis Investigative Site
Kolhapur, Maharashtra 416001
IndiaActive - Recruiting
Novartis Investigative Site
Nagpur, Maharashtra 441108
IndiaActive - Recruiting
Novartis Investigative Site
Nashik, Maharashtra 422101
IndiaActive - Recruiting
Novartis Investigative Site
Pune, Maharashtra 411001
IndiaActive - Recruiting
Novartis Investigative Site
Secunderabad, Telangana 500003
IndiaActive - Recruiting
Novartis Investigative Site
New Delhi, 110029
IndiaActive - Recruiting
Novartis Investigative Site
Puducherry, 605006
IndiaActive - Recruiting
Novartis Investigative Site
Visakhapatnam, 530040
IndiaActive - Recruiting
Novartis Investigative Site
Ancona, AN 60126
ItalyActive - Recruiting
Novartis Investigative Site
Caserta, CE 81100
ItalyActive - Recruiting
Novartis Investigative Site
Cona, FE 44100
ItalyActive - Recruiting
Novartis Investigative Site
Padova, PD 35128
ItalyActive - Recruiting
Novartis Investigative Site
Pisa, PI 56124
ItalyActive - Recruiting
Novartis Investigative Site
Roma, RM 00152
ItalyActive - Recruiting
Novartis Investigative Site
Torino, TO 10128
ItalyActive - Recruiting
Novartis Investigative Site
Milano, 20126
ItalyActive - Recruiting
Novartis Investigative Site
Daejeon, Korea 35015
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Gwangju Gwangyeoksi, 61748
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Seoul, 04763
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Seremban, Negeri Sembilan 70300
MalaysiaActive - Recruiting
Novartis Investigative Site
Ipoh, Perak 30450
MalaysiaActive - Recruiting
Novartis Investigative Site
Kuching, Sarawak 93586
MalaysiaActive - Recruiting
Novartis Investigative Site
Petaling Jaya, Selangor Darul Ehsan 46150
MalaysiaActive - Recruiting
Novartis Investigative Site
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
Novartis Investigative Site
Selangor Darul Ehsan, 68100
MalaysiaActive - Recruiting
Novartis Investigative Site
Ciudad de Mexico, Distrito Federal 06700
MexicoActive - Recruiting
Novartis Investigative Site
Leon, Guanajuato 37160
MexicoActive - Recruiting
Novartis Investigative Site
Guadalajara, Jalisco 44160
MexicoActive - Recruiting
Novartis Investigative Site
Morelia, Michoacan 58000
MexicoActive - Recruiting
Novartis Investigative Site
Merida, Yucatan 97070
MexicoActive - Recruiting
Novartis Investigative Site
Mexico, 07760
MexicoActive - Recruiting
Novartis Investigative Site
Brasov, 500283
RomaniaActive - Recruiting
Novartis Investigative Site
Bucuresti, 011172
RomaniaActive - Recruiting
Novartis Investigative Site
Cluj Napoca, 400006
RomaniaActive - Recruiting
Novartis Investigative Site
Cluj-Napoca, 400006
RomaniaSite Not Available
Novartis Investigative Site
Kaohsiung, 83301
TaiwanActive - Recruiting
Novartis Investigative Site
Taichung, 40447
TaiwanActive - Recruiting
Novartis Investigative Site
Taipei, 11217
TaiwanActive - Recruiting
Novartis Investigative Site
Taoyuan, 33305
TaiwanActive - Recruiting
Novartis Investigative Site
Birmingham, B15 2TH
United KingdomActive - Recruiting
Novartis Investigative Site
Leeds, LS7 4SA
United KingdomSite Not Available
Novartis Investigative Site
Leicester, LE1 5WW
United KingdomActive - Recruiting
Novartis Investigative Site
Anniston, Alabama 36207-5710
United StatesActive - Recruiting
Pinnacle Research Group LLC
Anniston, Alabama 36207-5710
United StatesActive - Recruiting
Pinnacle Research Group LLC .
Anniston, Alabama 36207-5710
United StatesSite Not Available
University of Calif Irvine Med Cntr
Irvine, California 92660
United StatesActive - Recruiting
Advanced Medical Research
La Palma, California 90623
United StatesActive - Recruiting
Novartis Investigative Site
La Palma, California 90623
United StatesActive - Recruiting
Homestead Assoc In Research Inc
Homestead, Florida 33033
United StatesActive - Recruiting
Homestead Associates in Research Inc
Miami, Florida 33032
United StatesSite Not Available
Integral Rheumatology and Immunology Specialists IRIS
Plantation, Florida 33324
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30307
United StatesActive - Recruiting
Emory University .
Atlanta, Georgia 30307
United StatesSite Not Available
Illinois Bone And Joint Institute
Hinsdale, Illinois 60521
United StatesActive - Recruiting
Bluegrass Community Research Inc
Lexington, Kentucky 40504
United StatesCompleted
Novartis Investigative Site
Lexington, Kentucky 40504
United StatesActive - Recruiting
Accurate Clinical Research
Lake Charles, Louisiana 70601
United StatesActive - Recruiting
Accurate Clinical Research Research
Lake Charles, Louisiana 70601
United StatesSite Not Available
Novartis Investigative Site
Lake Charles, Louisiana 70601
United StatesActive - Recruiting
UMC New Orleans
New Orleans, Louisiana 70112
United StatesActive - Recruiting
UMC New Orleans Nephrologist
New Orleans, Louisiana 70112
United StatesSite Not Available
University Of Maryland
Baltimore, Maryland 21201
United StatesActive - Recruiting
University Of Maryland Rheumatology
Baltimore, Maryland 21201
United StatesSite Not Available
Ahmed Arif Medical Research Center
Grand Blanc, Michigan 48439
United StatesActive - Recruiting
Novartis Investigative Site
Grand Blanc, Michigan 48439
United StatesActive - Recruiting
Washington Univ School Of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Thomas Jefferson University Einstein Healthcare Network
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Novartis Investigative Site
Jackson, Tennessee 38305
United StatesActive - Recruiting
West Tennessee Research Institute
Jackson, Tennessee 38305
United StatesActive - Recruiting
Novartis Investigative Site
Bellaire, Texas 77401
United StatesActive - Recruiting
Novel Research LLC
Bellaire, Texas 77401
United StatesActive - Recruiting
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