Phase
Condition
Musculoskeletal Diseases
Lupus
Cutaneous Lupus Erythematosus
Treatment
Placebo
Ianalumab
Clinical Study ID
Ages 12-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Signed informed consent prior to participation in the extension study. Parent orlegal guardian's signed informed consent and child's assent, if appropriate, arerequired before any assessment is performed for participants <18 years of age. Ofnote, if the participant reaches age of consent (age as per local law) during thestudy, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
Participants must have participated in either one of the two SIRIUS-SLE corestudies, CVAY736F12301 or CVAY736F12302, and have completed the treatment periodthrough Week 60 without treatment discontinuation.
In the judgement of the investigator, participants must be expected to clinicallybenefit from continued study treatment.
Exclusion
Key Exclusion Criteria:
Use of prohibited therapies.
Active viral, bacterial or other infections requiring intravenous or intramusculartreatment for clinically significant infection which in the opinion of theinvestigator will place the participant at risk for participation.
Plans for administration of live vaccines during the study period.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, refusing or unable to use highly effective methods ofcontraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
United States (and other countries, if locally required): sexually active males,unless they agree to use barrier protection during intercourse with women ofchild-bearing potential while taking study treatment.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires C1015ABO
ArgentinaSite Not Available
Novartis Investigative Site
San Miguel, Buenos Aires 1663
ArgentinaSite Not Available
Novartis Investigative Site
San Miguel 7645166, Buenos Aires 3435907 B1663GKT
ArgentinaActive - Recruiting
Novartis Investigative Site
San Miguel de Tucuman, Tucuman T4000CBC
ArgentinaSite Not Available
Novartis Investigative Site
San Miguel 3836920, Tucumán Province 3833578 T4000CBC
ArgentinaActive - Recruiting
Novartis Investigative Site
Buenos Aires 3435910, C1015ABO
ArgentinaSite Not Available
Novartis Investigative Site
Caba, C1015ABO
ArgentinaActive - Recruiting
Novartis Investigative Site
San Miguel de Tucumán 3836873, 4000
ArgentinaActive - Recruiting
Novartis Investigative Site
Tucuman, 4000
ArgentinaSite Not Available
Novartis Investigative Site
Maroochydore, Queensland 4558
AustraliaSite Not Available
Novartis Investigative Site
Maroochydore 2207268, Queensland 2152274 4558
AustraliaActive - Recruiting
Novartis Investigative Site
Salvador, BA 40150 150
BrazilSite Not Available
Novartis Investigative Site
Salvador 3450554, Estado de Bahia 3471168 40150 150
BrazilActive - Recruiting
Novartis Investigative Site
Belo Horizonte, MG 30150-221
BrazilSite Not Available
Novartis Investigative Site
Belo Horizonte 3470127, Minas Gerais 3457153 30150-221
BrazilActive - Recruiting
Novartis Investigative Site
Rio de Janeiro 3451190, Rio de Janeiro 3451189 22211-230
BrazilActive - Recruiting
Novartis Investigative Site
Sao Paulo, SP 01244-030
BrazilSite Not Available
Novartis Investigative Site
Barretos, Sao Paulo 14784 400
BrazilSite Not Available
Novartis Investigative Site
Barretos 3470451, São Paulo 3448433 14784 400
BrazilActive - Recruiting
Novartis Investigative Site
São Paulo 3448439, São Paulo 3448433 04038-002
BrazilActive - Recruiting
Novartis Investigative Site
Plovdiv 728193, Bulgaria 4002
BulgariaActive - Recruiting
Novartis Investigative Site
Plovdiv, 4002
BulgariaSite Not Available
Novartis Investigative Site
Sofia 727011, 1431
BulgariaActive - Recruiting
Novartis Investigative Site
Vancouver 6173331, British Columbia 5909050 V5Z 1L7
CanadaActive - Recruiting
Novartis Investigative Site
Rimouski, Quebec G5L 5T1
CanadaSite Not Available
Novartis Investigative Site
Rimouski 6354895, Quebec 6115047 G5L 5T1
CanadaActive - Recruiting
Novartis Investigative Site
Valdivia 3868707, Los Ríos Region 6693563 5110683
ChileActive - Recruiting
Novartis Investigative Site
Santiago 3871336, RM 7500588
ChileActive - Recruiting
Novartis Investigative Site
Guangzhou, Guangdong 510080
ChinaSite Not Available
Novartis Investigative Site
Shantou, Guangdong 515041
ChinaSite Not Available
Novartis Investigative Site
Guangzhou 1809858, Guangdong 1809935 510080
ChinaActive - Recruiting
Novartis Investigative Site
Shantou 1795940, Guangdong 1809935 515000
ChinaActive - Recruiting
Novartis Investigative Site
Nanjing, Jiangsu 210008
ChinaSite Not Available
Novartis Investigative Site
Suzhou, Jiangsu 215004
ChinaSite Not Available
Novartis Investigative Site
Nanjing 1799962, Jiangsu 1806260 210008
ChinaActive - Recruiting
Novartis Investigative Site
Suzhou 1886760, Jiangsu 1806260 215004
ChinaActive - Recruiting
Novartis Investigative Site
Nanchang, Jiangxi 330006
ChinaSite Not Available
Novartis Investigative Site
Pingxiang, Jiangxi 337000
ChinaSite Not Available
Novartis Investigative Site
Nanchang 1800163, Jiangxi 1806222 330006
ChinaActive - Recruiting
Novartis Investigative Site
Pingxiang 1798654, Jiangxi 1806222 337000
ChinaActive - Recruiting
Novartis Investigative Site
Chang Chun, Jilin 130021
ChinaSite Not Available
Novartis Investigative Site
Changchun 2038180, Jilin 2036500 130021
ChinaActive - Recruiting
Novartis Investigative Site
Linyi, Shandong 276000
ChinaSite Not Available
Novartis Investigative Site
Linyi 1803318, Shandong 1796328 276000
ChinaActive - Recruiting
Novartis Investigative Site
Urumqi, Xinjiang 830001
ChinaSite Not Available
Novartis Investigative Site
Ürümqi 1529102, Xinjiang 1529047 830001
ChinaActive - Recruiting
Novartis Investigative Site
Ningbo 1799397, Zhejiang 1784764 315016
ChinaActive - Recruiting
Novartis Investigative Site
Beijing, 100069
ChinaSite Not Available
Novartis Investigative Site
Beijing 1816670, 100730
ChinaActive - Recruiting
Novartis Investigative Site
Shanghai, 200127
ChinaSite Not Available
Novartis Investigative Site
Shanghai 1796236, 200127
ChinaActive - Recruiting
Novartis Investigative Site
Zhejiang, 315016
ChinaSite Not Available
Novartis Investigative Site
Zhejiang 9898779, 315016
ChinaSite Not Available
Novartis Investigative Site
Medellin, Antioquia 050001
ColombiaSite Not Available
Novartis Investigative Site
Medellín 3674962, Antioquia 3689815 050001
ColombiaSite Not Available
Novartis Investigative Site
Barranquilla, Atlantico 080020
ColombiaSite Not Available
Novartis Investigative Site
Barranquilla 3689147, Atlántico 3689436 080020
ColombiaActive - Recruiting
Novartis Investigative Site
Chia, Cundinamarca 250001
ColombiaSite Not Available
Novartis Investigative Site
Chía 3686675, Cundinamarca 3685413 250001
ColombiaActive - Recruiting
Novartis Investigative Site
Bucaramanga, Santander 0001
ColombiaSite Not Available
Novartis Investigative Site
Bucaramanga 3688465, Santander Department 3668578 680003
ColombiaActive - Recruiting
Novartis Investigative Site
Bogota, 111211
ColombiaSite Not Available
Novartis Investigative Site
Bogotá 3688689, 111211
ColombiaActive - Recruiting
Novartis Investigative Site
Brno, 63800
CzechiaSite Not Available
Novartis Investigative Site
Brno 3078610, 638 00
CzechiaActive - Recruiting
Novartis Investigative Site
Uherske Hradiste, 686 01
CzechiaSite Not Available
Novartis Investigative Site
Uherské Hradiště 3063739, 686 01
CzechiaActive - Recruiting
Novartis Investigative Site
Montpellier 2992166, 34295
FranceActive - Recruiting
Novartis Investigative Site
Montpellier 5, 34295
FranceSite Not Available
Novartis Investigative Site
Montpellier Cedex 5, 34295
FranceSite Not Available
Novartis Investigative Site
Paris, 75013
FranceSite Not Available
Novartis Investigative Site
Paris 2988507, 75014
FranceActive - Recruiting
Novartis Investigative Site
Toulouse 2972315, 31054
FranceActive - Recruiting
Novartis Investigative Site
Leipzig, Sachsen 04103
GermanySite Not Available
Novartis Investigative Site
Leipzig 2879139, Saxony 2842566 04103
GermanyActive - Recruiting
Novartis Investigative Site
Guatemala City 3598132, Departamento de Guatemala 3595530 01010
GuatemalaActive - Recruiting
Novartis Investigative Site
Guatemala, 01010
GuatemalaSite Not Available
Novartis Investigative Site
Guatemala City, 01010
GuatemalaSite Not Available
Novartis Investigative Site
Szekesfehervar, Fejer 8000
HungarySite Not Available
Novartis Investigative Site
Székesfehérvár 3044774, Fejér 3053028 8000
HungaryActive - Recruiting
Novartis Investigative Site
Gyula 720334, 5700
HungaryActive - Recruiting
Novartis Investigative Site
Ahmedabad, Gujarat 380006
IndiaSite Not Available
Novartis Investigative Site
Ahmedabad 1279233, Gujarat 1270770 380006
IndiaActive - Recruiting
Novartis Investigative Site
Kozhikode 1265873, Kerala 1267254 673008
IndiaActive - Recruiting
Novartis Investigative Site
Nagpur 1262180, Maharashtra 1264418 441108
IndiaActive - Recruiting
Novartis Investigative Site
Pune 1259229, Maharashtra 1264418 411001
IndiaActive - Recruiting
Novartis Investigative Site
New Delhi 1261481, New Delhi 110029
IndiaActive - Recruiting
Novartis Investigative Site
Haifa 294801, 3109601
IsraelActive - Recruiting
Novartis Investigative Site
Ramat Gan, 5265601
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan 293788, 5265601
IsraelActive - Recruiting
Novartis Investigative Site
Torino, TO 10128
ItalySite Not Available
Novartis Investigative Site
Torino 8980539, TO 10128
ItalyActive - Recruiting
Novartis Investigative Site
Nagoya, Aichi 457 8510
JapanSite Not Available
Novartis Investigative Site
Nagoya 1856057, Aichi-ken 1865694 457 8510
JapanActive - Recruiting
Novartis Investigative Site
Sapporo city, Hokkaido 060 8648
JapanSite Not Available
Novartis Investigative Site
Sapporo 2128295, Hokkaido 2130037 060 8648
JapanActive - Recruiting
Novartis Investigative Site
Chuo Ku, Tokyo 1850144 104 8560
JapanActive - Recruiting
Novartis Investigative Site
Seoul, 04763
Korea, Republic ofSite Not Available
Novartis Investigative Site
Ipoh, Perak 30450
MalaysiaSite Not Available
Novartis Investigative Site
Ipoh 1734634, Perak 1733041 30450
MalaysiaActive - Recruiting
Novartis Investigative Site
Ciudad de Mexico, Distrito Federal 06700
MexicoSite Not Available
Novartis Investigative Site
Leon, Guanajuato 37160
MexicoSite Not Available
Novartis Investigative Site
León 3998655, Guanajuato 4005267 37160
MexicoActive - Recruiting
Novartis Investigative Site
Guadalajara, Jalisco 44160
MexicoSite Not Available
Novartis Investigative Site
Guadalajara 4005539, Jalisco 4004156 44160
MexicoActive - Recruiting
Novartis Investigative Site
Mexico City 3530597, Mexico City 3527646 06700
MexicoActive - Recruiting
Novartis Investigative Site
Morelia 3995402, Michoacán 3995955 58000
MexicoActive - Recruiting
Novartis Investigative Site
Merida, Yucatan 97070
MexicoSite Not Available
Novartis Investigative Site
Mérida 3523349, Yucatán 3514211 97070
MexicoActive - Recruiting
Novartis Investigative Site
Mexico, 07760
MexicoSite Not Available
Novartis Investigative Site
México 10248874, 07760
MexicoActive - Recruiting
Novartis Investigative Site
Wroclaw, Dolnoslaskie 52-210
PolandSite Not Available
Novartis Investigative Site
Wroclaw 3081368, Lower Silesian Voivodeship 3337492 52-210
PolandActive - Recruiting
Novartis Investigative Site
Bydgoszcz, 85 168
PolandSite Not Available
Novartis Investigative Site
Bydgoszcz 3102014, 85-168
PolandActive - Recruiting
Novartis Investigative Site
Bytom, 41 902
PolandSite Not Available
Novartis Investigative Site
Bytom 3101950, 41 902
PolandActive - Recruiting
Novartis Investigative Site
Warsaw 756135, 04-141
PolandActive - Recruiting
Novartis Investigative Site
Warszawa, 00-874
PolandSite Not Available
Novartis Investigative Site
Braga, 4710243
PortugalSite Not Available
Novartis Investigative Site
Braga 2742032, 4710243
PortugalActive - Recruiting
Novartis Investigative Site
Cluj-Napoca 681290, Cluj 681291 400006
RomaniaActive - Recruiting
Novartis Investigative Site
Brasov, 500283
RomaniaSite Not Available
Novartis Investigative Site
Brasov 683844, 500283
RomaniaActive - Recruiting
Novartis Investigative Site
Bucharest 683506, 011172
RomaniaActive - Recruiting
Novartis Investigative Site
Cluj Napoca, 400006
RomaniaSite Not Available
Novartis Investigative Site
Cape Town 3369157, Western Cape 1085599 7500
South AfricaActive - Recruiting
Novartis Investigative Site
Gwangju Gwangyeoksi, Gwangju 1841808 61748
South KoreaActive - Recruiting
Novartis Investigative Site
Seoul 1835848, 04763
South KoreaActive - Recruiting
Novartis Investigative Site
Santiago Compostela, A Coruna 15706
SpainActive - Recruiting
Novartis Investigative Site
Elche, Alicante 03203
SpainSite Not Available
Novartis Investigative Site
Badalona 3129028, Barcelona 08916
SpainActive - Recruiting
Novartis Investigative Site
Santander, Cantabria 39008
SpainSite Not Available
Novartis Investigative Site
Santander 3109718, Cantabria 3336898 39008
SpainActive - Recruiting
Novartis Investigative Site
Barcelona 3128760, Catalonia 3336901 08003
SpainActive - Recruiting
Novartis Investigative Site
Badalona, Catalunya 08916
SpainSite Not Available
Novartis Investigative Site
Barcelona, Catalunya 08003
SpainSite Not Available
Novartis Investigative Site
Santiago De Compostela, Galicia 15706
SpainSite Not Available
Novartis Investigative Site
Santiago de Compostela 3109642, Galicia 3336902 15706
SpainSite Not Available
Novartis Investigative Site
San Sebastian Reyes, Madrid 3117732 28702
SpainActive - Recruiting
Novartis Investigative Site
Madrid, 28034
SpainSite Not Available
Novartis Investigative Site
Madrid 3117735, 28034
SpainActive - Recruiting
Novartis Investigative Site
Kaohsiung, 83301
TaiwanSite Not Available
Novartis Investigative Site
Kaohsiung City 1673820, 83301
TaiwanActive - Recruiting
Novartis Investigative Site
Taichung, 407219
TaiwanSite Not Available
Novartis Investigative Site
Taichung 1668399, 407219
TaiwanActive - Recruiting
Novartis Investigative Site
Taipei 1668341, 11217
TaiwanActive - Recruiting
Novartis Investigative Site
Taoyuan, 33305
TaiwanSite Not Available
Novartis Investigative Site
Taoyuan District 1667905, 33305
TaiwanActive - Recruiting
Novartis Investigative Site
Bangkok, 10400
ThailandSite Not Available
Novartis Investigative Site
Bangkok 1609350, 10400
ThailandActive - Recruiting
Pinnacle Research Group Llc
Anniston, Alabama 36207
United StatesSite Not Available
Pinnacle Research Group Llc .
Anniston, Alabama 36207
United StatesActive - Recruiting
Pinnacle Research Group Llc
Anniston 4830198, Alabama 4829764 36207
United StatesActive - Recruiting
Advanced Medical Research
La Palma, California 90623
United StatesSite Not Available
Millennium Clinical Trials
Westlake Village, California 91361
United StatesSite Not Available
Providence Medical Center
Burbank 5331835, California 5332921 91505
United StatesActive - Recruiting
Advanced Medical Research
La Palma 5364022, California 5332921 90623
United StatesActive - Recruiting
Millennium Clinical Trials
Westlake Village 5408395, California 5332921 91361
United StatesActive - Recruiting
University of Colorado Denver
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Clinical Res Of W Florida
Clearwater, Florida 33765
United StatesSite Not Available
Clinical Res. of W Florida
Clearwater, Florida 33765
United StatesActive - Recruiting
Clinical Res Of W Florida
Clearwater 4151316, Florida 4155751 33765
United StatesActive - Recruiting
GNP Research
Cooper City 4151824, Florida 4155751 33024
United StatesActive - Recruiting
IRIS Research and Development
Plantation 4168782, Florida 4155751 33324
United StatesActive - Recruiting
Robert A Hozman MD SC
Skokie 4911600, Illinois 4896861 60076
United StatesActive - Recruiting
Willow Rheumatology Wellness
Willowbrook 4916709, Illinois 4896861 60527
United StatesActive - Recruiting
Accurate Clinical Research
Lake Charles, Louisiana 70601
United StatesSite Not Available
Accurate Clinical Research
Lake Charles 4330236, Louisiana 4331987 70601
United StatesActive - Recruiting
University Of Maryland Med Ctr
Baltimore, Maryland 21201
United StatesSite Not Available
University Of Maryland Med Ctr
Baltimore 4347778, Maryland 4361885 21201
United StatesSite Not Available
Ahmed Arif Medical Research Center
Grand Blanc, Michigan 48439
United StatesSite Not Available
Henry Ford Health
Detroit 4990729, Michigan 5001836 48202
United StatesActive - Recruiting
Ahmed Arif Medical Research Center
Grand Blanc 4994320, Michigan 5001836 48439
United StatesActive - Recruiting
Paramount Med Rsrch and Consult LLC
Middleburg Heights 5162851, Ohio 5165418 44130
United StatesActive - Recruiting
West Tennessee Research Institute
Jackson, Tennessee 38305
United StatesSite Not Available
Shelby Research LLC
Memphis, Tennessee 38119
United StatesSite Not Available
West Tennessee Research Institute
Jackson 4632595, Tennessee 4662168 38305
United StatesActive - Recruiting
Shelby Research LLC
Memphis 4641239, Tennessee 4662168 38119
United StatesActive - Recruiting
Novel Research LLC
Bellaire, Texas 77401
United StatesSite Not Available
Novel Research LLC
Bellaire 4673353, Texas 4736286 77401
United StatesActive - Recruiting
Accurate Clinical Research
League City 4705692, Texas 4736286 77573
United StatesActive - Recruiting

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