Study Description
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302). The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.
Interventions
Ianalumab
Placebo
Eligibility Criteria
Key Inclusion Criteria:
* Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \<18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, 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 core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
* In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.
Key Exclusion Criteria:
* Use of prohibited therapies.
* Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator 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 of becoming pregnant, refusing or unable to use highly effective methods of contraception 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 of child-bearing potential while taking study treatment.
Other protocol-defined inclusion/exclusion criteria may apply.
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San Miguel de Tucumán,Tucumán Province,T4000cbc,Argentina
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San Miguel de Tucumán,4000,Argentina
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Ciudad Autonoma de Bs As,Buenos Aires,C1015abo,Argentina
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San Miguel,Buenos Aires,1663,Argentina
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Maroochydore,Queensland,4558,Australia
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Salvador,Estado de Bahia,40150 150,Brazil
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Barretos,São Paulo,14784 400,Brazil
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Belo Horizonte,Minas Gerais,30150-221,Brazil
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São Paulo,São Paulo,01244-030,Brazil
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Plovdiv,4002,Bulgaria
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Rimouski,Quebec,G5l 5t1,Canada
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Pingxiang,Jiangxi,337000,China
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Linyi,Shandong,276000,China
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Zhejiang,315016,China
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Changchun,Jilin,130021,China
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Guangzhou,Guangdong,510080,China
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Nanchang,Jiangxi,330006,China
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Ürümqi,Xinjiang,830001,China
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Shanghai,200127,China
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Shantou,Guangdong,515041,China
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Beijing,100069,China
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Nanjing,Jiangsu,210008,China
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Suzhou,Jiangsu,215004,China
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Chía,Cundinamarca,250001,Colombia
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Barranquilla,Atlántico,080020,Colombia
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Bucaramanga,Santander Department,0001,Colombia
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Bogotá,111211,Colombia
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Brno,63800,Czechia
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Uherské Hradiště,686 01,Czechia
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Paris,75014,France
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Montpellier,34295,France
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Paris,75013,France
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Leipzig,Saxony,04103,Germany
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Guatemala City,01010,Guatemala
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Székesfehérvár,Fejér,8000,Hungary
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Ahmedabad,Gujarat,380006,India
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Ramat Gan,5265601,Israel
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Torino,TO,10128,Italy
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Nagoya,Aichi-ken,457 8510,Japan
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Sapporo,Hokkaido,060 8648,Japan
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Seoul,Seocho Gu,06591,Korea, Republic of
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Seoul,04763,Korea, Republic of
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Ipoh,Perak,30450,Malaysia
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Mexico City,Mexico City,06700,Mexico
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León,Guanajuato,37160,Mexico
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Guadalajara,Jalisco,44160,Mexico
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Mérida,Yucatán,97070,Mexico
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México,07760,Mexico
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Bydgoszcz,85-065,Poland
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Warsaw,00-874,Poland
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Warsaw,04141,Poland
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Wroclaw,Lower Silesian Voivodeship,52-210,Poland
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Bytom,41 902,Poland
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Bydgoszcz,85 168,Poland
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Braga,4710243,Portugal
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Brasov,500283,Romania
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Cluj-Napoca,400006,Romania
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Seoul,Seocho Gu,06591,South Korea
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Seoul,04763,South Korea
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Badalona,Catalonia,08916,Spain
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Barcelona,Catalonia,08035,Spain
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Santiago de Compostela,Galicia,15706,Spain
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Santander,Cantabria,39008,Spain
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Barcelona,Catalonia,08003,Spain
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Madrid,28034,Spain
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Taichung,40447,Taiwan
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Taichung,407219,Taiwan
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Taoyuan District,33305,Taiwan
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Kaohsiung City,83301,Taiwan
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Bangkok,10400,Thailand
Clinical Res Of W Florida
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Clearwater,Florida,33765,United States
Robert Levin
West Tennessee Research Institute
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Jackson,Tennessee,38305,United States
Jacob A Aelion
Shelby Research LLC
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Memphis,Tennessee,38119,United States
Ramesh C Gupta
Pinnacle Research Group Llc
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Anniston,Alabama,36207,United States
Vishala L Chindalore
Millennium Clinical Trials
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Westlake Village,California,91361,United States
Edward B Portnoy
Jasmine Medina
Advanced Medical Research
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La Palma,California,90623,United States
Gerald Ho
Accurate Clinical Research
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Lake Charles,Louisiana,70601,United States
Enrique Mendez
Machell Broussard
Ahmed Arif Medical Research Center
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Grand Blanc,Michigan,48439,United States
Ali Karrar
Novel Research LLC
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Bellaire,Texas,77401,United States
Hina Arshad
Wajeeha Yousaf
University Of Maryland Med Ctr
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Baltimore,Maryland,21201,United States
Violeta Rus
Worldwide Contacts
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