Last Update: Dec 19, 2024
A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CVAY736F12301E1
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Systemic Lupus Erythematosus
Phase3
Recruiting
550
May 21, 2024
Dec 23, 2031
All
12 Years - 100 Years (Child, Adult, Older Adult)

Interventions

Drug

Ianalumab

Ianalumab s.c. monthly Ianalumab s.c. quarterly
Drug

Placebo

Placebo s.c. monthly

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.

Novartis Investigative Site

Recruiting

San Miguel de Tucuman,Tucuman,T4000cbc,Argentina

Novartis Investigative Site

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Tucuman,4000,Argentina

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Maroochydore,Queensland,4558,Australia

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Plovdiv,4002,Bulgaria

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Rimouski,Quebec,G5l 5t1,Canada

Novartis Investigative Site

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Pingxiang,Jiangxi,337000,China

Novartis Investigative Site

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Linyi,Shandong,276000,China

Novartis Investigative Site

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Zhejiang,315016,China

Novartis Investigative Site

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Chang Chun,Jilin,130021,China

Novartis Investigative Site

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Brno,63800,Czechia

Novartis Investigative Site

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Montpellier Cedex 5,34295,France

Novartis Investigative Site

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Paris,75014,France

Novartis Investigative Site

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Leipzig,04103,Germany

Novartis Investigative Site

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Szekesfehervar,Fejer,8000,Hungary

Novartis Investigative Site

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Nagoya,Aichi,457 8510,Japan

Novartis Investigative Site

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Sapporo city,Hokkaido,060 8648,Japan

Novartis Investigative Site

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Ipoh,Perak,30450,Malaysia

Novartis Investigative Site

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Wroclaw,Dolnoslaskie,52-210,Poland

Novartis Investigative Site

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Bydgoszcz,85-065,Poland

Novartis Investigative Site

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Bytom,41 902,Poland

Novartis Investigative Site

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Warszawa,00-874,Poland

Novartis Investigative Site

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Warszawa,04141,Poland

Novartis Investigative Site

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Cluj Napoca,400006,Romania

Novartis Investigative Site

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Brasov,500283,Romania

Novartis Investigative Site

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Badalona,Catalunya,08916,Spain

Novartis Investigative Site

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Santander,Cantabria,39008,Spain

Novartis Investigative Site

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Barcelona,Catalunya,08035,Spain

Novartis Investigative Site

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Santiago De Compostela,Galicia,15706,Spain

Novartis Investigative Site

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Taichung,40447,Taiwan

Novartis Investigative Site

Recruiting

Bangkok,10400,Thailand

Pinnacle Research Group Llc

Recruiting

Anniston,Alabama,36207,United States

Vishala L Chindalore
Jamie Bush

Clinical Res Of W Florida

Recruiting

Clearwater,Florida,33765,United States

Robert Levin
Sydney K Mullen

Millennium Clinical Trials

Recruiting

Westlake Village,California,91361,United States

Edward B Portnoy
Jasmine Medina

West Tennessee Research Institute

Recruiting

Jackson,Tennessee,38305,United States

Jacob A. Aelion
Rachel Williams

Shelby Research LLC

Recruiting

Memphis,Tennessee,38119,United States

Anitha Das
Ramesh C Gupta

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