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NCT06133972PHASE3Recruiting

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

Novartis Pharmaceuticals

Start Date

5/21/2024

Completion Date

4/5/2032

Summary

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).

Detailed Description

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.

Eligibility Criteria

Age Range: 12 years to 100 years

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.

Interventions

DRUG

Placebo

DRUG

Ianalumab

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Conditions

Systemic Lupus Erythematosus

Locations

Pinnacle Research Group Llc

Anniston, Alabama 36207

United States

Providence Medical Center

Burbank, California 91505

United States

Advanced Medical Research

La Palma, California 90623

United States

Millennium Clinical Trials

Westlake Village, California 91361

United States

University of Colorado Denver

Aurora, Colorado 80045

United States

Clinical Res Of W Florida

Clearwater, Florida 33765

United States

GNP Research

Cooper City, Florida 33024

United States

IRIS Research and Development

Plantation, Florida 33324

United States

Clinical Research of West Florida Inc

Tampa, Florida 33603

United States

Parris and Associates Rheumatology

Lawrenceville, Georgia 30044

United States

Robert A Hozman MD SC

Skokie, Illinois 60076

United States

Willow Rheumatology Wellness

Willowbrook, Illinois 60527

United States

Accurate Clinical Research

Lake Charles, Louisiana 70601

United States

University Of Maryland

Baltimore, Maryland 21201

United States

Henry Ford Health

Detroit, Michigan 48202

United States

Ahmed Arif Medical Research Center

Grand Blanc, Michigan 48439

United States

Paramount Med Rsrch and Consult LLC

Middleburg Heights, Ohio 44130

United States

West Tennessee Research Institute

Jackson, Tennessee 38305

United States

Shelby Research LLC

Memphis, Tennessee 38121

United States

Novel Research LLC

Bellaire, Texas 77401

United States

Accurate Clinical Research

League City, Texas 77573

United States

Epic Medical Research

Red Oak, Texas 75154

United States

Novartis Investigative Site

La Plata, Buenos Aires B1900AWT

Argentina

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Quilmes, Buenos Aires 1878

Argentina

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San Miguel, Buenos Aires B1663GKT

Argentina

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San Miguel, Tucumán Province T4000CBC

Argentina

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Caba, C1015ABO

Argentina

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Caba, C1427CCL

Argentina

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San Miguel de Tucumán, T4000AXL

Argentina

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Maroochydore, Queensland 4558

Australia

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Salvador, Estado de Bahia 40150 150

Brazil

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Belo Horizonte, Minas Gerais 30150-221

Brazil

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Niterói, Rio de Janeiro 24020 096

Brazil

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Rio de Janeiro, Rio de Janeiro 22211-230

Brazil

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Barretos, São Paulo 14784 400

Brazil

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São Paulo, São Paulo 01244-030

Brazil

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São Paulo, São Paulo 04038-002

Brazil

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Salvador, 40323-010

Brazil

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Plovdiv, 4002

Bulgaria

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Sofia, 1431

Bulgaria

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Vancouver, British Columbia V5Z 1L7

Canada

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Rimouski, Quebec G5L 5T1

Canada

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Valdivia, Los Ríos Region 5110683

Chile

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Santiago, RM 7500588

Chile

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Santiago, Santiago Metropolitan 7500710

Chile

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Guangzhou, Guangdong 510080

China

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Shantou, Guangdong 515000

China

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Nanjing, Jiangsu 210008

China

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Suzhou, Jiangsu 215004

China

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Nanchang, Jiangxi 330006

China

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Pingxiang, Jiangxi 337000

China

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Changchun, Jilin 130021

China

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Linyi, Shandong 276000

China

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Chengdu, Sichuan 610041

China

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Ürümqi, Xinjiang 830001

China

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Ningbo, Zhejiang 315016

China

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Beijing, 100069

China

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Beijing, 100730

China

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Shanghai, 200127

China

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Xinxiang, 453099

China

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Medellín, Antioquia 050001

Colombia

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Barranquilla, Atlántico 080020

Colombia

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Chía, Cundinamarca 250001

Colombia

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Bucaramanga, Santander Department 680003

Colombia

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Cali, Valle del Cauca Department 760046

Colombia

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Bogotá, 111211

Colombia

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Brno, 638 00

Czechia

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Prague, 128 00

Czechia

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Uherské Hradiště, 686 01

Czechia

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Montpellier, 34295

France

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Paris, 75013

France

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Paris, 75014

France

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Toulouse, 31054

France

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Toulouse, 31059

France

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Cologne, North Rhine-Westphalia 50937

Germany

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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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Gyula, 5700

Hungary

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Zalaegerszeg, 8900

Hungary

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Ahmedabad, Gujarat 380006

India

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Ahmedabad, Gujarat 380015

India

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Kozhikode, Kerala 673008

India

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Kolhāpur, Maharashtra 416001

India

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Nagpur, Maharashtra 441108

India

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Nashik, Maharashtra 422101

India

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Pune, Maharashtra 411001

India

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New Delhi, 110029

India

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New Delhi, 110075

India

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Haifa, 3109601

Israel

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Ramat Gan, 5265601

Israel

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Pisa, PI 56126

Italy

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Torino, TO 10128

Italy

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Nagoya, Aichi-ken 4578510

Japan

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Nagoya, Aichi-ken 4578511

Japan

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Sapporo, Hokkaido 060-8648

Japan

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Yokohama, Kanagawa 236-0004

Japan

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Bunkyo-ku, Tokyo 1138519

Japan

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Chuo Ku, Tokyo 104-8560

Japan

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Fuchū, Tokyo 1838524

Japan

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Shinjuku-ku, Tokyo 1608582

Japan

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Ipoh, Perak 30450

Malaysia

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León, Guanajuato 37160

Mexico

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Guadalajara, Jalisco 44160

Mexico

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Mexico City, Mexico City 06700

Mexico

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Morelia, Michoacán 58000

Mexico

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Mérida, Yucatán 97070

Mexico

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México, 07760

Mexico

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Wroclaw, Lower Silesian Voivodeship 52-210

Poland

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Bydgoszcz, 85-065

Poland

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Bydgoszcz, 85-168

Poland

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Bytom, 41 902

Poland

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Warsaw, 00-874

Poland

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Warsaw, 04-141

Poland

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Braga, 4710243

Portugal

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Lisbon, 1050-034

Portugal

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Cluj-Napoca, Cluj 400006

Romania

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Brasov, 500283

Romania

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Bucharest, 011172

Romania

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Košice, 040 01

Slovakia

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Pretoria, Gauteng 0002

South Africa

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Cape Town, Western Cape 7405

South Africa

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Cape Town, Western Cape 7500

South Africa

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Somerset West, Western Cape 7130

South Africa

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Umhlanga, 4320

South Africa

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Gwangju, 61469

South Korea

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Seoul, 04763

South Korea

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Seoul, 06591

South Korea

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Santiago Compostela, A Coruna 15706

Spain

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Badalona, Barcelona 08916

Spain

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Santander, Cantabria 39008

Spain

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Barcelona, Catalonia 08003

Spain

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San Sebastian Reyes, Madrid 28702

Spain

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Barcelona, 08035

Spain

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Madrid, 28034

Spain

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Valencia, 46014

Spain

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Kaohsiung City, 83301

Taiwan

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Taichung, 40447

Taiwan

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Taichung, 407219

Taiwan

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Taipei, 11217

Taiwan

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Taoyuan, 33305

Taiwan

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Bangkok, 10400

Thailand

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Bangkok, 10700

Thailand