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

Last updated: January 23, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Musculoskeletal Diseases

Lupus

Cutaneous Lupus Erythematosus

Treatment

Placebo

Ianalumab

Clinical Study ID

NCT06133972
CVAY736F12301E1
2023-505929-14-00
2023-505929-14
  • Ages 12-100
  • All Genders

Study 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).

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

Total Participants: 550
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 21, 2024
Estimated Completion Date:
April 16, 2032

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires C1015ABO
    Argentina

    Site Not Available

  • Novartis Investigative Site

    San Miguel, Buenos Aires 1663
    Argentina

    Site Not Available

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    San Miguel 7645166, Buenos Aires 3435907 B1663GKT
    Argentina

    Active - Recruiting

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    San Miguel de Tucuman, Tucuman T4000CBC
    Argentina

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    San Miguel 3836920, Tucumán Province 3833578 T4000CBC
    Argentina

    Active - Recruiting

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    Buenos Aires 3435910, C1015ABO
    Argentina

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    Caba, C1015ABO
    Argentina

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    San Miguel de Tucumán 3836873, 4000
    Argentina

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    Tucuman, 4000
    Argentina

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  • Novartis Investigative Site

    Maroochydore, Queensland 4558
    Australia

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    Maroochydore 2207268, Queensland 2152274 4558
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Salvador, BA 40150 150
    Brazil

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    Salvador 3450554, Estado de Bahia 3471168 40150 150
    Brazil

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    Belo Horizonte, MG 30150-221
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    Belo Horizonte 3470127, Minas Gerais 3457153 30150-221
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    Rio de Janeiro 3451190, Rio de Janeiro 3451189 22211-230
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    Sao Paulo, SP 01244-030
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    Barretos, Sao Paulo 14784 400
    Brazil

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    Barretos 3470451, São Paulo 3448433 14784 400
    Brazil

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    São Paulo 3448439, São Paulo 3448433 04038-002
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    Bulgaria

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    Chile

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    Chile

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    China

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    Nanjing, Jiangsu 210008
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    Suzhou, Jiangsu 215004
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    Suzhou 1886760, Jiangsu 1806260 215004
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    Nanchang, Jiangxi 330006
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    Pingxiang, Jiangxi 337000
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    Nanchang 1800163, Jiangxi 1806222 330006
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    Pingxiang 1798654, Jiangxi 1806222 337000
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    Chang Chun, Jilin 130021
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    Linyi, Shandong 276000
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    Zhejiang, 315016
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    Medellin, Antioquia 050001
    Colombia

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    Medellín 3674962, Antioquia 3689815 050001
    Colombia

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    Barranquilla 3689147, Atlántico 3689436 080020
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    Nagoya 1856057, Aichi-ken 1865694 457 8510
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    Ipoh 1734634, Perak 1733041 30450
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    Leon, Guanajuato 37160
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    Guadalajara, Jalisco 44160
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    Mexico City 3530597, Mexico City 3527646 06700
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    Morelia 3995402, Michoacán 3995955 58000
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    Mérida 3523349, Yucatán 3514211 97070
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    Mexico, 07760
    Mexico

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    México 10248874, 07760
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  • Novartis Investigative Site

    Wroclaw, Dolnoslaskie 52-210
    Poland

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    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 52-210
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    Bydgoszcz, 85 168
    Poland

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    Bydgoszcz 3102014, 85-168
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    Bytom, 41 902
    Poland

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    Bytom 3101950, 41 902
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    Warsaw 756135, 04-141
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    Warszawa, 00-874
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    Braga, 4710243
    Portugal

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    Braga 2742032, 4710243
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    Cluj-Napoca 681290, Cluj 681291 400006
    Romania

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    Brasov, 500283
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    Brasov 683844, 500283
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    Bucharest 683506, 011172
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    Cape Town 3369157, Western Cape 1085599 7500
    South Africa

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    Gwangju Gwangyeoksi, Gwangju 1841808 61748
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    Seoul 1835848, 04763
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    Santiago Compostela, A Coruna 15706
    Spain

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    Badalona 3129028, Barcelona 08916
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    Santander, Cantabria 39008
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    Santander 3109718, Cantabria 3336898 39008
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    Barcelona 3128760, Catalonia 3336901 08003
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    Barcelona, Catalunya 08003
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    Bangkok, 10400
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  • Pinnacle Research Group Llc

    Anniston, Alabama 36207
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  • Pinnacle Research Group Llc .

    Anniston, Alabama 36207
    United States

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  • Pinnacle Research Group Llc

    Anniston 4830198, Alabama 4829764 36207
    United States

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  • Advanced Medical Research

    La Palma, California 90623
    United States

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  • Millennium Clinical Trials

    Westlake Village, California 91361
    United States

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  • Providence Medical Center

    Burbank 5331835, California 5332921 91505
    United States

    Active - Recruiting

  • Advanced Medical Research

    La Palma 5364022, California 5332921 90623
    United States

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    United States

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  • University of Colorado Denver

    Aurora 5412347, Colorado 5417618 80045
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    Clearwater, Florida 33765
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    Clearwater, Florida 33765
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  • Clinical Res Of W Florida

    Clearwater 4151316, Florida 4155751 33765
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  • IRIS Research and Development

    Plantation 4168782, Florida 4155751 33324
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    Skokie 4911600, Illinois 4896861 60076
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    Lake Charles, Louisiana 70601
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  • University Of Maryland Med Ctr

    Baltimore, Maryland 21201
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  • University Of Maryland Med Ctr

    Baltimore 4347778, Maryland 4361885 21201
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  • Ahmed Arif Medical Research Center

    Grand Blanc, Michigan 48439
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  • Henry Ford Health

    Detroit 4990729, Michigan 5001836 48202
    United States

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  • Ahmed Arif Medical Research Center

    Grand Blanc 4994320, Michigan 5001836 48439
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    Jackson, Tennessee 38305
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    Memphis, Tennessee 38119
    United States

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  • West Tennessee Research Institute

    Jackson 4632595, Tennessee 4662168 38305
    United States

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  • Shelby Research LLC

    Memphis 4641239, Tennessee 4662168 38119
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    Bellaire, Texas 77401
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  • Accurate Clinical Research

    League City 4705692, Texas 4736286 77573
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