Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

Last updated: March 10, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Lupus Nephritis

Kidney Disease

Nephritis

Treatment

Ianalumab

Clinical Study ID

NCT06711887
CVAY736K12301E1
  • Ages 18-100
  • All Genders

Study Summary

The purpose of this 2-year extension study is the evaluation of the efficacy and safety

  1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response [CRR] or partial renal response [PRR]) on double-blind treatment at the end of the SIRIUS-LN core study, and

  2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent prior to participation in the extension study.

  2. Participants must have participated in the SIRIUS-LN core study and must havecompleted the entire treatment up to Week 144 on double-blind or open label studytreatment.

Exclusion

Exclusion Criteria:

  1. Use of prohibited therapies

  2. Pregnant or nursing (lactating) women.

Study Design

Total Participants: 315
Treatment Group(s): 1
Primary Treatment: Ianalumab
Phase: 3
Study Start date:
May 19, 2025
Estimated Completion Date:
July 16, 2032

Study Description

The SIRIUS-LN extension study is a 2-year open-label extension study for participants who have completed the treatment periods (blinded Treatment Period-1 and blinded Treatment Period-2) of the SIRIUS-LN core study on double-blind or open-label study treatment.

Investigators will use their clinical judgment to decide if it is beneficial for participants to continue with the extension study. In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required. These 2 additional years in the extension study will allow to measure sustained remission, flares and safety off-study treatment. However, in the event of renal flares during the extension study, these participants who withdraw study treatment will have the option to receive open-label ianalumab.

Connect with a study center

  • Novartis Investigative Site

    Salvador, Estado de Bahia 40150 150
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Shantou, Guangdong 515000
    China

    Site Not Available

  • Novartis Investigative Site

    Liuchow, Guangxi 545005
    China

    Active - Recruiting

  • Novartis Investigative Site

    Liuchow 1803300, Guangxi 1809867 545005
    China

    Site Not Available

  • Novartis Investigative Site

    Wuhan, Hubei 430060
    China

    Active - Recruiting

  • Novartis Investigative Site

    Wuhan 1791247, Hubei 1806949 430060
    China

    Site Not Available

  • Novartis Investigative Site

    Binzhou, Shandong 256603
    China

    Active - Recruiting

  • Novartis Investigative Site

    Binzhou 1816336, Shandong 1796328 256603
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100034
    China

    Active - Recruiting

  • Novartis Investigative Site

    Beijing 1816670, 100034
    China

    Site Not Available

  • Novartis Investigative Site

    Guang Zhou, 510080
    China

    Site Not Available

  • Novartis Investigative Site

    Guangzhou, 510080
    China

    Active - Recruiting

  • Novartis Investigative Site

    Guangzhou 1809858, 510280
    China

    Site Not Available

  • Novartis Investigative Site

    Shanghai, 200080
    China

    Active - Recruiting

  • Novartis Investigative Site

    Barranquilla, Atlántico 080020
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Barranquilla 3689147, Atlántico 3689436 080020
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Budapest, H-1097
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Budapest 3054643, H-1097
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Suwon si, Gyeonggi Do 16499
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Seoul, 04763
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    León, Guanajuato 37160
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    León 3998655, Guanajuato 4005267 37160
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Oaxaca City, 68020
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Oaxaca City 3522507, 68020
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Querétaro, 76070
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Querétaro 3816887, 76070
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Bucharest, 022328
    Romania

    Active - Recruiting

  • Novartis Investigative Site

    Singapore, S308433
    Singapore

    Active - Recruiting

  • Novartis Investigative Site

    Singapore 1880252, S308433
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Suwon, Gyeonggi-do 16499
    South Korea

    Active - Recruiting

  • Novartis Investigative Site

    Suwon 1835553, Gyeonggi-do 1841610 16499
    South Korea

    Site Not Available

  • Novartis Investigative Site

    Seoul, 04763
    South Korea

    Active - Recruiting

  • Novartis Investigative Site

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Novartis Investigative Site

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Novartis Investigative Site

    Taichung 1668399, 40447
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Songkhla, Hat Yai 90110
    Thailand

    Active - Recruiting

  • Novartis Investigative Site

    Songkhla 1606147, Hat Yai 90110
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Bangkok, 10400
    Thailand

    Active - Recruiting

  • Novartis Investigative Site

    Bangkok 1609350, 10330
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Novartis Investigative Site

    Chiang Mai 1153671, 50200
    Thailand

    Site Not Available

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