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: July 28, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Lupus Nephritis

Nephritis

Kidney Disease

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: 316
Treatment Group(s): 1
Primary Treatment: Ianalumab
Phase: 3
Study Start date:
May 19, 2025
Estimated Completion Date:
July 28, 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 In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required.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

    Guang Zhou, 510080
    China

    Active - Recruiting

  • Novartis Investigative Site

    Budapest, H-1097
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Suwon si, Gyeonggi Do 16499
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Seoul, 04763
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Singapore, 169608
    Singapore

    Active - Recruiting

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