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

NCT06711887 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CVAY736K12301E1
• Study Type: interventional
• Target: 315
• Locations: 10 countries
• Sites: 25

Brief Summary

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

1. 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. 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.

Conditions

Lupus Nephritis

Keywords

Lupus Nephritis (LN); B cell depletion; ianalumab; VAY736

Outcome Measures

Primary Outcomes (5)

• For cohort 1: Incidence of renal flare, escalation of immunosuppressive medication, or death

  Cohort 1: To estimate the incidence of renal flare, escalation of immunosuppressive medication, or death following study treatment withdrawal in participants who completed the SIRIUS-LN core study on double-blind treatment and achieved CRR or PRR at Week 140 of the core study

  Between Week 144E1 and Week 248

• Cohort 2: Number of participants with Treatment Emergent Adverse Events (TEAE) as assessed by CTAE v4.0

  Cohort 2: To assess the safety and tolerability of ianalumab for participants 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

  From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study

• Cohort 2: Number of participants with Serious Adverse Events (SAE) as assessed by CTCAE v4.0

  Cohort 2: Incidence of SAEs, from the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study

  From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study

• Cohort 2: Number of participants with clinically significant abnormal vital signs

  Cohort 2: Analysis of the vital sign measurements using summary statistics for the change from baseline for each post-baseline visit will be performed

  From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study

• Cohort 2: Number of participants with clinically significant laboratory evaluations.

  Cohort 2: The summary of laboratory evaluations will be presented for two groups of laboratory tests (hematology and serum chemistry). Descriptive summary statistics for the change from baseline to each study visit will be presented. These descriptive summaries will be presented by test group, laboratory test and treatment group.

  From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study

Secondary Outcomes (6)

• Cohort 1: Number of participants with Treatment Emergent Adverse Events (TEAE) as assessed by CTCAE v4.0

  From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study

• Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay)

  from Week 144E1 up to Week 248

• Cohort 2: Ianalumab concentration in serum using a validated ELISA

  from Week 144E1 up to Week 248

• Cohort 1: Number of participants with Serious Adverse Events (SAE) as assessed by CTAE v4.0

  From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study

• Cohort 1: Number of participants with clinically significant abnormal vital signs

  From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study

Study Arms (2)

Study Treatment Withdrawal (cohort 1)

NO INTERVENTION

(Cohort 1): Study Treatment-Withdrawal group. Participants who received blinded study treatment in the core study and achieve CRR or PRR at Week 140 in the core study will enter the extension study and discontinue study treatment while maintaining standard of care (SoC) medication, as required. If renal flare criteria are met, participants will be eligible to receive open-label ianalumab.

Open-Label Ianalumab (cohort 2)

EXPERIMENTAL

(Cohort 2): Open-Label Ianalumab group: Participants who received blinded study treatment throughout the core study and did not achieve CRR or PRR at Week 140 of the core study, or who had switched to open-label ianalumab during the core study, will be eligible or will continue to receive open-label ianalumab in the extension study.

Drug: Ianalumab

Interventions

Ianalumab DRUG

Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).

Also known as: VAY736

Open-Label Ianalumab (cohort 2)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to participation in the extension study.
• Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.

You may not qualify if:

• Use of prohibited therapies
• Pregnant or nursing (lactating) women.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (25)

Novartis Investigative Site

Salvador, Estado de Bahia, 40150 150, Brazil

RECRUITING

Novartis Investigative Site

Shantou, Guangdong, 515000, China

ACTIVE NOT RECRUITING

Novartis Investigative Site

Liuchow, Guangxi, 545005, China

RECRUITING

Novartis Investigative Site

Wuhan, Hubei, 430060, China

RECRUITING

Novartis Investigative Site

Binzhou, Shandong, 256603, China

RECRUITING

Novartis Investigative Site

Beijing, 100034, China

RECRUITING

Novartis Investigative Site

Guangzhou, 510080, China

RECRUITING

Novartis Investigative Site

Guangzhou, 510280, China

RECRUITING

Novartis Investigative Site

Shanghai, 200080, China

RECRUITING

Novartis Investigative Site

Barranquilla, Atlántico, 080020, Colombia

RECRUITING

Novartis Investigative Site

Budapest, H-1097, Hungary

RECRUITING

Novartis Investigative Site

León, Guanajuato, 37160, Mexico

RECRUITING

Novartis Investigative Site

Oaxaca City, 68020, Mexico

RECRUITING

Novartis Investigative Site

Querétaro, 76070, Mexico

RECRUITING

Novartis Investigative Site

Bucharest, 022328, Romania

RECRUITING

Novartis Investigative Site

Singapore, 169608, Singapore

RECRUITING

Novartis Investigative Site

Singapore, S308433, Singapore

RECRUITING

Novartis Investigative Site

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 03722, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 04763, South Korea

RECRUITING

Novartis Investigative Site

Taichung, 40447, Taiwan

RECRUITING

Novartis Investigative Site

Songkhla, Hat Yai, 90110, Thailand

RECRUITING

Novartis Investigative Site

Bangkok, 10330, Thailand

RECRUITING

Novartis Investigative Site

Bangkok, 10400, Thailand

RECRUITING

Novartis Investigative Site

Chiang Mai, 50200, Thailand

RECRUITING

Related Publications (1)

• Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.

  PMID: 40465397 DERIVED

MeSH Terms

Conditions

Lupus Nephritis

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: December 2, 2024
• Study Start: May 19, 2025
• Primary Completion (Estimated): July 16, 2030
• Study Completion (Estimated): July 16, 2032
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

RO (1); BR (1); HU (1); KR (3); SG (2); ME (3); TH (4); CN (8); CO (1); TW (1)