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Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN).

NCT05126277•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

Detailed Description

This trial will evaluate the efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or ianalumab given every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous). using the 2003 International Society for Nephrology (ISN)/Renal Pathology Society (RPS) criteria).

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants eligible for inclusion in this study must meet all of the following criteria:
•Adult male and female participants aged 18 years or older at the time of screening
•Weigh at least 35 kg at screening
•Have a confirmed clinical diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus (SLE) classification criteria
•Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result
•Active LN at screening, as defined by meeting the 3 following criteria:

Exclusion Criteria

•UPCR ≥ 1.0 g/g on 24h urine collection at Screening
•eGFR ≥ 25mL/min/1.73 m2. Participants with eGFR \< 30 mL/min/1.73 m2 require renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli
•Newly diagnosed participants as well as pre-treated LN participants (including refractory cases) can be included, as long as they are currently on, or willing to initiate SoC induction therapy for LN using MPA
•* Induction therapy, as defined by treatment including both high dose corticosteroids and MPA, should be initiated prior to or on day of randomization
•* Anti-malarial treatment at stable dosing prior to randomization is strongly recommended, in the absence of contraindications
•* Participants on azathioprine treatment at Screening must be switched to MPA prior to randomization
•Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day up to 3000 mg cumulative dose) or equivalent for treatment of current episode of active LN within 60 days prior randomization. Participant who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/day (max 80mg/day) oral predniso(lo)ne.
•Able to communicate well with the Investigator to understand and comply with the requirements of the study
•Severe renal impairment as defined by i.) presence of oliguria (defined as a documented urine volume \<400 mL/24 hrs) or ii.) End-Stage Renal Disease (ESRD) requiring dialysis or transplantation
•Sclerosis in \> 50% of glomeruli on renal biopsy
+26 more criteria

Locations (188)

University Of Alabama

Birmingham, Alabama, United States

Advanced Medical Research

La Palma, California, United States

Wallace Rheumatic Study Center

Los Angeles, California, United States

University of California LA

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

School Of Medicine

Sacramento, California, United States

University of California San Diego

San Diego, California, United States

Kaiser Permanente

San Diego, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

University Of Miami

Miami, Florida, United States

Key Dates

Start Date

July 14, 2022

Primary Completion Date

June 22, 2027

Completion Date

February 11, 2031

Last Updated

March 18, 2026

Enrollment

462

ESTIMATED participants

Conditions

Lupus Nephritis

Interventions

ianalumab s.c. q4w

DRUG

ianalumab s.c. q12w

DRUG

placebo s.c.

DRUG

Contacts

Novartis Pharmaceuticals

CONTACT

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

Novartis Pharmaceuticals

CONTACT

+41613241111

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Inclusion Criteria

Exclusion Criteria

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