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Evaluating Ianalumab for Systemic Lupus Erythematosus Treatment

A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

Phase 3 Interventional Novartis · NCT05639114

This study is testing if a new treatment called ianalumab can help people with active systemic lupus erythematosus feel better while they are already on standard therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment406 (estimated)
Ages12 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsianalumab, belimumab, cyclophosphamide
Locations174 sites (Burbank, California and 173 other locations)
Trial IDNCT05639114 on ClinicalTrials.gov

What this trial studies

This phase 3 trial assesses the efficacy, safety, and tolerability of two regimens of ianalumab, administered as monthly or quarterly subcutaneous injections, in patients with active systemic lupus erythematosus (SLE) who are already receiving standard-of-care therapy. The study is designed as a randomized, double-blind, parallel group, placebo-controlled trial, meaning participants will be randomly assigned to receive either the treatment or a placebo without knowing which they are receiving. The goal is to determine if ianalumab can improve disease outcomes compared to placebo in this patient population.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 12 years or older with a confirmed diagnosis of systemic lupus erythematosus and active disease.

Not a fit: Patients with mild SLE or those not currently receiving standard-of-care treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with systemic lupus erythematosus, potentially improving their disease management and quality of life.

How similar studies have performed: Previous studies have shown promise with similar B cell-targeting therapies in systemic lupus erythematosus, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male and female participants aged 12 years or older at the time of screening, or limited to 18 years or older in European Economic Area countries and other countries where inclusion of participants below 18 years is not allowed.
* Diagnosis of systemic lupus erythematosus meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria at least 6 months prior to screening.
* Elevated serum titers at screening of anti-nuclear antibodies ≥ 1:80 as determined by a central laboratory with a SLE-typical fluorescence pattern.
* Currently receiving CS and/or anti-malarial treatment and/or another disease-modifying antirheumatic drug (DMARD) as specified in the protocol.
* SLEDAI-2K criteria at screening: SLEDAI-2K score ≥ 6 points, excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome"
* BILAG-2004 disease activity level at screening of at least 1 of the following:

  * BILAG-2004 level 'A' disease in ≥ 1 organ system, Or
  * BILAG-2004 level 'B' disease in ≥ 2 organ systems
* Weigh at least 35 kg at screening

Exclusion Criteria:

* Prior treatment with ianalumab
* History of receiving following treatment: I) high dose CS, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) administered within 12 weeks prior to screening. II) cyclophosphamide or biologics such as immunoglobulins (intravenous or s.c.), plasmapheresis, anti-type I interferon receptor biologic agents, anti-CD40 agents, CTLA4-Fc Ig or B-cell activating factor (BAFF)-targeting agents administered within 24 weeks prior to screening; belimumab administered within 12 weeks prior to screening. III) any B cell-depleting therapies, other than ianalumab administered within 36 weeks prior to randomization or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower). IV) Traditional Chinese medicines administered within 30 days prior to randomization.
* Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection
* Chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Evidence of active tuberculosis infection
* History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening
* Any one of the following abnormal laboratory values prior to randomization

  * Platelets \< 25000/mm\^3 (\< 25 x 10\^3/μL)
  * Hemoglobin (Hgb) \< 8.0 g/dL (\< 5 mmol/L), or \< 7.0 g/dL (\< 4.3 mmol/L) if related to participant's SLE such as in active hemolytic anaemia
  * Absolute neutrophil count (ANC) (\< 0.8 x 10\^3/ μL)
* Severe organ dysfunction or life-threatening disease at screening
* Presence of severe lupus kidney disease as defined by proteinuria above 2 g/day or equivalent using spot urine protein creatinine ratio, or serum creatinine greater than 2.0 mg/dL (176.84 µmol/L), or requiring immune-suppressive induction or maintenance treatment at screening
* Receipt of live/attenuated vaccine within a 4-week period before first dosing
* Any uncontrolled, co-existing serious disease, which in the opinion of the investigator will place the participant at risk for participation or interfere with evaluation for SLE-related symptoms
* Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic CS
* History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational drug.
* Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study

Where this trial is running

Burbank, California and 173 other locations

+124 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusSLEB cell depletionSLEDAI-2KBILAG-2004SRIANA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.