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Systemic Lupus ErythematosusPhase 3SIRIUS-SLE 2NCT05624749

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

A Phase 3 study testing ianalumab in people with Systemic Lupus Erythematosus, run by Novartis Pharmaceuticals at 90 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 12 to 100 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
ianalumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
288 participants
Where
90 sitesin 15 countries
Study dates
21 Apr 2023to 9 Apr 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

90 sites in 15 countries.

90 sites in 15 countries

United States15 sites

  • Pinnacle Research Group LLC

    Anniston, Alabama, 36207-5710

  • Emory University

    Atlanta, Georgia, 30307

  • University Of Maryland

    Baltimore, Maryland, 21201

  • Novel Research LLC

    Bellaire, Texas, 77401

  • Ahmed Arif Medical Research Center

    Grand Blanc, Michigan, 48439

  • Homestead Assoc In Research Inc

    Homestead, Florida, 33033

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Advanced Medical Research

    La Palma, California, 90623

  • Accurate Clinical Research

    Lake Charles, Louisiana, 70601

  • Bluegrass Community Research Inc

    Lexington, Kentucky, 40504

  • University of California LA

    Los Angeles, California, 90095

  • UMC New Orleans

    New Orleans, Louisiana, 70112

  • IRIS Research and Development

    Plantation, Florida, 33324

  • Washington Univ School Of Medicine

    St Louis, Missouri, 63110

  • Willow Rheumatology Wellness

    Willowbrook, Illinois, 60527

Other trials in United States

India12 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380006

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380015

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001

  • Novartis Investigative Site

    Kolhāpur, Maharashtra, 416001

  • Novartis Investigative Site

    Kozhikode, Kerala, 673008

  • Novartis Investigative Site

    Nagpur, Maharashtra, 441108

  • Novartis Investigative Site

    Nashik, Maharashtra, 422101

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060

  • Novartis Investigative Site

    New Delhi, New Delhi, 110029

  • Novartis Investigative Site

    New Delhi, 110075

  • Novartis Investigative Site

    Pune, Maharashtra, 411001

  • Novartis Investigative Site

    Pune, Maharashtra, 411007

Other trials in India

Argentina7 sites

  • Novartis Investigative Site

    Caba, C1015ABO

  • Novartis Investigative Site

    Caba, C1427CCL

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1900AWT

  • Novartis Investigative Site

    Quilmes, Buenos Aires, 1878

  • Novartis Investigative Site

    San Miguel, Buenos Aires, B1663GKT

  • Novartis Investigative Site

    San Miguel, Tucumán Province, T4000CBC

  • Novartis Investigative Site

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Colombia7 sites

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020

  • Novartis Investigative Site

    Bogotá, 111211

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 680003

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760046

  • Novartis Investigative Site

    Chía, Cundinamarca, 250001

  • Novartis Investigative Site

    Medellín, Antioquia, 050001

Other trials in Colombia

France7 sites

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Paris, 75013

  • Novartis Investigative Site

    Paris, 75014

  • Novartis Investigative Site

    Paris, 75018

  • Novartis Investigative Site

    Toulouse, 31054

  • Novartis Investigative Site

    Toulouse, 31059

  • Novartis Investigative Site

    Tours, 37044

Other trials in France

Mexico7 sites

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44160

  • Novartis Investigative Site

    León, Guanajuato, 37160

  • Novartis Investigative Site

    Mérida, Yucatán, 97000

  • Novartis Investigative Site

    Mérida, Yucatán, 97070

  • Novartis Investigative Site

    México, 07760

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700

  • Novartis Investigative Site

    Morelia, Michoacán, 58000

Other trials in Mexico

Italy6 sites

  • Novartis Investigative Site

    Ancona, AN, 60020

  • Novartis Investigative Site

    Cona, FE, 44124

  • Novartis Investigative Site

    Padova, PD, 35128

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Roma, RM, 00152

  • Novartis Investigative Site

    Torino, TO, 10128

Other trials in Italy

Taiwan6 sites

  • Novartis Investigative Site

    Kaohsiung City, 833

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Taichung, 407219

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taipei, 11217

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Germany5 sites

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

  • Novartis Investigative Site

    Mainz, 55131

Other trials in Germany

Chile4 sites

  • Novartis Investigative Site

    Concepción, Biobio, 4070280

  • Novartis Investigative Site

    Santiago, RM, 7500588

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500710

  • Novartis Investigative Site

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

Malaysia4 sites

  • Novartis Investigative Site

    Ipoh, Perak, 30450

  • Novartis Investigative Site

    Kuala Lumpur, 59100

  • Novartis Investigative Site

    Selangor Darul Ehsan, 68100

  • Novartis Investigative Site

    Seremban, Negeri Sembilan, 70300

Other trials in Malaysia

Romania3 sites

  • Novartis Investigative Site

    Brasov, 500283

  • Novartis Investigative Site

    Bucharest, 011172

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400006

Other trials in Romania

South Korea3 sites

  • Novartis Investigative Site

    Gwangju Gwangyeoksi, Gwangju, 61748

  • Novartis Investigative Site

    Seoul, 04763

  • Novartis Investigative Site

    Seoul, 06591

Other trials in South Korea

Australia2 sites

  • Novartis Investigative Site

    Maroochydore, Queensland, 4558

  • Novartis Investigative Site

    St Leonards, 2065

Other trials in Australia

United Kingdom2 sites

  • Novartis Investigative Site

    Doncaster, DN2 5LT

  • Novartis Investigative Site

    Leeds, West Yorkshire, LS7 4SA

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

Read the detailed description

A randomized, double-blind, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 2)

Being tested
ianalumab, placebo
Keywords
Systemic Lupus Erythematosus, SLE, B cell depletion, SLEDAI-2K, BILAG-2004, SRI, ANA
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ianalumabDrug

    Also called VAY736

    ianalumab s.c. monthly

  • placeboDrug

    placebo s.c. monthly

Study groups in NCT05624749
Study groupRoleWhat they receive
ianalumab s.c. monthlyExperimentalianalumab s.c. monthly
Receives: Drug: ianalumab
placebo s.c. monthlyPlacebo comparatorplacebo s.c. monthly
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)

    SRI-4 response is defined as:

    • Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points
    • No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline
    • No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale

    Measured: Week 60

Secondary outcomes (11)

  1. Proportion of participants with no moderate or severe BILAG flare

    Moderate BILAG flare is defined as 2 or more new BILAG-2004 B items compared to the previous visit; severe BILAG flare is defined as 1 or more new BILAG-2004 A items compared to the previous visit

    Measured: Baseline to Week 60

  2. Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid (CS) dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower

    Maintaining reduced CS dose from Week 36 to Week 60

    Measured: Week 36 to Week 60

  3. Proportion of participants achieving BILAG-based Composite Lupus Assessment (BICLA)

    BICLA response is defined as:

    • Reduction of all baseline BILAG-2004 A to B/C/D and baseline B to C/D and no worsening in other organ systems defined as ≥ 1 new A or ≥ 2 new B items compared to baseline
    • No worsening from baseline in SLEDAI-2K defined as an increase from baseline of > 0 points
    • No worsening in PhGA defined as an increase of ≥ 0.3 from baseline on a 0 to 3 PhGA visual analog scale

    Measured: Week 60

  4. Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)

    LLDAS response is defined as:

    • SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) (Golder et al 2019)
    • No new lupus disease activity compared with the previous assessment, defined as any new SLEDAI-2K component that was not present at the previous assessment
    • PhGA (scale 0-3) ≤ 1
    • Current predniso(lo)ne (or equivalent) dose ≤ 7.5 mg daily
    • Well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents

    Measured: Week 60

  5. Time to first occurrence of SRI-4

    Time to first occurrence of SRI-4 from baseline to Week 60

    Measured: Baseline to Week 60

  6. Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced CS dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower

    Achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced CS dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower

    Measured: Week 36 to Week 60

  7. Proportion of participants achieving SRI-6

    SRI-6 response is defined as:

    • SLEDAI-2K reduction from baseline of ≥ 6 points
    • No BILAG-2004 worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline
    • No worsening in PhGA, defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale

    Measured: Week 60

  8. Proportion of participants achieving SF-36 Bodily Pain response

    Achieving Short Form 36 (SF-36) Bodily Pain response

    Measured: Week 60

  9. Proportion of participants with Adverse Events (AEs)

    To evaluate safety and tolerability of ianalumab s.c. monthly

    Measured: Baseline to Week 60

  10. Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time

    To evaluate immunogenicity of ianalumab s.c. monthly

    Measured: Baseline to Week 164

  11. Ianalumab concentration in serum during the treatment and follow-up

    Concentration of Ianalumab in serum

    Measured: Baseline to Week 164

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2022
  2. Study start21 Apr 2023
  3. Primary completion12 Apr 2027 (estimated)
  4. Study completion9 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05624749
Sponsor's protocol ID
CVAY736F12302
Other IDs
2022-002690-29, 2023-508499-12-00, 2023
Acronym
SIRIUS-SLE 2
Status last verified
Oct 2026
First submitted
7 Nov 2022
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ianalumab in people with Systemic Lupus Erythematosus, run by Novartis Pharmaceuticals at 90 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, India, Argentina, Colombia, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) (time frame: Week 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05624749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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