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New lupus drug shows promise in major trial

NCT ID NCT05624749

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This phase 3 study tests whether adding a monthly injection of ianalumab to standard lupus treatments helps control active disease better than placebo. About 288 people aged 12 and older with systemic lupus erythematosus (SLE) are taking part. The main goal is to see if ianalumab reduces lupus activity without causing serious flares. This is not a cure, but aims to improve disease control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

288 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

  • Accurate Clinical Research

    Lake Charles, Louisiana, 70601, United States

  • Advanced Medical Research

    La Palma, California, 90623, United States

  • Ahmed Arif Medical Research Center

    Grand Blanc, Michigan, 48439, United States

  • Bluegrass Community Research Inc

    Lexington, Kentucky, 40504, United States

  • Emory University

    Atlanta, Georgia, 30307, United States

  • Homestead Assoc In Research Inc

    Homestead, Florida, 33033, United States

  • IRIS Research and Development

    Plantation, Florida, 33324, United States

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1900AWT, Argentina

  • Novartis Investigative Site

    Quilmes, Buenos Aires, 1878, Argentina

  • Novartis Investigative Site

    San Miguel, Buenos Aires, B1663GKT, Argentina

  • Novartis Investigative Site

    San Miguel, Tucumán Province, T4000CBC, Argentina

  • Novartis Investigative Site

    Caba, C1015ABO, Argentina

  • Novartis Investigative Site

    Caba, C1427CCL, Argentina

  • Novartis Investigative Site

    San Miguel de Tucumán, T4000AXL, Argentina

  • Novartis Investigative Site

    Maroochydore, Queensland, 4558, Australia

  • Novartis Investigative Site

    St Leonards, 2065, Australia

  • Novartis Investigative Site

    Concepción, Biobio, 4070280, Chile

  • Novartis Investigative Site

    Valdivia, Los Ríos Region, 5110683, Chile

  • Novartis Investigative Site

    Santiago, RM, 7500588, Chile

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500710, Chile

  • Novartis Investigative Site

    Medellín, Antioquia, 050001, Colombia

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002, Colombia

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020, Colombia

  • Novartis Investigative Site

    Chía, Cundinamarca, 250001, Colombia

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 680003, Colombia

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760046, Colombia

  • Novartis Investigative Site

    Bogotá, 111211, Colombia

  • Novartis Investigative Site

    Montpellier, 34295, France

  • Novartis Investigative Site

    Paris, 75013, France

  • Novartis Investigative Site

    Paris, 75014, France

  • Novartis Investigative Site

    Paris, 75018, France

  • Novartis Investigative Site

    Toulouse, 31054, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Tours, 37044, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Herne, 44649, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380006, India

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380015, India

  • Novartis Investigative Site

    Kozhikode, Kerala, 673008, India

  • Novartis Investigative Site

    Kolhāpur, Maharashtra, 416001, India

  • Novartis Investigative Site

    Nagpur, Maharashtra, 441108, India

  • Novartis Investigative Site

    Nashik, Maharashtra, 422101, India

  • Novartis Investigative Site

    Pune, Maharashtra, 411001, India

  • Novartis Investigative Site

    Pune, Maharashtra, 411007, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060, India

  • Novartis Investigative Site

    New Delhi, New Delhi, 110029, India

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001, India

  • Novartis Investigative Site

    New Delhi, 110075, India

  • Novartis Investigative Site

    Ancona, AN, 60020, Italy

  • Novartis Investigative Site

    Cona, FE, 44124, Italy

  • Novartis Investigative Site

    Padova, PD, 35128, Italy

  • Novartis Investigative Site

    Pisa, PI, 56126, Italy

  • Novartis Investigative Site

    Roma, RM, 00152, Italy

  • Novartis Investigative Site

    Torino, TO, 10128, Italy

  • Novartis Investigative Site

    Seremban, Negeri Sembilan, 70300, Malaysia

  • Novartis Investigative Site

    Ipoh, Perak, 30450, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Selangor Darul Ehsan, 68100, Malaysia

  • Novartis Investigative Site

    León, Guanajuato, 37160, Mexico

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44160, Mexico

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700, Mexico

  • Novartis Investigative Site

    Morelia, Michoacán, 58000, Mexico

  • Novartis Investigative Site

    Mérida, Yucatán, 97000, Mexico

  • Novartis Investigative Site

    Mérida, Yucatán, 97070, Mexico

  • Novartis Investigative Site

    México, 07760, Mexico

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400006, Romania

  • Novartis Investigative Site

    Brasov, 500283, Romania

  • Novartis Investigative Site

    Bucharest, 011172, Romania

  • Novartis Investigative Site

    Gwangju Gwangyeoksi, Gwangju, 61748, South Korea

  • Novartis Investigative Site

    Seoul, 04763, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Kaohsiung City, 833, Taiwan

  • Novartis Investigative Site

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    Taichung, 407219, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    Leeds, West Yorkshire, LS7 4SA, United Kingdom

  • Novartis Investigative Site

    Doncaster, DN2 5LT, United Kingdom

  • Novel Research LLC

    Bellaire, Texas, 77401, United States

  • Pinnacle Research Group LLC

    Anniston, Alabama, 36207-5710, United States

  • UMC New Orleans

    New Orleans, Louisiana, 70112, United States

  • University Of Maryland

    Baltimore, Maryland, 21201, United States

  • University of California LA

    Los Angeles, California, 90095, United States

  • Washington Univ School Of Medicine

    St Louis, Missouri, 63110, United States

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305, United States

  • Willow Rheumatology Wellness

    Willowbrook, Illinois, 60527, United States

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