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New lupus drug shows promise in major trial

NCT ID NCT05639114

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug called ianalumab for people with active systemic lupus erythematosus (SLE), a chronic autoimmune disease. About 436 participants receive either ianalumab or a placebo as a shot under the skin, once a month or once every three months, along with their usual treatments. The goal is to see if ianalumab can better control lupus activity and reduce flares compared to placebo.

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

436 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Mar 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

    League City, Texas, 77573, United States

  • Accurate Clinical Research Research

    Baytown, Texas, 77521, United States

  • Chicago Clinical Research Inst

    Chicago, Illinois, 60607, United States

  • Clinical Res Of W Florida

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida Inc

    Tampa, Florida, 33603, United States

  • Epic Medical Research

    Red Oak, Texas, 75154, United States

  • GNP Research

    Cooper City, Florida, 33024, United States

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Lake Cumberland Rheumatology and In

    New Albany, Indiana, 47150, United States

  • Millennium Clinical Trials

    Westlake Village, California, 91361, United States

  • Novartis Investigative Site

    San Miguel, Tucumán Province, T4000CBC, Argentina

  • Novartis Investigative Site

    San Miguel de Tucumán, T4000AXL, Argentina

  • Novartis Investigative Site

    Fortaleza, Ceará, 60125-025, Brazil

  • Novartis Investigative Site

    Vitória, Espírito Santo, 29055-450, Brazil

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40444-130, Brazil

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Novartis Investigative Site

    Curitiba, Paraná, 80030-110, Brazil

  • Novartis Investigative Site

    Recife, Pernambuco, 50740-900, Brazil

  • Novartis Investigative Site

    Niterói, Rio de Janeiro, 24020-096, Brazil

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 22211-230, Brazil

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01244-030, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04038-002, Brazil

  • Novartis Investigative Site

    Salvador, 40323-010, Brazil

  • Novartis Investigative Site

    Plovdiv, Bulgaria, 4002, Bulgaria

  • Novartis Investigative Site

    Rousse, 7002, Bulgaria

  • Novartis Investigative Site

    Sofia, 1680, Bulgaria

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4Z6, Canada

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1L7, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5T 2S8, Canada

  • Novartis Investigative Site

    Rimouski, Quebec, G5L 5T1, Canada

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    Shantou, Guangdong, 515000, China

  • Novartis Investigative Site

    Haikou, Hainan, 570311, China

  • Novartis Investigative Site

    Zhuzhou, Hunan, 412000, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210008, China

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004, China

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    Pingxiang, Jiangxi, 337000, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Linyi, Shandong, 276000, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001, China

  • Novartis Investigative Site

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000, China

  • Novartis Investigative Site

    Beijing, 100069, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Shanghai, 200127, China

  • Novartis Investigative Site

    Xinxiang, 453099, China

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020, Colombia

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 680003, Colombia

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760046, Colombia

  • Novartis Investigative Site

    Brno, 638 00, Czechia

  • Novartis Investigative Site

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    Uherské Hradiště, 686 01, Czechia

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01010, Guatemala

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01011, Guatemala

  • Novartis Investigative Site

    Guatemala City, 01010, Guatemala

  • Novartis Investigative Site

    Székesfehérvár, Fejér, 8000, Hungary

  • Novartis Investigative Site

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    Budapest, 1134, Hungary

  • Novartis Investigative Site

    Gyula, 5700, Hungary

  • Novartis Investigative Site

    Zalaegerszeg, 8900, Hungary

  • Novartis Investigative Site

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578510, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578511, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 222-0036, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236-0004, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 9838512, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113-8655, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-8560, Japan

  • Novartis Investigative Site

    Fuchū, Tokyo, 1838524, Japan

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 1738610, Japan

  • Novartis Investigative Site

    Meguro City, Tokyo, 153-8515, Japan

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 1608582, Japan

  • Novartis Investigative Site

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    Miyazaki, 889-1692, Japan

  • Novartis Investigative Site

    Osaka, 5458586, Japan

  • Novartis Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

  • Novartis Investigative Site

    Bydgoszcz, 85-065, Poland

  • Novartis Investigative Site

    Bydgoszcz, 85-168, Poland

  • Novartis Investigative Site

    Bytom, 41 902, Poland

  • Novartis Investigative Site

    Lodz, 90-338, Poland

  • Novartis Investigative Site

    Warsaw, 00-874, Poland

  • Novartis Investigative Site

    Warsaw, 04-141, Poland

  • Novartis Investigative Site

    Braga, 4710243, Portugal

  • Novartis Investigative Site

    Lisbon, 1050-034, Portugal

  • Novartis Investigative Site

    Lisbon, 1349-019, Portugal

  • Novartis Investigative Site

    Lisbon, 1649-035, Portugal

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434-502, Portugal

  • Novartis Investigative Site

    Bratislava, 811 08, Slovakia

  • Novartis Investigative Site

    Košice, 040 01, Slovakia

  • Novartis Investigative Site

    Košice, 040 11, Slovakia

  • Novartis Investigative Site

    Pretoria, Gauteng, 0002, South Africa

  • Novartis Investigative Site

    Cape Town, Western Cape, 7405, South Africa

  • Novartis Investigative Site

    Cape Town, Western Cape, 7500, South Africa

  • Novartis Investigative Site

    Somerset West, Western Cape, 7130, South Africa

  • Novartis Investigative Site

    Umhlanga, 4320, South Africa

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    Elche, Alicante, 03203, Spain

  • Novartis Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    San Sebastian Reyes, Madrid, 28702, Spain

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Vigo, Pontevedra, 36214, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Valencia, 46014, Spain

  • Novartis Investigative Site

    Valladolid, 47012, Spain

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110, Thailand

  • Novartis Investigative Site

    Muang, Thailand, 12120, Thailand

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Ankara, Bilkent Cankaya, 06800, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Etlik, 06010, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Umraniye, 34766, Turkey (Türkiye)

  • Novel Research LLC

    Bellaire, Texas, 77401, United States

  • Paramount Med Rsrch and Consult LLC

    Middleburg Heights, Ohio, 44130, United States

  • Parris and Associates Rheumatology

    Lawrenceville, Georgia, 30044, United States

  • Pinnacle Research Group Llc

    Anniston, Alabama, 36207, United States

  • Providence Medical Center

    Burbank, California, 91505, United States

  • Robert A Hozman MD SC

    Skokie, Illinois, 60076, United States

  • Sahni Rheumatology and Therapy

    West Long Branch, New Jersey, 07764, United States

  • Shelby Research LLC

    Memphis, Tennessee, 38119, United States

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of California San Diego

    La Jolla, California, 92093, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.