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New lupus drug ianalumab tested for Long-Term safety

NCT ID NCT06133972

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study is testing the long-term safety of a drug called ianalumab in people with lupus who have already completed a previous study with the same drug. About 550 participants will receive either ianalumab or a placebo monthly or quarterly for up to several years. The main goal is to see if the drug is safe and tolerable over time, with secondary goals looking at how well it controls lupus symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ianalumab (a biologic drug given as a shot under the skin)
What this could lead to
If successful, this could show that ianalumab is a safe long-term treatment option for people with lupus, helping to control the disease over time.
What could go wrong
This is an extension study focused on safety, not on proving the drug works. It only includes people who already tolerated the drug, so results may not apply to everyone with lupus. Side effects are still possible.

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

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Apr 2032

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.

Key Inclusion Criteria: * Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \<18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit. * Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation. * In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment. Key Exclusion Criteria: * Use of prohibited therapies. * Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation. * Plans for administration of live vaccines during the study period. * Pregnant or nursing (lactating) women. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications). * United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment. Other protocol-defined inclusion/exclusion criteria may apply.

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Get notified about 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    113 sites in 29 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accurate Clinical Research

    RECRUITING

    Lake Charles, Louisiana, 70601, United States

  • Accurate Clinical Research

    RECRUITING

    League City, Texas, 77573, United States

  • Advanced Medical Research

    RECRUITING

    La Palma, California, 90623, United States

  • Ahmed Arif Medical Research Center

    RECRUITING

    Grand Blanc, Michigan, 48439, United States

  • Clinical Res Of W Florida

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida Inc

    RECRUITING

    Tampa, Florida, 33603, United States

  • Epic Medical Research

    RECRUITING

    Red Oak, Texas, 75154, United States

  • GNP Research

    RECRUITING

    Cooper City, Florida, 33024, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • IRIS Research and Development

    RECRUITING

    Plantation, Florida, 33324, United States

  • Millennium Clinical Trials

    ACTIVE_NOT_RECRUITING

    Westlake Village, California, 91361, United States

  • Novartis Investigative Site

    RECRUITING

    La Plata, Buenos Aires, B1900AWT, Argentina

  • Novartis Investigative Site

    RECRUITING

    Quilmes, Buenos Aires, 1878, Argentina

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    San Miguel, Buenos Aires, B1663GKT, Argentina

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    San Miguel, Tucumán Province, T4000CBC, Argentina

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Caba, C1015ABO, Argentina

  • Novartis Investigative Site

    RECRUITING

    Caba, C1427CCL, Argentina

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    San Miguel de Tucumán, T4000AXL, Argentina

  • Novartis Investigative Site

    RECRUITING

    Maroochydore, Queensland, 4558, Australia

  • Novartis Investigative Site

    RECRUITING

    Salvador, Estado de Bahia, 40150 150, Brazil

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Niterói, Rio de Janeiro, 24020 096, Brazil

  • Novartis Investigative Site

    RECRUITING

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

  • Novartis Investigative Site

    RECRUITING

    Barretos, São Paulo, 14784 400, Brazil

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    São Paulo, São Paulo, 01244-030, Brazil

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    São Paulo, São Paulo, 04038-002, Brazil

  • Novartis Investigative Site

    RECRUITING

    Salvador, 40323-010, Brazil

  • Novartis Investigative Site

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Sofia, 1431, Bulgaria

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Vancouver, British Columbia, V5Z 1L7, Canada

  • Novartis Investigative Site

    RECRUITING

    Rimouski, Quebec, G5L 5T1, Canada

  • Novartis Investigative Site

    RECRUITING

    Valdivia, Los Ríos Region, 5110683, Chile

  • Novartis Investigative Site

    RECRUITING

    Santiago, RM, 7500588, Chile

  • Novartis Investigative Site

    RECRUITING

    Santiago, Santiago Metropolitan, 7500710, Chile

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    RECRUITING

    Shantou, Guangdong, 515000, China

  • Novartis Investigative Site

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Novartis Investigative Site

    RECRUITING

    Suzhou, Jiangsu, 215004, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    RECRUITING

    Pingxiang, Jiangxi, 337000, China

  • Novartis Investigative Site

    RECRUITING

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    RECRUITING

    Linyi, Shandong, 276000, China

  • Novartis Investigative Site

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    RECRUITING

    Ürümqi, Xinjiang, 830001, China

  • Novartis Investigative Site

    RECRUITING

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100069, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100730, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200127, China

  • Novartis Investigative Site

    RECRUITING

    Xinxiang, 453099, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Medellín, Antioquia, 050001, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Barranquilla, Atlántico, 080020, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Chía, Cundinamarca, 250001, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bucaramanga, Santander Department, 680003, Colombia

  • Novartis Investigative Site

    RECRUITING

    Cali, Valle del Cauca Department, 760046, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bogotá, 111211, Colombia

  • Novartis Investigative Site

    RECRUITING

    Brno, 638 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Uherské Hradiště, 686 01, Czechia

  • Novartis Investigative Site

    RECRUITING

    Montpellier, 34295, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Paris, 75013, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Paris, 75014, France

  • Novartis Investigative Site

    RECRUITING

    Toulouse, 31054, France

  • Novartis Investigative Site

    RECRUITING

    Toulouse, 31059, France

  • Novartis Investigative Site

    WITHDRAWN

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    RECRUITING

    Guatemala City, 01010, Guatemala

  • Novartis Investigative Site

    RECRUITING

    Székesfehérvár, Fejér, 8000, Hungary

  • Novartis Investigative Site

    RECRUITING

    Gyula, 5700, Hungary

  • Novartis Investigative Site

    RECRUITING

    Zalaegerszeg, 8900, Hungary

  • Novartis Investigative Site

    RECRUITING

    Ahmedabad, Gujarat, 380006, India

  • Novartis Investigative Site

    RECRUITING

    Ahmedabad, Gujarat, 380015, India

  • Novartis Investigative Site

    RECRUITING

    Kozhikode, Kerala, 673008, India

  • Novartis Investigative Site

    RECRUITING

    Kolhāpur, Maharashtra, 416001, India

  • Novartis Investigative Site

    RECRUITING

    Nagpur, Maharashtra, 441108, India

  • Novartis Investigative Site

    RECRUITING

    Nashik, Maharashtra, 422101, India

  • Novartis Investigative Site

    RECRUITING

    Pune, Maharashtra, 411001, India

  • Novartis Investigative Site

    RECRUITING

    New Delhi, 110029, India

  • Novartis Investigative Site

    RECRUITING

    New Delhi, 110075, India

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    RECRUITING

    Pisa, PI, 56126, Italy

  • Novartis Investigative Site

    RECRUITING

    Torino, TO, 10128, Italy

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Nagoya, Aichi-ken, 4578510, Japan

  • Novartis Investigative Site

    RECRUITING

    Nagoya, Aichi-ken, 4578511, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Yokohama, Kanagawa, 236-0004, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Novartis Investigative Site

    RECRUITING

    Chuo Ku, Tokyo, 104-8560, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Fuchū, Tokyo, 1838524, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Shinjuku-ku, Tokyo, 1608582, Japan

  • Novartis Investigative Site

    RECRUITING

    Ipoh, Perak, 30450, Malaysia

  • Novartis Investigative Site

    RECRUITING

    León, Guanajuato, 37160, Mexico

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Guadalajara, Jalisco, 44160, Mexico

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Mexico City, Mexico City, 06700, Mexico

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Morelia, Michoacán, 58000, Mexico

  • Novartis Investigative Site

    RECRUITING

    Mérida, Yucatán, 97070, Mexico

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    México, 07760, Mexico

  • Novartis Investigative Site

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

  • Novartis Investigative Site

    RECRUITING

    Bydgoszcz, 85-065, Poland

  • Novartis Investigative Site

    RECRUITING

    Bydgoszcz, 85-168, Poland

  • Novartis Investigative Site

    RECRUITING

    Bytom, 41 902, Poland

  • Novartis Investigative Site

    RECRUITING

    Warsaw, 00-874, Poland

  • Novartis Investigative Site

    RECRUITING

    Warsaw, 04-141, Poland

  • Novartis Investigative Site

    RECRUITING

    Braga, 4710243, Portugal

  • Novartis Investigative Site

    RECRUITING

    Lisbon, 1050-034, Portugal

  • Novartis Investigative Site

    RECRUITING

    Cluj-Napoca, Cluj, 400006, Romania

  • Novartis Investigative Site

    RECRUITING

    Brasov, 500283, Romania

  • Novartis Investigative Site

    RECRUITING

    Bucharest, 011172, Romania

  • Novartis Investigative Site

    RECRUITING

    Košice, 040 01, Slovakia

  • Novartis Investigative Site

    RECRUITING

    Pretoria, Gauteng, 0002, South Africa

  • Novartis Investigative Site

    RECRUITING

    Cape Town, Western Cape, 7405, South Africa

  • Novartis Investigative Site

    RECRUITING

    Cape Town, Western Cape, 7500, South Africa

  • Novartis Investigative Site

    RECRUITING

    Somerset West, Western Cape, 7130, South Africa

  • Novartis Investigative Site

    RECRUITING

    Umhlanga, 4320, South Africa

  • Novartis Investigative Site

    RECRUITING

    Gwangju, 61469, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 04763, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    RECRUITING

    San Sebastian Reyes, Madrid, 28702, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28034, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46014, Spain

  • Novartis Investigative Site

    RECRUITING

    Kaohsiung City, 83301, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taichung, 407219, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    RECRUITING

    Bangkok, 10700, Thailand

  • Novel Research LLC

    TERMINATED

    Bellaire, Texas, 77401, United States

  • Paramount Med Rsrch and Consult LLC

    RECRUITING

    Middleburg Heights, Ohio, 44130, United States

  • Parris and Associates Rheumatology

    RECRUITING

    Lawrenceville, Georgia, 30044, United States

  • Pinnacle Research Group Llc

    RECRUITING

    Anniston, Alabama, 36207, United States

  • Providence Medical Center

    RECRUITING

    Burbank, California, 91505, United States

  • Robert A Hozman MD SC

    RECRUITING

    Skokie, Illinois, 60076, United States

  • Shelby Research LLC

    RECRUITING

    Memphis, Tennessee, 38121, United States

  • University Of Maryland

    ACTIVE_NOT_RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Colorado Denver

    RECRUITING

    Aurora, Colorado, 80045, United States

  • West Tennessee Research Institute

    RECRUITING

    Jackson, Tennessee, 38305, United States

  • Willow Rheumatology Wellness

    RECRUITING

    Willowbrook, Illinois, 60527, United States

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