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New lupus drug shows promise in major trial

NCT ID NCT04961567

Disease control Sponsor: Biogen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug called litifilimab for people with active systemic lupus erythematosus (SLE), a chronic autoimmune disease. About 562 adults already on standard lupus treatments will receive either litifilimab or a placebo as a shot every 4 weeks for 52 weeks. The goal is to see if litifilimab can reduce disease activity and improve symptoms, while continuing their usual medications.

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

562 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Mar 2027

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

18 years and older

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: * Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, at screening by a qualified physician. * Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-200 (SLEDAI-2K) score ≥6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated). * Participant has a modified clinical SLEDAI-2K score ≥4 (excluding anti-dsDNA, low complement component 3 \[C3\] and/or complement component 4 \[C4\], alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated) and randomization. * Participant has BILAG-2004 grade A in ≥1 organ system or BILAG-2004 grade B in ≥2 organ systems at screening (adjudicated) and randomization. * Participants must be treated with one of the following background nonbiologic lupus SOC therapies, initiated ≥12 weeks prior to screening and at stable dose ≥4 weeks prior to randomization: 1. Antimalarials as stand-alone treatment 2. Antimalarial treatment in combination with OCS and/or a single immunosuppressant 3. Treatment with OCS and/or a single immunosuppressant. Key Exclusion Criteria: * History of or positive test result for human immunodeficiency virus (HIV). * Current hepatitis C infection (defined as positive hepatitis C virus \[HCV\] antibody and detectable HCV ribonucleic acid \[RNA\]). * Current hepatitis B infection (defined as positive for antibody to hepatitis B surface antigen \[HBsAg\] and/or positive for total antibody to hepatitis B core antigen \[anti-HBc\] with positive reflex HBV DNA). * History of severe herpes infection. * Presence of uncontrolled or New York Heart Association class III or IV congestive heart failure. * Active severe lupus nephritis where, in the opinion of the investigator, protocol-specified SOC is insufficient and use of a more aggressive therapeutic approach, such as adding intravenous (IV) cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated; or urine protein-creatinine ratio \>2.0 or severe chronic kidney disease (estimated glomerular filtration rate \<30 milliliters per minute per 1.73 meter square \[mL/min/1.73 m\^2\]) calculated using the abbreviated Modification of Diet in Renal Disease equation. * Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced lupus. * History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome. * Active neuropsychiatric SLE. * Use of oral prednisone (or equivalent) above 20 mg/day. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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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.

Lupus erythematosus, systemic

Contacts and locations

Locations

  • APRILLUS Asistencia e Investigacion

    Buenos Aires, Ciudad Autonoma Buenos Aires, C1406AGA, Argentina

  • Amsterdam UMC, Locatie VUMC

    Amsterdam, 1081 HV, Netherlands

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Glendale, Arizona, 85306, United States

  • Arthritis & Osteoporosis Associates, PA

    Freehold, New Jersey, 07728, United States

  • Arthritis & Rheumatology Institute

    Allen, Texas, 75013, United States

  • Arthritis and Osteoporosis Associates of New Mexico

    Las Cruces, New Mexico, 88011, United States

  • Azienda Ospedale-Università di Padova

    Padova, 35100, Italy

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00151, Italy

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Roma, 00161, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56100, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25123, Italy

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, 100020, China

  • Bekes Varmegyei Kozponti Korhaz

    Gyula, 5700, Hungary

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603, China

  • Boston University School of Medicine

    Boston, Massachusetts, 02118, United States

  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

    San Juan, 5400, Argentina

  • Cannock Chase Hospital

    Cannock, Staffordshire, WS11 5XY, United Kingdom

  • Care Access Research - Huntington BeachCare Access Research - Huntington Beach

    Huntington Beach, California, 92648, United States

  • Carolina Arthritis Associates

    Wilmington, North Carolina, 28401, United States

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, Tokyo-To, 162-8655, Japan

  • Centre Hospitalier Universitaire de Liege

    Liège, 4000, Belgium

  • Centro Dermatologico Schejtman

    San Miguel, Buenos Aires, B1663, Argentina

  • Centro Medico Barrio Parque

    Buenos Aires, C1425, Argentina

  • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

    Ciudad Autonoma Buenos Aires, 1425, Argentina

  • Centro Privado de Medicina Familiar - Mind Out Research

    Ciudad Autonoma Buenos Aires, C1417, Argentina

  • Centro Reumatologico

    Caguas, 00725, Puerto Rico

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla, 080020, Colombia

  • Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.

    Bogotá, 110221, Colombia

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FYK, Argentina

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • Chiba University Hospital

    Chiba, Chiba, 260-8677, Japan

  • Chibaken Saiseikai Narashino Hospital

    Narashino-shi, Chiba, 275-8580, Japan

  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Clinical Hospital Center Bezanijska kosa

    Belgrade, 11080, Serbia

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606, United States

  • Clínica de la Costa Ltda.

    Barranquilla, 080020, Colombia

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210, United States

  • DM Clinical Research - Boston

    Brookline, Massachusetts, 02445, United States

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097, Hungary

  • Doncaster Royal Infirmary

    Doncaster, South Yorkshire, DN2 5LT, United Kingdom

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523059, China

  • EBGS Clinical Trials

    Snellville, Georgia, 30078, United States

  • EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Fakultni nemocnice Olomouc

    Olomouc, 77520, Czechia

  • Fujita Health University Hospital

    Toyoake-shi, Aichi-ken, 470-1192, Japan

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong, 510317, China

  • Guy's Hospital

    London, Greater London, SE1 9RT, United Kingdom

  • HMD Research, LLC

    Orlando, Florida, 32819, United States

  • Hainan General Hospital

    Haikou, Hainan, 570311, China

  • Hamilton Health Sciences Corporation

    Hamilton, Ontario, L8V 1C3, Canada

  • Healthy Medical Center

    Zipaquirá, 250252, Colombia

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551, Japan

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1280AEB, Argentina

  • Hospital General de Agudos Dr. J. M. Ramos Mejia

    Ciudad Autonoma Buenos Aires, Buenos Aires, C1221ADC, Argentina

  • Hospital Italiano de La Plata

    Buenos Aires, Buenos Aires, B1900AXI, Argentina

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu-shi, Fukuoka, 807-8556, Japan

  • IPS Centro Medico Julián Coronel S.A.

    Cali, 760001, Colombia

  • Institute of Rheumatology

    Belgrade, 11000, Serbia

  • Institute of Treatment and Rehabilitation 'Niska Banja'

    Niška Banja, 18205, Serbia

  • Instituto CAICI

    Rosario, Santa Fe Province, S2000PBJ, Argentina

  • Instituto de Investigaciones Clinicas Quilmes

    Buenos Aires, Buenos Aires, B1878GEG, Argentina

  • Instituto de Reumatologia

    Mendoza, M5500, Argentina

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000ICL, Argentina

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089, Italy

  • JCHO Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510, Japan

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520, Japan

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, Hyōgo, 670-8540, Japan

  • Jefrey Lieberman, M.D., P.C.

    Decatur, Georgia, 30033, United States

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055, China

  • Jilin Province People's Hospital

    Changchun, Jilin, 130021, China

  • Jiujiang No.1 People's Hospital

    Jiujiang, Jiujiang, 332000, China

  • Joo-Hyung Lee MD

    Orange, California, 92868, United States

  • KKR Hamanomachi Hospital

    Fukuoka, Fukuoka, 810-8539, Japan

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793, Japan

  • Keio University Hospital

    Shinjuku-ku, Tokyo-To, 160-8582, Japan

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa, 252-0375, Japan

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017, Japan

  • Low Country Rheumatology, PA

    Summerville, South Carolina, 29486, United States

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Medvin Clinical Research

    Whittier, California, 90602, United States

  • Meir Medical Center

    Kfar Saba, 44281, Israel

  • NHO Chibahigashi National Hospital

    Chiba, Chiba, 260-8712, Japan

  • NHO Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563, Japan

  • NHO Osaka Minami Medical Center

    Kawachinagano-shi, Osaka, 586-8521, Japan

  • NHO Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575, Japan

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501, Japan

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Neurovations

    Napa, California, 94558, United States

  • Nihon University Itabashi Hospital

    Itabashi-ku, Tokyo-To, 173-8610, Japan

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036, Hungary

  • Office of John P. Lavery M.D., PA

    Allen, Texas, 75013, United States

  • Organizacion Medica de Investigacion (OMI)

    Ciudad Autonoma Buenos Aires, C1015ABO, Argentina

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-shi, Osaka, 569-8686, Japan

  • Ospedale M. Scarlato

    Scafati, Salerno, 84018, Italy

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Piedmont Arthritis Clinic, P.A.

    Greenville, South Carolina, 29601, United States

  • Policlìnica Red Omip S.A - Ensayos Clinicos GC

    Mar del Plata, Buenos Aires, B7600GNY, Argentina

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034, United States

  • Preventive Care Ltda

    Chía, 250001, Colombia

  • Prime Clinical Research

    Mansfield, Texas, 76063, United States

  • R and H Clinical Research

    Katy, Texas, 77494, United States

  • R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center

    Monterey Park, California, 91754, United States

  • RASF - Clinical Research Center

    Boca Raton, Florida, 33486, United States

  • RNA America Health Sciences

    Gainesville, Georgia, 30518, United States

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 49372, Israel

  • Rambam Health Care Center

    Haifa, 3109601, Israel

  • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

    Shanghai, Shanghai Municipality, 200001, China

  • Revmatologie s.r.o.

    Brno, 638 00, Czechia

  • Ruijin Hospital of Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200011, China

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • S C Delta Health Care SRL

    Bucharest, 014142, Romania

  • S.C Centrul Medical Unirea SRL

    Târgu Mureş, 540136, Romania

  • S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

    Brasov, 500283, Romania

  • S.C.Centrul Medical Unirea SRL

    Iași, 700023, Romania

  • STAT Research

    Dayton, Ohio, 45417, United States

  • STAT Research S.A.

    Ciudad Autonoma Buenos Aires, C1013AAB, Argentina

  • Saint Louis Rheumatology

    St Louis, Missouri, 63119, United States

  • Saitama Medical University Hospital

    Iruma-gun, Saitama, 350-0495, Japan

  • Sanatorio Allende

    Córdoba, X5000JHQ, Argentina

  • Servimed S.A.S.

    Bucaramanga, 680003, Colombia

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020, China

  • SouthWest Rheumatology Research, LLC

    Mesquite, Texas, 75150, United States

  • Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia

    Gainesville, Georgia, 30501, United States

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400006, Romania

  • Spitalul Judetean de Urgenta 'Sf. Ioan cel Nou' Suceava

    Suceava, 720284, Romania

  • St. Luke's International Hospital

    Chūōku, Tokyo-To, 104-8560, Japan

  • St. Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • Sun Research Institute, LLC

    San Antonio, Texas, 78215, United States

  • Swedish Medical Center

    Seattle, Washington, 98104, United States

  • Tazuke-kofukai Medical Research Institute Kitano Hospital

    Osaka, Osaka, 530-8480, Japan

  • Tekton Research

    Austin, Texas, 78745, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The Emory Clinic Emory University

    Atlanta, Georgia, 30322, United States

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan, 610500, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • The Practice of Medicine

    Los Angeles, California, 90004, United States

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • The Waterside Clinic

    Barrie, Ontario, L4M 6L2, Canada

  • The second Xiangya Hospital of Central South University

    Changsha, Hu'nan, 410011, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo-To, 153-8515, Japan

  • Toho University Omori Medical Center

    Ōta-ku, Tokyo-To, 143-8541, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, Tokyo-To, 113-8519, Japan

  • Tonan Hospital

    Sapporo, Hokkaido, 060-0004, Japan

  • UMC Utrecht

    Utrecht, 3584 CX, Netherlands

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitaetsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitaetsmedizin Goettingen

    Göttingen, Lower Saxony, 37075, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB, Netherlands

  • University Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45206-0829, United States

  • University of Florida

    Gainesville, Florida, 32611, United States

  • University of Massachusetts

    Worcester, Massachusetts, 01655, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • Università Campus Bio-Medico di Roma

    Roma, 00155, Italy

  • Valerius Medical Group

    Los Alamitos, California, 90720, United States

  • Vida Clinical Research

    Kissimmee, Florida, 34741, United States

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

    Székesfehérvár, 8000, Hungary

  • Vital Medical Center

    Veszprém, 8200, Hungary

  • Wenzhou People's Hospital

    Wenzhou, Zhejiang, 325000, China

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305, United States

  • Whipps Cross University Hospital

    London, Greater London, E11 1NR, United Kingdom

  • Xiangya Hospital, Central South University

    Changsha, 410008, China

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053, China

  • Yanbian University Hospital (Yanbian Hospital)

    Yanji, Jilin, 133000, China

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024, Japan

  • ZhuZhou Central Hospital

    Zhuzhou, Hu'nan, 412000, China

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