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New lupus drug shows promise in major trial

NCT ID NCT04895241

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tests litifilimab, an experimental drug, in 548 adults with active systemic lupus erythematosus (SLE) who are already on standard treatments. Participants receive either high or low doses of litifilimab or a placebo as injections every 4 weeks for 52 weeks. The main goal is to see if litifilimab reduces lupus symptoms better than placebo, using standard disease activity scores.

What this could mean

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

Active substance
litifilimab (BIIB059)
What this could lead to
If it works, this could offer a new treatment option to help control lupus symptoms and improve quality of life for people with active disease.
What could go wrong
This is an early-phase 3 trial, so results may not confirm benefit. Side effects are possible, and the drug may not work for everyone. Long-term safety is still being studied.

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

548 people

The number who actually took part.

Started

May 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 systemic lupus erythematosus (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-2000 (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. * Participant 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 hepatitis antibody to 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 is indicated, such as adding 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

  • A2Z Clinical Centro Avancado de Pesquisa Clinica

    Valinhos, São Paulo, 13271-130, Brazil

  • AA MRC LLC Ahmed Arif Medical Research Center

    Flint, Michigan, 48504, United States

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000, Mexico

  • Accurate Clinical Management LLC

    Houston, Texas, 77089, United States

  • Accurate Clinical Research

    Stafford, Texas, 77477, United States

  • Accurate Clinical Research Inc.

    Lake Charles, Louisiana, 70605, United States

  • Accurate Clinical Research, Inc.

    Humble, Texas, 77346, United States

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382, United States

  • AdventHealth Medical Group

    Tampa, Florida, 33613, United States

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Akademiska Sjukhuset

    Uppasala, 75185, Sweden

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida, 33180, United States

  • Arthritis Care Texas

    Corpus Christi, Texas, 78415, United States

  • Asan Medical Center

    Seoul, 5505, South Korea

  • Atlanta Research Center for Rheumatology LLC

    Marietta, Georgia, 30060, United States

  • Believe Clinical Trials

    Coral Springs, Florida, 33065, United States

  • BioMedica Research Group

    Santiago, 7500710, Chile

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055-450, Brazil

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

    São Paulo, São Paulo, 04266-010, Brazil

  • CETI - Centro de Estudos em Terapias Inovadoras Ltda.

    Curitiba, Paraná, 80030-110, Brazil

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, Puy De Dome, 63003, France

  • CLS Research Ctr, PLLC

    Webster, Texas, 77598, United States

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora, Minas Gerais, 36010-570, Brazil

  • CTR Estudios

    Santiago, 7500571, Chile

  • CeCim Biocinetic

    Santiago, 8331143, Chile

  • Centre for Rheumatology, Immunology and Arthritis

    Fort Lauderdale, Florida, 33334, United States

  • Centro Medico Prosalud

    Santiago, 7500000, Chile

  • Centro Multidisciplinar de Estudos Clínicos - CEMEC

    São Bernardo do Campo, São Paulo, 09715-090, Brazil

  • Centro Peninsular de Investigacion Clinica, SCP

    Mérida, Yucatán, 97000, Mexico

  • Centro de Investigacion Clinica Immunoreumatologioa

    Lima, Lima 11, Peru

  • Centro de Investigacion Clínica GRAMEL S.C

    Mexico City, Mexico City, 3720, Mexico

  • Centro de Investigacion Farmaceutica Especializada de Occidente S.C

    Guadalajara, Jalisco, 44160, Mexico

  • Centro de Investigacion y Atencion Integral Durango CIAID

    Durango, 34080, Mexico

  • Centro de investigacion medica y reumatologia

    Guadalajara, Jalisco, 44959, Mexico

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

    Malbork, 82-200, Poland

  • Centrum Medyczne All-Med

    Krakow, 31-023, Poland

  • Centrum Medyczne Intercor Sp. z o.o

    Bydgoszcz, 85-605, Poland

  • Centrum Medyczne Plejady

    Krakow, 30-363, Poland

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan County, 333, Taiwan

  • Charisma Medical and Research Center

    Miami Lakes, Florida, 33014, United States

  • Chong Hua Hospital

    Cebu City, 6000, Philippines

  • Chung Shan Medical University Hospital

    Taichung, 40201, Taiwan

  • Clinica Alemana de Osorno

    Osorno, 5290000, Chile

  • Clinica de Investigacion en Reumatologia y Obesidad S.C.

    Guadalajara, Jalisco, 44650, Mexico

  • Clinical Research Chile SpA.

    Valdivia, 5090000, Chile

  • Clinical Research of West Florida - Corporate

    Clearwater, Florida, 33765, United States

  • Clinstile, S.A. de C.V.

    Mexico City, Mexico City, 6700, Mexico

  • Clínica SER da Bahia

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Consultorio Privado Dr. Miguel Cortes Hernandez

    Cuernavaca, Morelos, 62448, Mexico

  • DCC 'Alexandrovska', EOOD

    Sofia, 1431, Bulgaria

  • DCC 'Sv. Georgi', EOOD

    Plovdiv, 4000, Bulgaria

  • DCC 1 - Ruse, EOOD

    Rousse, 7002, Bulgaria

  • Davao Doctors Hospital

    Davao City, 8000, Philippines

  • Diseno y Planeacion en Investigacion Medica S.C.

    Guadalajara, Jalisco, 44130, Mexico

  • Dong-A University Hospital

    Busan, 49201, South Korea

  • Enroll Spa

    Santiago, 7500587, Chile

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900, Mexico

  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation

    Quezon City, Metro Manila, 1118, Philippines

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Footscray Hospital

    Footscray, Victoria, 3011, Australia

  • Fort Bend Rheumatology Associates

    Sugar Land, Texas, 77407, United States

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

  • GNP Research at Mark Jaffe, MD

    Hollywood, Florida, 33024, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • General Hospital of Athens Laiko

    Athens, 11527, Greece

  • Georgetown University Hospital-Medstar

    Washington D.C., District of Columbia, 20007-2113, United States

  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin

    Bordeaux, Gironde, 33000, France

  • HMA - Hospital Maria Auxiliadora

    Lima, LIMA 29, Peru

  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

    Fortaleza, Ceará, 60430-370, Brazil

  • Hanyang University Seoul Hospital

    Seoul, 4763, South Korea

  • Harbor-UCLA Medical Center

    Torrance, California, 90509, United States

  • Highlands Rheumatology

    Avon Park, Florida, 33825, United States

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102, United States

  • Hogar Clínica San Juan de Dios - Arequipa

    Arequipa, 40103, Peru

  • Hopital Lapeyronie

    Montpellier, Herault, 34295, France

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-000, Brazil

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

  • Hospital Nacional Edgardo Rebagliati Martins

    Lima, LIMA 11, Peru

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitario Dr. Peset

    Valencia, 46017, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Rio Hortega

    Valladolid, Cantabria, 47012, Spain

  • Hospital Universitario San Cecilio

    Granada, 18016, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786, United States

  • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

    Mexico City, Mexico City, 14080, Mexico

  • Interin

    Santiago, 7500010, Chile

  • Invest Clinicas Sac Inst de Ginecologia y Reproduccion

    Lima, Lima 33, Peru

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua City, 31000, Mexico

  • Joint and Muscle Research Institute

    Charlotte, North Carolina, 28204, United States

  • Jose R. Reyes Memorial Medical Center

    Manila, 1012, Philippines

  • Joseph S. and Diane H. Steinberg Ambulatory Care Center

    Brooklyn, New York, 11201, United States

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833, Taiwan

  • Karolinska Universitetssjukhuset Solna

    Stockholm, SE-171 76, Sweden

  • Konkuk University Medical Center

    Seoul, 5030, South Korea

  • L2IP - Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730, Brazil

  • LMK Serviços Médicos S/S Ltda

    Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

  • Life Clinical Trials

    Margate, Florida, 33063, United States

  • Lorma Medical Center

    San Fernando City, La Union, 2500, Philippines

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874, Poland

  • Malopolskie Badania Kliniczne

    Krakow, 30-002, Poland

  • Manila Doctors Hospital

    Manila, 1000, Philippines

  • Mary Mediatrix Medical Center

    Lipa City, 4217, Philippines

  • Medical Care & Research SA de CV

    Mérida, Yucatán, 97070, Mexico

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Medical Center Manila

    Manila, 1000, Philippines

  • Medication Management, LLC

    Greensboro, North Carolina, 27405, United States

  • Military Medical Academy - MHAT - Sofia

    Sofia, 1606, Bulgaria

  • NNA Hospita;

    Athens, 11521, Greece

  • Niepubliczny Zakład Opieki Zdrowotnej 'Biogenes' Sp. z o.o.

    Wroclaw, 53-224, Poland

  • Northwell Health Center for Advanced Medicine

    New Hyde Park, New York, 11042-1118, United States

  • Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    Bialystok, 15-707, Poland

  • Nzoz Bif-Med

    Bytom, 41-902, Poland

  • Omega Research Consultants

    DeBary, Florida, 32713, United States

  • OnSite Clinical Solutions, LLC - Charlotte

    Salisbury, North Carolina, 28144, United States

  • Oncovida - Centro de Onco-Hematologia de Mato Grosso

    Cuiabá, Mato Grosso, 78043-142, Brazil

  • Ospital Ng Makati

    City of Taguig, 1642, Philippines

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130, United States

  • Philippine General Hospital

    Manila, 1000, Philippines

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77099, United States

  • Pratia MCM Krakow

    Krakow, 30-727, Poland

  • Precision Comprehensive Clinical Research Solution

    Colleyville, Texas, 76034-5913, United States

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034, United States

  • PrimeCare 360

    Allen, Texas, 75013, United States

  • Prolato Clinical Research Center

    Houston, Texas, 77054, United States

  • Providence Facey Medical Foundation

    Mission Hills, California, 91345, United States

  • Prywatna Praktyka Lekarska prof Pawel Hrycaj

    Poznan, 61-397, Poland

  • Przychodnia Care Access Warszawa

    Warsaw, 00-719, Poland

  • RDSS Ricardo Diaz Scientific Solution

    São Paulo, 04037-030, Brazil

  • Ramesh C Gupta, MD

    Memphis, Tennessee, 38119, United States

  • Renown Medical Group

    Reno, Nevada, 89502, United States

  • Reumed Spolka z o.o.

    Lublin, 20-607, Poland

  • Rheumatology Associates of Central Florida

    Orlando, Florida, 32806, United States

  • Rheumatology care of Georgia

    Kennesaw, Georgia, 30144, United States

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • SCLA Management

    Thousand Oaks, California, 91360, United States

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210, United States

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • St. Luke's Medical Center

    Quenzon City, 1102, Philippines

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, 87-100, Poland

  • The Medical City Clark

    Mabalacat, Pampanga, 2023, Philippines

  • The Medical City Iloilo

    Iloilo City, 5000, Philippines

  • Tilda Research Birmingham

    Homewood, Alabama, 35209, United States

  • Twoja Przychodnia NCM

    Nowa Sól, 67-100, Poland

  • UMHAT "Pulmed" OOD

    Plovdiv, 4002, Bulgaria

  • UMHAT 'Sv. Ivan Rilski', EAD

    Sofia, 1612, Bulgaria

  • UMHAT-Plovdiv AD

    Plovdiv, 4003, Bulgaria

  • Unidad de Atencion Medica e Investigacion en Salud S.C.

    Mérida, Yucatán, 97000, Mexico

  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460, Mexico

  • Universitetssjukhuset Orebro

    Örebro, 70185, Sweden

  • University General Hospital 'Attikon'

    Athens, 12462, Greece

  • University of California San Diego School of Medicine

    San Diego, California, 92103, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Vantage Clinical Trials

    Tampa, Florida, 33614, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Wallace Rheumatic Study Center

    Beverly Hills, California, 90211, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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