AzTrials
AzTrials

Systemic Lupus Erythematosus (SLE)Phase 3EMERALDNCT05352919

A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE)

A Phase 3 study testing Litifilimab in people with Systemic Lupus Erythematosus (SLE), run by Biogen at 214 sites in 28 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on adults who have active disease and are already taking standard of care medications. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus (SLE)
What is being tested?
Litifilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
864 participants
Where
214 sitesin 28 countries
Study dates
10 Jun 2022to 3 May 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52.

Who cannot join

  • Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
  • Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period)
  • Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)
  • Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.
  • NOTE: Other inclusion/exclusion criteria may apply.

Trial locations and contacts

214 sites in 28 countries. Contact the study team or a site near you to ask about taking part.

214 sites in 28 countries

United States38 sites

  • Arthritis & Rheumatology Research Institute

    Allen, Texas, 75013

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Tekton Research - PARENT

    Austin, Texas, 78745

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • Highlands Research Institute

    Avon Park, Florida, 33825

  • Accurate Clinical Research

    Baytown, Texas, 77521

  • Wallace Rheumatic Study Center

    Beverly Hills, California, 90211

  • NYU Langone Brooklyn

    Brooklyn, New York, 11220

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Clinical Research of West Florida - Corporate

    Clearwater, Florida, 33765

  • Precision Comprehensive Clinical Research Solution

    Colleyville, Texas, 76034-5913

  • GNP Research at Mark Jaffe, MD

    Cooper City, Florida, 33024

  • Omega Research Consultants

    DeBary, Florida, 32713

  • AA MRC LLC Ahmed Arif Medical Research Center

    Flint, Michigan, 48504

  • Arthritis Center of North Georgia

    Gainesville, Georgia, 30501

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • Accurate Clinical Research, Inc.

    Humble, Texas, 77338

  • Care Access Research - Huntington Beach

    Huntington Beach, California, 92648

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • R and H Clinical Research

    Katy, Texas, 77450

  • Life Clinical Trials

    Margate, Florida, 33063

  • Ramesh C Gupta, MD

    Memphis, Tennessee, 38119

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • Providence Facey Medical Foundation

    Mission Hills, California, 91345

  • HMD Research, LLC

    Orlando, Florida, 32819

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Phoenix, Arizona, 85037

  • Precision Comprehensive Clinical Research Solutions

    Rochester Hills, Michigan, 48307

  • Onyx Clinical Research, LLC

    Salisbury, North Carolina, 28144

  • Sun Research Institute, LLC

    San Antonio, Texas, 78215

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Saint Louis Rheumatology

    St Louis, Missouri, 63119

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606

  • AdventHealth Medical Group

    Tampa, Florida, 33613

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786

  • Georgetown University Hospital-Medstar

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

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Japan21 sites

  • NHO Chibahigashi National Hospital

    Chiba, Chiba, 260-8712

  • KKR Hamanomachi Hospital

    Fukuoka, Fukuoka, 810-8539

  • NHO Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, Hyōgo, 670-8540

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Nihon University Itabashi Hospital

    Itabashi-ku, Tokyo-To, 173-8610

  • Eiraku Clinic

    Kagoshima, Kagoshima-ken, 890-0063

  • NHO Osaka Minami Medical Center

    Kawachinagano-shi, Osaka, 586-8521

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka, 807-8556

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo-To, 153-8515

  • JCHO Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • Tonan Hospital

    Sapporo, Hokkaido, 060-0004

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

    Shinjuku-ku, Tokyo-To, 162-8655

  • Fujita Health University Hospital

    Toyoake-shi, Aichi-ken, 470-1192

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • NHO Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575

Other trials in Japan

Argentina19 sites

  • APRILLUS Asistencia e Investigacion

    Buenos Aires, Ciudad Autonoma Buenos Aires, 1406

  • Centro Medico Barrio Parque

    Buenos Aires, Ciudad Autonoma Buenos Aires, 1425

  • Hospital Italiano de La Plata

    Buenos Aires, 17251900

  • Instituto de Investigaciones Clinicas Quilmes

    Buenos Aires, 3151878

  • Cenemar SRL

    Buenos Aires, 7600

  • Organizacion Medica de Investigacion (OMI)

    CABA, Buenos Aires, C1015ABO

  • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

    Ciudad Autonoma Buenos Aires, 1425

  • STAT Research S.A.

    Ciudad Autonoma Buenos Aires, C1013AAB

  • Sanatorio Allende

    Córdoba, 5000

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600

  • Policlìnica Red Omip S.A - Ensayos Clinicos GC

    Mar del Plata, Buenos Aires, B7600GNY

  • Instituto de Reumatologia

    Mendoza, 5500

  • Instituto CAICI

    Rosario, Santa Fe Province, S2000PBJ

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

    San Juan, 5400

  • Centro Dermatologico Schejtman

    San Miguel, Buenos Aires, B1663

  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

    San Miguel de Tucumán, Tucumán Province, 4000

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000ICL

  • Consultorio Alto Dorrego

    Villa Nueva, Mendoza Province, CP 5519

Other trials in Argentina

China18 sites

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603

  • Jilin Province People's Hospital

    Changchun, Jilin, 130021

  • The First Hospital of Jilin University

    Changchun, 130021

  • Xiangya Hospital, Central South University

    Changsha, Hu'nan, 410008

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523059

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong, 510317

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Jiujiang No.1 People's Hospital

    Jiujiang, Jiangxi, 332000

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055

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

    Shanghai, Shanghai Municipality, 200001

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50000

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsushe, 215004

  • Zhongshan TCM Hospital

    Zhongshan, Guangdong, 528400

  • ZhuZhou Central Hospital

    Zhuzhou, Hu'nan, 412000

Other trials in China

Brazil17 sites

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • L2IP - Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730

  • CETI - Centro de Estudos em Terapias Inovadoras Ltda.

    Curitiba, Paraná, 80030-110

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

    Fortaleza, Ceará, 60430-372

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora, Minas Gerais, 36010-570

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • LMK Serviços Médicos S/S Ltda

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560032

  • Clínica SER da Bahia

    Salvador, Estado de Bahia, 40150-150

  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

    Santo Ângelo, Mato Grosso, 78020-500

  • Centro Multidisciplinar de Estudos Clínicos - CEMEC

    São Bernardo do Campo, São Paulo, 09715-090

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    Sao Jose Rio Preto, São Paulo, 15090-000

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

    São Paulo, São Paulo, 01228-200

  • CPCLIN - Centro de Pesquisas Clinicas

    São Paulo, 01228-200

  • RDSS Ricardo Diaz Scientific Solution

    São Paulo, 04037-030

  • A2Z Clinical Centro Avancado de Pesquisa Clinica

    Valinhos, São Paulo, 13271-130

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Colombia11 sites

  • Fundacion Cardiomet CEQUIN S.A.S

    Armenia, 630004

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla, 080020

  • Clínica de la Costa S.A.S

    Barranquilla, 080020

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

    Bogotá, 110221

  • Servimed S.A.S.

    Bucaramanga, 680003

  • IPS Centro Medico Julian Coronel S.A.

    Cali, Valle del Cauca Department, 760001

  • Preventive Care Ltda

    Chía, 250001

  • Fundacion Oftalmologica de Santander - FOSCAL

    Floridablanca, 681004

  • IPS Medicos Internistas de Caldas S.A.S.

    Manizales, 170004

  • Centro de Investigacion Clinica CIC

    Medellín, 050021

  • Healthy Medical Center

    Zipaquirá, 250252

Other trials in Colombia

Mexico11 sites

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua City, 31000

  • Consultorio Privado Dr. Miguel Cortes Hernandez

    Cuernavaca, Morelos, 62448

  • Centro de Investigacion y Atencion Integral Durango CIAID

    Durango, 34080

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

    Guadalajara, Jalisco, 44650

  • Centro de investigacion medica y reumatologia

    Guadalajara, Jalisco, 44950

  • Centro Peninsular de Investigacion Clinica, SCP

    Mérida, Yucatán, 97000

  • Medical Care & Research SA de CV

    Mérida, Yucatán, 97070

  • Centro de Investigacion Clínica GRAMEL S.C

    Mexico City, Mexico City, 03720

  • Clinstile, S.A. de C.V.

    Mexico City, Mexico City, 06700

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

    Mexico City, Mexico City, 14080

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000

Other trials in Mexico

Philippines11 sites

  • Ospital Ng Makati

    City of Taguig, 1642

  • Davao Doctors Hospital

    Davao City, Davao Region, 8000

  • The Medical City Iloilo

    Iloilo City, 5000

  • Mary Mediatrix Medical Center

    Lipa City, Batangas, 4217

  • The Medical City Clark

    Mabalacat, Pampanga, 2023

  • University of the Philippines Manila - Philippine General Hospital

    Manila, National Capital Region, 1000

  • Medical Center Manila

    Manila, 1000

  • Jose R. Reyes Memorial Medical Center

    Manila, 1012

  • St. Luke's Medical Center

    Quezon City, National Capital Region, 1102

  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation

    Quezon City, National Capital Region, 1118

  • Lorma Medical Center

    San Fernando City, La Union, 2500

Other trials in Philippines

Poland9 sites

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

    Bialystok, 15-707

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, 87-100

  • Nzoz Bif-Med

    Bytom, 41-902

  • Pratia MCM Krakow

    Krakow, 30-510

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

    Malbork, 82-200

  • Prywatna Praktyka Lekarska prof Pawel Hrycaj

    Poznan, 61-397

  • Gabinety Lekarskie Rivermed

    Poznan, 61-441

  • Przychodnia Care Access Warszawa

    Warsaw, 00-719

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

Other trials in Poland

Bulgaria8 sites

  • MC Artmed OOD

    Plovdiv, 4002

  • UMHAT "Pulmed" OOD

    Plovdiv, 4002

  • UMHAT-Plovdiv AD

    Plovdiv, 4003

  • DCC 1 - Ruse, EOOD

    Rousse, 7002

  • DCC 'Alexandrovska', EOOD

    Sofia, 1431

  • DCC Focus 5 - MEOH OOD

    Sofia, 1463

  • Military Medical Academy - MHAT - Sofia

    Sofia, 1606

  • UMHAT 'Sv. Ivan Rilski', EAD

    Sofia, 1612

Other trials in Bulgaria

Ukraine7 sites

  • CNE Cherkasy Regional Hospital of Cherkasy Regional Council,

    Cherkasy, 18009

  • CNE Regional Clinical Hospital of IFRC, Center of Cardiology, Rheumatology & Interventional Med.;

    Ivano-Frankivsk, 76018

  • CNE Kyiv City Clinical Hospital #3

    Kyiv, 02125

  • CE M.V. Sklifosovskyi Poltava Regional Clinical Hospital of PRC

    Poltava, 36011

  • Private Small Enterprise, Medical Centre 'Pulse'

    Vinnytsia, 21001

  • CNE M.I. Pyrohov Vinnytsia Reg Clinic Hosp, HSC Center of Rheumatol, Osteoporosis & Biologic Therapy

    Vinnytsia, 21008

  • University Clinic of NPMMU, Vinnytsya (TESC). Dep of Rheumatology with therapeutic beds,

    Vinnytsia, 21018

Other trials in Ukraine

Chile5 sites

  • Centro Medico Prosalud

    Santiago, 7500000

  • CTR Estudios

    Santiago, 7500571

  • Enroll Spa

    Santiago, 7500587

  • BioMedica Research Group

    Santiago, 7500710

  • Clinical Research Chile SpA.

    Valdivia, 5090000

Other trials in Chile

Romania5 sites

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

    Brasov, 500283

  • HIPERDIA SA- Centrul de Diagnostic si Tratament Hiperdia Oltenitei

    Bucharest, 041303

  • S C Delta Health Care SRL

    Bucharest, 14142

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400006

  • S.C.Centrul Medical Unirea SRL

    Iași, 700023

Other trials in Romania

Spain5 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital General de Castellon

    Castellon, Castellón, 12004

  • Hospital Universitario Marques de Valdecilla

    Santander, Castellón, 39008

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41009

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

Other trials in Spain

Hungary4 sites

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097

  • Bekes Varmegyei Kozponti Korhaz

    Gyula, 5700

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

    Székesfehérvár, Fejér, 8000

  • Vital Medical Center

    Veszprém, 8200

Other trials in Hungary

Israel4 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Meir Medical Center

    Kfar Saba, 44281

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Tel Aviv Sourasky Medical Center Pt

    Tel Aviv, 6423906

Other trials in Israel

Peru3 sites

  • Centro de Investigacion Clinica Inmunoreumatologia - ACQ Medic

    Lima, LIMA 11

  • HMA - Hospital Maria Auxiliadora

    Lima, LIMA 29

  • Invest Clinicas Sac Inst de Ginecologia y Reproduccion

    Lima, LIMA 33

Other trials in Peru

Serbia3 sites

  • Institute of Rheumatology

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Center "Bezanijska Kosa "

    Belgrade, 11080

Other trials in Serbia

United Kingdom3 sites

  • Cannock Chase Hospital

    Cannock, Staffordshire, WS11 5XY

  • Doncaster Royal Infirmary

    Doncaster, South Yorkshire, DN2 5LT

  • Guy's Hospital

    London, Greater London, SE1 9RT

Other trials in United Kingdom

Czechia2 sites

  • Revmatologie s.r.o.

    Brno, 63800

  • Fakultni nemocnice Olomouc

    Olomouc, 77520

Other trials in Czechia

South Korea2 sites

  • Hanyang University Seoul Hospital

    Seoul, 4763

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Taiwan2 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833401

  • Chung Shan Medical University Hospital

    Taichung, 40201

Other trials in Taiwan

Belgium1 site

  • Centre Hospitalier Universitaire de Liege

    Liège, 4000

Other trials in Belgium

Canada1 site

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

France1 site

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, Drôme, 63003

Other trials in France

Greece1 site

  • NNA Hospital

    Athens, Attica, 11521

Other trials in Greece

Italy1 site

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 152

Other trials in Italy

Puerto Rico1 site

  • Centro Reumatologico

    Caguas, 00725

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on adults who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will include participants who completed the treatment periods of either one of those parent studies.

The main goal of the study is to learn more about the long-term safety of litifilimab in adults. The main question researchers want to answer is:

Read more
  • How many participants have adverse events and serious adverse events during the study? Adverse events are health problems that may or may not be caused by the study drug.

Researchers will also learn about:

  • The effect of litifilimab on controlling symptoms of SLE and lowering its activity.
  • How participants' immune systems respond to litifilimab.
  • The effect of litifilimab on the quality of life of participants.

The study will be done as follows:

  • This study begins when the participant has finished 1 of the parent studies (either 230LE303 or 230LE304).
  • Participants who were getting either a high or low dose of litifilimab in either parent study will continue getting the same doses.
  • Participants who were getting the placebo in the parent studies will be randomized to get either a high or low dose of litifilimab.
  • Neither the researchers nor the participants will know which doses of litifilimab the participants are getting.
  • All participants will get litifilimab as injections under the skin once every 4 weeks. The treatment period will last up to 260 weeks. Participants may continue to take their standard of care medications.
  • There will be a follow-up safety period that lasts up to 24 weeks.
  • In total, participants will have up to 73 study visits. At these visits, the study doctor will do tests to check the participants' overall health, including the status of their SLE symptoms. They will also measure the participants' height, weight, and vital signs and collect blood and urine samples. Participants will also complete questionnaires or answer questions about how they are feeling and about their daily lives.
  • Each participant will be in the study for up to 284 weeks.

Optional Substudy:

  • Some participants may be invited to join an optional "substudy" after being in the main study for at least 4 months.
  • This substudy will test a new injector device for delivering litifilimab. The injector device is an automatic device that delivers the full dose in 1 injection without needing to push a plunger.
  • Researchers will learn more about the safety of the injector device and how the body reacts to it. This will be compared to the current prefilled syringe method.
  • The substudy will last up to 3 months and will include about 120 participants.
Read the detailed description

This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue litifilimab or placebo. Eligible participants from parent phase 3 studies will be followed for up to 284 weeks.

The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE).

The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

A phase-3, randomized, dose-blind, substudy is added in this extension study for all participants who have been enrolled in the 230LE306 Phase 3 LTE study for a minimum of 4 months and have at least four remaining visits in the Phase 3 LTE study.

The primary objective of this substudy is to evaluate the safety of injector device used for administering litifilimab in participants with active SLE.

The secondary objective of this substudy is to evaluate the tolerability of injector device used for administering litifilimab in participants with active SLE.

Being tested
Litifilimab, Litifilimab-matching placebo
Keywords
Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases, Immune System Diseases
Medical subject headings
Lupus Erythematosus, Systemic, Connective Tissue Diseases, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LitifilimabDrug

    Also called BIIB059

    Administered as specified in the treatment arm.

  • Litifilimab-matching placeboDrug

    Also called BIIB059

    Administered as specified in the treatment arm.

Study groups in NCT05352919
Study groupRoleWhat they receive
Litifilimab Low DoseExperimentalParticipants who are receiving background nonbiologic lupus standard of care (SOC) therapy and received litifilimab low dose, subcutaneously (SC), every 4 weeks (Q4W) during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab low dose, SC, Q4W from Day 1 to 260 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab low dose, SC, Q4W from Day 1 to 260 weeks with an additional dose at Week 2.
Receives: Drug: Litifilimab; Drug: Litifilimab-matching placebo
Litifilimab High DoseExperimentalParticipants who are receiving background nonbiologic lupus SOC therapy and received litifilimab high dose, SC, Q4W during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab high dose, SC, Q4W from Day 1 to 260 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab high dose, SC, Q4W from Day 1 to 260 weeks with an additional dose at Week 2.
Receives: Drug: Litifilimab; Drug: Litifilimab-matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier.

    Measured: Up to Week 284

  2. Number of Participants with Serious Adverse Events (SAEs)

    An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, and is a medically important event.

    Measured: Up to Week 284

Secondary outcomes (22)

  1. Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response

    SRI-4 is a composite endpoint defined as the following:

    • A reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score.
    • No new organ system affected, as defined by no new British Isles Lupus Activity Group-2004 (BILAG-2004 grade A) and no more than 1 new BILAG 2004 grade B versus previous visit.
    • No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point Physician's Global Assessment (PGA) visual analog scale (VAS).
    • No violation of protocol-specified medication rules

    Measured: Up to Week 284

  2. Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline who Achieved a Joint-50 Response

    Joint-50 response is a 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.

    Measured: Up to Week 284

  3. Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Score ≥10 at Baseline who Achieved a CLASI-50, CLASI-70, and CLASI-90 Response

    CLASI score is used to evaluate lupus skin manifestations. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Scores for each area are assigned based on the most severe lesion within the area of interest. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50, CLASI-70, and CLASI-90 responders are defined as ≥ 50%, ≥ 70%, and ≥ 90% improvement in CLASI-A score from baseline at the specified timepoint.

    Measured: Up to Week 284

  4. Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response

    BICLA is a composite endpoint defined as the following:

    • BILAG-2004 improvement, defined as all of BILAG-2004 Grade A at baseline improved to B, C, or D and all of BILAG-2004 Grade B at baseline improved to C or D.
    • No BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 Grade A or greater than 1 new BILAG-2004 Grade B.
    • No worsening in the SLEDAI-2K total score compared to baseline.
    • No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA VAS.
    • No violation of protocol-specified medication rules.

    Measured: Up to Week 260

  5. Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate

    A severe flare is defined as any of the following:

    • Change in SLEDAI instrument score to >12
    • New or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000/mL, or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose, increase to >0.5 milligrams per kilograms per day (mg/kg/day) or hospitalization
    • Increase in prednisone dose to >0.5 mg/kg/day
    • New requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity
    • Hospitalization for SLE activity
    • Increase in PGA score to >2.5

    Measured: Up to Week 260

  6. Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)

    LLDAS is a composite endpoint defined as the following:

    1. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents.

    "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.

    Measured: Up to Week 284

  7. Percentage of Participants With Sustained LLDAS

    LLDAS is a composite endpoint defined as the following:

    1. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents.

    "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.

    Measured: Up to Week 284

  8. Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS

    LLDAS is a composite endpoint defined as the following:

    1. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents.

    "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.

    Measured: Up to Week 284

  9. Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) Score

    SDI score is used to assess the accumulated damage in participants with SLE. It assess 12 organ systems and records damage in participants with lupus, regardless of its cause. Damage could be due to previous disease activity, medication, or intercurrent illness (such as surgery or cancer). To distinguish between active inflammation and damage, an item must be present for at least 6 months. It is assumed that persistent inflammation (for at least 6 months) would result in tissue injury and hence damage. SDI is evaluated on a scale 0-47 with higher score indicating higher damage.

    Measured: Up to Week 260

  10. Cumulative Exposure to OCS Over Time

    Measured: Up to Week 260

  11. Percentage of Participants With OCS ≤7.5 mg

    Measured: Up to Week 260

  12. Percentage of Participants With OCS ≤5 mg

    Measured: Up to Week 260

  13. Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score

    The LupusQoL is a participant-reported, lupus-specific, HRQoL questionnaire consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all the time. A LupusQoL score for each domain will be reported on a 0 to 100 scale, with greater values indicating better HRQoL.

    Measured: Up to Week 260

  14. Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score

    The SF-36 is a 36-item scale which assesses HRQoL in 8 domains: limitations in physical activities due to health problems, limitations in social activities due to physical or emotional problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to emotional problems, vitality (energy and fatigue), general health perceptions. The SF-36 (Acute Version) form asks for participants to reply to questions (items) according to how they have felt over a specifically defined period of time. Items 1-4 primarily contribute to the physical component summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36 where higher scores indicate best health. Scores on each item are summed and averaged (range: 0=worse health to 100=best possible health).

    Measured: Up to Week 156

  15. Change From Baseline in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)

    The EQ-5D is a standardized generic measure of health status developed by the European Quality of Life Group. This study uses the EQ-5D-3L version of the instrument. This instrument consists of 2 sections. The first section comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. All dimensions are measured on a 3-point scale, 1: No problems; 2: Some problems; 3: Extreme problems. The second section comprises the Visual Analogue Scale, which records the respondent's self-rated health on a vertical scale ranging from 0 to 100, lower scores indicate the worst possible health state.

    Measured: Up to Week 156

  16. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score

    The FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in 5 broad categories: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns. The level of fatigue is measured by questions assessed on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue.

    Measured: Up to Week 260

  17. Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score

    The PHQ-9 is a participant-administered HRQoL questionnaire to screen for the presence and severity of depression. The PHQ-9 is a participant-reported outcome (PRO) that is used to measure depression in adults. It contains 9 questions, with a 2 week recall period. The PHQ-9 yields an overall severity score that can range from 0 to 27 with the following severity scores: 0-4 = none; 5-9 = mild; 10-14 = moderate; 15-19 = moderate-to-severe; and 20-27 = severe.

    Measured: Up to Week 260

  18. Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score

    WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. Each score ranges from 0 to 100, with higher numbers indicating greater impairment and less productivity.

    Measured: Up to Week 260

  19. Change from Baseline in Patient Global Assessment (PtGA) Score

    The PtGA is participant-administered, single-item question evaluating the impact of health and illness, with responses ranging from very poor to very well on a 100 mm VAS. The participant will consider the previous week when addressing this question.

    Measured: Up to Week 260

  20. Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters

    Standard laboratory parameters will include hematology, blood chemistry, urinalysis, and coagulation.

    Measured: Up to Week 284

  21. Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results

    Measured: Up to Week 260

  22. Number of Participants with Antibodies to Litifilimab

    Measured: Up to Week 284

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start10 Jun 2022
  3. Primary completion3 May 2032 (estimated)
  4. Study completion3 May 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
864 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352919
Sponsor's protocol ID
230LE306
Other IDs
2021-006378-22, 2023-505635-13, 2023
Acronym
EMERALD
Status last verified
Sep 2026
First submitted
25 Apr 2022
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Litifilimab in people with Systemic Lupus Erythematosus (SLE), run by Biogen at 214 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 214 sites in United States, Japan, Argentina, China, Brazil and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Week 284). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05352919.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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