An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (EMERALD)

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 participants 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 enroll participants who completed the treatment periods of either one of the parent studies.

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

- How many participants have adverse events and serious adverse events? Researchers will also learn about the effect litifilimab has on controlling symptoms of SLE and lowering its activity. They will measure symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the British Isles Lupus Activity Group-2004 (BILAG-2004), among others.

Researchers will also study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires.

The study will be done as follows:

• The Week 52 visit of studies 230LE303 and 230LE304 will be Day 1 of this study.
• Participants who were receiving either a high or low dose of litifilimab in the parent studies will continue receiving the same doses.
• Participants who were receiving placebo in the parent studies will be randomized to receive either a high or low dose of litifilimab.
• All participants will receive litifilimab as injections under the skin once every 4 weeks. The treatment period will last 156 weeks. Participants may continue to take their standard of care medications.
• Neither the researchers nor the participants will know which doses of litifilimab the participants are receiving.
• There will be a follow-up safety period that lasts up to 24 weeks.
• In total, participants will have up to 47 study visits. The total study duration for participants will be up to 180 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 giving litifilimab. The injector device is an automatic device that delivers the full dose in one injection without needing to push a plunger. Researchers will compare the safety and tolerability of the injector device and how the body reacts to it to the current prefilled syringe method. The substudy will last 3 months and will include about 120 participants.

Study Overview

• Status: Enrolling by invitation
• Conditions: Systemic Lupus Erythematosus (SLE)
• Intervention / Treatment: Drug: Litifilimab; Drug: Litifilimab-matching placebo

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 180 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.

• Study Type: Interventional
• Enrollment (Estimated): 864
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 17251900
    • Hospital Italiano de La Plata
  • Buenos Aires, Argentina, 3151878
    • Instituto de Investigaciones Clinicas Quilmes
  • Ciudad Autonoma Buenos Aires, Argentina, C1013AAB
    • Stat Research S.A.
  • Ciudad Autonoma Buenos Aires, Argentina, 1425
    • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
  • Córdoba, Argentina, 5000
    • Sanatorio Allende
  • Mendoza, Argentina, 5500
    • Instituto de Reumatologia
  • San Juan, Argentina, 5400
    • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1015ABO
      • Organizacion Medica de Investigacion (OMI)
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Centro de Investigaciones Medicas Mar del Plata
    • Mar del Plata, Buenos Aires, Argentina, B7600GNY
      • Policlìnica Red Omip S.A - Ensayos Clinicos GC
    • San Miguel, Buenos Aires, Argentina, B1663
      • Centro Dermatologico Schejtman
  • Ciudad Autonoma Buenos Aires
    • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1425
      • Centro Medico Barrio Parque
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000PBJ
      • Instituto CAICI
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
      • Centro de Investigaciones Médicas Tucuman
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000ICL
      • Investigaciones Clinicas Tucuman
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
• Belgium
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège
• Brazil
  • São Paulo, Brazil, 04037-030
    • RDSS Ricardo Diaz Scientific Solution
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-372
      • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29055-450
      • CEDOES - Diagnóstico e Pesquisa
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40150-150
      • Clínica SER da Bahia
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • L2IP - Instituto de Pesquisas Clínicas Ltda.
  • Mato Grosso
    • Santo Ângelo, Mato Grosso, Brazil, 78020-500
      • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Santa Casa De Misericórdia de Belo Horizonte
    • Juiz de Fora, Minas Gerais, Brazil, 36010-570
      • CMiP - Centro Mineiro de Pesquisa
  • Paraná
    • Curitiba, Paraná, Brazil, 80030-110
      • CETI - Centro de Estudos em Terapias Inovadoras Ltda.
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
      • LMK Serviços Médicos S/S Ltda
    • Porto Alegre, Rio Grande do Sul, Brazil, 90560032
      • Hospital Moinhos de Vento
  • São Paulo
    • Sao Jose Rio Preto, São Paulo, Brazil, 15090-000
      • Fundação Faculdade Regional de Medicina de São José do Rio Preto
    • São Bernardo do Campo, São Paulo, Brazil, 09715-090
      • Centro Multidisciplinar de Estudos Clínicos - CEMEC
    • São Paulo, São Paulo, Brazil, 01228-200
      • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
    • Valinhos, São Paulo, Brazil, 13271-130
      • A2Z Clinical Centro Avancado de Pesquisa Clinica
• Bulgaria
  • Plovdiv, Bulgaria, 4003
    • UMHAT-Plovdiv AD
  • Plovdiv, Bulgaria, 4002
    • MC Artmed OOD
  • Plovdiv, Bulgaria, 4002
    • UMHAT "Pulmed" OOD
  • Rousse, Bulgaria, 7002
    • DCC 1 - Ruse, EOOD
  • Sofia, Bulgaria, 1431
    • Dcc 'Alexandrovska', Eood
  • Sofia, Bulgaria, 1606
    • Military Medical Academy - MHAT - Sofia
  • Sofia, Bulgaria, 1463
    • DCC Focus 5 - MEOH OOD
  • Sofia, Bulgaria, 1612
    • UMHAT 'Sv. Ivan Rilski', EAD
• Chile
  • Santiago, Chile, 7500710
    • Biomedica Research Group
  • Santiago, Chile, 7500000
    • Centro Medico Prosalud
  • Santiago, Chile, 7500571
    • Ctr Estudios
  • Santiago, Chile, 7500587
    • Enroll SpA
  • Valdivia, Chile, 5090000
    • Clinical Research Chile SpA.
• China
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Xuanwu Hospital Capital Medical University
  • Guangdong
    • Dongguan, Guangdong, China, 523059
      • Dongguan People's Hospital
    • Guangzhou, Guangdong, China, 510317
      • Guangdong Second Provincial General Hospital
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
    • Shenzhen, Guangdong, China, 518020
      • Shenzhen People's Hospital
    • Zhongshan, Guangdong, China, 528400
      • Zhongshan TCM Hospital
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 50000
      • The Second Hospital of Hebei Medical University
  • Hu'nan
    • Changsha, Hu'nan, China, 410008
      • Xiangya Hospital, Central South University
    • Zhuzhou, Hu'nan, China, 412000
      • Zhuzhou Central Hospital
  • Jiangsushe
    • Suzhou, Jiangsushe, China, 215004
      • The Second Affiliated Hospital of Soochow University
  • Jiangxi
    • Jiujiang, Jiangxi, China, 332000
      • Jiujiang No.1 People's Hospital
    • Pingxiang, Jiangxi, China, 337055
      • Pingxiang People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • Jilin Province People's Hospital
  • Shandong
    • Binzhou, Shandong, China, 256603
      • Binzhou Medical University Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200001
      • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • The First Affiliated Hospital of Ningbo University
• Colombia
  • Armenia, Colombia, 630004
    • Fundacion Cardiomet CEQUIN S.A.S
  • Barranquilla, Colombia, 080020
    • Centro de Investigacion Medico Asistencial S.A.S
  • Barranquilla, Colombia, 080020
    • Clinica de la Costa S.A.S
  • Bogotá, Colombia, 110221
    • Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
  • Bucaramanga, Colombia, 680003
    • Servimed S.A.S.
  • Chía, Colombia, 250001
    • Preventive Care Ltda
  • Zipaquirá, Colombia, 250252
    • Healthy Medical Center
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760001
      • IPS Centro Medico Julián Coronel S.A.
• Czechia
  • Brno, Czechia, 63800
    • Revmatologie s.r.o.
  • Olomouc, Czechia, 77520
    • Fakultni nemocnice Olomouc
• France
  • Drôme
    • Clermont-Ferrand, Drôme, France, 63003
      • CHU Clermont Ferrand - Hopital Gabriel Montpied
• Greece
  • Attica
    • Athens, Attica, Greece, 11521
      • NNA Hospital
• Hungary
  • Budapest, Hungary, 1097
    • Dél-Pesti Centrumkórház - Országos Hematológiai És Infektológiai Intézet
  • Gyula, Hungary, 5700
    • Békés Vármegyei Központi Kórház
  • Veszprém, Hungary, 8200
    • Vital Medical Center
  • Fejér
    • Székesfehérvár, Fejér, Hungary, 8000
      • Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center Pt
• Italy
  • Roma, Italy, 152
    • Azienda Ospedaliera San Camillo Forlanini
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 457-8510
      • Jcho Chukyo Hospital
    • Toyoake-shi, Aichi-ken, Japan, 470-1192
      • Fujita Health University Hospital
  • Chiba
    • Chiba, Chiba, Japan, 260-8712
      • NHO Chibahigashi National Hospital
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 810-8539
      • KKR Hamanomachi Hospital
    • Fukuoka, Fukuoka, Japan, 810-8563
      • NHO Kyushu Medical Center
    • Kitakyushu-shi, Fukuoka, Japan, 807-8556
      • Hospital of the University of Occupational and Environmental Health
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 734-8551
      • Hiroshima University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0004
      • Tonan Hospital
  • Hyōgo
    • Himeji-shi, Hyōgo, Japan, 670-8540
      • Japanese Red Cross Society Himeji Hospital
    • Kobe, Hyōgo, Japan, 650-0017
      • Kobe University Hospital
  • Kagawa-ken
    • Kita-gun, Kagawa-ken, Japan, 761-0793
      • Kagawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 245-8575
      • NHO Yokohama Medical Center
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 861-8520
      • Japanese Red Cross Kumamoto Hospital
  • Osaka
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital
  • Tokyo-To
    • Itabashi-ku, Tokyo-To, Japan, 173-8610
      • Nihon University Itabashi Hospital
    • Meguro-ku, Tokyo-To, Japan, 153-8515
      • Toho University Ohashi Medical Center
    • Shinjuku-ku, Tokyo-To, Japan, 162-8655
      • Center Hospital of the National Center for Global Health and Medicine
• Mexico
  • Chihuahua City, Mexico, 31000
    • Investigacion y Biomedicina de Chihuahua, S.C.
  • Durango, Mexico, 34080
    • Centro de Investigacion y Atencion Integral Durango CIAID
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • Clinica de Investigacion en Reumatologia y Obesidad S.C.
    • Guadalajara, Jalisco, Mexico, 44950
      • Centro de investigacion medica y reumatologia
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06700
      • Clinstile, S.A. de C.V.
    • Mexico City, Mexico City, Mexico, 03720
      • Centro de Investigacion Clínica GRAMEL S.C
    • Mexico City, Mexico City, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62448
      • Consultorio Privado Dr. Miguel Cortes Hernandez
  • Yucatán
    • Mérida, Yucatán, Mexico, 97000
      • Centro Peninsular de Investigacion Clinica, SCP
    • Mérida, Yucatán, Mexico, 97070
      • Medical Care & Research SA de CV
• Peru
  • Lima, Peru, LIMA 33
    • Invest Clinicas Sac Inst de Ginecologia y Reproduccion
  • Lima, Peru, LIMA 29
    • HMA - Hospital Maria Auxiliadora
  • Lima, Peru, LIMA 11
    • Centro de Investigacion Clinica Inmunoreumatologia - ACQ Medic
• Philippines
  • City of Taguig, Philippines, 1642
    • Ospital ng Makati
  • Iloilo City, Philippines, 5000
    • The Medical City Iloilo
  • Manila, Philippines, 1000
    • Medical Center Manila
  • Batangas
    • Lipa City, Batangas, Philippines, 4217
      • Mary Mediatrix Medical Center
  • Davao Region
    • Davao City, Davao Region, Philippines, 8000
      • Davao Doctors Hospital
  • National Capital Region
    • Manila, National Capital Region, Philippines, 1000
      • University of the Philippines Manila - Philippine General Hospital
    • Quezon City, National Capital Region, Philippines, 1102
      • St. Luke's Medical Center
    • Quezon City, National Capital Region, Philippines, 1118
      • Far Eastern University - Dr. Nicanor Reyes Medical Foundation
• Poland
  • Bialystok, Poland, 15-707
    • Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
  • Bydgoszcz, Poland, 87-100
    • Szpital Uniwersytecki nr 2 im.dr J. Biziela
  • Bytom, Poland, 41-902
    • Nzoz Bif-Med
  • Krakow, Poland, 30-510
    • Pratia McM Krakow
  • Malbork, Poland, 82-200
    • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
  • Poznan, Poland, 61-441
    • Gabinety Lekarskie Rivermed
  • Poznan, Poland, 61-397
    • Prywatna Praktyka Lekarska prof Pawel Hrycaj
  • Warsaw, Poland, 00-874
    • MICS Centrum Medyczne Warszawa
  • Warsaw, Poland, 00-719
    • Przychodnia Care Access Warszawa
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Centro Reumatologico
• Romania
  • Brasov, Romania, 500283
    • S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
  • Bucharest, Romania, 14142
    • S C Delta Health Care SRL
  • Cluj-Napoca, Romania, 400006
    • Spitalul Clinic Judetean de Urgenta Cluj Napoca
  • Iași, Romania, 700023
    • S.C.Centrul Medical Unirea SRL
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia
  • Belgrade, Serbia, 11080
    • Clinical Center "Bezanijska Kosa "
• South Korea
  • Seoul, South Korea, 4763
    • Hanyang University Seoul Hospital
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Seville, Spain, 41010
    • Hospital Quironsalud Infanta Luisa
  • Castellón
    • Santander, Castellón, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • Sevilla
    • Seville, Sevilla, Spain, 41009
      • Hospital Universitario Virgen Macarena
• Taiwan
  • Kaohsiung City, Taiwan, 833401
    • Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, SE1 9RT
      • Guy's Hospital
  • South Yorkshire
    • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
      • Doncaster Royal Infirmary
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85037
      • Arizona Arthritis & Rheumatology Associates, P.C.
  • California
    • Beverly Hills, California, United States, 90211
      • Wallace Rheumatic Study Center
    • Huntington Beach, California, United States, 92648
      • Care Access Research - Huntington Beach
    • Mission Hills, California, United States, 91345
      • Providence Facey Medical Foundation
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007-2113
      • Georgetown University Hospital-Medstar
  • Florida
    • Aventura, Florida, United States, 33180
      • Arthritis & Rheumatic Disease Specialties
    • Avon Park, Florida, United States, 33825
      • Highlands Research Institute
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida - Corporate
    • Cooper City, Florida, United States, 33024
      • GNP Research at Mark Jaffe, MD
    • DeBary, Florida, United States, 32713
      • Omega Research Consultants
    • Margate, Florida, United States, 33063
      • Life Clinical Trials
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida, Inc.
    • Tampa, Florida, United States, 33613
      • AdventHealth Medical Group
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Arthritis Center of North Georgia
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Chan Medical School
  • Michigan
    • Flint, Michigan, United States, 48504
      • AA MRC LLC Ahmed Arif Medical Research Center
    • Rochester Hills, Michigan, United States, 48307
      • Precision Comprehensive Clinical Research Solutions
  • Missouri
    • St Louis, Missouri, United States, 63119
      • Saint Louis Rheumatology
  • New York
    • Brooklyn, New York, United States, 11220
      • NYU Langone Brooklyn
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research, PLLC
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research & Consulting, LLC
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
    • Memphis, Tennessee, United States, 38119
      • Ramesh C Gupta, MD
  • Texas
    • Allen, Texas, United States, 75013
      • Arthritis & Rheumatology Research Institute
    • Austin, Texas, United States, 78745
      • Tekton Research - PARENT
    • Baytown, Texas, United States, 77521
      • Accurate Clinical Research
    • Colleyville, Texas, United States, 76034
      • Precision Comprehensive Clinical Research Solutions
    • Colleyville, Texas, United States, 76034-5913
      • Precision Comprehensive Clinical Research Solution
    • Houston, Texas, United States, 77054
      • Prolato Clinical Research Center
    • Humble, Texas, United States, 77338
      • Accurate Clinical Research, Inc.
    • Katy, Texas, United States, 77450
      • R and H Clinical Research
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute, LLC
    • The Woodlands, Texas, United States, 77382
      • Advanced Rheumatology of Houston
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Litifilimab Low Dose; Participants 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 up to 152 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 up to 152 weeks with an additional dose at Week 2.	Drug: Litifilimab; Administered as specified in the treatment arm.; Other Names: BIIB059; Drug: Litifilimab-matching placebo; Administered as specified in the treatment arm.; Other Names: BIIB059
Experimental: Litifilimab High Dose; Participants 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 up to 152 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 up to 152 weeks with an additional dose at Week 2.	Drug: Litifilimab; Administered as specified in the treatment arm.; Other Names: BIIB059; Drug: Litifilimab-matching placebo; Administered as specified in the treatment arm.; Other Names: BIIB059

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Week 180
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.	Up to Week 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to Week 180
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	Up to Week 156
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.	Up to Week 156
Cumulative Exposure to OCS Over Time		Up to Week 156
Percentage of Participants With OCS ≤7.5 mg		Up to Week 156
Percentage of Participants With OCS ≤5 mg		Up to Week 156
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.	Up to Week 156
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).	Up to Week 156
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.	Up to Week 156
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.	Up to Week 156
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.	Up to Week 156
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.	Up to Week 156
Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters	Standard laboratory parameters will include hematology, blood chemistry, urinalysis, and coagulation.	Up to Week 180
Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)	LLDAS is a composite endpoint defined as the following: i. 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.	Up to Week 180
Percentage of Participants With Sustained LLDAS	LLDAS is a composite endpoint defined as the following: i. 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.	Up to Week 180
Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS	LLDAS is a composite endpoint defined as the following: i. 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.	Up to Week 180
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.	Up to Week 156
Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results		Up to Week 156
Number of Participants with Antibodies to Litifilimab		Up to Week 180
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.	Up to Week 180
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.	Up to Week 180
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.	Up to Week 180

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Estimated): March 29, 2030
• Study Completion (Estimated): March 29, 2030

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Immune System Diseases; Connective Tissue Diseases; Lupus Erythematosus; Systemic Autoimmune Diseases
• Additional Relevant MeSH Terms: Autoimmune Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Immune System Diseases; Connective Tissue Diseases
• Other Study ID Numbers: 230LE306; 2021-006378-22 (EudraCT Number); 2023-505635-13 (Other Identifier: EU CTIS Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No