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

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

864

Participants

Timeline

Start Date

June 10, 2022

Primary Completion Date

March 29, 2030

Study Completion Date

March 29, 2030

Conditions
Systemic Lupus Erythematosus (SLE)
Interventions
DRUG

Litifilimab

Administered as specified in the treatment arm.

DRUG

Litifilimab-matching placebo

Administered as specified in the treatment arm.

Trial Locations (157)

152

Azienda Ospedaliera San Camillo Forlanini, Roma

1000

University of the Philippines Manila - Philippine General Hospital, Manila

Medical Center Manila, Manila

1097

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest

1118

Far Eastern University - Dr. Nicanor Reyes Medical Foundation, Quezon City

1425

Centro Medico Barrio Parque, Buenos Aires

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada, Ciudad Autonoma Buenos Aires

1431

DCC 'Alexandrovska', EOOD, Sofia

1463

DCC Focus 5 - MEOH OOD, Sofia

1606

Military Medical Academy - MHAT - Sofia, Sofia

4000

Clinica Mayo de Urgencias Medicas Cruz Blanca SRL, San Miguel de Tucumán

Centre Hospitalier Universitaire de Liege, Liège

4002

MC Artmed OOD, Plovdiv

"UMHAT Pulmed OOD", Plovdiv

4003

UMHAT-Plovdiv AD, Plovdiv

4217

Mary Mediatrix Medical Center, Lipa City

4763

Hanyang University Seoul Hospital, Seoul

5400

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

5500

Instituto de Reumatologia, Mendoza

5700

Bekes Varmegyei Kozponti Korhaz, Gyula

7002

DCC 1 - Ruse, EOOD, Rousse

7600

Centro de Investigaciones Medicas Mar del Plata, Mar del Plata

8000

Vita Verum Medical Egeszsegugyi Szolgaltato Bt., Székesfehérvár

Davao Doctors Hospital, Davao City

8200

Vital Medical Center, Veszprém

11000

Institute of Rheumatology, Belgrade

University Clinical Center of Serbia, Belgrade

11080

"Clinical Center Bezanijska Kosa ", Belgrade

11220

NYU Langone Brooklyn, Brooklyn

11521

NNA Hospital, Athens

14080

Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran, Mexico City

14142

S C Delta Health Care SRL, Bucharest

16499

Ajou University Hospital, Suwon

28210

DJL Clinical Research, PLLC, Charlotte

30501

Arthritis Center of North Georgia, Gainesville

31000

Investigacion y Biomedicina de Chihuahua, S.C., Chihuahua City

32713

Omega Research Consultants, DeBary

33024

GNP Research at Mark Jaffe, MD, Cooper City

33063

Life Clinical Trials, Margate

33180

Arthritis & Rheumatic Disease Specialties, Aventura

33606

Clinical Research of West Florida, Inc., Tampa

33613

AdventHealth Medical Group, Tampa

33765

Clinical Research of West Florida - Corporate, Clearwater

34080

Centro de Investigacion y Atencion Integral Durango CIAID, Durango

38119

Ramesh C Gupta, MD, Memphis

38305

West Tennessee Research Institute, Jackson

39008

Hospital Universitario Marques de Valdecilla, Santander

41009

Hospital Universitario Virgen Macarena, Seville

41010

Hospital Quironsalud Infanta Luisa, Seville

44130

Paramount Medical Research & Consulting, LLC, Middleburg Heights

44281

Meir Medical Center, Kfar Saba

44650

Clinica de Investigacion en Reumatologia y Obesidad S.C., Guadalajara

44950

Centro de investigacion medica y reumatologia, Guadalajara

45219

University of Cincinnati, Cincinnati

48504

AA MRC LLC Ahmed Arif Medical Research Center, Flint

62448

Consultorio Privado Dr. Miguel Cortes Hernandez, Cuernavaca

63003

CHU Clermont Ferrand - Hopital Gabriel Montpied, Clermont-Ferrand

63119

Saint Louis Rheumatology, St Louis

63800

Revmatologie s.r.o., Brno

76034

Precision Comprehensive Clinical Research Solutions, Colleyville

77338

Accurate Clinical Research, Inc., Humble

77382

Advanced Rheumatology of Houston, The Woodlands

77520

Fakultni nemocnice Olomouc, Olomouc

77521

Accurate Clinical Research, Baytown

78215

Sun Research Institute, LLC, San Antonio

80045

University of Colorado Denver, Aurora

85037

Arizona Arthritis & Rheumatology Associates, P.C., Phoenix

90211

Wallace Rheumatic Study Center, Beverly Hills

91345

Providence Facey Medical Foundation, Mission Hills

91786

Inland Rheumatology Clinical Trials, Inc., Upland

92648

Care Access Research - Huntington Beach, Huntington Beach

97000

Centro Peninsular de Investigacion Clinica, SCP, Mérida

97070

Medical Care & Research SA de CV, Mérida

98104

Swedish Medical Center, Seattle

100053

Xuanwu Hospital Capital Medical University, Beijing

110221

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

130021

Jilin Province People's Hospital, Changchun

The First Hospital of Jilin University, Changchun

200001

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

250001

Preventive Care Ltda, Chía

250252

Healthy Medical Center, Zipaquirá

256603

Binzhou Medical University Hospital, Binzhou

315010

The First Affiliated Hospital of Ningbo University, Ningbo

332000

Jiujiang No.1 People's Hospital, Jiujiang

337055

Pingxiang People's Hospital, Pingxiang

400006

Spitalul Clinic Judetean de Urgenta Cluj Napoca, Cluj-Napoca

410008

Xiangya Hospital, Central South University, Changsha

412000

ZhuZhou Central Hospital, Zhuzhou

500283

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

510317

Guangdong Second Provincial General Hospital, Guangzhou

510515

Nanfang Hospital of Southern Medical University, Guangzhou

518020

Shenzhen People's Hospital, Shenzhen

523059

Dongguan People's Hospital, Dongguan

570311

Hainan General Hospital, Haikou

680003

Servimed S.A.S., Bucaramanga

700023

S.C.Centrul Medical Unirea SRL, Iași

760001

IPS Centro Medico Julian Coronel S.A., Santiago de Cali

833401

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

3109601

Rambam Health Care Campus, Haifa

3151878

Instituto de Investigaciones Clinicas Quilmes, Buenos Aires

6423906

Tel Aviv Sourasky Medical Center Pt, Tel Aviv

7500000

Centro Medico Prosalud, Santiago

7500571

CTR Estudios, Santiago

7500587

Enroll Spa, Santiago

7500710

BioMedica Research Group, Santiago

17251900

Hospital Italiano de La Plata, Buenos Aires

20007-2113

Georgetown University Hospital-Medstar, Washington D.C.

01655

University of Massachusetts Chan Medical School, Worcester

76034-5913

Precision Comprehensive Clinical Research Solution, Colleyville

C1015ABO

Organizacion Medica de Investigacion (OMI), CABA

B7600GNY

Policlìnica Red Omip S.A - Ensayos Clinicos GC, Mar del Plata

B1663

Centro Dermatologico Schejtman, San Miguel

S2000PBJ

Instituto CAICI, Rosario

T4000AXL

Centro de Investigaciones Medicas Tucuman, San Miguel de Tucumán

T4000ICL

Investigaciones Clinicas Tucuman, San Miguel de Tucumán

C1013AAB

STAT Research S.A., Ciudad Autonoma Buenos Aires

60430-372

HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará, Fortaleza

29055-450

CEDOES - Diagnóstico e Pesquisa, Vitória

40150-150

Clínica SER da Bahia, Salvador

70200-730

L2IP - Instituto de Pesquisas Clínicas Ltda., Brasília

78020-500

IPC MT Instituto de Pesquisas Clinicas do Mato Grosso, Santo Ângelo

30150-221

Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte

36010-570

CMiP - Centro Mineiro de Pesquisa, Juiz de Fora

80030-110

CETI - Centro de Estudos em Terapias Inovadoras Ltda., Curitiba

90480-000

LMK Serviços Médicos S/S Ltda, Porto Alegre

15090-000

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

09715-090

Centro Multidisciplinar de Estudos Clínicos - CEMEC, São Bernardo do Campo

01228-200

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos, São Paulo

080020

Centro de Investigacion Medico Asistencial S.A.S, Barranquilla

Clínica de la Costa S.A.S, Barranquilla

457-8510

JCHO Chukyo Hospital, Nagoya

260-8712

NHO Chibahigashi National Hospital, Chiba

810-8539

KKR Hamanomachi Hospital, Fukuoka

810-8563

NHO Kyushu Medical Center, Fukuoka

734-8551

Hiroshima University Hospital, Hiroshima

060-0004

Tonan Hospital, Sapporo

670-8540

Japanese Red Cross Society Himeji Hospital, Himeji-shi

761-0793

Kagawa University Hospital, Kita-gun

245-8575

NHO Yokohama Medical Center, Yokohama

861-8520

Japanese Red Cross Kumamoto Hospital, Kumamoto

589-8511

Kindai University Hospital, Osakasayama-shi

173-8610

Nihon University Itabashi Hospital, Itabashi-ku

153-8515

Toho University Ohashi Medical Center, Meguro-ku

162-8655

Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku

03720

Centro de Investigacion Clínica GRAMEL S.C, Mexico City

06700

Clinstile, S.A. de C.V., Mexico City

LIMA 29

HMA - Hospital Maria Auxiliadora, Lima

15-707

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

87-100

Szpital Uniwersytecki nr 2 im.dr J. Biziela, Bydgoszcz

41-902

Nzoz Bif-Med, Bytom

30-510

Pratia MCM Krakow, Krakow

82-200

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

00-874

MICS Centrum Medyczne Warszawa, Warsaw

00725

Centro Reumatologico, Caguas

08035

Hospital Universitari Vall d'Hebron, Barcelona

SE1 9RT

Guy's Hospital, London

DN2 5LT

Doncaster Royal Infirmary, Doncaster

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY