A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

Who is this study for? Adults with active systemic lupus erythematosus receiving background nonbiologic lupus standard of care
What treatments are being studied? BIIB059
Status: Recruiting
Location: See all (177) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: \- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the 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 Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will 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: * After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. * All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. * Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, at screening by a qualified physician.

• Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-200 (SLEDAI-2K) score ≥6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated).

• Participant has a modified clinical SLEDAI-2K score ≥4 (excluding anti-dsDNA, low complement component 3 \[C3\] and/or complement component 4 \[C4\], alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated) and randomization.

• Participant has BILAG-2004 grade A in ≥1 organ system or BILAG-2004 grade B in ≥2 organ systems at screening (adjudicated) and randomization.

• Participants must be treated with one of the following background nonbiologic lupus SOC therapies, initiated ≥12 weeks prior to screening and at stable dose ≥4 weeks prior to randomization:

‣ Antimalarials as stand-alone treatment

⁃ Antimalarial treatment in combination with OCS and/or a single immunosuppressant

⁃ Treatment with OCS and/or a single immunosuppressant.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Arizona Arthritis & Rheumatology Associates, P.C.
RECRUITING
Glendale
California
Care Access Research - Huntington BeachCare Access Research - Huntington Beach
RECRUITING
Huntington Beach
Valerius Medical Group
RECRUITING
Los Alamitos
The Practice of Medicine
RECRUITING
Los Angeles
R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
RECRUITING
Monterey Park
Neurovations
RECRUITING
Napa
Joo-Hyung Lee MD
RECRUITING
Orange
Medvin Clinical Research
RECRUITING
Whittier
Florida
RASF - Clinical Research Center
COMPLETED
Boca Raton
University of Florida
RECRUITING
Gainesville
Vida Clinical Research
RECRUITING
Kissimmee
University of Miami Miller School of Medicine
RECRUITING
Miami
HMD Research, LLC
RECRUITING
Orlando
Clinical Research of West Florida, Inc.
RECRUITING
Tampa
Georgia
The Emory Clinic Emory University
RECRUITING
Atlanta
Jefrey Lieberman, M.D., P.C.
COMPLETED
Decatur
RNA America Health Sciences
COMPLETED
Gainesville
Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia
RECRUITING
Gainesville
EBGS Clinical Trials
RECRUITING
Snellville
Illinois
Rush University Medical Center
RECRUITING
Chicago
Massachusetts
Boston University School of Medicine
RECRUITING
Boston
DM Clinical Research - Boston
RECRUITING
Brookline
University of Massachusetts
RECRUITING
Worcester
Missouri
Saint Louis Rheumatology
RECRUITING
St Louis
North Carolina
DJL Clinical Research, PLLC
RECRUITING
Charlotte
Carolina Arthritis Associates
COMPLETED
Wilmington
New Jersey
Arthritis & Osteoporosis Associates, PA
COMPLETED
Freehold
New Mexico
Arthritis and Osteoporosis Associates of New Mexico
RECRUITING
Las Cruces
Ohio
University of Cincinnati
RECRUITING
Cincinnati
STAT Research
RECRUITING
Dayton
South Carolina
Piedmont Arthritis Clinic, P.A.
RECRUITING
Greenville
Low Country Rheumatology, PA
COMPLETED
Summerville
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Texas
Arthritis & Rheumatology Institute
RECRUITING
Allen
Office of John P. Lavery M.D., PA
COMPLETED
Allen
Tekton Research
RECRUITING
Austin
Precision Comprehensive Clinical Research Solutions
RECRUITING
Colleyville
R and H Clinical Research
RECRUITING
Katy
Prime Clinical Research
RECRUITING
Mansfield
SouthWest Rheumatology Research, LLC
COMPLETED
Mesquite
Sun Research Institute, LLC
RECRUITING
San Antonio
The University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
Argentina
APRILLUS Asistencia e Investigacion
RECRUITING
Buenos Aires
Centro Medico Barrio Parque
RECRUITING
Buenos Aires
Hospital Italiano de La Plata
RECRUITING
Buenos Aires
Instituto de Investigaciones Clinicas Quilmes
RECRUITING
Buenos Aires
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
RECRUITING
Ciudad Autonoma Buenos Aires
Centro Privado de Medicina Familiar - Mind Out Research
RECRUITING
Ciudad Autonoma Buenos Aires
Hospital Britanico de Buenos Aires
RECRUITING
Ciudad Autonoma Buenos Aires
Hospital General de Agudos Dr. J. M. Ramos Mejia
RECRUITING
Ciudad Autonoma Buenos Aires
Organizacion Medica de Investigacion (OMI)
RECRUITING
Ciudad Autonoma Buenos Aires
STAT Research S.A.
RECRUITING
Ciudad Autonoma Buenos Aires
Sanatorio Allende
RECRUITING
Córdoba
Centro de Investigaciones Medicas Mar del Plata
RECRUITING
Mar Del Plata
Policlìnica Red Omip S.A - Ensayos Clinicos GC
RECRUITING
Mar Del Plata
Instituto de Reumatologia
RECRUITING
Mendoza
Instituto CAICI
RECRUITING
Rosario
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
RECRUITING
San Juan
Centro Dermatologico Schejtman
RECRUITING
San Miguel
Centro de Investigaciones Medicas Tucuman
RECRUITING
San Miguel De Tucumán
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
RECRUITING
San Miguel De Tucumán
Investigaciones Clinicas Tucuman
RECRUITING
San Miguel De Tucumán
Belgium
UZ Leuven
RECRUITING
Leuven
Centre Hospitalier Universitaire de Liege
RECRUITING
Liège
Canada
The Waterside Clinic
RECRUITING
Barrie
Hamilton Health Sciences Corporation
RECRUITING
Hamilton
The Ottawa Hospital - General Campus
RECRUITING
Ottawa
China
Beijing Chaoyang Hospital, Capital Medical University
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
Binzhou Medical University Hospital
RECRUITING
Binzhou
Jilin Province People's Hospital
RECRUITING
Changchun
The First Hospital of Jilin University
RECRUITING
Changchun
The second Xiangya Hospital of Central South University
RECRUITING
Changsha
Xiangya Hospital, Central South University
RECRUITING
Changsha
The First Affiliated Hospital of Chengdu Medical College
RECRUITING
Chengdu
Dongguan People's Hospital
RECRUITING
Dongguan
Guangdong Second Provincial General Hospital
RECRUITING
Guangzhou
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
Hainan General Hospital
RECRUITING
Haikou
Jiujiang No.1 People's Hospital
RECRUITING
Jiujiang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Jiangxi Pingxiang People's Hospital
RECRUITING
Pingxiang
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
RECRUITING
Shanghai
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shenzhen People's Hospital
RECRUITING
Shenzhen
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Wenzhou People's Hospital
RECRUITING
Wenzhou
EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Yanbian University Hospital (Yanbian Hospital)
RECRUITING
Yanji
ZhuZhou Central Hospital
RECRUITING
Zhuzhou
Colombia
Centro de Investigacion Medico Asistencial S.A.S
RECRUITING
Barranquilla
Clínica de la Costa Ltda.
RECRUITING
Barranquilla
Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
RECRUITING
Bogotá
Servimed S.A.S.
RECRUITING
Bucaramanga
Preventive Care Ltda
RECRUITING
Chía
IPS Centro Medico Julián Coronel S.A.
RECRUITING
Santiago De Cali
Healthy Medical Center
RECRUITING
Zipaquirá
Germany
Universitaetsklinikum Koeln
RECRUITING
Cologne
Universitaetsmedizin Goettingen
RECRUITING
Göttingen
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
RECRUITING
Mainz
Universitaetsklinikum Muenster
RECRUITING
Münster
Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
RECRUITING
Budapest
Obudai Egeszsegugyi Centrum Kft.
RECRUITING
Budapest
Bekes Varmegyei Kozponti Korhaz
RECRUITING
Gyula
Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
RECRUITING
Székesfehérvár
Vital Medical Center
RECRUITING
Veszprém
Israel
Rambam Health Care Center
RECRUITING
Haifa
Meir Medical Center
RECRUITING
Kfar Saba
Rabin Medical Center-Beilinson Campus
RECRUITING
Petah Tikva
Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
RECRUITING
Brescia
Azienda Ospedale-Università di Padova
RECRUITING
Padua
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Azienda Ospedaliera San Camillo Forlanini
RECRUITING
Roma
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
RECRUITING
Roma
Università Campus Bio-Medico di Roma
RECRUITING
Roma
Istituto Clinico Humanitas
COMPLETED
Rozzano
Ospedale M. Scarlato
RECRUITING
Scafati
Japan
Tokyo Medical and Dental University Hospital
RECRUITING
Bunkyō City
Chiba University Hospital
RECRUITING
Chiba
NHO Chibahigashi National Hospital
RECRUITING
Chiba
St. Luke's International Hospital
RECRUITING
Chūōku
KKR Hamanomachi Hospital
RECRUITING
Fukuoka
NHO Kyushu Medical Center
RECRUITING
Fukuoka
Japanese Red Cross Society Himeji Hospital
RECRUITING
Himeji-shi
Hiroshima University Hospital
RECRUITING
Hiroshima
Saitama Medical University Hospital
RECRUITING
Iruma-gun
Nihon University Itabashi Hospital
RECRUITING
Itabashi-ku
NHO Osaka Minami Medical Center
RECRUITING
Kawachinagano-shi
St. Marianna University Hospital
RECRUITING
Kawasaki-shi
Kagawa University Hospital
RECRUITING
Kita-gun
Hospital of the University of Occupational and Environmental Health, Japan
RECRUITING
Kitakyushu-shi
Kobe City Hospital Organization Kobe City Medical Center General Hospital
RECRUITING
Kobe
Kobe University Hospital
RECRUITING
Kobe
Japanese Red Cross Kumamoto Hospital
RECRUITING
Kumamoto
Toho University Ohashi Medical Center
RECRUITING
Meguro-ku
Nagasaki University Hospital
RECRUITING
Nagasaki
JCHO Chukyo Hospital
RECRUITING
Nagoya
Chibaken Saiseikai Narashino Hospital
RECRUITING
Narashino-shi
Tazuke-kofukai Medical Research Institute Kitano Hospital
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Osakasayama-shi
Toho University Omori Medical Center
RECRUITING
Ōta-ku
Kitasato University Hospital
RECRUITING
Sagamihara-shi
Tonan Hospital
RECRUITING
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
Center Hospital of the National Center for Global Health and Medicine
RECRUITING
Shinjuku-ku
Keio University Hospital
RECRUITING
Shinjuku-ku
Osaka Medical and Pharmaceutical University Hospital
RECRUITING
Takatsuki-shi
Fujita Health University Hospital
RECRUITING
Toyoake-shi
NHO Yokohama Medical Center
RECRUITING
Yokohama
Yokohama City University Medical Center
RECRUITING
Yokohama
Netherlands
Amsterdam UMC, Locatie VUMC
RECRUITING
Amsterdam
Universitair Medisch Centrum Groningen
RECRUITING
Groningen
UMC Utrecht
RECRUITING
Utrecht
Puerto Rico
Centro Reumatologico
RECRUITING
Caguas
Romania
S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
RECRUITING
Brasov
S C Delta Health Care SRL
RECRUITING
Bucharest
Spitalul Clinic Judetean de Urgenta Cluj Napoca
RECRUITING
Cluj-napoca
S.C.Centrul Medical Unirea SRL
RECRUITING
Iași
Spitalul Judetean de Urgenta 'Sf. Ioan cel Nou' Suceava
RECRUITING
Suceava
S.C Centrul Medical Unirea SRL
RECRUITING
Târgu Mureş
Serbia
Clinical Hospital Center Bezanijska kosa
RECRUITING
Belgrade
Institute of Rheumatology
RECRUITING
Belgrade
Institute of Rheumatology
RECRUITING
Belgrade
Institute of Rheumatology
RECRUITING
Belgrade
University Clinical Center of Serbia
RECRUITING
Belgrade
Institute of Treatment and Rehabilitation 'Niska Banja'
COMPLETED
Niška Banja
United Kingdom
Cannock Chase Hospital
RECRUITING
Cannock
Doncaster Royal Infirmary
RECRUITING
Doncaster
Guy's Hospital
RECRUITING
London
Whipps Cross University Hospital
COMPLETED
London
Contact Information
Primary
US Biogen Clinical Trial Center
clinicaltrials@biogen.com
866-633-4636
Backup
Global Biogen Clinical Trial
clinicaltrials@biogen.com
Time Frame
Start Date: 2021-07-16
Estimated Completion Date: 2027-03-16
Participants
Target number of participants: 540
Treatments
Experimental: Litifilimab High Dose
Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of litifilimab, subcutaneously (SC), every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.
Experimental: Litifilimab Low Dose
Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of litifilimab, SC Q4W, up to Week 48 with an additional dose at Week 2.
Placebo_comparator: Placebo
Participants who are receiving background nonbiologic lupus SOC therapy will receive litifilimab-matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.
Related Therapeutic Areas
Sponsors
Leads: Biogen

This content was sourced from clinicaltrials.gov

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