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? Patients with Systemic Lupus Erythematosus
What treatments are being studied? BIIB059
Status: Recruiting
Location: See all (168) 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 systemic lupus erythematosus (SLE) at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria for SLE at screening by a qualified physician.

• Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score ≥ 6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated).

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

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

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

‣ 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
Tilda Research Birmingham
RECRUITING
Homewood
California
Wallace Rheumatic Study Center
RECRUITING
Beverly Hills
University of Southern California
COMPLETED
Los Angeles
Providence Facey Medical Foundation
RECRUITING
Mission Hills
University of California San Diego School of Medicine
RECRUITING
San Diego
SCLA Management
RECRUITING
Thousand Oaks
Harbor-UCLA Medical Center
RECRUITING
Torrance
Inland Rheumatology Clinical Trials, Inc.
RECRUITING
Upland
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Washington, D.c.
Georgetown University Hospital-Medstar
RECRUITING
Washington D.c.
Florida
Arthritis & Rheumatic Disease Specialties
RECRUITING
Aventura
Highlands Rheumatology
RECRUITING
Avon Park
Clinical Research of West Florida - Corporate
RECRUITING
Clearwater
Believe Clinical Trials
RECRUITING
Coral Springs
Believe Clinical Trials
RECRUITING
Coral Springs
Omega Research Consultants
RECRUITING
Debary
Centre for Rheumatology, Immunology and Arthritis
COMPLETED
Fort Lauderdale
GNP Research at Mark Jaffe, MD
RECRUITING
Hollywood
Life Clinical Trials
RECRUITING
Margate
Charisma Medical and Research Center
RECRUITING
Miami Lakes
Rheumatology Associates of Central Florida
RECRUITING
Orlando
AdventHealth Medical Group
COMPLETED
Tampa
Vantage Clinical Trials
RECRUITING
Tampa
Georgia
Rheumatology care of Georgia
RECRUITING
Kennesaw
Atlanta Research Center for Rheumatology LLC
RECRUITING
Marietta
Louisiana
Accurate Clinical Research Inc.
RECRUITING
Lake Charles
Michigan
AA MRC LLC Ahmed Arif Medical Research Center
RECRUITING
Flint
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Joint and Muscle Research Institute
COMPLETED
Charlotte
Medication Management, LLC
COMPLETED
Greensboro
OnSite Clinical Solutions, LLC - Charlotte
RECRUITING
Salisbury
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Nevada
Renown Medical Group
RECRUITING
Reno
New York
Joseph S. and Diane H. Steinberg Ambulatory Care Center
RECRUITING
Brooklyn
Northwell Health Center for Advanced Medicine
RECRUITING
New Hyde Park
University of Rochester Medical Center
RECRUITING
Rochester
SUNY Upstate Medical Center
RECRUITING
Syracuse
Ohio
Paramount Medical Research & Consulting, LLC
RECRUITING
Middleburg Heights
Oklahoma
Hightower Clinical
RECRUITING
Oklahoma City
Tennessee
Ramesh C Gupta, MD
RECRUITING
Memphis
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
PrimeCare 360
RECRUITING
Allen
Precision Comprehensive Clinical Research Solution
RECRUITING
Colleyville
Precision Comprehensive Clinical Research Solution
RECRUITING
Colleyville
Precision Comprehensive Clinical Research Solutions
RECRUITING
Colleyville
Arthritis Care Texas
RECRUITING
Corpus Christi
Accurate Clinical Management LLC
RECRUITING
Houston
Accurate Clinical Management LLC
RECRUITING
Houston
Pioneer Research Solutions, Inc.
COMPLETED
Houston
Prolato Clinical Research Center
RECRUITING
Houston
Accurate Clinical Research, Inc.
RECRUITING
Humble
Accurate Clinical Research
RECRUITING
Stafford
Fort Bend Rheumatology Associates
RECRUITING
Sugar Land
Advanced Rheumatology of Houston
RECRUITING
The Woodlands
CLS Research Ctr, PLLC
COMPLETED
Webster
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Australia
Box Hill Hospital
RECRUITING
Box Hill
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Footscray Hospital
COMPLETED
Footscray
Fiona Stanley Hospital
RECRUITING
Murdoch
Brazil
Santa Casa de Misericórdia de Belo Horizonte
RECRUITING
Belo Horizonte
L2IP - Instituto de Pesquisas Clínicas Ltda.
RECRUITING
Brasília
Oncovida - Centro de Onco-Hematologia de Mato Grosso
RECRUITING
Cuiabá
CETI - Centro de Estudos em Terapias Inovadoras Ltda.
RECRUITING
Curitiba
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
RECRUITING
Fortaleza
CMiP - Centro Mineiro de Pesquisa
RECRUITING
Juiz De Fora
Hospital Bruno Born
RECRUITING
Lajeado
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital Moinhos de Vento
RECRUITING
Porto Alegre
LMK Serviços Médicos S/S Ltda
RECRUITING
Porto Alegre
Clínica SER da Bahia
RECRUITING
Salvador
Centro Multidisciplinar de Estudos Clínicos - CEMEC
RECRUITING
São Bernardo Do Campo
Fundação Faculdade Regional de Medicina de São José do Rio Preto
RECRUITING
Sao Jose Rio Preto
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
RECRUITING
São Paulo
RDSS Ricardo Diaz Scientific Solution
RECRUITING
São Paulo
A2Z Clinical Centro Avancado de Pesquisa Clinica
RECRUITING
Valinhos
CEDOES - Diagnóstico e Pesquisa
RECRUITING
Vitória
Bulgaria
DCC 'Sv. Georgi', EOOD
RECRUITING
Plovdiv
UMHAT Pulmed OOD
RECRUITING
Plovdiv
UMHAT-Plovdiv AD
RECRUITING
Plovdiv
DCC 1 - Ruse, EOOD
RECRUITING
Rousse
DCC 'Alexandrovska', EOOD
RECRUITING
Sofia
Medical Center Hera EOOD
RECRUITING
Sofia
Military Medical Academy - MHAT - Sofia
RECRUITING
Sofia
UMHAT 'Sv. Ivan Rilski', EAD
RECRUITING
Sofia
UMHAT 'Sv. Ivan Rilski', EAD
RECRUITING
Sofia
Chile
Clinica Alemana de Osorno
COMPLETED
Osorno
BioMedica Research Group
RECRUITING
Santiago
CeCim Biocinetic
RECRUITING
Santiago
Centro Medico Prosalud
RECRUITING
Santiago
CTR Estudios
RECRUITING
Santiago
Enroll Spa
RECRUITING
Santiago
Interin
COMPLETED
Santiago
Clinical Research Chile SpA.
RECRUITING
Valdivia
France
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
RECRUITING
Bordeaux
CHU Clermont Ferrand - Hopital Gabriel Montpied
RECRUITING
Clermont-ferrand
Hopital Lapeyronie
RECRUITING
Montpellier
Greece
General Hospital of Athens Laiko
COMPLETED
Athens
NNA Hospita;
RECRUITING
Athens
University General Hospital 'Attikon'
RECRUITING
Athens
Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
RECRUITING
Chihuahua City
Consultorio Privado Dr. Miguel Cortes Hernandez
RECRUITING
Cuernavaca
Centro de Investigacion y Atencion Integral Durango CIAID
RECRUITING
Durango
Centro de Investigacion Farmaceutica Especializada de Occidente S.C
RECRUITING
Guadalajara
Centro de investigacion medica y reumatologia
RECRUITING
Guadalajara
Clinica de Investigacion en Reumatologia y Obesidad S.C.
RECRUITING
Guadalajara
Diseno y Planeacion en Investigacion Medica S.C.
COMPLETED
Guadalajara
Centro Peninsular de Investigacion Clinica, SCP
RECRUITING
Mérida
Medical Care & Research SA de CV
RECRUITING
Mérida
Unidad de Atencion Medica e Investigacion en Salud S.C.
RECRUITING
Mérida
Centro de Investigacion Clínica GRAMEL S.C
RECRUITING
Mexico City
Clinstile, S.A. de C.V.
RECRUITING
Mexico City
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
RECRUITING
Mexico City
Accelerium S. de R.L. de C.V.
RECRUITING
Monterrey
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
RECRUITING
Monterrey
FAICIC S. de R.L. de C.V.
RECRUITING
Veracruz
Peru
Hogar Clínica San Juan de Dios - Arequipa
RECRUITING
Arequipa
Centro de Investigacion Clinica Immunoreumatologioa
RECRUITING
Lima
HMA - Hospital Maria Auxiliadora
RECRUITING
Lima
Hospital Nacional Edgardo Rebagliati Martins
RECRUITING
Lima
Invest Clinicas Sac Inst de Ginecologia y Reproduccion
RECRUITING
Lima
Philippines
Chong Hua Hospital
RECRUITING
Cebu City
Ospital Ng Makati
RECRUITING
City Of Taguig
Davao Doctors Hospital
RECRUITING
Davao City
The Medical City Iloilo
RECRUITING
Iloilo City
Mary Mediatrix Medical Center
RECRUITING
Lipa City
The Medical City Clark
RECRUITING
Mabalacat, Pampanga
Jose R. Reyes Memorial Medical Center
RECRUITING
Manila
Manila Doctors Hospital
RECRUITING
Manila
Medical Center Manila
RECRUITING
Manila
Philippine General Hospital
RECRUITING
Manila
St. Luke's Medical Center
RECRUITING
Quenzon City
Far Eastern University - Dr. Nicanor Reyes Medical Foundation
RECRUITING
Quezon City, Metro Manila
Lorma Medical Center
RECRUITING
San Fernando City, La Union
Poland
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
RECRUITING
Bialystok
Centrum Medyczne Intercor Sp. z o.o
RECRUITING
Bydgoszcz
Szpital Uniwersytecki nr 2 im.dr J. Biziela
RECRUITING
Bydgoszcz
Nzoz Bif-Med
RECRUITING
Bytom
Centrum Medyczne All-Med
RECRUITING
Krakow
Centrum Medyczne Plejady
RECRUITING
Krakow
Malopolskie Badania Kliniczne
RECRUITING
Krakow
Pratia MCM Krakow
RECRUITING
Krakow
Reumed Spolka z o.o.
RECRUITING
Lublin
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
RECRUITING
Malbork
Twoja Przychodnia NCM
RECRUITING
Nowa Sól
Prywatna Praktyka Lekarska prof Pawel Hrycaj
RECRUITING
Poznan
MICS Centrum Medyczne Warszawa
RECRUITING
Warsaw
Przychodnia Care Access Warszawa
RECRUITING
Warsaw
Niepubliczny Zakład Opieki Zdrowotnej 'Biogenes' Sp. z o.o.
COMPLETED
Wroclaw
Republic of Korea
Dong-A University Hospital
RECRUITING
Busan
Gachon University Gil Medical Center
RECRUITING
Incheon
Asan Medical Center
RECRUITING
Seoul
Hanyang University Seoul Hospital
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario San Cecilio
RECRUITING
Granada
Hospital Universitario Marques de Valdecilla
COMPLETED
Santander
Hospital Quironsalud Infanta Luisa
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitario Dr. Peset
RECRUITING
Valencia
Hospital Universitario Rio Hortega
RECRUITING
Valladolid
Sweden
Universitetssjukhuset Orebro
RECRUITING
Örebro
Karolinska Universitetssjukhuset Solna
RECRUITING
Stockholm
Akademiska Sjukhuset
RECRUITING
Uppasala
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Chung Shan Medical University Hospital
RECRUITING
Taichung
Chang Gung Memorial Hospital,Linkou
RECRUITING
Taoyuan
Contact Information
Primary
US Biogen Clinical Trial Center
clinicaltrials@biogen.com
866-633-4636
Backup
Global Biogen Clinical Trial Center
clinicaltrials@biogen.com
Time Frame
Start Date: 2021-05-25
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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