A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
TOPAZ-1
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
2 other identifiers
interventional
548
15 countries
164
Brief 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), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2021
Longer than P75 for phase_3
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
May 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 16, 2027
February 10, 2026
February 1, 2026
5.4 years
May 17, 2021
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
SRI-4 response is a composite endpoint defined by the following criteria: * Reduction from baseline of ≥4 points in systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K). * No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline. * 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 to protocol-specified medication rules.
Week 52
Secondary Outcomes (33)
Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG) - Based Combined Lupus Assessment (BICLA) Response at Week 52
Week 52
Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
Week 52
Percentage of Participants With Oral Corticosteroid(s) (OCS) ≥10 milligrams per day (mg/day) at Baseline With OCS Reduction to ≤7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52
Week 40 to Week 52
Percentage of Participants With a CLASI-A score ≥10 at Baseline Who Achieved a 50% Improvement From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-50) Response at Week 24
Week 24
Annualized Flare Rate Through Week 52
Up to Week 52
- +28 more secondary outcomes
Study Arms (3)
Litifilimab High Dose
EXPERIMENTALParticipants 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.
Litifilimab Low Dose
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants 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.
Interventions
Administered as specified in the treatment arm.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of or positive test result for human immunodeficiency virus (HIV).
- Current hepatitis C infection (defined as positive hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid \[RNA\]).
- Current hepatitis B infection (defined as positive for antibody to hepatitis B surface antigen (HBsAg) and/or positive for total hepatitis antibody to B core antigen \[anti-HBc\] with positive reflex HBV DNA).
- History of severe herpes infection.
- Presence of uncontrolled or New York Heart Association class III or IV congestive heart failure.
- Active severe lupus nephritis where, in the opinion of the Investigator, protocol-specified SOC is insufficient and use of a more aggressive therapeutic approach is indicated, such as adding IV cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol is indicated; or urine protein-creatinine ratio \> 2.0 or severe chronic kidney disease (estimated glomerular filtration rate \< 30 milliliters per minute per 1.73 meter square \[mL/min/1.73 m\^2\]) calculated using the abbreviated modification of diet in renal disease equation.
- Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced lupus.
- History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome.
- Active neuropsychiatric SLE.
- Use of oral prednisone (or equivalent) above 20 mg/day.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (164)
Tilda Research Birmingham
Homewood, Alabama, 35209, United States
Wallace Rheumatic Study Center
Beverly Hills, California, 90211, United States
University of Southern California
Los Angeles, California, 90033, United States
Providence Facey Medical Foundation
Mission Hills, California, 91345, United States
University of California San Diego School of Medicine
San Diego, California, 92103, United States
SCLA Management
Thousand Oaks, California, 91360, United States
Harbor-UCLA Medical Center
Torrance, California, 90509, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Georgetown University Hospital-Medstar
Washington D.C., District of Columbia, 20007-2113, United States
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Highlands Rheumatology
Avon Park, Florida, 33825, United States
Clinical Research of West Florida - Corporate
Clearwater, Florida, 33765, United States
Believe Clinical Trials
Coral Springs, Florida, 33065, United States
Omega Research Consultants
DeBary, Florida, 32713, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33334, United States
GNP Research at Mark Jaffe, MD
Hollywood, Florida, 33024, United States
Life Clinical Trials
Margate, Florida, 33063, United States
Charisma Medical and Research Center
Miami Lakes, Florida, 33014, United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806, United States
AdventHealth Medical Group
Tampa, Florida, 33613, United States
Vantage Clinical Trials
Tampa, Florida, 33614, United States
Rheumatology care of Georgia
Kennesaw, Georgia, 30144, United States
Atlanta Research Center for Rheumatology LLC
Marietta, Georgia, 30060, United States
Accurate Clinical Research Inc.
Lake Charles, Louisiana, 70605, United States
AA MRC LLC Ahmed Arif Medical Research Center
Flint, Michigan, 48504, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Renown Medical Group
Reno, Nevada, 89502, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, 11201, United States
Northwell Health Center for Advanced Medicine
New Hyde Park, New York, 11042-1118, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY Upstate Medical Center
Syracuse, New York, 13210, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204, United States
Medication Management, LLC
Greensboro, North Carolina, 27405, United States
OnSite Clinical Solutions, LLC - Charlotte
Salisbury, North Carolina, 28144, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102, United States
Ramesh C Gupta, MD
Memphis, Tennessee, 38119, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
PrimeCare 360
Allen, Texas, 75013, United States
Precision Comprehensive Clinical Research Solution
Colleyville, Texas, 76034-5913, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034, United States
Arthritis Care Texas
Corpus Christi, Texas, 78415, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
Accurate Clinical Management LLC
Houston, Texas, 77089, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77099, United States
Accurate Clinical Research, Inc.
Humble, Texas, 77346, United States
Accurate Clinical Research
Stafford, Texas, 77477, United States
Fort Bend Rheumatology Associates
Sugar Land, Texas, 77407, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382, United States
CLS Research Ctr, PLLC
Webster, Texas, 77598, United States
University of Washington
Seattle, Washington, 98195, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Footscray Hospital
Footscray, Victoria, 3011, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, 60430-370, Brazil
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, 29055-450, Brazil
Clínica SER da Bahia
Salvador, Estado de Bahia, 40150-150, Brazil
L2IP - Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, 70200-730, Brazil
Oncovida - Centro de Onco-Hematologia de Mato Grosso
Cuiabá, Mato Grosso, 78043-142, Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221, Brazil
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, 36010-570, Brazil
CETI - Centro de Estudos em Terapias Inovadoras Ltda.
Curitiba, Paraná, 80030-110, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, 95900-000, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
LMK Serviços Médicos S/S Ltda
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Sao Jose Rio Preto, São Paulo, 15090-000, Brazil
Centro Multidisciplinar de Estudos Clínicos - CEMEC
São Bernardo do Campo, São Paulo, 09715-090, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo, São Paulo, 04266-010, Brazil
A2Z Clinical Centro Avancado de Pesquisa Clinica
Valinhos, São Paulo, 13271-130, Brazil
RDSS Ricardo Diaz Scientific Solution
São Paulo, 04037-030, Brazil
DCC 'Sv. Georgi', EOOD
Plovdiv, 4000, Bulgaria
UMHAT "Pulmed" OOD
Plovdiv, 4002, Bulgaria
UMHAT-Plovdiv AD
Plovdiv, 4003, Bulgaria
DCC 1 - Ruse, EOOD
Rousse, 7002, Bulgaria
DCC 'Alexandrovska', EOOD
Sofia, 1431, Bulgaria
Medical Center Hera EOOD
Sofia, 1510, Bulgaria
Military Medical Academy - MHAT - Sofia
Sofia, 1606, Bulgaria
UMHAT 'Sv. Ivan Rilski', EAD
Sofia, 1612, Bulgaria
Clinica Alemana de Osorno
Osorno, 5290000, Chile
Centro Medico Prosalud
Santiago, 7500000, Chile
Interin
Santiago, 7500010, Chile
CTR Estudios
Santiago, 7500571, Chile
Enroll Spa
Santiago, 7500587, Chile
BioMedica Research Group
Santiago, 7500710, Chile
CeCim Biocinetic
Santiago, 8331143, Chile
Clinical Research Chile SpA.
Valdivia, 5090000, Chile
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, Gironde, 33000, France
Hopital Lapeyronie
Montpellier, Herault, 34295, France
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Puy De Dome, 63003, France
NNA Hospita;
Athens, 11521, Greece
General Hospital of Athens Laiko
Athens, 11527, Greece
University General Hospital 'Attikon'
Athens, 12462, Greece
Diseno y Planeacion en Investigacion Medica S.C.
Guadalajara, Jalisco, 44130, Mexico
Centro de Investigacion Farmaceutica Especializada de Occidente S.C
Guadalajara, Jalisco, 44160, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, 44650, Mexico
Centro de investigacion medica y reumatologia
Guadalajara, Jalisco, 44959, Mexico
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
Mexico City, Mexico City, 14080, Mexico
Centro de Investigacion Clínica GRAMEL S.C
Mexico City, Mexico City, 3720, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico City, 6700, Mexico
Consultorio Privado Dr. Miguel Cortes Hernandez
Cuernavaca, Morelos, 62448, Mexico
Accelerium S. de R.L. de C.V.
Monterrey, Nuevo León, 64000, Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Centro Peninsular de Investigacion Clinica, SCP
Mérida, Yucatán, 97000, Mexico
Unidad de Atencion Medica e Investigacion en Salud S.C.
Mérida, Yucatán, 97000, Mexico
Medical Care & Research SA de CV
Mérida, Yucatán, 97070, Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, 31000, Mexico
Centro de Investigacion y Atencion Integral Durango CIAID
Durango, 34080, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91900, Mexico
Hogar Clínica San Juan de Dios - Arequipa
Arequipa, 40103, Peru
Centro de Investigacion Clinica Immunoreumatologioa
Lima, Lima 11, Peru
Hospital Nacional Edgardo Rebagliati Martins
Lima, LIMA 11, Peru
HMA - Hospital Maria Auxiliadora
Lima, LIMA 29, Peru
Invest Clinicas Sac Inst de Ginecologia y Reproduccion
Lima, Lima 33, Peru
Chong Hua Hospital
Cebu City, 6000, Philippines
Ospital Ng Makati
City of Taguig, 1642, Philippines
Davao Doctors Hospital
Davao City, 8000, Philippines
The Medical City Iloilo
Iloilo City, 5000, Philippines
Mary Mediatrix Medical Center
Lipa City, 4217, Philippines
The Medical City Clark
Mabalacat, Pampanga, 2023, Philippines
Manila Doctors Hospital
Manila, 1000, Philippines
Medical Center Manila
Manila, 1000, Philippines
Philippine General Hospital
Manila, 1000, Philippines
Jose R. Reyes Memorial Medical Center
Manila, 1012, Philippines
St. Luke's Medical Center
Quenzon City, 1102, Philippines
Far Eastern University - Dr. Nicanor Reyes Medical Foundation
Quezon City, Metro Manila, 1118, Philippines
Lorma Medical Center
San Fernando City, La Union, 2500, Philippines
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, 15-707, Poland
Centrum Medyczne Intercor Sp. z o.o
Bydgoszcz, 85-605, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, 87-100, Poland
Nzoz Bif-Med
Bytom, 41-902, Poland
Malopolskie Badania Kliniczne
Krakow, 30-002, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Pratia MCM Krakow
Krakow, 30-727, Poland
Centrum Medyczne All-Med
Krakow, 31-023, Poland
Reumed Spolka z o.o.
Lublin, 20-607, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
Malbork, 82-200, Poland
Twoja Przychodnia NCM
Nowa Sól, 67-100, Poland
Prywatna Praktyka Lekarska prof Pawel Hrycaj
Poznan, 61-397, Poland
Przychodnia Care Access Warszawa
Warsaw, 00-719, Poland
MICS Centrum Medyczne Warszawa
Warsaw, 00-874, Poland
Niepubliczny Zakład Opieki Zdrowotnej 'Biogenes' Sp. z o.o.
Wroclaw, 53-224, Poland
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Hanyang University Seoul Hospital
Seoul, 4763, South Korea
Konkuk University Medical Center
Seoul, 5030, South Korea
Asan Medical Center
Seoul, 5505, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Rio Hortega
Valladolid, Cantabria, 47012, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 8035, Spain
Hospital Universitario San Cecilio
Granada, 18016, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Quironsalud Infanta Luisa
Seville, 41010, Spain
Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Universitetssjukhuset Orebro
Örebro, 70185, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, SE-171 76, Sweden
Akademiska Sjukhuset
Uppasala, 75185, Sweden
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan, 333, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2021
First Posted
May 20, 2021
Study Start
May 25, 2021
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
March 16, 2027
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/