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
Launched by BIOGEN · May 17, 2021
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment called litifilimab (BIIB059) to see if it can help improve symptoms in adults with systemic lupus erythematosus (SLE), a condition that causes the immune system to attack healthy tissues. The study will involve participants who are already taking standard medications for lupus and will track how well litifilimab works in reducing their disease activity over a period of 52 weeks. Researchers will measure improvements in symptoms using specific scoring tools and will also assess the safety of the treatment.
To participate, individuals must have a confirmed diagnosis of SLE for at least six months and show signs of active disease. They should be on stable doses of lupus medications like antimalarials or steroids. Participants will receive either litifilimab, a lower dose of it, or a placebo (which looks like the drug but has no active ingredients) through injections every four weeks. Throughout the study, neither the participants nor the researchers will know who is receiving the actual medication versus the placebo. Participants can expect to have regular check-ins over the course of up to 80 weeks to monitor their health and how they respond to the treatment.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • 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:
- • 1. Antimalarials as stand-alone treatment
- • 2. Antimalarial treatment in combination with OCS and/or a single immunosuppressant
- • 3. Treatment with OCS and/or a single immunosuppressant
- Key Exclusion Criteria:
- • 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.
- • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
About Biogen
Biogen is a leading biotechnology company dedicated to discovering, developing, and delivering innovative therapies for neurological and neurodegenerative diseases. With a strong focus on research and development, Biogen leverages advanced science and cutting-edge technology to address the unmet needs of patients suffering from conditions such as multiple sclerosis, Alzheimer's disease, and spinal muscular atrophy. The company is committed to advancing the understanding of the underlying biology of these diseases and is actively engaged in clinical trials to evaluate new treatment options, aiming to improve patient outcomes and enhance quality of life. With a global presence and a robust pipeline of therapies, Biogen is at the forefront of innovation in the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Seattle, Washington, United States
Saint Louis, Missouri, United States
Rochester, New York, United States
Box Hill, Victoria, Australia
Winston Salem, North Carolina, United States
Nashville, Tennessee, United States
Orlando, Florida, United States
Barcelona, , Spain
Nashville, Tennessee, United States
Camperdown, New South Wales, Australia
Santiago, , Chile
Footscray, Victoria, Australia
Los Angeles, California, United States
Orlando, Florida, United States
Manila, , Philippines
Syracuse, New York, United States
Torrance, California, United States
Valencia, , Spain
Santander, Cantabria, Spain
Upland, California, United States
Clearwater, Florida, United States
Charlotte, North Carolina, United States
Athens, , Greece
Santander, Cantabria, Spain
Sevilla, , Spain
Incheon, , Korea, Republic Of
Aventura, Florida, United States
Upland, California, United States
Cebu City, , Philippines
Seoul, , Korea, Republic Of
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Box Hill, Victoria, Australia
Tampa, Florida, United States
Aventura, Florida, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Busan, , Korea, Republic Of
Suwon, , Korea, Republic Of
Brooklyn, New York, United States
Chihuahua, , Mexico
Saint Louis, Missouri, United States
Footscray, Victoria, Australia
Athens, , Greece
Manila, , Philippines
Incheon, , Korea, Republic Of
Davao City, , Philippines
Fort Lauderdale, Florida, United States
Ruse, , Bulgaria
Sevilla, , Spain
Memphis, Tennessee, United States
Webster, Texas, United States
Merida, Yucatán, Mexico
Murdoch, Western Australia, Australia
Bytom, , Poland
Aurora, Colorado, United States
Lublin, , Poland
Greensboro, North Carolina, United States
Colleyville, Texas, United States
Margate, Florida, United States
Belo Horizonte, Minas Gerais, Brazil
Kaohsiung, , Taiwan
Durango, , Mexico
Santiago, , Chile
Houston, Texas, United States
Barcelona, , Spain
Taichung, , Taiwan
Manila, , Philippines
Santiago, , Chile
Durango, , Mexico
Lipa City, , Philippines
Granada, , Spain
Middleburg Heights, Ohio, United States
örebro, , Sweden
Murdoch, Western Australia, Australia
Valencia, , Spain
Fort Lauderdale, Florida, United States
Wroclaw, , Poland
Santiago, , Chile
Bydgoszcz, , Poland
Grand Blanc, Michigan, United States
Charlotte, North Carolina, United States
Guadalajara, Jalisco, Mexico
Tampa, Florida, United States
Suwon, Gyeonggi Do, Korea, Republic Of
Ruse, , Bulgaria
Merida, , Mexico
Sevilla, , Spain
Monterrey, , Mexico
Taoyuan, , Taiwan
Debary, Florida, United States
Incheon, , Korea, Republic Of
Guadalajara, Jalisco, Mexico
Cleveland, Ohio, United States
Monterrey, Nuevo León, Mexico
Beverly Hills, California, United States
Clearwater, Florida, United States
Chihuahua, , Mexico
Lima, , Peru
Busan, , Korea, Republic Of
Debary, Florida, United States
Bytom, , Poland
Houston, Texas, United States
Memphis, Tennessee, United States
Merida, , Mexico
Porto Alegre, Rio Grande Do Sul, Brazil
Sofia, , Bulgaria
Seoul, , Korea, Republic Of
Stafford, Texas, United States
Santiago, , Chile
Mexico, Distrito Federal, Mexico
Lajeado, Rio Grande Do Sul, Brazil
Juiz De Fora, Minas Gerais, Brazil
Cuernavaca, , Mexico
Seoul, , Korea, Republic Of
Fortaleza, Ceará, Brazil
Vitória, Espírito Santo, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Monterrey, Nuevo León, Mexico
Reno, Nevada, United States
Krakow, , Poland
Santiago, , Chile
Warszawa, , Poland
The Woodlands, Texas, United States
Flint, Michigan, United States
São Paulo, Sao Paulo, Brazil
Miami Lakes, Florida, United States
Colleyville, Texas, United States
The Woodlands, Texas, United States
Mexico, Distrito Federal, Mexico
Sofia, , Bulgaria
Krakow, , Poland
Bordeaux, Gironde, France
Montpellier Cedex 5, Herault, France
Granada, , Spain
Moscow, , Russian Federation
Veracruz, , Mexico
Oklahoma City, Oklahoma, United States
Osorno, , Chile
Quenzon City, , Philippines
Guadalajara, Jalisco, Mexico
Margate, Florida, United States
Krakow, , Poland
Santiago, , Chile
Houston, Texas, United States
Hollywood, Florida, United States
Greensboro, North Carolina, United States
Mission Hills, California, United States
Webster, Texas, United States
Plovdiv, , Bulgaria
Seoul, , Korea, Republic Of
Warszawa, , Poland
Viña Del Mar, Valparaíso, Chile
Taoyuan City, Taiwan, China
Athina, , Greece
Benito Juárez, Ciudad De México, Mexico
Kaohsiung City, Niaosong District, Taiwan
Krakow, , Poland
San Diego, California, United States
Seoul, , Korea, Republic Of
Sofia, , Bulgaria
Clermont Ferrand Cedex 1, Puy De Dome, France
Suwon, Gyeonggi Do, Korea, Republic Of
Bialystok, , Poland
Los Lagos, , Chile
Malbork, , Poland
Mansfield, Texas, United States
Lancaster, California, United States
Bydgoszcz, , Poland
Valladolid, Cantabria, Spain
Krakow, , Poland
Merida, Yucatán, Mexico
Valdivia, , Chile
Brooklyn, New York, United States
Sao Jose Rio Preto, Sao Paulo, Brazil
Salvador, Bahia, Brazil
Plovdiv, , Bulgaria
Santiago, , Chile
Montpellier Cedex 5, Herault, France
Clermont Ferrand Cedex 1, Puy De Dome, France
Merida, Yucatán, Mexico
Lima, , Peru
Lima, , Peru
Bialystok, , Poland
örebro, , Sweden
Lublin, , Poland
Ciudad De México, Distrito Federal, Mexico
Cuernavaca, Morelos, Mexico
Nowa Sol, , Poland
Washington, District Of Columbia, United States
Santiago, , Chile
Brasilia, Distrito Federal, Brazil
Coral Springs, Florida, United States
New Hyde Park, New York, United States
Colleyville, Texas, United States
Humble, Texas, United States
Stafford, Texas, United States
Cuiabá, Mato Grosso, Brazil
São Bernardo Do Campo, Sao Paulo, Brazil
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Bordeaux, Gironde, France
Athens, , Greece
Athens, , Greece
Iloilo, , Philippines
Mabalacat, Pampanga, , Philippines
Quezon City, Metro Manila, , Philippines
Bydgoszcz, , Poland
Wroclaw, , Poland
Kemerovo, , Russian Federation
Orenburg, , Russian Federation
Stockholm, , Sweden
Uppasala, , Sweden
Taoyuan County, , Taiwan
Guadalajara, Jalisco, Mexico
Manila, , Philippines
Houston, Texas, United States
Avon Park, Florida, United States
Kennesaw, Georgia, United States
Lima, , Peru
Arequipa, , Peru
Homewood, Alabama, United States
Thousand Oaks, California, United States
Lake Charles, Louisiana, United States
Salisbury, North Carolina, United States
Allen, Texas, United States
Corpus Christi, Texas, United States
Valinhos, Sao Paulo, Brazil
Sao Paulo, , Brazil
Guadalajara, Jalisco, Mexico
Merida, Yucatán, Mexico
Poznan, , Poland
Warszawa, , Poland
Taguig, , Philippines
Tampa, Florida, United States
Marietta, Georgia, United States
Sugar Land, Texas, United States
San Fernando City, La Union, , Philippines
Fortaleza, , Brazil
Curitiba, , Brazil
Monterrey, , Mexico
Vitória, , Brazil
Merida, , Mexico
Patients applied
Trial Officials
Medical Director
Study Director
Biogen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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