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
Launched by BIOGEN · Apr 25, 2022
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue litifilimab or placebo. Eligible participants from parent phase 3 studies will be followed for up to 180 weeks.
The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE).
The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with ...
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52
- Key Exclusion Criteria:
- • Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
- • Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period)
- • Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)
- • Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies
- • NOTE: Other 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
Boston, Massachusetts, United States
Rochester, New York, United States
Chicago, Illinois, United States
Santander, , Spain
Gainesville, Florida, United States
Cincinnati, Ohio, United States
London, , United Kingdom
Orlando, Florida, United States
Barcelona, , Spain
Padova, , Italy
Seattle, Washington, United States
Seattle, Washington, United States
Birmingham, Alabama, United States
Rochester, New York, United States
Camperdown, New South Wales, Australia
Aurora, Colorado, United States
Footscray, Victoria, Australia
Orlando, Florida, United States
Syracuse, New York, United States
San Antonio, Texas, United States
Nashville, Tennessee, United States
Rosario, Santa Fe, Argentina
Manila, , Philippines
Belgrade, , Serbia
Syracuse, New York, United States
Poway, California, United States
Aurora, Colorado, United States
Valencia, , Spain
Santander, Cantabria, Spain
Utrecht, , Netherlands
Beijing, , China
Miami, Florida, United States
Upland, California, United States
Fort Worth, Texas, United States
Clearwater, Florida, United States
Cincinnati, Ohio, United States
Hannover, , Germany
Seattle, Washington, United States
Los Alamitos, California, United States
Charlotte, North Carolina, United States
Leuven, , Belgium
Tel Aviv, , Israel
Liege, , Belgium
Toronto, Ontario, Canada
Leuven, , Belgium
Plovdiv, , Bulgaria
Miami, Florida, United States
Athens, , Greece
Szekesfehervar, , Hungary
Groningen, , Netherlands
Paris, , France
Athens, , Greece
Los Angeles, California, United States
Aventura, Florida, United States
Upland, California, United States
Boca Raton, Florida, United States
Lipa City, Batangas, Philippines
Quezon City, , Philippines
Seoul, , Korea, Republic Of
La Jolla, California, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Winston Salem, North Carolina, United States
Jackson, Tennessee, United States
Quilmes, Buenos Aires, Argentina
Camperdown, New South Wales, Australia
Sofia, , Bulgaria
Veszprem, , Hungary
Groningen, , Netherlands
Targu Mures, , Romania
Uppsala, , Sweden
Box Hill, Victoria, Australia
Mission Hills, California, United States
Aventura, Florida, United States
Phoenix, Arizona, United States
Charlotte, North Carolina, United States
Jackson, Tennessee, United States
Mesquite, Texas, United States
Busan, , Korea, Republic Of
Seoul, , Korea, Republic Of
Worcester, Massachusetts, United States
Barcelona, , Spain
Uppsala, , Sweden
Tampa, Florida, United States
Chihuahua, , Mexico
Gainesville, Georgia, United States
Utrecht, , Netherlands
Olomouc, , Czechia
Milano, , Italy
Barrie, Ontario, Canada
Footscray, Victoria, Australia
Gyula, , Hungary
Maastricht, , Netherlands
Whittier, California, United States
Roma, , Italy
Wilmington, North Carolina, United States
Athens, , Greece
Brescia, , Italy
Olomouc, , Czechia
Shreveport, Louisiana, United States
Wilmington, North Carolina, United States
Austin, Texas, United States
Changchun, Jilin, China
Boca Raton, Florida, United States
Beverly Hills, California, United States
Lund, , Sweden
Atlanta, Georgia, United States
Decatur, Georgia, United States
Manila, , Philippines
Beijing, Beijing, China
Sevilla, , Spain
Brno, , Czechia
Amsterdam, , Netherlands
Rozzano, Milano, Italy
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
Tianjin, Tianjin, China
Phoenix, Arizona, United States
Davao City, , Philippines
Nanchang, Jiangxi, China
Dayton, Ohio, United States
Ruse, , Bulgaria
Szczecin, , Poland
Belgrade, , Serbia
Sevilla, , Spain
Brno, , Czechia
Budapest, , Hungary
Memphis, Tennessee, United States
Mesquite, Texas, United States
Webster, Texas, United States
Haikou, Hainan, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Merida, Yucatán, Mexico
Quezon City, , Philippines
Murdoch, Western Australia, Australia
Lima, , Peru
Bytom, , Poland
Las Cruces, New Mexico, United States
Maastricht, , Netherlands
Whittier, California, United States
Changchun, , China
Freehold, New Jersey, United States
Lublin, , Poland
Worcester, Massachusetts, United States
Greensboro, North Carolina, United States
Iloilo City, , Philippines
Lipa City, , Philippines
Austin, Texas, United States
Margate, Florida, United States
Belo Horizonte, Minas Gerais, Brazil
Chicago, Illinois, United States
Pisa, , Italy
Durango, , Mexico
Haikou, Hainan, China
Doncaster, South Yorkshire, United Kingdom
Brno, , Czechia
Santiago, , Chile
Manila, , Philippines
Liege, , Belgium
Santiago, , Chile
Budapest, , Hungary
Durango, , Mexico
Lipa City, , Philippines
Middleburg Heights, Ohio, United States
Cuernavaca, Morelos, Mexico
Cluj Napoca, , Romania
örebro, , Sweden
Murdoch, Western Australia, Australia
Valencia, , Spain
San Antonio, Texas, United States
Kaohsiung, , Taiwan
Beijing, Beijing, China
Haifa, , Israel
Changsha, Hunan, China
Greenville, South Carolina, United States
Curitiba, Paraná, Brazil
Monterrey, Nuevo León, Mexico
Barrie, Ontario, Canada
Dongguan, Guangdong, China
Pisa, , Italy
Fort Lauderdale, Florida, United States
Las Cruces, New Mexico, United States
Vitória, Espírito Santo, Brazil
Wroclaw, , Poland
Caguas, , Puerto Rico
Lund, , Sweden
Itabashi Ku, Tokyo To, Japan
Meguro Ku, Tokyo To, Japan
Gainesville, Florida, United States
Roma, , Italy
Santiago, , Chile
Bydgoszcz, , Poland
Gyula, , Hungary
Guangzhou, Guangdong, China
Saint Louis, Missouri, United States
Bydgoszcz, , Poland
Grand Blanc, Michigan, United States
Pasig City, , Philippines
Brasov, , Romania
Hiroshima Shi, Hiroshima Ken, Japan
Guadalajara, Jalisco, Mexico
Changsha, Hunan, China
Zhuzhou, Hunan, China
Tianjin, Tianjin, China
Ningbo, Zhejiang, China
Charlotte, North Carolina, United States
Seoul, , Korea, Republic Of
San Antonio, Texas, United States
Belo Horizonte, Minas Gerais, Brazil
Krakow, , Poland
Guadalajara, Jalisco, Mexico
Houston, Texas, United States
Tampa, Florida, United States
Mar Del Plata, Buenos Aires, Argentina
Pingxiang, Jiangxi, China
Ningbo, Zhejiang, China
Suwon, Gyeonggi Do, Korea, Republic Of
Ruse, , Bulgaria
Merida, , Mexico
Sevilla, , Spain
Middleburg Heights, Ohio, United States
Stockholm, , Sweden
Debary, Florida, United States
Hollywood, Florida, United States
Granada, , Spain
Grand Blanc, Michigan, United States
Brno, , Czechia
São José Do Rio Preto, Sao Paulo, Brazil
Nagasaki Shi, Nagasaki Ken, Japan
Incheon, , Korea, Republic Of
Sendai Shi, Miyagi Ken, Japan
Washington, District Of Columbia, United States
Ciudad Autonoma Buenos Aires, , Argentina
San Juan, , Argentina
Beverly Hills, California, United States
Clearwater, Florida, United States
San Miguel De Tucuman, Tucuman, Argentina
Sofia, , Bulgaria
Mainz, Rheinland Pfalz, Germany
Chihuahua, , Mexico
Fort Lauderdale, Florida, United States
Belgrade, , Serbia
Busan, , Korea, Republic Of
Göttingen, Niedersachsen, Germany
Santiago, , Chile
Koeln, Nordrhein Westfalen, Germany
Bogotá, , Colombia
Debary, Florida, United States
Haifa, , Israel
Bytom, , Poland
Baytown, Texas, United States
Houston, Texas, United States
Barranquilla, , Colombia
Petach Tikva, , Israel
Memphis, Tennessee, United States
Liège, , Belgium
Kaohsiung, , Taiwan
San Miguel De Tucuman, Tucuman, Argentina
Orenburg, , Russian Federation
Sofia, , Bulgaria
Bucaramanga, , Colombia
Iruma Gun, Saitama Ken, Japan
Kita Gun, Kagawa Ken, Japan
Veszprem, , Hungary
Osakasayama Shi, Osaka Fu, Japan
Brooklyn, New York, United States
Kraków, , Poland
Göttingen, Niedersachsen, Germany
Roma, , Italy
Mexico, Distrito Federal, Mexico
Haifa, , Israel
Kobe Shi, Hyogo Ken, Japan
Brooklyn, Maryland, United States
Juiz De Fora, Minas Gerais, Brazil
Shinjuku Ku, Tokyo To, Japan
Seoul, , Korea, Republic Of
Kita Gun, Kagawa Ken, Japan
Sapporo Shi, Hokkaido, Japan
Mesa, Arizona, United States
Mar Del Plata, Buenos Aires, Argentina
Fortaleza, Ceará, Brazil
Doncaster, South Yorkshire, United Kingdom
Sofia, , Bulgaria
Huntington Beach, California, United States
Yokohama Shi, Kanagawa Ken, Japan
Saint Petersburg, , Russian Federation
Vitória, Espírito Santo, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Mexico, Distrito Federal, Mexico
Monterrey, Nuevo León, Mexico
Summerville, South Carolina, United States
Kraków, , Poland
Niska Banja, , Serbia
Jiujiang, Jiangxi, China
Davao City, , Philippines
Krakow, , Poland
Niska Banja, , Serbia
Pingxiang, Jiangxi, China
Shanghai, Shanghai, China
Rozzano, Milano, Italy
Kawasaki Shi, Kanagawa Ken, Japan
Binzhou, Shandong, China
Santiago, , Chile
Bucaramanga, , Colombia
Incheon, Namdong Gu, Korea, Republic Of
Amsterdam, , Netherlands
Krakow, , Poland
Warszawa, , Poland
The Woodlands, Texas, United States
Mendoza, , Argentina
Pingxiang, Jiangxi, China
Flint, Michigan, United States
Barranquilla, , Colombia
Toyoake Shi, Aichi Ken, Japan
Yokohama Shi, Kanagawa Ken, Japan
Brasov, , Romania
La Plata, Buenos Aires, Argentina
Los Alamitos, California, United States
Summerville, South Carolina, United States
Colleyville, Texas, United States
Houston, Texas, United States
The Woodlands, Texas, United States
San Juan, , Argentina
Sofia, , Bulgaria
Wuhan, Hubei, China
Budapest, , Hungary
Bordeaux, Gironde, France
Montpellier Cedex 5, Herault, France
Paris Cedex 14, Paris, France
Muenchen, Bayern, Germany
Mainz, Rheinland Pfalz, Germany
Granada, , Spain
Moscow, , Russian Federation
Guangzhou, Guangdong, China
Allen, Texas, United States
Iruma Gun, Saitama Ken, Japan
Cluj Napoca, , Romania
Wuhan, Hubei, China
Guangzhou, Guangdong, China
Chia, , Colombia
Brescia, , Italy
Sagamihara Shi, Kanagawa Ken, Japan
Shinjuku Ku, Tokyo To, Japan
Fort Worth, Texas, United States
Sendai Shi, Miyagi Ken, Japan
Margate, Florida, United States
Santiago, , Chile
Brooklyn, New York, United States
San Miguel De Tucuman, Tucuman, Argentina
Moscow, , Russian Federation
Changsha, Hunan, China
Nashville, Tennessee, United States
Hollywood, Florida, United States
Caguas, , Puerto Rico
Ramat Gan, , Israel
Kumamoto Shi, Kumamoto Ken, Japan
Kobe Shi, Hyogo Ken, Japan
Greensboro, North Carolina, United States
Tampa, Florida, United States
Ota Ku, Tokyo To, Japan
Mission Hills, California, United States
Webster, Texas, United States
Kaohsiung, , Taiwan
Roma, , Italy
Plovdiv, , Bulgaria
Shenzhen, Guangdong, China
Mar Del Plata, Buenos Aires, Argentina
Seoul, , Korea, Republic Of
Warszawa, , Poland
Worcester, Massachusetts, United States
Davao City, Davao, Philippines
Shanghai, Shanghai, China
Sun City Center, Florida, United States
Elblag, , Poland
Sofia, , Bulgaria
Bucuresti, , Romania
Colleyville, Texas, United States
La Plata, Buenos Aires, Argentina
San Miguel, Buenos Aires, Argentina
Mendoza, , Argentina
Salvador, Bahia, Brazil
Brasilia, Distrito Federal, Brazil
Cuiabá, Mato Grosso, Brazil
Juiz De Fora, Minas Gerais, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Campinas, Sao Paulo, Brazil
Sao Jose, Sao Paulo, Brazil
São Bernardo, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Los Lagos, , Chile
Beijing, Beijing, China
Jiujiang, Jiangxi, China
Binzhou, Shandong, China
Urumqi, Xinjiang, China
Taoyuan, , China
Chia, , Colombia
Zipaquirá, , Colombia
Clermont Ferrand Cedex 1, Puy De Dome, France
Hannover, Niedersachsen, Germany
Koeln, Nordrhein Westfalen, Germany
Kfar Sava, , Israel
Ramat Gan, , Israel
Scafati, Salerno, Italy
Padova, , Italy
Nagoya Shi, Aichi Ken, Japan
Toyoake Shi, Aichi Ken, Japan
Chiba Shi, Chiba Ken, Japan
Narashino Shi, Chiba Ken, Japan
Fukuoka Shi, Fukuoka Ken, Japan
Kitakyushu Shi, Fukuoka Ken, Japan
Hiroshima Shi, Hiroshima Ken, Japan
Himeji Shi, Hyogo Ken, Japan
Kobe Shi, Hyogo Ken, Japan
Sagamihara Shi, Kanagawa Ken, Japan
Yokohama Shi, Kanagawa Ken, Japan
Kumamoto Shi, Kumamoto Ken, Japan
Nagasaki Shi, Nagasaki Ken, Japan
Osaka Shi, Osaka Fu, Japan
Osakasayama Shi, Osaka Fu, Japan
Osaka, Osaka Fu, Japan
Takatsuki Shi, Osaka Fu, Japan
Bunkyo Ku, Tokyo To, Japan
Chuo Ku, Tokyo To, Japan
Itabashi Ku, Tokyo To, Japan
Meguro Ku, Tokyo To, Japan
Ota Ku, Tokyo To, Japan
Shinjuku Ku, Tokyo To, Japan
Suwon, Gyeonggi Do, Korea, Republic Of
Ciudad De México, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Arequipa, , Peru
Angeles City, , Philippines
Bialystok, , Poland
Malbork, , Poland
Iasi, , Romania
Kemerovo, , Russian Federation
Moscow, , Russian Federation
Saint Petersburg, , Russian Federation
Santander, Castellón, Spain
Stockholm, , Sweden
London, Greater London, United Kingdom
Edinburgh, Lothian Region, United Kingdom
Cannock, Staffordshire, United Kingdom
Saint Louis, Missouri, United States
Zhuzhou, Hunan, China
Chengdu, Sichuan, China
Urumqi, Xinjiang, China
Wenzhou, Zhejiang, China
Barranquilla, , Colombia
Bogotá, , Colombia
Kfar Sava, , Israel
Petach Tikva, , Israel
Scafati, Salerno, Italy
Iasi, , Romania
Targu Mures, , Romania
Springboro, Ohio, United States
Malbork, , Poland
Belo Horizonte, Minas Gerais, Brazil
Taoyuan, , Taiwan
Ciudad Autonoma Buenos Aires, , Argentina
Sofia, , Bulgaria
Merida, Yucatán, Mexico
Fukuoka Shi, Fukuoka Ken, Japan
Kawasaki Shi, Kanagawa Ken, Japan
San Miguel, Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Atlanta, Georgia, United States
Saint Louis, Missouri, United States
Greenville, South Carolina, United States
Allen, Texas, United States
Mendoza, , Argentina
Shanghai, Shanghai, China
Ningbo, Zhejiang, China
Zipaquirá, , Colombia
Gyula, , Hungary
Cannock, Staffordshire, United Kingdom
Kitakyushu Shi, Fukuoka Ken, Japan
La Jolla, California, United States
Washington, District Of Columbia, United States
Ruskin, Florida, United States
Decatur, Georgia, United States
Trenton, New Jersey, United States
Sayre, Pennsylvania, United States
Colleyville, Texas, United States
Houston, Texas, United States
Seattle, Washington, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Tucuman, , Argentina
Caulfield, Victoria, Australia
Salvador, Bahia, Brazil
Fortaleza, Ceará, Brazil
Brasilia, Distrito Federal, Brazil
Cuiabá, Mato Grosso, Brazil
Campinas, Sao Paulo, Brazil
Santo André, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Hamilton, Ontario, Canada
Osorno, , Chile
Santiago, , Chile
Bordeaux, Gironde, France
Montpellier Cedex 5, Herault, France
Clermont Ferrand Cedex 1, Puy De Dome, France
Szekesfehervar, , Hungary
Tel Aviv, , Israel
Milano, , Italy
Roma, , Italy
Nagoya Shi, Aichi Ken, Japan
Chiba Shi, Chiba Ken, Japan
Narashino Shi, Chiba Ken, Japan
Fukuoka Shi, Fukuoka Ken, Japan
Sapporo Shi, Hokkaido, Japan
Himeji Shi, Hyogo Ken, Japan
Kawachi Nagano, Osaka Fu, Japan
Osaka Shi, Osaka Fu, Japan
Takatsuki Shi, Osaka Fu, Japan
Bunkyo Ku, Tokyo To, Japan
Chuo Ku, Tokyo To, Japan
Ciudad De México, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Cuernavaca, Morelos, Mexico
Merida, Yucatán, Mexico
Yucatan, Yucatán, Mexico
Arequipa, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Manila, , Philippines
Manila, , Philippines
Manila, , Philippines
Quezon City, , Philippines
Bialystok, , Poland
Bydgoszcz, , Poland
Lublin, , Poland
Szczecin, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Bucuresti, , Romania
Iasi, , Romania
Kemerovo, , Russian Federation
Orenburg, , Russian Federation
Belgrade, , Serbia
Sevilla, , Spain
örebro, , Sweden
Leytonstone, Greater London, United Kingdom
London, Greater London, United Kingdom
Cuernavaca, Morelos, Mexico
Washington, District Of Columbia, United States
Santiago, , Chile
Brasilia, Distrito Federal, Brazil
Colleyville, Texas, United States
Stafford, Texas, United States
São Bernardo Do Campo, Sao Paulo, Brazil
Bydgoszcz, , Poland
Ciudad Autonoma Buenos Aires, , Argentina
Santo ângelo, Mato Grosso, Brazil
Humble, Texas, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Barranquilla, , Colombia
Clermont Ferrand Cedex 1, Drôme, France
Kfar Saba, , Israel
Bucuresti, , Romania
Santander, Castellón, Spain
Quezon City, Metro Manila, Philippines
Fortaleza, Ceara, Brazil
Manila, Metro Manila, Philippines
Guadalajara, Jalisco, Mexico
Athens, Attica, Greece
Szekesfehervar, Fejer, Hungary
Belgrade, , Serbia
Cali, Valle Del Cauca, Colombia
Sao Jose Rio Preto, Sao Paulo, Brazil
Ciudad Autonoma De Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Curitiba, , Brazil
Merida, , Mexico
Clermont Ferrand Cedex 1, , France
Patients applied
Trial Officials
Medical Director
Study Director
Biogen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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