A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (AMETHYST)
Launched by BIOGEN · Sep 2, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called litifilimab (BIIB059) to see if it can help improve skin symptoms in adults with cutaneous lupus erythematosus (CLE), a type of lupus that affects the skin. The trial is focused on people who have either subacute or chronic CLE and have not had success with traditional antimalarial treatments. Participants will be monitored over time to see how well litifilimab reduces their skin disease activity, as measured by specific scoring tools that look at skin redness and overall disease severity.
To participate, individuals must have a confirmed diagnosis of CLE with active skin symptoms and a certain level of disease severity. Participants can expect to receive either the study drug or a placebo (a treatment that looks like the drug but has no active ingredients) through injections under the skin every four weeks for 24 weeks. After this initial period, everyone will receive litifilimab for an additional 28 weeks. The entire study will last up to 80 weeks, during which participants will also help researchers understand how safe the medication is and how it impacts their quality of life.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • 1. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
- • 2. Must have active cutaneous manifestations that meet study criteria.
- • 3. Must have a CLASI-A score ≥10.
- • 4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.
- Key Exclusion Criteria:
- • 1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
- • 2. Diagnosis of mixed connective tissue disease \[(within 1 year of signing the informed consent form (ICF)\] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren's syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year.
- • 3. Active severe lupus nephritis.
- • 4. Active neuropsychiatric SLE.
- • 5. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
- • 6. Use of immunosuppressive or disease-modifying treatments for SLE or CLE \[via an oral, intravenous (IV), or SC route\] that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose.
- • 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
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
New York, New York, United States
Boston, Massachusetts, United States
Salt Lake City, Utah, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Omaha, Nebraska, United States
Nashville, Tennessee, United States
Gainesville, Florida, United States
Chapel Hill, North Carolina, United States
Denver, Colorado, United States
Saint Louis, Missouri, United States
Rosario, Santa Fe, Argentina
Manila, , Philippines
Belgrade, , Serbia
Dallas, Texas, United States
Barcelona, , Spain
Barcelona, , Spain
Cordoba, , Spain
Taichung, , Taiwan
Paris, , France
Houston, Texas, United States
Milano, , Italy
St. Gallen, , Switzerland
Gainesville, Florida, United States
Sevilla, , Spain
Heidelberg, , Germany
Dallas, Texas, United States
Beijing, Beijing, China
Los Angeles, California, United States
Ann Arbor, Michigan, United States
Chongqing, Chongqing, China
Anniston, Alabama, United States
Upland, California, United States
Quezon City, , Philippines
Porto Alegre, Rio Grande Do Sul, Brazil
Piestany, , Slovakia
Jinan, Shandong, China
Bucaramanga, Santander, Colombia
Gwangju, , Korea, Republic Of
Suwon, , Korea, Republic Of
Worcester, Massachusetts, United States
Indianapolis, Indiana, United States
Ottawa, Ontario, Canada
Milano, , Italy
Barcelona, , Spain
Riyadh, , Saudi Arabia
Murray, Utah, United States
Cebu City, , Philippines
Santa Monica, California, United States
Cleveland, Ohio, United States
Pleven, , Bulgaria
Shanghai, Shanghai, China
Buenos Aires, , Argentina
Fort Lauderdale, Florida, United States
Baotou, Inner Mongolia, China
La Coruña, , Spain
Taipei, , Taiwan
Manchester, Greater Manchester, United Kingdom
Zhengzhou, Henan, China
Changsha, Hunan, China
Majadahonda, Madrid, Spain
Albuquerque, New Mexico, United States
Waco, Texas, United States
Lausanne, , Switzerland
Kaohsiung, , Taiwan
Santiago, , Chile
Manila, , Philippines
Lipa City, , Philippines
Fuzhou, Fujian, China
Novi Sad, , Serbia
Hershey, Pennsylvania, United States
Dongguan, Guangdong, China
Itabashi Ku, Tokyo To, Japan
Guangzhou, Guangdong, China
Kunming, Yunnan, China
Wenzhou, Zhejiang, China
Fairport, New York, United States
Seoul, Seodaemun Gu, Korea, Republic Of
La Jolla, California, United States
Hangzhou, Zhejiang, China
Quilmes, Buenos Aires, Argentina
Suwon, Gyeonggi Do, Korea, Republic Of
Miami, Florida, United States
Ruse, , Bulgaria
Merida, , Mexico
Muenster, Nordrhein Westfalen, Germany
Quincy, Massachusetts, United States
Grand Blanc, Michigan, United States
Lisboa, , Portugal
Nagasaki Shi, Nagasaki Ken, Japan
Suita Shi, Osaka Fu, Japan
Stockholm, , Sweden
Sendai Shi, Miyagi Ken, Japan
Seoul, , Korea, Republic Of
Dallas, Texas, United States
Austin, Texas, United States
San Miguel De Tucuman, Tucuman, Argentina
Chihuahua, , Mexico
Lima, , Peru
Fort Lauderdale, Florida, United States
Belgrade, , Serbia
Pleven, , Bulgaria
Besançon Cedex, Doubs, France
Heidelberg, Baden Wuerttemberg, Germany
Kraków, , Poland
Shenzhen, Guangdong, China
Hangzhou, Zhejiang, China
Santiago, , Chile
Sofia, , Bulgaria
Marseille Cedex 5, Bouches Du Rhône, France
Seoul, , Korea, Republic Of
Dresden, Sachsen, Germany
Aachen, Nordrhein Westfalen, Germany
Bonn, Nordrhein Westfalen, Germany
Zhenjiang, Jiangsu, China
Kiel, Schleswig Holstein, Germany
Phoenix, Arizona, United States
Osakasayama Shi, Osaka Fu, Japan
Rockford, Illinois, United States
Lajeado, Rio Grande Do Sul, Brazil
Great Neck, New York, United States
Wakayama Shi, Wakayama Ken, Japan
London, Greater London, United Kingdom
Juiz De Fora, Minas Gerais, Brazil
Otsu Shi, Shiga Ken, Japan
Kumamoto Shi, Kumamoto Ken, Japan
Marseille Cedex 5, , France
Aguascalientes, , Mexico
Sapporo Shi, Hokkaido, Japan
Yokohama Shi, Kanagawa Ken, Japan
Ansan Si, Gyeonggi Do, Korea, Republic Of
Fortaleza, Ceará, Brazil
Vitória, Espírito Santo, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Bogotá, , Colombia
Richmond, Virginia, United States
Santiago, , Chile
Albuquerque, New Mexico, United States
Nagoya Shi, Aichi Ken, Japan
Barranquilla, , Colombia
Flint, Michigan, United States
São Paulo, Sao Paulo, Brazil
Toyoake Shi, Aichi Ken, Japan
Yokohama Shi, Kanagawa Ken, Japan
Pecs, , Hungary
Miami Lakes, Florida, United States
Miami, Florida, United States
Colleyville, Texas, United States
San Juan, , Argentina
Mexico, Distrito Federal, Mexico
Badalona, Barcelona, Spain
Shanghai, Shanghai, China
San Miguel De Tucuman, Tucuman, Argentina
Zipaquirá, Cundinamarca, Colombia
Indianapolis, Indiana, United States
Troy, Michigan, United States
Caguas, , Puerto Rico
Sherbrooke, Quebec, Canada
Brescia, , Italy
Genova, , Italy
Antony, Hauts De Seine, France
Bad Bentheim, Niedersachsen, Germany
Warszawa, , Poland
Bologna, , Italy
Brooklyn, New York, United States
San Miguel De Tucuman, Tucuman, Argentina
Izumo Shi, Shimane Ken, Japan
Auburn Hills, Michigan, United States
Frisco, Texas, United States
Santiago, , Chile
Riyadh, , Saudi Arabia
Beijing, Beijing, China
Mar Del Plata, , Argentina
Debary, Florida, United States
Duesseldorf, Nordrhein Westfalen, Germany
Ciudad Autonoma Buenos Aires, , Argentina
Yokohama Shi, Kanagawa Ken, Japan
Greensboro, North Carolina, United States
Niigata Shi, Niigata Ken, Japan
Mabalacat, Pampanga, Philippines
Nanyang, Henan, China
Changhua, , Taiwan
Mar Del Plata, Buenos Aires, Argentina
Guangzhou, Guangzhou, China
Seoul, , Korea, Republic Of
Erlangen, Bayern, Germany
Sofia, , Bulgaria
Buxtehude, Niedersachsen, Germany
Sudbury, Ontario, Canada
Viña Del Mar, , Chile
Sapporo Shi, Hokkaido, Japan
Kanazawa Shi, Ishikawa Ken, Japan
Gwangju, Dong Gu, Korea, Republic Of
Valladolid, Cantabria, Spain
Alcorcón, Madrid, Spain
Belo Horizonte, Minas Gerais, Brazil
Dallas, Texas, United States
Grand Blanc, Michigan, United States
Dallas, Texas, United States
Ciudad Autonoma Buenos Aires, , Argentina
Sofia, , Bulgaria
Toulouse Cedex 9, Haute Garonne, France
Merida, Yucatán, Mexico
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Valdivia, , Chile
Kawasaki Shi, Kanagawa Ken, Japan
Las Condes, , Chile
Napoli, , Italy
Rzeszow, , Poland
Mendoza, , Argentina
Kitakyushu Shi, Fukuoka Ken, Japan
Salvador, Bahia, Brazil
Nagoya Shi, Aichi Ken, Japan
Berlin, , Germany
Ciudad Autonoma De Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Nanjing, Jiangsu, China
Birmingham, Alabama, United States
Durham, North Carolina, United States
Galveston, Texas, United States
Ciudad Autonoma De Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Ottawa, Ontario, Canada
Nice Cedex 3, Alpes Maritimes, France
Montpellier Cedex 5, Herault, France
Cedex 10, Paris, France
Lyon, Rhone, France
Oldenburg, Niedersachsen, Germany
Firenze, , Italy
Roma, , Italy
Ciudad De México, Distrito Federal, Mexico
Cuernavaca, Morelos, Mexico
Krakow, , Poland
Lodz, , Poland
Lisboa, , Portugal
Porto, , Portugal
Viana Do Castelo, , Portugal
San Juan, , Puerto Rico
Kosice, , Slovakia
Lucerne (Luzern), , Switzerland
Birmingham, West Midlands, United Kingdom
Leeds, West Yorkshire, United Kingdom
Natick, Massachusetts, United States
Cincinnati, Ohio, United States
Brasilia, Distrito Federal, Brazil
Rio De Janeiro, Rio Do Janeiro, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Bernardo Do Campo, Sao Paulo, Brazil
Halle, Sachsen Anhalt, Germany
Yoshida Gun, Fukui Ken, Japan
Ono Shi, Hyogo Ken, Japan
Caen, Calvados, France
Wroclaw, , Poland
Quezon City, Metro Manila, , Philippines
Napoli, , Italy
Rio De Janeiro, Rio Do Janeiro, Brazil
Okayama Shi, Okayama Ken, Japan
Kawachinagano Shi, Osaka Fu, Japan
Coimbra, , Portugal
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Shinagawa Ku, Tokyo To, Japan
Guadalajara, Jalisco, Mexico
Manila, , Philippines
San Fenando, La Union, , Philippines
Warszawa, , Poland
Shanghai, Shanghai, China
Izumo Shi, , Japan
Santo ângelo, Mato Grosso, Brazil
Osaka Shi, Osaka Fu, Japan
Aomori Shi, Aomori Ken, Japan
Urayasu Shi, Chiba Ken, Japan
Kakogawa Shi, Hyogo Ken, Japan
Takatsuki Shi, Osaka Fu, Japan
Barranquilla, Atlántico, Colombia
Changchun City, Jilin, China
Caba, Buenos Aires, Argentina
New Orleans, Louisiana, United States
Zurich Flughafen, Zurich, Switzerland
Fortaleza, , Brazil
Vitória, , Brazil
Patients applied
Trial Officials
Medical Director
Study Director
Biogen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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