A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Launched by BRISTOL-MYERS SQUIBB · May 19, 2021
Trial Information
Current as of May 06, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called Afimetoran for people with active Systemic Lupus Erythematosus (SLE), a condition where the immune system attacks the body's own tissues. The main goal is to see how effective and safe Afimetoran is compared to a placebo, which is a dummy treatment that doesn't contain any active medication. The trial is currently looking for participants aged 18 and older who have been diagnosed with SLE for at least 12 weeks and show specific signs of the disease, such as joint pain or rashes.
If you choose to participate, you will receive either Afimetoran or a placebo during the trial. After this initial phase, those who received the placebo will have the chance to switch to Afimetoran for further treatment. Throughout the study, researchers will closely monitor your health to gather information about how well the treatment works and its safety over time. This trial is an important step in finding better options for people living with SLE.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
- • Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
- • Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash
- Exclusion Criteria:
- • Active severe lupus nephritis (LN) as assessed by the investigator
- • Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
- • Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
- • Antiphospholipid Syndrome
- • Other protocol-defined inclusion/exclusion criteria apply
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Oklahoma City, Oklahoma, United States
Sapporo, Hokkaido, Japan
Birmingham, Alabama, United States
Gainesville, Florida, United States
Galway, , Ireland
Taichung, , Taiwan
Wheaton, Maryland, United States
Tokyo, , Japan
Berlin, , Germany
Essen, , Germany
Manchester, , United Kingdom
Leon, Guanajuato, Mexico
Cambridge, Cambridgeshire, United Kingdom
Taichung, , Taiwan
Tamarac, Florida, United States
Columbus, Ohio, United States
Manchester, , United Kingdom
Brest Cedex, , France
New Delhi, Delhi, India
San Juan, , Puerto Rico
Bydgoszcz, , Poland
Merida, Yucatan, Mexico
Middleburg Heights, Ohio, United States
San Antonio, Texas, United States
Fullerton, California, United States
Monterrey, Nuevo Leon, Mexico
Kanazawa, Ishikawa, Japan
Nanjing, Jiangsu, China
Ormond Beach, Florida, United States
San Juan, , Puerto Rico
Manhasset, New York, United States
Charlotte, North Carolina, United States
Chiba, , Japan
Las Vegas, Nevada, United States
Madrid, , Spain
Taipei, , Taiwan
Tamarac, Florida, United States
Lille Cedex, , France
Suzhou, Jiangsu, China
Eagan, Minnesota, United States
Sosnowiec, , Poland
Atlanta, Georgia, United States
Middleburg Heights, Ohio, United States
Brandon, Florida, United States
Juiz De Fora, Minas Gerais, Brazil
Saint Louis, Missouri, United States
Juiz De Fora, Minas Gerais, Brazil
Charlotte, North Carolina, United States
Saint Louis, Missouri, United States
Kitakyushu, Fukuoka, Japan
Guadalajara, Jalisco, Mexico
Nanjing, Jiangsu, China
Nanjing, , China
Cambridge, , United Kingdom
Changchun, Jilin, China
Taipei, , Taiwan
Sao Paulo, , Brazil
Freiburg, , Germany
Mexico City, Distrito Federal, Mexico
Mesquite, Texas, United States
Beijing, Beijing, China
Strasbourg, , France
Plantation, Florida, United States
San Diego, California, United States
Lawrenceville, Georgia, United States
Clearwater, Florida, United States
Jining, Shandong, China
Lakewood, Colorado, United States
Ciudad De Mexico, Distrito Federal, Mexico
Bangalore, Karnataka, India
Gainesville, Florida, United States
Mexico, Distrito Federal, Mexico
São Paulo, , Brazil
Ahmedabad, Gujarat, India
Barranquilla, , Colombia
Barranquilla, , Colombia
Memphis, Tennessee, United States
Brest, Finistère, France
Botany, New South Wales, Australia
Salvador, Bahia, Brazil
Allen, Texas, United States
Warszawa, , Poland
Huntington Beach, California, United States
La Palma, California, United States
West Hills, California, United States
Orlando, Florida, United States
Plantation, Florida, United States
South Miami, Florida, United States
Atlanta, Georgia, United States
Orland Park, Illinois, United States
Hopkinsville, Kentucky, United States
Wheaton, Maryland, United States
Bronx, New York, United States
Allen, Texas, United States
Amarillo, Texas, United States
Quilmes, Buenos Aires, Argentina
Córdoba, Cordoba, Argentina
Buenos Aires, Distrito Federal, Argentina
Caba, Distrito Federal, Argentina
San Miguel De Tucumán, Tucuman, Argentina
Buenos Aires, , Argentina
San Juan, , Argentina
Westmead, New South Wales, Australia
Maroochydore, Queensland, Australia
Woodville, South Australia, Australia
Camberwell, Victoria, Australia
Ivanhoe, Victoria, Australia
Cuiaba, Mato Grosso, Brazil
Curitiba, Parana, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São Bernardo Do Campo, Sao Paulo, Brazil
São José Do Rio Preto, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Osorno, Los Lagos, Chile
Valdivia, Los Rios, Chile
Santiago, Metropolitana, Chile
Santiago, Metropolitana, Chile
Santiago, Región Metropolitana De Santiago, Chile
Shenzhen, Guangdong, China
Dalian, Liaoning, China
Jinan, Shandong, China
Jining, Shandong, China
Cali, Valle Del Cauca, Colombia
Bogotá, , Colombia
Cali, , Colombia
Chia, , Colombia
Zipaquira, , Colombia
Bordeaux, , France
Caen, , France
Freiburg Im Breisgau, , Germany
Köln, , Germany
Manorhamilton, Leitrim, Ireland
Dublin, , Ireland
Chiba Shi, Chiba, Japan
Eiheiji Cho,Yoshida Gun, Fukui, Japan
Kitakyushu, Fukuoka, Japan
Sapporo, Hokkaido, Japan
Kanazawa, Ishikawa, Japan
Sendai Shi, Miyagi, Japan
Bunkyo Ku, Tokyo, Japan
Itabashiku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Aichi, , Japan
Tokyo, , Japan
Tokyo, , Japan
Mexico City, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Chihuahua, , Mexico
Poznan, , Poland
Rzeszów, , Poland
Warszawa, , Poland
Wrocław, , Poland
San Juan, , Puerto Rico
Bucharest, , Romania
Bucuresti, , Romania
Râmnicu Vâlcea, , Romania
Timisoara, , Romania
A Coruña, , Spain
Barcelona, , Spain
Sevilla, , Spain
Kaohsiung, , Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Bradford, , United Kingdom
Edinburgh, , United Kingdom
Allen, Texas, United States
Fullerton, California, United States
Strasbourg, , France
Buenos Aires, , Argentina
West Hills, California, United States
Juiz De Fora, Minas Gerais, Brazil
Valdivia, Los Rios, Chile
Baoding, Hebei, China
Suzhou, Jiangsu, China
Chía, , Colombia
Medellín, , Colombia
Essen, , Germany
Chiba, , Japan
Fukushima, , Japan
Taipei, , Taiwan
Zapopan, Jalisco, Mexico
Kissimmee, Florida, United States
Plantation, Florida, United States
San Fernando, Buenos Aires, Argentina
Caba, Distrito Federal, Argentina
Salvador, Bahia, Brazil
Salvador, Bahia, Brazil
Cuiaba, Mato Grosso, Brazil
Curitiba, Parana, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São Bernardo Do Campo, Sao Paulo, Brazil
São José Do Rio Preto, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Nanjing, Jiangsu, China
Changzhi, Shanxi, China
Marseille, , France
Meguro Ku, Tokyo, Japan
Mexico City, Distrito Federal, Mexico
Mexico City, Distrito Federal, Mexico
Leon, Guanajuato, Mexico
Monterrey, Nuevo Leon, Mexico
Merida, , Mexico
Kaohsiung Niao Sung Dist, , Taiwan
Köln, Nordrhein Westfalen, Germany
Lille Cedex, , France
Zipaquira, , Colombia
Warszawa, Mazowieckie, Poland
Baton Rouge, Louisiana, United States
Medellín, Antioquia, Colombia
Pessac, Aquitaine, France
Brest, , France
Ciudad De Mexico, Distrito Federal, Mexico
łomża, Podlaskie, Poland
Bydgoszcz, , Poland
Columbus, Ohio, United States
Bucharest, , Romania
Taipei, , Taiwan
Los Angeles, California, United States
La Jolla, California, United States
Manorhamilton, Leitrim, Ireland
Bradford, , United Kingdom
Freiburg, , Germany
Dublin, , Ireland
Warszawa, Mazowieckie, Poland
Shenzhen, Guangdong, China
Charlotte, North Carolina, United States
Decatur, Georgia, United States
Beijing, Beijing, China
Nanjing, Jiangsu, China
Marseille, , France
Bunkyo Ku, Tokyo, Japan
Bucharest, , Romania
Woodland Hills, California, United States
Changchun, Jilin, China
Buena Park, California, United States
Farmington, Connecticut, United States
Salvador, Bahia, Brazil
Jinan, Shandong, China
Fuchu, Tokyo, Japan
Tokyo, , Japan
Manchester, , United Kingdom
Shinjuku Ku, Tokyo, Japan
Madrid, , Spain
Berlin, , Germany
Botany, New South Wales, Australia
Ivanhoe, Victoria, Australia
Shinjuku Ku, Tokyo, Japan
Mexico City, Distrito Federal, Mexico
Denver, Colorado, United States
Wheaton, Maryland, United States
Las Vegas, Nevada, United States
Buenos Aires, , Argentina
São Paulo, Sao Paulo, Brazil
Beijing, Beijing, China
Kunming, Yunnan, China
Medellín, Antioquia, Colombia
Barranquilla, , Colombia
Cali, , Colombia
Bordeaux, , France
Brest, , France
Caen, , France
Berlin, , Germany
New Delhi, Delhi, India
Gurugram, Haryana, India
Bengaluru, Karnataka, India
Hyderabad, Telangana, India
Galway, , Ireland
Bydgoszcz, , Poland
Rzeszów, , Poland
Sosnowiec, , Poland
Giroc, , Romania
Râmnicu Vâlcea, , Romania
Santander, Cantabria, Spain
Madrid, , Spain
Cambridge, Cambridgeshire, United Kingdom
Bradford, , United Kingdom
Edinburgh, , United Kingdom
Oklahoma City, Oklahoma, United States
Jinan, Shandong, China
Buenos Aires, Distrito Federal, Argentina
Santiago, Metropolitana, Chile
Dalian, Liaoning, China
Medellín, Antioquia, Colombia
Bogotá, , Colombia
Chía, , Colombia
Fuchu, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Chihuahua, , Mexico
Poznan, , Poland
Giroc, , Romania
Râmnicu Vâlcea, , Romania
Los Angeles, California, United States
Rochester Hills, Michigan, United States
Itabashiku, Tokyo, Japan
San Juan, , Argentina
Santiago, Metropolitana, Chile
Leon, Guanajuato, Mexico
Monterrey, Nuevo Leon, Mexico
Merida, , Mexico
A Coruña, , Spain
Barcelona, , Spain
Taipei, , Taiwan
Santiago, Región Metropolitana De Santiago, Chile
Cali, , Colombia
Galway, , Ireland
Zipaquira, , Colombia
Córdoba, Cordoba, Argentina
Caba, Distrito Federal, Argentina
Secunderabad, Telangana, India
Quilmes, Buenos Aires, Argentina
San Miguel De Tucumán, Tucuman, Argentina
Westmead, New South Wales, Australia
Cuiabá, Mato Grosso, Brazil
Köln, Nordrhein Westfalen, Germany
Bunkyo Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Aichi, , Japan
Mexico City, Distrito Federal, Mexico
Wrocław, , Poland
Bucharest, , Romania
Bucharest, , Romania
Madrid, , Spain
Sevilla, , Spain
Kaohsiung Niao Sung Dist, , Taiwan
Charlotte, North Carolina, United States
Valdivia, Los Rios, Chile
Sendai Shi, Miyagi, Japan
South Miami, Florida, United States
Baton Rouge, Louisiana, United States
Saint Louis, Missouri, United States
West Long Branch, New Jersey, United States
Bronx, New York, United States
Bellevue, Washington, United States
Beijing, , China
Manorhamilton, Leitrim, Ireland
Râmnicu Vâlcea, Vâlcea, Romania
Bellevue, Washington, United States
Woodland Hills, California, United States
San Isidro, Buenos Aires, Argentina
Gurugram, Haryana, India
Mexico City, , Mexico
San Juan, , Puerto Rico
Birmingham, Alabama, United States
Allen, Texas, United States
Mesquite, Texas, United States
West Long Branch, New Jersey, United States
Suwanee, Georgia, United States
Ahmedabad, Gujarat, India
Bengaluru, Karnataka, India
Providencia, Región Metropolitana De Santiago, Chile
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials