A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
- Registration Number
- NCT04895696
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 268
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Afimetoran: Dose 1 Afimetoran - Placebo Placebo - Afimetoran: Dose 2 Afimetoran - Afimetoran: Dose 3 Afimetoran -
- Primary Outcome Measures
Name Time Method Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48 Up to 48 Weeks
- Secondary Outcome Measures
Name Time Method Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48 Up to 48 Weeks Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with ≥ 2 swollen joints at baseline Up to 48 Weeks Change from baseline in PGA score of disease activity at Week 24 and Week 48 Up to 48 Weeks PGA = Physician Global Assessment of disease activity (score of "0" indicating no disease activity and higher scores indicating higher disease activity)
Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48 Up to 48 Weeks Number of participants with Adverse Events (AEs) Up to 100 Weeks Number of participants with physical examination abnormalities Up to 100 Weeks Number of participants with electrocardiogram (ECG) abnormalities Up to 52 Weeks Proportion of participants who achieve an SRI(4) response at Week 24 Up to 24 Weeks Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score ≥ 10 at baseline who achieve a decrease of ≥ 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48 Up to 48 Weeks Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a ≥ 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48 Up to 48 Weeks Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with ≥ 2 tender joints at baseline Up to 48 Weeks Change in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36) Up to 48 Weeks The SF-36 was designed as an indicator of health status in population surveys, and health policy evaluations, and for use as an outcome measure in clinical practice and research. Scores for each domain range from 0 to 100, with high scores indicating a better health status.
Number of participants with Serious Adverse Events (SAEs) Up to 100 Weeks Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48 Up to 48 Weeks Number of participants with clinical laboratory abnormalities Up to 100 Weeks Number of participants with vital sign abnormalities Up to 100 Weeks
Trial Locations
- Locations (174)
Local Institution - 0196
🇨🇳Baoding, Hebei, China
Private Practice - Dr. Jefrey Lieberman
🇺🇸Decatur, Georgia, United States
Local Institution - 0100
🇺🇸Birmingham, Alabama, United States
St Joseph Heritage Healthcare-Rheumatology
🇺🇸Fullerton, California, United States
Christine Thai, MD
🇺🇸Huntington Beach, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
🇺🇸La Jolla, California, United States
Advanced Medical Research - La Palma
🇺🇸La Palma, California, United States
Local Institution - 0202
🇺🇸Los Angeles, California, United States
Rheumatology Center of San Diego
🇺🇸San Diego, California, United States
Private Practice - Dr. Nazanin Firooz
🇺🇸West Hills, California, United States
Local Institution - 0164
🇺🇸Woodland Hills, California, United States
Colorado Arthritis Associates
🇺🇸Denver, Colorado, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
Bay Area Arthritis and Osteoporosis
🇺🇸Brandon, Florida, United States
Clinical Research of West Florida, Inc. (Clearwater)
🇺🇸Clearwater, Florida, United States
University Of Florida
🇺🇸Gainesville, Florida, United States
Vida Clinical Research
🇺🇸Kissimmee, Florida, United States
Omega Research MetroWest
🇺🇸Orlando, Florida, United States
Millennium Research
🇺🇸Ormond Beach, Florida, United States
IRIS Research and Development, LLC
🇺🇸Plantation, Florida, United States
Local Institution - 0137
🇺🇸South Miami, Florida, United States
West Broward Rheumatology Associates
🇺🇸Tamarac, Florida, United States
Piedmont West
🇺🇸Atlanta, Georgia, United States
North Georgia Rheumatology
🇺🇸Suwanee, Georgia, United States
Greater Chicago Specialty Physicians - Orland Park
🇺🇸Orland Park, Illinois, United States
Western KY Rheumatology
🇺🇸Hopkinsville, Kentucky, United States
Local Institution - 0171
🇺🇸Baton Rouge, Louisiana, United States
Local Institution - 0134
🇺🇸Wheaton, Maryland, United States
Local Institution - 0221
🇺🇸Rochester Hills, Michigan, United States
Saint Paul Rheumatology
🇺🇸Eagan, Minnesota, United States
Washington University/ Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0165
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0091
🇺🇸Las Vegas, Nevada, United States
Sahni Rheumatology & Therapy
🇺🇸West Long Branch, New Jersey, United States
Local Institution - 0132
🇺🇸Bronx, New York, United States
The Feinstein Institute for Medical Research
🇺🇸Manhasset, New York, United States
Local Institution - 0203
🇺🇸Charlotte, North Carolina, United States
DJL Clinical Research, PLLC
🇺🇸Charlotte, North Carolina, United States
The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East-Rheumatology and Immunolog
🇺🇸Columbus, Ohio, United States
Paramount Medical Research and Consulting, Llc
🇺🇸Middleburg Heights, Ohio, United States
Oklahoma Medical Research Foundation-Multiple Sclerosis Center of Excellence
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Shelby Research LLC
🇺🇸Memphis, Tennessee, United States
Arthritis and Rheumatology Research Institute
🇺🇸Allen, Texas, United States
Local Institution - 0152
🇺🇸Allen, Texas, United States
Amarillo Center for Clinical Research-Research
🇺🇸Amarillo, Texas, United States
Local Institution - 0029
🇺🇸Mesquite, Texas, United States
Overlake Arthritis and Osteoporosis Center
🇺🇸Bellevue, Washington, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Local Institution - 0130
🇦🇷Quilmes, Buenos Aires, Argentina
Local Institution - 0195
🇦🇷San Fernando, Buenos Aires, Argentina
Local Institution - 0024
🇦🇷San Isidro, Buenos Aires, Argentina
Local Institution - 0025
🇦🇷Córdoba, Cordoba, Argentina
Local Institution - 0074
🇦🇷Buenos Aires, Distrito Federal, Argentina
Local Institution - 0145
🇦🇷Caba, Distrito Federal, Argentina
Local Institution - 0041
🇦🇷San Juan, Argentina
Local Institution - 0040
🇦🇷Caba, Distrito Federal, Argentina
Local Institution - 0027
🇦🇷San Miguel de Tucumán, Tucuman, Argentina
Local Institution - 0207
🇦🇷Buenos Aires, Argentina
Local Institution - 0128
🇦🇷Buenos Aires, Argentina
Local Institution - 0063
🇦🇺Botany, New South Wales, Australia
Local Institution - 0072
🇦🇺Westmead, New South Wales, Australia
Local Institution - 0066
🇦🇺Maroochydore, Queensland, Australia
Local Institution - 0065
🇦🇺Woodville, South Australia, Australia
Local Institution - 0062
🇦🇺Camberwell, Victoria, Australia
Local Institution - 0064
🇦🇺Ivanhoe, Victoria, Australia
Serviços Especializados em Reumatologia
🇧🇷Salvador, Bahia, Brazil
Centro de Pesquisas da Clínica IBIS
🇧🇷Salvador, Bahia, Brazil
IPC-MT Instituto de Pesquisas Clínicas de Mato Grosso
🇧🇷Cuiabá, Mato Grosso, Brazil
Cmip-Centro Mineiro de Pesquisa
🇧🇷Juiz de Fora, Minas Gerais, Brazil
Centro de Estudos em Terapias Inovadoras-Rheumatology
🇧🇷Curitiba, Parana, Brazil
LMK Serviços Médicos S/S-Reumacenter
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Centro Multidisciplinar de Estudos Clinicos
🇧🇷São Bernardo do Campo, SAO Paulo, Brazil
Local Institution - 0013
🇧🇷São Paulo, SAO Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷São José do Rio Preto, São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Local Institution - 0127
🇨🇱Osorno, LOS Lagos, Chile
Local Institution - 0143
🇨🇱Valdivia, Los Rios, Chile
Local Institution - 0073
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0043
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0075
🇨🇱Providencia, Región Metropolitana De Santiago, Chile
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
The Seventh Affiliated Hospital, Sun Yat-sen University
🇨🇳Shenzhen, Guangdong, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The 2nd Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Qilu Hospital of Shandong University (Qingdao)
🇨🇳Jinan, Shandong, China
Jining No.1 People's Hospital
🇨🇳Jining, Shandong, China
Local Institution - 0194
🇨🇳Changzhi, Shanxi, China
Local Institution - 0181
🇨🇳Kunming, Yunnan, China
Local Institution - 0191
🇨🇳Beijing, China
Salud SURA Industriales
🇨🇴Medellín, Antioquia, Colombia
Local Institution - 0185
🇨🇴Cali, Valle Del Cauca, Colombia
Centro de Reumatologia y Ortopedia
🇨🇴Barranquilla, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S
🇨🇴Bogotá, Colombia
Centro de Estudios de Reumatología y Dermatología SAS
🇨🇴Cali, Colombia
Preventive Care
🇨🇴Chía, Colombia
Healthy Medical Center S.A.S
🇨🇴Zipaquira, Colombia
CHU Bordeaux Haut-Leveque
🇫🇷Pessac, Aquitaine, France
CHRU de Brest
🇫🇷Brest, Finistère, France
Bordeaux University Hospital - Pellegrin-Rhumatologie
🇫🇷Bordeaux, France
Centre Hospitalier Universitaire de Caen Normandie
🇫🇷Caen, France
Chru De Lille
🇫🇷Lille Cedex, France
Hôpital Européen Marseille-Service de recherche clinique
🇫🇷Marseille, France
CHU Strasbourg-Hautepierre-Service de Rhumatologie
🇫🇷Strasbourg, France
Local Institution - 0087
🇩🇪Köln, Nordrhein-Westfalen, Germany
Charité Research Organisation
🇩🇪Berlin, Germany
Local Institution - 0086
🇩🇪Essen, Germany
Klinikum Der Albrecht-Ludwigs-Universitat
🇩🇪Freiburg, Germany
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India
Amber Clinic
🇮🇳Ahmedabad, Gujarat, India
Medanta The Medicity
🇮🇳Gurugram, Haryana, India
ChanRe Rheumatology And Immunology Center And Research
🇮🇳Bengaluru, Karnataka, India
Krishna Institute of Medical Science
🇮🇳Secunderabad, Telangana, India
Local Institution - 0119
🇮🇪Manorhamilton, Leitrim, Ireland
Local Institution - 0106
🇮🇪Dublin, Ireland
Local Institution - 0107
🇮🇪Galway, Ireland
University of Fukui Hospital
🇯🇵Eiheiji-cho,Yoshida-gun, Fukui, Japan
University of Occupational and Enviromental Health
🇯🇵Kitakyushu, Fukuoka, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Tohoku University Hospital-Department of Rheumatology
🇯🇵Sendai-shi, Miyagi, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Tama Medical Center
🇯🇵Fuchu, Tokyo, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashiku, Tokyo, Japan
Toho University Ohashi Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Keio university hospital-Division of Rheumatology, Department of Internal Medicine
🇯🇵Shinjuku-ku, Tokyo, Japan
National Center for Global Health and Medicine
🇯🇵Shinjuku-ku, Tokyo, Japan
Koujunkai Daido Clinic
🇯🇵Aichi, Japan
National Hospital Organization Chibahigashi National Hospital
🇯🇵Chiba, Japan
Fukushima Medical University
🇯🇵Fukushima, Japan
St. Luke's International Hospital
🇯🇵Tokyo, Japan
The University Of Tokyo Hospital
🇯🇵Tokyo, Japan
Local Institution - 0060
🇲🇽Mexico City, Distrito Federal, Mexico
Local Institution - 0018
🇲🇽Mexico City, Distrito Federal, Mexico
Local Institution - 0182
🇲🇽Mexico City, Distrito Federal, Mexico
Local Institution - 0020
🇲🇽Leon, Guanajuato, Mexico
Local Institution - 0017
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0022
🇲🇽Zapopan, Jalisco, Mexico
Local Institution - 0071
🇲🇽Monterrey, Nuevo LEON, Mexico
Local Institution - 0021
🇲🇽Chihuahua, Mexico
Local Institution - 0061
🇲🇽Merida, Mexico
Local Institution - 0158
🇲🇽Mexico City, Mexico
Centrum Medyczne Reuma Park
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0161
🇵🇱Łomża, Podlaskie, Poland
Local Institution - 0051
🇵🇱Bydgoszcz, Poland
Medyczne Centrum Hetmańska
🇵🇱Poznan, Poland
Local Institution - 0142
🇵🇱Rzeszów, Poland
Local Institution - 0050
🇵🇱Sosnowiec, Poland
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Poland
Uniwersytecki Szpital Kliniczny-Klinika Reumatologii i Chorób Wewnętrznych
🇵🇱Wrocław, Poland
GCM Medical Group, PSC - Hato Rey Site-Hato Rey
🇵🇷San Juan, Puerto Rico
Local Institution - 0131
🇵🇷San Juan, Puerto Rico
Sc Medaudio-Optica Srl
🇷🇴Râmnicu Vâlcea, Vâlcea, Romania
Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
🇷🇴Bucharest, Romania
Spital Clinic Sf. Maria
🇷🇴Bucharest, Romania
Centrul de Kinetoterapie si Masaj Banat SRL
🇷🇴Giroc, Romania
Local Institution - 0206
🇪🇸Santander, Cantabria, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia
🇪🇸A Coruña, Spain
Hospital Universitari Vall d'Hebron-Rheumatology
🇪🇸Barcelona, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Reumatología
🇪🇸Madrid, Spain
Hospital Universitario Virgen de Valme-RHEUMATOLOGY
🇪🇸Sevilla, Spain
Chang Gung Memorial Hospital at Kaohsiung-Rheumatology
🇨🇳Kaohsiung Niao Sung Dist, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital-Immunology
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Addenbrooke's Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Local Institution - 0110
🇬🇧Bradford, United Kingdom
Local Institution - 0120
🇬🇧Edinburgh, United Kingdom
Local Institution - 0125
🇬🇧Manchester, United Kingdom