A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

June 25, 2024 updated by: Bristol-Myers Squibb

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

268

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Completed
        • Local Institution - 0207
      • Buenos Aires, Argentina, C1426ABP
        • Active, not recruiting
        • Local Institution - 0128
      • San Juan, Argentina, 5400
        • Active, not recruiting
        • Local Institution - 0041
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, 1878
        • Active, not recruiting
        • Local Institution - 0130
      • San Fernando, Buenos Aires, Argentina, 1646
        • Completed
        • Local Institution - 0195
    • Cordoba
      • Córdoba, Cordoba, Argentina, 5004
        • Active, not recruiting
        • Local Institution - 0025
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, C1121ABE
        • Active, not recruiting
        • Local Institution - 0074
      • Caba, Distrito Federal, Argentina, 1111
        • Withdrawn
        • Local Institution - 0145
      • Caba, Distrito Federal, Argentina, 1406
        • Active, not recruiting
        • Local Institution - 0040
    • Tucuman
      • San Miguel de Tucumán, Tucuman, Argentina, T4000
        • Active, not recruiting
        • Local Institution - 0027
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Completed
        • Local Institution - 0063
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital-Department of Clinical Immunology and Allergy
        • Contact:
          • Sanjay Swaminathan, Site 0072
          • Phone Number: +61288903791
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Completed
        • Local Institution - 0066
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Completed
        • Local Institution - 0065
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Completed
        • Local Institution - 0062
      • Ivanhoe, Victoria, Australia, 3079
        • Recruiting
        • Local Institution - 0064
        • Contact:
          • Site 0064
  • Brazil
      • São Paulo, Brazil, 04266-010
        • Recruiting
        • CEPIC - Centro Paulista de Investigação Clínica
        • Contact:
          • Andrea Lomonte, Site 0009
          • Phone Number: 55 11 991977209
    • Bahia
      • Salvador, Bahia, Brazil, 41820-020
        • Recruiting
        • Centro de Pesquisas da Clínica IBIS
        • Contact:
          • Rafael de Carvalho, Site 0031
          • Phone Number: 55 71 3012-3755
      • Salvador, Bahia, Brazil, 40150-150
        • Recruiting
        • Serviços Especializados em Reumatologia
        • Contact:
          • Mittermayer Santiago, Site 0006
          • Phone Number: 5571988355001
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brazil, 78020-500
        • Recruiting
        • IPC-MT Instituto de Pesquisas Clínicas de Mato Grosso
        • Contact:
          • Luiz Barbosa, Site 0093
          • Phone Number: +5565999814014
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Recruiting
        • Cmip-Centro Mineiro de Pesquisa
        • Contact:
          • Viviane De Souza, Site 0008
          • Phone Number: ( 32 ) 33128920
    • Parana
      • Curitiba, Parana, Brazil, 80030110
        • Recruiting
        • Centro de Estudos em Terapias Inovadoras-Rheumatology
        • Contact:
          • Sebastiao Radominski, Site 0010
          • Phone Number: +55 41 991149119
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
        • Recruiting
        • LMK Serviços Médicos S/S-Reumacenter
        • Contact:
          • Mauro Keiserman, Site 0007
          • Phone Number: +5551998089284
    • SAO Paulo
      • São Bernardo do Campo, SAO Paulo, Brazil, 09715-090
        • Recruiting
        • Centro Multidisciplinar de Estudos Clinicos
        • Contact:
          • Anna Fernandes, Site 0014
          • Phone Number: 1149304243
      • São José do Rio Preto, SAO Paulo, Brazil, 15091-000
        • Recruiting
        • Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas
        • Contact:
          • Mariana Martins, Site 0045
          • Phone Number: 551732015054
      • São Paulo, SAO Paulo, Brazil, 04032-060
        • Withdrawn
        • Local Institution - 0013
  • Chile
    • LOS Lagos
      • Osorno, LOS Lagos, Chile, 5290000
        • Completed
        • Local Institution - 0127
    • Los Rios
      • Valdivia, Los Rios, Chile, 2279374
        • Completed
        • Local Institution - 0143
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Active, not recruiting
        • Local Institution - 0073
      • Santiago, Metropolitana, Chile, 7501126
        • Active, not recruiting
        • Local Institution - 0043
    • Región Metropolitana De Santiago
      • Santiago, Región Metropolitana De Santiago, Chile, 7500571
        • Active, not recruiting
        • Local Institution - 0075
  • China
      • Beijing, China, 100034
        • Withdrawn
        • Local Institution - 0191
    • Beijing
      • Beijing, Beijing, China, 100144
        • Recruiting
        • Peking University Shougang Hospital
        • Contact:
          • kuanting wang, Site 0180
          • Phone Number: 13810463252
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Local Institution - 0177
        • Contact:
          • Site 0177
    • Guangdong
      • Shenzhen, Guangdong, China, 518107
        • Recruiting
        • The Seventh Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Jieruo Gu, Site 0184
          • Phone Number: +8613922280820
    • Hebei
      • Baoding, Hebei, China, 071066
        • Withdrawn
        • Local Institution - 0196
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Wenfeng Tan, Site 0188
          • Phone Number: 18061202878
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
        • Contact:
          • Lingyun Sun, Site 0176
          • Phone Number: 13705186409
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Jian Wu, Site 0193
          • Phone Number: +86 15358805676
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Zhenyu Jiang, Site 0174
          • Phone Number: 18243051812
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Recruiting
        • The 2nd Affiliated Hospital of Dalian Medical University
        • Contact:
          • xiaodan kong, Site 0179
          • Phone Number: 17709876336
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University (Qingdao)
        • Contact:
          • Qiang Shu, Site 0178
          • Phone Number: 18560081681
      • Jining, Shandong, China, 272011
        • Recruiting
        • Jining No.1 People's Hospital
        • Contact:
          • Jianhong Zhao, Site 0183
          • Phone Number: 18678769698
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Withdrawn
        • Local Institution - 0194
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • Withdrawn
        • Local Institution - 0181
  • Colombia
      • Barranquilla, Colombia, 080020
        • Recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
      • Bogotá, Colombia, 110221
        • Recruiting
        • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S
        • Contact:
          • PATRICIA VELEZ SANCHEZ, Site 0004
          • Phone Number: 0573143941742
      • Cali, Colombia, 760042
        • Recruiting
        • Centro de Estudios de Reumatología y Dermatología SAS
        • Contact:
          • Carlos Toro, Site 0076
          • Phone Number: +573012568236
      • Chía, Colombia, 250001
        • Recruiting
        • Preventive Care
        • Contact:
          • John Londono Patino, Site 0005
          • Phone Number: 57 1 8613503
      • Zipaquira, Colombia, 250252
        • Recruiting
        • Healthy Medical Center S.A.S
        • Contact:
          • Danny Gomez, Site 0003
          • Phone Number: 5718815449
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Recruiting
        • Salud SURA Industriales
        • Contact:
          • Miguel Mesa, Site 0190
          • Phone Number: 3176470282
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Not yet recruiting
        • Local Institution - 0185
        • Contact:
          • Site 0185
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Bordeaux University Hospital - Pellegrin-Rhumatologie
        • Contact:
          • Christophe Richez, Site 0048
          • Phone Number: +33556795556
      • Caen, France, 14033
        • Recruiting
        • Centre Hospitalier Universitaire de Caen Normandie
        • Contact:
          • Achille AOUBA, Site 0144
          • Phone Number: 02.31.06.45.79
      • Lille Cedex, France, 59037
        • Recruiting
        • Chru De Lille
        • Contact:
          • Eric Hachulla, Site 0129
          • Phone Number: 33320445048
      • Marseille, France, 13003
        • Recruiting
        • Hôpital Européen Marseille-Service de recherche clinique
        • Contact:
          • Laurent CHICHE, Site 0112
          • Phone Number: 0616834430
      • Strasbourg, France, 67098
        • Recruiting
        • CHU Strasbourg-Hautepierre-Service de Rhumatologie
        • Contact:
          • Laurent ARNAUD, Site 0044
          • Phone Number: 0388128656
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Recruiting
        • CHU Bordeaux Haut-Leveque
        • Contact:
          • Jean-Francois VIALLARD, Site 0156
          • Phone Number: 0557656483
    • Finistère
      • Brest, Finistère, France, 29609
        • Recruiting
        • CHRU de Brest
        • Contact:
          • Sandrine JOUSSE-JOULIN, Site 0083
          • Phone Number: 111-111-1111
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Research Organisation
        • Contact:
          • Thomas Dörner, Site 0085
          • Phone Number: +4930450513025
      • Essen, Germany, 45122
        • Completed
        • Local Institution - 0086
      • Freiburg, Germany, 79106
        • Recruiting
        • Klinikum Der Albrecht-Ludwigs-Universitat
        • Contact:
          • Stephanie Finzel, Site 0084
          • Phone Number: +4976127074490
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Completed
        • Local Institution - 0087
  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Not yet recruiting
        • Local Institution - 0208
        • Contact:
          • Site 0208
    • Haryana
      • Gurugram, Haryana, India, 122018
        • Not yet recruiting
        • Local Institution - 0214
        • Contact:
          • Site 0214
    • Karnataka
      • Bangalore, Karnataka, India, 560010
        • Recruiting
        • ChanRe Rheumatology And Immunology Center And Research
        • Contact:
          • Chandrashekara Srikantiah, Site 0210
          • Phone Number: 9845071151
    • Telangana
      • Secunderabad, Telangana, India, 500003
        • Recruiting
        • Krishna Institute of Medical Science
        • Contact:
          • Sarath Veeravalli, Site 0209
          • Phone Number: 9866000685
  • Ireland
      • Dublin, Ireland, D15 X40D
        • Completed
        • Local Institution - 0106
      • Galway, Ireland, H91 TY80
        • Recruiting
        • Merlin Park Hospital-Rheumatology
        • Contact:
          • Amina Gsel, Site 0107
          • Phone Number: 087 3374060
    • Leitrim
      • Manorhamilton, Leitrim, Ireland
        • Recruiting
        • Our Ladys Hospital - Leitrim-Rheumatology
        • Contact:
          • Bryan Whelan, Site 0119
          • Phone Number: 0876374764
  • Japan
      • Aichi, Japan, 457-8511
        • Recruiting
        • Koujunkai Daido Clinic
        • Contact:
          • Yoichiro Haji, Site 0138
          • Phone Number: 0526116261
      • Chiba, Japan, 260-8712
        • Recruiting
        • National Hospital Organization Chiba-East Hospital
        • Contact:
          • Yoshihiro Oya, Site 0115
          • Phone Number: +81432615171
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Local Institution - 0162
        • Contact:
          • Site 0162
      • Tokyo, Japan, 104-8560
        • Recruiting
        • Local Institution - 0097
        • Contact:
          • Site 0097
      • Tokyo, Japan, 113-8654
        • Recruiting
        • Local Institution - 0116
        • Contact:
          • Site 0116
    • Fukui
      • Eiheiji-cho,Yoshida-gun, Fukui, Japan, 910-1193
        • Recruiting
        • Local Institution - 0114
        • Contact:
          • Site 0114
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Recruiting
        • University of Occupational and Enviromental Health
        • Contact:
          • Shingo Nakayamada, Site 0095
          • Phone Number: +8193-603-1611
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
          • Masaru Kato, Site 0096
          • Phone Number: +81-11-706-5915
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
          • Yasunori Iwata, Site 0104
          • Phone Number: 076-265-2000
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital-Department of Rheumatology
        • Contact:
          • Tsuyoshi Shirai, Site 0099
          • Phone Number: +81227177165
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138431
        • Recruiting
        • Juntendo University Hospital
        • Contact:
          • Naoto Tamura, Site 0117
          • Phone Number: 0358021067
      • Fuchu, Tokyo, Japan, 1838524
        • Recruiting
        • Tokyo Metropolitan Tama Medical Center
        • Contact:
          • Naoto Yokogawa, Site 0218
          • Phone Number: +81-42-323-5111
      • Itabashiku, Tokyo, Japan, 173-8610
        • Recruiting
        • Local Institution - 0113
        • Contact:
          • Site 0113
      • Meguro-ku, Tokyo, Japan, 1538515
        • Recruiting
        • Local Institution - 0150
        • Contact:
          • Site 0150
      • Shinjuku-ku, Tokyo, Japan, 1600035
        • Recruiting
        • Keio university hospital-Division of Rheumatology, Department of Internal Medicine
        • Contact:
          • Yuko Kaneko, Site 0098
          • Phone Number: 81333531211
      • Shinjuku-ku, Tokyo, Japan, 1628655
        • Recruiting
        • National Center for Global Health and Medicine
        • Contact:
          • Hiroshi Kaneko, Site 0105
          • Phone Number: 81332027181
  • Mexico
      • Chihuahua, Mexico, 31210
        • Active, not recruiting
        • Local Institution - 0021
      • Merida, Mexico, 97070
        • Active, not recruiting
        • Local Institution - 0061
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14080
        • Withdrawn
        • Local Institution - 0182
      • Mexico City, Distrito Federal, Mexico, 06760
        • Completed
        • Local Institution - 0060
      • Mexico City, Distrito Federal, Mexico, 11850
        • Active, not recruiting
        • Local Institution - 0018
      • Mexico City, Distrito Federal, Mexico, 14080
        • Completed
        • Local Institution - 0158
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Active, not recruiting
        • Local Institution - 0020
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Active, not recruiting
        • Local Institution - 0017
      • Zapopan, Jalisco, Mexico, 45070
        • Completed
        • Local Institution - 0022
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64000
        • Active, not recruiting
        • Local Institution - 0071
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Withdrawn
        • Local Institution - 0051
      • Poznan, Poland, 60-218
        • Recruiting
        • Medyczne Centrum Hetmańska
        • Contact:
          • Piotr Leszczynski, Site 0049
          • Phone Number: +4861698806606
      • Rzeszów, Poland, 35-055
        • Withdrawn
        • Local Institution - 0142
      • Sosnowiec, Poland, 41-200
        • Withdrawn
        • Local Institution - 0050
      • Warszawa, Poland, 00-874
        • Recruiting
        • MICS Centrum Medyczne Warszawa
        • Contact:
          • Katarzyna Romanowska - Prochnicka, Site 0149
          • Phone Number: +48608552294
      • Wrocław, Poland, 50-556
        • Recruiting
        • Uniwersytecki Szpital Kliniczny-Klinika Reumatologii i Chorób Wewnętrznych
        • Contact:
          • Piotr Wiland, Site 0052
          • Phone Number: +48717343350
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-665
        • Recruiting
        • Centrum Medyczne Reuma Park
        • Contact:
          • Katarzyna Woszuk, Site 0204
          • Phone Number: 48605832570
    • Podlaskie
      • Łomża, Podlaskie, Poland, 18-404
        • Withdrawn
        • Local Institution - 0161
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • GCM Medical Group, PSC - Hato Rey Site-Hato Rey
        • Contact:
          • Gregorio Cortes-Maisonet, Site 0037
          • Phone Number: 787-936-2100
      • San Juan, Puerto Rico, 00918
        • Withdrawn
        • Mindful Medical Research
  • Romania
      • Bucharest, Romania, 011053
        • Recruiting
        • Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
        • Contact:
          • Daniela Anghel, Site 0157
          • Phone Number: +40731040974
      • Bucharest, Romania, 011172
        • Recruiting
        • Spital Clinic Sf. Maria
        • Contact:
          • Violeta Bojinca, Site 0067
          • Phone Number: 0723924823
      • Giroc, Romania, 307220
        • Recruiting
        • Centrul de Kinetoterapie si Masaj Banat SRL
        • Contact:
          • ROXANA CERBULESCU, Site 0068
          • Phone Number: 0724338781
      • Râmnicu Vâlcea, Romania, 240762
        • Recruiting
        • SC MEDAUDIO-OPTICA SRL-Rheumatology
        • Contact:
          • RAZVAN IONITESCU, Site 0082
          • Phone Number: 0040722557297
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia
        • Contact:
          • Francisco Javier Blanco Garcia, Site 0056
          • Phone Number: 981176399
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Rheumatology
        • Contact:
          • JOSEFINA CORTES-HERNANDEZ, Site 0058
          • Phone Number: 934894171
      • Madrid, Spain, 28009
        • Recruiting
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Reumatología
        • Contact:
          • Jose Alvaro-Gracia, Site 0055
          • Phone Number: 915866681
      • Sevilla, Spain, 41014
        • Recruiting
        • Hospital Universitario Virgen de Valme-RHEUMATOLOGY
        • Contact:
          • Jose Marenco, Site 0057
          • Phone Number: +34955015790
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Local Institution - 0206
        • Contact:
          • Site 0206
  • Taiwan
      • Kaohsiung Niao Sung Dist, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung-Rheumatology
        • Contact:
          • TIENTSAI CHENG, Site 0080
          • Phone Number: +886975056124
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
          • Yi-hsing Chen, Site 0078
          • Phone Number: 886-919872668
      • Taichung, Taiwan, 404
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Joung-Liang LAN, Site 0081
          • Phone Number: 886937759007
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • wei-sheng chen, Site 0077
          • Phone Number: +886966285571
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital-Immunology
        • Contact:
          • Song-Chou Hsieh, Site 0079
          • Phone Number: +886968661048
  • United Kingdom
      • Bradford, United Kingdom, BD5 0NA
        • Recruiting
        • St Luke's Hospital
        • Contact:
          • Sarah Twigg, Site 0110
          • Phone Number: 01274 365388
      • Edinburgh, United Kingdom, EH42XU
        • Withdrawn
        • Local Institution - 0120
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester Royal Infirmary
        • Contact:
          • Ben Parker, Site 0125
          • Phone Number: 01612764357
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Contact:
          • Rachel Jones, Site 0111
          • Phone Number: 00 44 (0) 7957572073
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Jose Rubio, Site 0100
    • California
      • Fullerton, California, United States, 92835
        • Withdrawn
        • St Joseph Heritage Healthcare-Rheumatology
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Christine Thai, MD
        • Contact:
          • Christine Thai, Site 0123
          • Phone Number: 714-861-9644
      • La Jolla, California, United States, 92037
        • Not yet recruiting
        • UCSD - Altman Clinical and Translational Research Institute (ACTRI)
        • Contact:
          • Chelsey Smith, Site 0170
          • Phone Number: 858-246-2392
      • La Palma, California, United States, 90623
        • Recruiting
        • Advanced Medical Research - La Palma
        • Contact:
          • Gerald Ho, Site 0159
          • Phone Number: 562-867-8195
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • Local Institution - 0202
        • Contact:
          • Site 0202
      • San Diego, California, United States, 92128
        • Recruiting
        • Rheumatology Center of San Diego
        • Contact:
          • Tania Rivera, Site 0172
          • Phone Number: 858-336-2810
      • West Hills, California, United States, 91307
        • Withdrawn
        • Private Practice - Dr. Nazanin Firooz
      • Woodland Hills, California, United States, 91364
        • Recruiting
        • Center for Rheumatology Research
        • Contact:
          • Nazanin Firooz, Site 0164
          • Phone Number: 818-598-0000
    • Colorado
      • Denver, Colorado, United States, 80204
        • Withdrawn
        • Colorado Arthritis Associates
    • Connecticut
      • Farmington, Connecticut, United States, 06030-3805
        • Withdrawn
        • UConn Health
    • Florida
      • Brandon, Florida, United States, 33511
        • Withdrawn
        • Bay Area Arthritis And Osteoporosis
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research of West Florida, Inc. (Clearwater)
        • Contact:
          • Robert Levin, Site 0121
          • Phone Number: 727-466-0078
      • Gainesville, Florida, United States, 32610
        • Withdrawn
        • University of Florida
      • Kissimmee, Florida, United States, 34741
        • Recruiting
        • Vida Clinical Research
        • Contact:
          • Karamali Bandealy, Site 0167
          • Phone Number: 407-750-5300
      • Orlando, Florida, United States, 32808
        • Recruiting
        • Omega Research MetroWest
        • Contact:
          • Kwabena Ayesu, Site 0122
          • Phone Number: 386-668-4202
      • Ormond Beach, Florida, United States, 32174
        • Recruiting
        • Millennium Research
        • Contact:
          • Michael Kohen, Site 0173
          • Phone Number: 386672 1985
      • Plantation, Florida, United States, 33324
        • Recruiting
        • IRIS Research and Development, LLC
        • Contact:
          • Guillermo Valenzuela, Site 0154
          • Phone Number: 9544762338211
      • South Miami, Florida, United States, 33143
        • Completed
        • Local Institution - 0137
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • West Broward Rheumatology Associates
        • Contact:
          • Elias Halpert, Site 0155
          • Phone Number: 954-545-8401
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Piedmont West
        • Contact:
          • wambui machua, Site 0160
          • Phone Number: 404-367-3350
      • Decatur, Georgia, United States, 30033
        • Withdrawn
        • Private Practice - Dr. Jefrey Lieberman
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • North Georgia Rheumatology
        • Contact:
          • Theresa Lawrence Ford, Site 0205
          • Phone Number: 111-111-1111
    • Illinois
      • Orland Park, Illinois, United States, 60467
        • Recruiting
        • Greater Chicago Specialty Physicians - Orland Park
        • Contact:
          • Cory Conniff, Site 0146
          • Phone Number: 847-599-2492
    • Kentucky
      • Hopkinsville, Kentucky, United States, 42240
        • Recruiting
        • Western KY Rheumatology
        • Contact:
          • Kishorkumar Desai, Site 0187
          • Phone Number: 270-885-3876
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Completed
        • Local Institution - 0171
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Completed
        • Local Institution - 0134
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Withdrawn
        • Local Institution - 0221
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Recruiting
        • Saint Paul Rheumatology
        • Contact:
          • Elvia Moreta, Site 0070
          • Phone Number: 651-361-8659
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University/ Barnes Jewish Hospital
        • Contact:
          • Reema Syed, Site 0124
          • Phone Number: 314-273-8259
      • Saint Louis, Missouri, United States, 63141
        • Completed
        • Local Institution - 0165
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Completed
        • Local Institution - 0091
    • New Jersey
      • West Long Branch, New Jersey, United States, 07764
        • Not yet recruiting
        • Local Institution - 0219
        • Contact:
          • Site 0219
    • New York
      • Bronx, New York, United States, 10461
        • Completed
        • Local Institution - 0132
      • Manhasset, New York, United States, 11030
        • Recruiting
        • The Feinstein Institute for Medical Research
        • Contact:
          • Meggan Mackay, Site 0140
          • Phone Number: 516-562-3838
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • DJL Clinical Research, PLLC
        • Contact:
          • Emily Jane Herron Box, Site 0103
          • Phone Number: 704-247-9179
      • Charlotte, North Carolina, United States, 28204
        • Active, not recruiting
        • Local Institution - 0203
    • Ohio
      • Columbus, Ohio, United States, 43203
        • Recruiting
        • The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East-Rheumatology and Immunolog
        • Contact:
          • Judith Lin, Site 0151
          • Phone Number: 313-916-3156
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research and Consulting, Llc
        • Contact:
          • Isam Diab, Site 0042
          • Phone Number: 440-915-5759
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Withdrawn
        • Oklahoma Medical Research Foundation-Multiple Sclerosis Center of Excellence
      • Oklahoma City, Oklahoma, United States, 73104
        • Withdrawn
        • Oklahoma Medical Research Foundation
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Withdrawn
        • Shelby Research LLC
    • Texas
      • Allen, Texas, United States, 75013
        • Recruiting
        • Allen Arthritis
        • Contact:
          • John Lavery, Site 0152
          • Phone Number: 972-467-7921
      • Allen, Texas, United States, 75013
        • Recruiting
        • Arthritis and Rheumatology Research Institute
        • Contact:
          • Megha Patel-Banker, Site 0197
          • Phone Number: 516-859-2951
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Amarillo Center for Clinical Research-Research
        • Contact:
          • Constantine Saadeh, Site 0136
          • Phone Number: 806-352-5453
      • Mesquite, Texas, United States, 75150
        • Recruiting
        • Southwest Rheumatology Research
        • Contact:
          • Atul Singhal, Site 0029
          • Phone Number: 214-289-4686
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • Sun Research Institute
        • Contact:
          • Leonel Reyes, Jr., Site 0163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days
Experimental: Afimetoran: Dose 1
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256
Experimental: Afimetoran: Dose 2
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256
Experimental: Afimetoran: Dose 3
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
Time Frame: Up to 48 Weeks
Up to 48 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
Time Frame: Up to 48 Weeks
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
Time Frame: Up to 48 Weeks
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
Time Frame: Up to 48 Weeks
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
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Change from baseline in PGA score of disease activity at Week 24 and Week 48
Time Frame: 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)
Up to 48 Weeks
Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48
Time Frame: Up to 48 Weeks
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)
Time Frame: 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.
Up to 48 Weeks
Number of participants with Adverse Events (AEs)
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with Serious Adverse Events (SAEs)
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with physical examination abnormalities
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with vital sign abnormalities
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 52 Weeks
Up to 52 Weeks
Proportion of participants who achieve an SRI(4) response at Week 24
Time Frame: Up to 24 Weeks
Up to 24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Estimated)

March 29, 2026

Study Completion (Estimated)

April 22, 2029

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM026-024
  • U1111-1241-6528 (Registry Identifier: UTN)
  • 2023-504320-25-00 (Registry Identifier: EU Trial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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