Systemic Lupus Erythematosus Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 268 |
| Est. completion date | April 22, 2029 |
| Est. primary completion date | March 29, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Fundacion Cidea | Buenos Aires | Distrito Federal |
| Argentina | Fundación Respirar | Buenos Aires | |
| Argentina | Local Institution - 0207 | Buenos Aires | |
| Argentina | APRILLUS Asistencia e Investigacion Clinica | Caba | Distrito Federal |
| Argentina | Local Institution - 0145 | Caba | Distrito Federal |
| Argentina | Centro Consultora Integral de Salud SRL | Córdoba | Cordoba |
| Argentina | CER medical Institute-Rheumatology | Quilmes | Buenos Aires |
| Argentina | Local Institution - 0195 | San Fernando | Buenos Aires |
| Argentina | CER San Juan-Rheumatology | San Juan | |
| Argentina | Centro Medico Privado de Reumatologia | San Miguel de Tucumán | Tucuman |
| Australia | Local Institution - 0063 | Botany | New South Wales |
| Australia | Local Institution - 0062 | Camberwell | Victoria |
| Australia | Local Institution - 0064 | Ivanhoe | Victoria |
| Australia | Local Institution - 0066 | Maroochydore | Queensland |
| Australia | Westmead Hospital-Department of Clinical Immunology and Allergy | Westmead | New South Wales |
| Australia | Local Institution - 0065 | Woodville | South Australia |
| Brazil | IPC-MT Instituto de Pesquisas Clínicas de Mato Grosso | Cuiabá | Mato Grosso |
| Brazil | Centro de Estudos em Terapias Inovadoras-Rheumatology | Curitiba | Parana |
| Brazil | Cmip-Centro Mineiro de Pesquisa | Juiz de Fora | Minas Gerais |
| Brazil | LMK Serviços Médicos S/S-Reumacenter | Porto Alegre | RIO Grande DO SUL |
| Brazil | Centro de Pesquisas da Clínica IBIS | Salvador | Bahia |
| Brazil | Serviços Especializados em Reumatologia | Salvador | Bahia |
| Brazil | Centro Multidisciplinar de Estudos Clinicos | São Bernardo do Campo | SAO Paulo |
| Brazil | Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas | São José do Rio Preto | SAO Paulo |
| Brazil | CEPIC - Centro Paulista de Investigação Clínica | São Paulo | |
| Brazil | Local Institution - 0013 | São Paulo | SAO Paulo |
| Chile | Local Institution - 0127 | Osorno | LOS Lagos |
| Chile | Centro Estudios Reumatologicos | Santiago | Metropolitana |
| Chile | Estudios Clinicos CTR | Santiago | Región Metropolitana De Santiago |
| Chile | Investigaciones y Terapias Reumatologicas LTDA. INTERIN LTDA | Santiago | Metropolitana |
| Chile | Sociedad De Prestaciones En Salud De Los Rios Ltda. | Valdivia | Los Rios |
| China | Local Institution - 0196 | Baoding | Hebei |
| China | Local Institution - 0177 | Beijing | Beijing |
| China | Local Institution - 0180 | Beijing | Beijing |
| China | The First Hospital of Jilin University | Changchun | Jilin |
| China | Local Institution - 0194 | Changzhi | Shanxi |
| 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 - 0181 | Kunming | Yunnan |
| China | Jiangsu Province Hospital | Nanjing | Jiangsu |
| China | Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu |
| China | The Seventh Affiliated Hospital, Sun Yat-sen University | Shenzhen | Guangdong |
| China | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
| Colombia | Local Institution - 0001 | 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 | Local Institution - 0185 | Cali | Valle Del Cauca |
| Colombia | Preventive Care | Chía | |
| Colombia | Salud SURA Industriales | Medellín | Antioquia |
| Colombia | Healthy Medical Center S.A.S | Zipaquira | |
| France | Bordeaux University Hospital - Pellegrin-Rhumatologie | Bordeaux | |
| France | CHRU de Brest | Brest | Finistère |
| 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 Bordeaux Haut-Leveque | Pessac | Aquitaine |
| France | CHU Strasbourg-Hautepierre-Service de Rhumatologie | Strasbourg | |
| Germany | Charité Research Organisation | Berlin | |
| Germany | Local Institution - 0086 | Essen | |
| Germany | Klinikum Der Albrecht-Ludwigs-Universitat | Freiburg | |
| Germany | Local Institution - 0087 | Köln | Nordrhein-Westfalen |
| India | Local Institution - 0210 | Bengaluru | Karnataka |
| India | Local Institution - 0214 | Gurugram | Haryana |
| India | Local Institution - 0209 | Hyderabad | Telangana |
| India | Local Institution - 0208 | New Delhi | Delhi |
| Ireland | Local Institution - 0106 | Dublin | |
| Ireland | Local Institution - 0107 | Galway | |
| Ireland | Local Institution - 0119 | Manorhamilton | Leitrim |
| Japan | Koujunkai Daido Clinic | Aichi | |
| Japan | Juntendo University Hospital | Bunkyo-ku | Tokyo |
| Japan | National Hospital Organization Chiba-East Hospital | Chiba | |
| Japan | Local Institution - 0114 | Eiheiji-cho,Yoshida-gun | Fukui |
| Japan | Tokyo Metropolitan Tama Medical Center | Fuchu | Tokyo |
| Japan | Local Institution - 0162 | Fukushima | |
| Japan | Local Institution - 0113 | Itabashiku | Tokyo |
| Japan | Kanazawa University Hospital | Kanazawa | Ishikawa |
| Japan | University of Occupational and Enviromental Health | Kitakyushu | Fukuoka |
| Japan | Local Institution - 0150 | Meguro-ku | Tokyo |
| Japan | Hokkaido University Hospital | Sapporo | Hokkaido |
| Japan | Tohoku University Hospital-Department of Rheumatology | Sendai-shi | Miyagi |
| 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 | Local Institution - 0097 | Tokyo | |
| Japan | Local Institution - 0116 | Tokyo | |
| Mexico | Mediadvance Clinical-Rheumatology | Chihuahua | |
| Mexico | Clinica de Investigacion en Reumatologia y Obesidad S. C. | Guadalajara | Jalisco |
| Mexico | Hospital Aranda de La Parra-Consultorio Médico de Reumatología | Leon | Guanajuato |
| Mexico | Unidad de Atención Médica e Investigación en Salud | Merida | |
| Mexico | Centro Medico Dialinde | Mexico City | Distrito Federal |
| Mexico | CINTRE - Centro de investigacion y tratamiento reumatologico, S.C. | Mexico City | Distrito Federal |
| Mexico | Local Institution - 0158 | Mexico City | Distrito Federal |
| Mexico | Local Institution - 0182 | Mexico City | Distrito Federal |
| Mexico | Accelerium S de RL de CV | Monterrey | Nuevo LEON |
| Mexico | Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V. | Zapopan | Jalisco |
| Poland | Local Institution - 0051 | Bydgoszcz | |
| Poland | Local Institution - 0161 | Lomza | Podlaskie |
| Poland | Medyczne Centrum Hetmanska | Poznan | |
| Poland | Local Institution - 0142 | Rzeszów | |
| Poland | Local Institution - 0050 | Sosnowiec | |
| Poland | Centrum Medyczne Reuma Park | Warszawa | Mazowieckie |
| Poland | MICS Centrum Medyczne Warszawa | Warszawa | |
| Poland | Uniwersytecki Szpital Kliniczny-Klinika Reumatologii i Chorób Wewnetrznych | Wroclaw | |
| Puerto Rico | GCM Medical Group, PSC - Hato Rey Site-Hato Rey | San Juan | |
| Puerto Rico | Mindful Medical Research | San Juan | |
| 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 | SC MEDAUDIO-OPTICA SRL-Rheumatology | Râmnicu Vâlcea | |
| 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 | Local Institution - 0206 | Santander | Cantabria |
| Spain | Hospital Universitario Virgen de Valme-RHEUMATOLOGY | Sevilla | |
| Taiwan | 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 | |
| United Kingdom | Local Institution - 0110 | Bradford | |
| United Kingdom | Local Institution - 0111 | Cambridge | Cambridgeshire |
| United Kingdom | Local Institution - 0120 | Edinburgh | |
| United Kingdom | Local Institution - 0125 | Manchester | |
| United States | Allen Arthritis | Allen | Texas |
| United States | Arthritis and Rheumatology Research Institute | Allen | Texas |
| United States | Amarillo Center for Clinical Research-Research | Amarillo | Texas |
| United States | Piedmont West | Atlanta | Georgia |
| United States | Ochsner Medical Complex - The Grove | Baton Rouge | Louisiana |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Bay Area Arthritis and Osteoporosis | Brandon | Florida |
| United States | Jacobi Medical Center-Research | Bronx | New York |
| United States | DJL Clinical Research, PLLC | Charlotte | North Carolina |
| United States | Local Institution - 0203 | Charlotte | North Carolina |
| United States | Clinical Research of West Florida, Inc. (Clearwater) | Clearwater | Florida |
| United States | The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East-Rheumatology and Immunolog | Columbus | Ohio |
| United States | Private Practice - Dr. Jefrey Lieberman | Decatur | Georgia |
| United States | Colorado Arthritis Associates | Denver | Colorado |
| United States | Saint Paul Rheumatology | Eagan | Minnesota |
| United States | UConn Health | Farmington | Connecticut |
| United States | St Joseph Heritage Healthcare-Rheumatology | Fullerton | California |
| United States | University Of Florida | Gainesville | Florida |
| United States | Western KY Rheumatology | Hopkinsville | Kentucky |
| United States | Christine Thai, MD | Huntington Beach | California |
| United States | Vida Clinical Research | Kissimmee | Florida |
| 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 - 0091 | Las Vegas | Nevada |
| United States | North Georgia Rheumatology | Lawrenceville | Georgia |
| United States | Local Institution - 0202 | Los Angeles | California |
| United States | The Feinstein Institute for Medical Research | Manhasset | New York |
| United States | Shelby Research LLC | Memphis | Tennessee |
| United States | Southwest Rheumatology Research | Mesquite | Texas |
| United States | Paramount Medical Research and Consulting, Llc | Middleburg Heights | Ohio |
| United States | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma |
| United States | Oklahoma Medical Research Foundation-Multiple Sclerosis Center of Excellence | Oklahoma City | Oklahoma |
| United States | Greater Chicago Specialty Physicians - Orland Park | Orland Park | Illinois |
| 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 - 0221 | Rochester Hills | Michigan |
| United States | Arthritis Consultants, Inc. | Saint Louis | Missouri |
| United States | Washington University/ Barnes Jewish Hospital | Saint Louis | Missouri |
| United States | Sun Research Institute | San Antonio | Texas |
| United States | Rheumatology Center of San Diego | San Diego | California |
| United States | Clin-Med Research & Development - 6141 Sunset Drive | South Miami | Florida |
| United States | West Broward Rheumatology Associates | Tamarac | Florida |
| United States | Private Practice - Dr. Nazanin Firooz | West Hills | California |
| United States | Local Institution - 0134 | Wheaton | Maryland |
| United States | Center for Rheumatology Research | Woodland Hills | California |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Brazil, Chile, China, Colombia, France, Germany, India, Ireland, Japan, Mexico, Poland, Puerto Rico, Romania, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48 | Up to 48 Weeks | ||
| Secondary | 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 | ||
| Secondary | Proportion of participants who achieve an SRI(4) response at Week 24 | Up to 24 Weeks | ||
| Secondary | Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48 | Up to 48 Weeks | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Change from baseline in PGA score of disease activity at Week 24 and Week 48 | 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 | |
| Secondary | Proportion of participants who achieve CS reduction or maintenance to = 7.5 mg per day at Week 48 | Up to 48 Weeks | ||
| Secondary | 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) | 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 | |
| Secondary | Number of participants with Adverse Events (AEs) | Up to 100 Weeks | ||
| Secondary | Number of participants with Serious Adverse Events (SAEs) | Up to 100 Weeks | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 100 Weeks | ||
| Secondary | Number of participants with physical examination abnormalities | Up to 100 Weeks | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 100 Weeks | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 52 Weeks |
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