Um estudo para investigar a eficácia e a segurança do efgartigimod PH20 SC em participantes adultos com miopatia inflamatória idiopática ativa. (ALKIVIA)
18 de setembro de 2026 atualizado por: argenx
Um estudo de fase 2/3, randomizado, duplo-cego, controlado por placebo, grupo paralelo, 2 braços, multicêntrico, operacionalmente contínuo para avaliar a eficácia, segurança, tolerabilidade, farmacodinâmica, farmacocinética e imunogenicidade do efgartigimod PH20 SC em participantes A partir de 18 anos com miopatia inflamatória idiopática ativa
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
265
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Berlin, Alemanha, 10117
- Charite - Universitaetsmedizin Berlin
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Düsseldorf, Alemanha, 40225
- Universitaetsklinikum Duesseldorf
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Göttingen, Alemanha, 37075
- Universitatsmedizin Gottingen - Georg-August-Universitat
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Hamburg, Alemanha, 20246
- Universitaetsklinikum Hamburg-Eppendorf
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Herne, Alemanha, 44649
- Rheumazentrum Ruhrgebiet
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Mannheim, Alemanha, 68167
- Universitatsmedizin Mannheim
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München, Alemanha, 80336
- Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik
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Sendenhorst, Alemanha, 48324
- St. Josef-Stift Sendenhorst
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Tübingen, Alemanha, 72076
- Universitaetsklinikum Tuebingen (UKT)
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Ulm, Alemanha, 89081
- Universitatsklinikum Ulm - Standort Oberer Eselsberg
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Córdoba, Argentina, 5000
- Consultora Integral de Salud
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La Plata, Argentina, B1902COS
- Framingham Centro Medico
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Ramos Mejía, Argentina, B1704ETD
- Dim Clinica Privada
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San Miguel, Argentina, B1663GKT
- Centro Dermatologico Schejtman
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San Miguel de Tucumán, Argentina, T4000AXL
- Centro de Investigaciones Medicas Tucuman
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Auchenflower, Austrália, 4066
- The Wesley Medical Research
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Murdoch, Austrália, 6150
- Fiona Stanley Hospital
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Plovdiv, Bulgária, 4002
- Multiprofile hospital for active treatment Kaspela EOOD
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Plovdiv, Bulgária, 4002
- Medical Centre Artmed
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Charleroi, Bélgica, 6042
- Centre Hospitalier Universitaire de Charleroi
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Ghent, Bélgica, 9000
- AZ Sint Lucas Gent-Campus Sint Lucas
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Leuven, Bélgica, 3000
- Universitair Ziekenhuis Leuven Gasthuisberg Campus
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Liège, Bélgica, 4000
- Centre Hospitalier Universitaire Sart Tilman
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Montreal, Canadá, H4A 3T2
- Genge Partners
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Ottawa, Canadá, K1Y 4E9
- Ottawa Hospital Research Institute-Civic Campus
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Beijing, China, 100730
- Peking Union Medical College Hospital
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Beijing, China, 100191
- Peking University Third Hospital
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Beijing, China, 100034
- Peking University First Hospital
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Changchun, China, 130021
- The First Hospital of Jilin University
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Changsha, China, 410008
- Xiangya Hospital Central South University
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Changsha, China, 410011
- The Second Xiangya Hospital of Central South University
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Chengdu, China, 610072
- Sichuan Provincial Peoples Hospital
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Guangzhou, China, 510515
- Nanfang Hospital, Southern Medical University
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Guangzhou, China, 510000
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Hangzhou, China, 310003
- The First Affiliated Hospital - School of Medicine - ZheJiang University
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Hefei, China, 230001
- Anhui Provincial Hospital
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Nanchang, China, 330000
- The Second Affiliated Hospital Of Nanchang University
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Nanjing, China, 210008
- Nanjing Drum Tower Hospital
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Shanghai, China, 200025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai, China, 200127
- Shanghai Renji Hospital
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Shanghai, China, 200000
- Huashan Hospital Affiliated to Fudan University
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Shanxi, China, 30001
- First Affiliated Hospital of Shanxi Medical College
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Shenyang, China, 110001
- China Medical University (CMU) - First Affiliated Hospital
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Wuhan, China, 430030
- Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
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Zhengzhou, China, 450052
- First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
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Nicosia, Chipre, 2371
- Cyprus Institute of Neurology and Genetics
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Daejeon, Coréia do Sul, 35015
- Chungnam National University Hospital (CNUH)
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Incheon, Coréia do Sul, 21565
- Gachon University Gil Medical Center
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Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
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Seoul, Coréia do Sul, 02447
- Kyung Hee University Medical Center
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Seoul, Coréia do Sul, 04763
- Hanyang University Seoul Hospital
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Suwon, Coréia do Sul, 16499
- Ajou University Hospital
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Copenhagen, Dinamarca, 2100
- Copenhagen University Hospital-Rigshospitalet University Hospital
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Piešťany, Eslováquia, 92112
- Narodny ustav reumatickych chorob
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Alicante, Espanha, 03010
- Hospital General Universitario de Alicante
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Barcelona, Espanha, 08036
- Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology
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Barcelona, Espanha, 08041
- Hospital de la Santa Creu i Sant Pau
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Madrid, Espanha, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Espanha, 28046
- Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
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Madrid, Espanha, 451086
- Hospital Universitario 12 de Octubre
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Seville, Espanha, 9-41014
- Hospital De Valme
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Valencia, Espanha, 46026
- Hospital Universitario y Politecnico La Fe
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Vigo, Espanha, 36200
- Hospital Do Meixoeiro
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Arizona
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Phoenix, Arizona, Estados Unidos, 85028
- Neuromuscular Research Center
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Scottsdale, Arizona, Estados Unidos, 85251
- HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
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California
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Beverly Hills, California, Estados Unidos, 90039
- Attune Health Research, Inc
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Los Angeles, California, Estados Unidos, 90033
- University of Southern California Norris Comprehensive Cancer Center
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Oceanside, California, Estados Unidos, 92056
- Profound Research LLC - Oceanside
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Orange, California, Estados Unidos, 92868
- University of California, Irvine
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Rancho Mirage, California, Estados Unidos, 92270
- Eisenhower Medical Center
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Redwood City, California, Estados Unidos, 94063-3132
- Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
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San Francisco, California, Estados Unidos, 94109
- California Pacific Medical Center - Sutter Health
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San Francisco, California, Estados Unidos, 94143-2202
- Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)
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Colorado
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Denver, Colorado, Estados Unidos, 80230
- Denver Arthritis Clinic
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale Cancer Center-Yale University School Of Medicine
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20007
- Georgetown University Hospital
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Florida
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Gainesville, Florida, Estados Unidos, 32610-3008
- UF Health Rheumatology
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic
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Tampa, Florida, Estados Unidos, 33616
- University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital, The Emory Clinic
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Augusta, Georgia, Estados Unidos, 30312
- Augusta University
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Memorial Hospital
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- University Of Kansas Medical Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins Medicine - Johns Hopkins Myositis Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115-6110
- Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC)
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Michigan
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East Lansing, Michigan, Estados Unidos, 48824
- Michigan State University - Neurology
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Minnesota
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Saint Paul, Minnesota, Estados Unidos, 55121
- St. Paul Rheumatology, PA
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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New York
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Great Neck, New York, Estados Unidos, 11021
- Northwell Health
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New York, New York, Estados Unidos, 10021
- Hospital for Special Surgery
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514-4220
- University of North Carolina (UNC) School of Medicine
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Wilmington, North Carolina, Estados Unidos, 28401
- Carolina Arthritis Associates
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic - Main Campus
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Columbus, Ohio, Estados Unidos, 43201
- The Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73120
- Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15261
- University of Pittsburg Medical Center
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232-0028
- Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
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Texas
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Austin, Texas, Estados Unidos, 78759
- Austin Neuromuscular Center
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Houston, Texas, Estados Unidos, 77030
- McGovern Medical School -The University of Texas Health Science Center at Houston
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Houston, Texas, Estados Unidos, 77030
- Nerve And Muscle Center Of Texas
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- University of Vermont Medical Center - Main Campus
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington Medical Center
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Lyon, França, 69003
- Hopital Edouard Herriot
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Paris, França, 75013
- Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
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Rouen, França, 76031
- Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
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Strasbourg, França, 67098
- Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
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Tbilisi, Geórgia, 0160
- Aversi Clinic
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Tbilisi, Geórgia, 0180
- The First Medical Center
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Tbilisi, Geórgia, 0114
- LTD New Hospitals
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Tbilisi, Geórgia, 0186
- LTD Tbilisi Heart Center
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Tbilisi, Geórgia, 0102
- American Hospital Network
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Tbilisi, Geórgia, 0179
- LLC MediClub Georgia
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Athens, Grécia, 115 27
- National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
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Athens, Grécia, 115 28
- National and Kapodistrian University of Athens - Eginition Hospital
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Athens, Grécia, 151 25
- Athens Medical Center
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Athens, Grécia, 12462
- Attikon General University Hospital
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Ioannina, Grécia, 45110
- University of Ioannina Medical School
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Amsterdam, Holanda, 1105 AZ
- Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
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Utrecht, Holanda, 3584 CX
- Universitair Medisch Centrum Utrecht (UMC Utrecht)
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Budapest, Hungria, 1083
- Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
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Debrecen, Hungria, 4032
- Debreceni Egyetem - University of Debrecen
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Dublin, Irlanda, D04 T6F4
- St. Vincents University Hospital
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Dublin, Irlanda, D15 X40D
- Connolly Hospital Blanchardstown
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Manorhamilton, Irlanda, F91 X012
- North West Rheumatology Unit - Our Lady's Hospital
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Haifa, Israel, 3109601
- Rambam Health Care Campus
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Haifa, Israel, 31048
- Bnai Zion Medical Center
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Kfar Saba, Israel, 44281
- Meir Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
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Ramat Gan, Israel, 52621
- Sheba Medical Center - Rheumatology
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Bari, Itália, 70124
- Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology
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Florence, Itália, 50139
- Azienda Ospedaliero Universitaria Careggi
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Milan, Itália, 20132
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
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Pavia, Itália, 27100
- San Matteo Hospital
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Pisa, Itália, 56126
- A.O. Universitaria Pisana
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Reggio Emilia, Itália, 42123
- IRCCS Arcispedale Santa Maria Nuova
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Roma, Itália, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
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Roma, Itália, 00189
- Azienda Ospedaliero Universitaria Sant'Andrea
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Rozzano, Itália, 20089
- IRCCS Istituto Clinico Humanitas - Rheumatology
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Torino, Itália, 10126
- Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
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Udine, Itália, 33100
- ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia
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Verona, Itália, 37134
- Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
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Bunkyō City, Japão, 113-8519
- Tokyo Medical And Dental University Hospital, Faculty of Medicine
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Bunkyō City, Japão, 113-8603
- Nippon Medical School - Nippon Medical School Hospital
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Kawasaki, Japão, 216-8511
- St. Marianna University School of Medicine Hospital
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Kurume, Japão, 830-0011
- Kurume University Hospital
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Matsudo-shi, Japão, 270-2251
- Chiba-Nishi General Hospital
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Nagoya, Japão, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
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Sagamihara-shi, Japão, 252-0375
- Kitasato University Hospital (KUH)
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Sapporo, Japão, 060-8604
- Sapporo City Hospital
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Sapporo, Japão, 060-8648
- Hokkaido University Hospital - Rheumatology
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Sasebo-shi, Japão, 857-1165
- Sasebo Chuo Hospital
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Sendai, Japão, 980-8574
- Tohoku University Hospital
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Tokushima, Japão, 770-8503
- Tokushima University Hospital
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Tokyo, Japão, 160-8582
- Keio University Hospital
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Tokyo, Japão, 113-8655
- The University of Tokyo Hospital
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Tokyo, Japão, 113-8431
- Juntendo University Hospital - Rheumatology
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Tsukuba, Japão, 305-8576
- University of Tsukuba Hospital - Rheumatology
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Ube-shi, Japão, 755-8505
- Yamaguchi University Hospital
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Wakayama, Japão, 641-8509
- Wakayama Medical University Hospital - Dermatology
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Kaunas, Lituânia, 50161
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
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Vilnius, Lituânia, 08661
- Vilnius University Hospital Santaros Klinikos
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Mexico City, México, 06700
- CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
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Mérida, México, 97000
- Centro Peninsular De Investigacion Clinica
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Arequipa, Peru, 4018
- Hogar Clinica San Juan de Dios
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Lima, Peru, 31
- Hospital Nacional Cayetano Heredia
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Lima, Peru, 15023
- Investigaciones Clinicas S.A.C.
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Lima, Peru, 27
- Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar
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Bydgoszcz, Polônia, 85-168
- Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
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Lodz, Polônia, 90-549
- USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113
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Szczecin, Polônia, 71-252
- Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie
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Lisbon, Portugal, 1649-035
- Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria
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Porto, Portugal, 4099-001
- Centro Hospitalar Universitario de Santo Antonio
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Bath, Reino Unido, BA1 3NG
- Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
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Doncaster, Reino Unido, DN2 5LT
- Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
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Leeds, Reino Unido, LS7 4SA
- Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds
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Liverpool, Reino Unido, L9 7AL
- Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
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London, Reino Unido, SE5 9RS
- Kings College Hospital NHS Foundation Trust
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London, Reino Unido, WC1N 3BG
- The National Hospital for Neurology and Neurosurgery
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London, Reino Unido, NW3 2QG
- The Royal Free Hospital - Royal Free London NHS Foundation Trust
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Middlesbrough, Reino Unido, TS4 3BW
- James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
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Salford, Reino Unido, M6 8HD
- Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
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Stockholm, Suécia, 17164
- Karolinska Universitestssjukhus Solna
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Lugano, Suíça, 6900
- Neurocenter of Southern Switzerland
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Belgrade, Sérvia, 11000
- Clinical Center of Serbia
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Belgrade, Sérvia, 11000
- Institute of Rheumatology
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Bangkok, Tailândia, 10400
- Phramongkutklao Hospital
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Bangkok, Tailândia, 10700
- Siriraj Hospital, Mahidol University of Internal medicine
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Bangkok, Tailândia, 10300
- Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
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Bangkok, Tailândia, 10400
- Ramathibodi hospital
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Chiang Mai, Tailândia, 50200
- Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
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Khon Kaen, Tailândia, 40000
- Khon Kaen University
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Pathum Thani, Tailândia, 12120
- Thammasat University Hospital
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taichung, Taiwan, 402
- Chung Shan Medical University Hospital
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Taichung, Taiwan, 40402
- China Medical University and Hospital
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Prague, Tcheca, 128 00
- Revmatologicky ustav
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Ankara, Turquia (Türkiye), 06800
- Ankara City Hospital
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Ankara, Turquia (Türkiye), 06230
- Ankara University Medical Faculty
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Konya, Turquia (Türkiye), 42090
- Necmettin Erbakan University Meram Medical Faculty
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Innsbruck, Áustria, 6020
- Medical University Innsbruck
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Vienna, Áustria, 1090
- Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Ability to consent in the jurisdiction in which the study is taking place and capable of giving signed informed consent.
- A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM)
- One of the following medical histories: Diagnosis of dermatomyositis (DM) or juvenile dermatomyositis (JDM), Diagnosis of polymyositis (PM) (including antisynthetase syndrome (ASyS)), Diagnosis of immune-mediated necrotizing myopathy (IMNM)
- Diagnosed with active disease as defined by the presence of at least 1 of the following criteria: Abnormal levels of at least 1 of the following enzymes: creatine kinase (CK), aldolase, lactate dehydrogenase, aspartate aminotransaminase (AST), alanine aminotransferase (ALT), based on central laboratory results; Electromyography demonstrating active disease within the past 3 months; Active dermatomyositis (DM) skin rash; Muscle biopsy indicative of active idiopathic inflammatory myopathy (IIM) in the past 3 months; Magnetic resonance imaging within the past 3 months indicative of active inflammation
- Muscle weakness
- Receiving a permitted background treatment for idiopathic inflammatory myopathy.
- Contraceptive use consistent with local regulations, where available, for individuals participating in clinical studies. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).
Exclusion Criteria:
- Any other known autoimmune disease that, in the investigator's opinion, would interfere with an accurate assessment of clinical symptoms of idiopathic inflammatory myopathy (IIM) or put the patient at undue risk
- A history of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for ≥ 3 years before the first administration of the investigational medicinal product (IMP). Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer ; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
- Severe muscle damage
- Glucocorticoid-induced myopathy that the investigator considers the primary cause of muscle weakness or permanent weakness linked to a non-idiopathic inflammatory myopathy (IIM) cause
- Uncontrolled interstitial lung disease or any other uncontrolled idiopathic inflammatory myopathy (IIM) manifestation that, in the opinion of the investigator, would be likely to require treatment with prohibited medication during the study
- Participant is pregnant or lactating or intends to become pregnant during the study.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: EFG PH20 SC
participants receiving efgartigimod PH20 SC on top of background treatment |
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer |
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Comparador de Placebo: PBO PH20 SC
participants receiving placebo PH20 SC on top of background treatment |
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean TIS
Prazo: phase 2: 24 weeks; phase 3: 52 weeks
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The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
phase 2: 24 weeks; phase 3: 52 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to reach TIS ≥ 20 (first "minimal clinical improvement")
Prazo: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Percentage of participants with TIS ≥ 20
Prazo: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Time to reach TIS ≥ 40 (first "moderate clinical improvement")
Prazo: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Percentage of participants with TIS ≥ 40
Prazo: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Change in MMT8 score
Prazo: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The manual muscle testing-8 (MMT8) is a physician assessment of muscle strength in a set of 8 designated muscles tested bilaterally and axially. The highest total potential MMT8 score is 150 |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Change in Patient Global Assessment of Disease Activity (PGA)
Prazo: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Patient Global Assessment of Disease Activity (PGA) is a tool that measures a patient's global evaluation of their overall disease activity at the time of assessment using a 10-cm VAS. The participant rates their overall disease activity by drawing a vertical mark on a 10-cm VAS from the left end of the line (no evidence of disease activity) to the right end of the line (extremely active or severe disease activity). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Change in Physician Global Assessment of Disease Activity (MDGA)
Prazo: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Physician Global Assessment of Disease Activity (MDGA) is a tool that measures the physician's global evaluation of the participant's overall disease activity, defined as potentially reversible pathology or physiology resulting from IIM. The physician rates disease activity on the MDGA using a 10-cm VAS. Overall disease activity is rated by drawing a vertical mark on a 10-cm VAS from the left end of the line (no evidence of disease activity), midpoint of the line (moderate disease activity), and the right end of the line (extremely active or severe disease activity). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Proportion of participants who have at least moderate improvement (≥40) in TIS at week 52 and adhere to an oral prednisone dosage of ≤5 mg/day (or equivalent) from week 44 onward
Prazo: Phase 3: up to 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
Phase 3: up to 52 weeks
|
|
Change in CK abnormality grades at week 52
Prazo: Phase 3: up to 52 weeks
|
CK: creatine kinase |
Phase 3: up to 52 weeks
|
|
Change in CDASI activity score at week 52
Prazo: Phase 3: up to 52 weeks
|
The Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) is a skin-specific outcome measure used to assess disease in patients with Dermatomyositis (DM). Disease in 15 different anatomical locations is rated using 3 activity measures (erythema, scale, erosion/ulceration) and 2 damage measures (poikiloderma, calcinosis). The resulting activity and damage scores range from 0 to 100 and 0 to 32, respectively. Higher scores indicate greater disease severity. |
Phase 3: up to 52 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
12 de outubro de 2022
Conclusão Primária (Real)
2 de julho de 2026
Conclusão do estudo (Real)
2 de julho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
30 de agosto de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de agosto de 2022
Primeira postagem (Real)
31 de agosto de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de setembro de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ARGX-113-2007
- 2024-512785-33-00 (Ctis)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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