Une étude pour étudier l'efficacité et l'innocuité de l'efgartigimod PH20 SC chez les participants adultes atteints de myopathie inflammatoire idiopathique active. (ALKIVIA)
18 septembre 2026 mis à jour par: argenx
Une étude de phase 2/3, randomisée, en double aveugle, contrôlée par placebo, en groupes parallèles, à 2 bras, multicentrique et opérationnellement transparente pour évaluer l'efficacité, l'innocuité, la tolérabilité, la pharmacodynamique, la pharmacocinétique et l'immunogénicité de l'efgartigimod PH20 SC chez les participants 18 ans et plus atteints de myopathie inflammatoire idiopathique active
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).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
265
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne, 10117
- Charite - Universitaetsmedizin Berlin
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Düsseldorf, Allemagne, 40225
- Universitaetsklinikum Duesseldorf
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Göttingen, Allemagne, 37075
- Universitatsmedizin Gottingen - Georg-August-Universitat
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Hamburg, Allemagne, 20246
- Universitaetsklinikum Hamburg-Eppendorf
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Herne, Allemagne, 44649
- Rheumazentrum Ruhrgebiet
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Mannheim, Allemagne, 68167
- Universitatsmedizin Mannheim
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München, Allemagne, 80336
- Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik
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Sendenhorst, Allemagne, 48324
- St. Josef-Stift Sendenhorst
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Tübingen, Allemagne, 72076
- Universitaetsklinikum Tuebingen (UKT)
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Ulm, Allemagne, 89081
- Universitatsklinikum Ulm - Standort Oberer Eselsberg
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Córdoba, Argentine, 5000
- Consultora Integral de Salud
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La Plata, Argentine, B1902COS
- Framingham Centro Medico
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Ramos Mejía, Argentine, B1704ETD
- Dim Clinica Privada
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San Miguel, Argentine, B1663GKT
- Centro Dermatologico Schejtman
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San Miguel de Tucumán, Argentine, T4000AXL
- Centro de Investigaciones Medicas Tucuman
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Auchenflower, Australie, 4066
- The Wesley Medical Research
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Murdoch, Australie, 6150
- Fiona Stanley Hospital
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Charleroi, Belgique, 6042
- Centre Hospitalier Universitaire de Charleroi
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Ghent, Belgique, 9000
- AZ Sint Lucas Gent-Campus Sint Lucas
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Leuven, Belgique, 3000
- Universitair Ziekenhuis Leuven Gasthuisberg Campus
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Liège, Belgique, 4000
- Centre Hospitalier Universitaire Sart Tilman
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Plovdiv, Bulgarie, 4002
- Multiprofile hospital for active treatment Kaspela EOOD
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Plovdiv, Bulgarie, 4002
- Medical Centre Artmed
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Montreal, Canada, H4A 3T2
- Genge Partners
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Ottawa, Canada, K1Y 4E9
- Ottawa Hospital Research Institute-Civic Campus
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Beijing, Chine, 100730
- Peking Union Medical College Hospital
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Beijing, Chine, 100191
- Peking University Third Hospital
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Beijing, Chine, 100034
- Peking University First Hospital
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Changchun, Chine, 130021
- The First Hospital of Jilin University
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Changsha, Chine, 410008
- Xiangya Hospital Central South University
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Changsha, Chine, 410011
- The Second Xiangya Hospital of Central South University
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Chengdu, Chine, 610072
- Sichuan Provincial Peoples Hospital
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Guangzhou, Chine, 510515
- Nanfang Hospital, Southern Medical University
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Guangzhou, Chine, 510000
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Hangzhou, Chine, 310003
- The First Affiliated Hospital - School of Medicine - ZheJiang University
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Hefei, Chine, 230001
- Anhui Provincial Hospital
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Nanchang, Chine, 330000
- The Second Affiliated Hospital Of Nanchang University
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Nanjing, Chine, 210008
- Nanjing Drum Tower Hospital
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Shanghai, Chine, 200025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai, Chine, 200127
- Shanghai Renji Hospital
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Shanghai, Chine, 200000
- Huashan Hospital Affiliated to Fudan University
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Shanxi, Chine, 30001
- First Affiliated Hospital of Shanxi Medical College
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Shenyang, Chine, 110001
- China Medical University (CMU) - First Affiliated Hospital
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Wuhan, Chine, 430030
- Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
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Zhengzhou, Chine, 450052
- First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
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Nicosia, Chypre, 2371
- Cyprus Institute of Neurology and Genetics
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Daejeon, Corée du Sud, 35015
- Chungnam National University Hospital (CNUH)
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Incheon, Corée du Sud, 21565
- Gachon University Gil Medical Center
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Seoul, Corée du Sud, 03080
- Seoul National University Hospital
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Seoul, Corée du Sud, 02447
- Kyung Hee University Medical Center
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Seoul, Corée du Sud, 04763
- Hanyang University Seoul Hospital
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Suwon, Corée du Sud, 16499
- Ajou University Hospital
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Copenhagen, Danemark, 2100
- Copenhagen University Hospital-Rigshospitalet University Hospital
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Alicante, Espagne, 03010
- Hospital General Universitario de Alicante
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Barcelona, Espagne, 08036
- Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology
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Barcelona, Espagne, 08041
- Hospital de la Santa Creu i Sant Pau
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Madrid, Espagne, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Espagne, 28046
- Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
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Madrid, Espagne, 451086
- Hospital Universitario 12 de Octubre
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Seville, Espagne, 9-41014
- Hospital De Valme
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Valencia, Espagne, 46026
- Hospital Universitario y Politecnico La Fe
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Vigo, Espagne, 36200
- Hospital Do Meixoeiro
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Lyon, France, 69003
- Hopital Edouard Herriot
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Paris, France, 75013
- Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
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Rouen, France, 76031
- Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
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Strasbourg, France, 67098
- Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
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Athens, Grèce, 115 27
- National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
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Athens, Grèce, 115 28
- National and Kapodistrian University of Athens - Eginition Hospital
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Athens, Grèce, 151 25
- Athens Medical Center
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Athens, Grèce, 12462
- Attikon General University Hospital
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Ioannina, Grèce, 45110
- University of Ioannina Medical School
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Tbilisi, Géorgie, 0160
- Aversi Clinic
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Tbilisi, Géorgie, 0180
- The First Medical Center
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Tbilisi, Géorgie, 0114
- LTD New Hospitals
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Tbilisi, Géorgie, 0186
- LTD Tbilisi Heart Center
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Tbilisi, Géorgie, 0102
- American Hospital Network
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Tbilisi, Géorgie, 0179
- LLC MediClub Georgia
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Budapest, Hongrie, 1083
- Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
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Debrecen, Hongrie, 4032
- Debreceni Egyetem - University of Debrecen
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Dublin, Irlande, D04 T6F4
- St. Vincents University Hospital
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Dublin, Irlande, D15 X40D
- Connolly Hospital Blanchardstown
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Manorhamilton, Irlande, F91 X012
- North West Rheumatology Unit - Our Lady's Hospital
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Haifa, Israël, 3109601
- Rambam Health Care Campus
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Haifa, Israël, 31048
- Bnai Zion Medical Center
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Kfar Saba, Israël, 44281
- Meir Medical Center
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Petah Tikva, Israël, 49100
- Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
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Ramat Gan, Israël, 52621
- Sheba Medical Center - Rheumatology
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Bari, Italie, 70124
- Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology
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Florence, Italie, 50139
- Azienda Ospedaliero Universitaria Careggi
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Milan, Italie, 20132
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
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Pavia, Italie, 27100
- San Matteo Hospital
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Pisa, Italie, 56126
- A.O. Universitaria Pisana
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Reggio Emilia, Italie, 42123
- IRCCS Arcispedale Santa Maria Nuova
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Roma, Italie, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
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Roma, Italie, 00189
- Azienda Ospedaliero Universitaria Sant'Andrea
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Rozzano, Italie, 20089
- IRCCS Istituto Clinico Humanitas - Rheumatology
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Torino, Italie, 10126
- Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
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Udine, Italie, 33100
- ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia
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Verona, Italie, 37134
- Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
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Bunkyō City, Japon, 113-8519
- Tokyo Medical And Dental University Hospital, Faculty of Medicine
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Bunkyō City, Japon, 113-8603
- Nippon Medical School - Nippon Medical School Hospital
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Kawasaki, Japon, 216-8511
- St. Marianna University School of Medicine Hospital
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Kurume, Japon, 830-0011
- Kurume University Hospital
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Matsudo-shi, Japon, 270-2251
- Chiba-Nishi General Hospital
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Nagoya, Japon, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
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Sagamihara-shi, Japon, 252-0375
- Kitasato University Hospital (KUH)
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Sapporo, Japon, 060-8604
- Sapporo City Hospital
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Sapporo, Japon, 060-8648
- Hokkaido University Hospital - Rheumatology
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Sasebo-shi, Japon, 857-1165
- Sasebo Chuo Hospital
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Sendai, Japon, 980-8574
- Tohoku University Hospital
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Tokushima, Japon, 770-8503
- Tokushima University Hospital
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Tokyo, Japon, 160-8582
- Keio University Hospital
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Tokyo, Japon, 113-8655
- The University of Tokyo Hospital
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Tokyo, Japon, 113-8431
- Juntendo University Hospital - Rheumatology
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Tsukuba, Japon, 305-8576
- University of Tsukuba Hospital - Rheumatology
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Ube-shi, Japon, 755-8505
- Yamaguchi University Hospital
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Wakayama, Japon, 641-8509
- Wakayama Medical University Hospital - Dermatology
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Innsbruck, L'Autriche, 6020
- Medical University Innsbruck
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Vienna, L'Autriche, 1090
- Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
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Lisbon, Le Portugal, 1649-035
- Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria
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Porto, Le Portugal, 4099-001
- Centro Hospitalar Universitario de Santo Antonio
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Kaunas, Lituanie, 50161
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
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Vilnius, Lituanie, 08661
- Vilnius University Hospital Santaros Klinikos
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Mexico City, Mexique, 06700
- CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
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Mérida, Mexique, 97000
- Centro Peninsular De Investigacion Clinica
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Amsterdam, Pays-Bas, 1105 AZ
- Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
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Utrecht, Pays-Bas, 3584 CX
- Universitair Medisch Centrum Utrecht (UMC Utrecht)
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Bydgoszcz, Pologne, 85-168
- Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
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Lodz, Pologne, 90-549
- USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113
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Szczecin, Pologne, 71-252
- Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie
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Arequipa, Pérou, 4018
- Hogar Clinica San Juan de Dios
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Lima, Pérou, 31
- Hospital Nacional Cayetano Heredia
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Lima, Pérou, 15023
- Investigaciones Clinicas S.A.C.
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Lima, Pérou, 27
- Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar
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Bath, Royaume-Uni, BA1 3NG
- Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
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Doncaster, Royaume-Uni, DN2 5LT
- Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
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Leeds, Royaume-Uni, LS7 4SA
- Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds
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Liverpool, Royaume-Uni, L9 7AL
- Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
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London, Royaume-Uni, SE5 9RS
- Kings College Hospital NHS Foundation Trust
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London, Royaume-Uni, WC1N 3BG
- The National Hospital for Neurology and Neurosurgery
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London, Royaume-Uni, NW3 2QG
- The Royal Free Hospital - Royal Free London NHS Foundation Trust
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Middlesbrough, Royaume-Uni, TS4 3BW
- James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
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Salford, Royaume-Uni, M6 8HD
- Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
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Belgrade, Serbie, 11000
- Clinical Center of Serbia
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Belgrade, Serbie, 11000
- Institute of Rheumatology
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Piešťany, Slovaquie, 92112
- Narodny ustav reumatickych chorob
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Lugano, Suisse, 6900
- Neurocenter of Southern Switzerland
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Stockholm, Suède, 17164
- Karolinska Universitestssjukhus Solna
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Taichung, Taïwan, 40705
- Taichung Veterans General Hospital
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Taichung, Taïwan, 402
- Chung Shan Medical University Hospital
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Taichung, Taïwan, 40402
- China Medical University and Hospital
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Prague, Tchéquie, 128 00
- Revmatologicky ustav
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Bangkok, Thaïlande, 10400
- Phramongkutklao Hospital
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Bangkok, Thaïlande, 10700
- Siriraj Hospital, Mahidol University of Internal medicine
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Bangkok, Thaïlande, 10300
- Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
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Bangkok, Thaïlande, 10400
- Ramathibodi hospital
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Chiang Mai, Thaïlande, 50200
- Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
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Khon Kaen, Thaïlande, 40000
- Khon Kaen University
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Pathum Thani, Thaïlande, 12120
- Thammasat University Hospital
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Ankara, Turquie (Türkiye), 06800
- Ankara City Hospital
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Ankara, Turquie (Türkiye), 06230
- Ankara University Medical Faculty
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Konya, Turquie (Türkiye), 42090
- Necmettin Erbakan University Meram Medical Faculty
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Arizona
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Phoenix, Arizona, États-Unis, 85028
- Neuromuscular Research Center
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Scottsdale, Arizona, États-Unis, 85251
- HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
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California
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Beverly Hills, California, États-Unis, 90039
- Attune Health Research, Inc
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Los Angeles, California, États-Unis, 90033
- University of Southern California Norris Comprehensive Cancer Center
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Oceanside, California, États-Unis, 92056
- Profound Research LLC - Oceanside
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Orange, California, États-Unis, 92868
- University of California, Irvine
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Rancho Mirage, California, États-Unis, 92270
- Eisenhower Medical Center
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Redwood City, California, États-Unis, 94063-3132
- Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
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San Francisco, California, États-Unis, 94109
- California Pacific Medical Center - Sutter Health
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San Francisco, California, États-Unis, 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, États-Unis, 80230
- Denver Arthritis Clinic
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Connecticut
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New Haven, Connecticut, États-Unis, 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, États-Unis, 20007
- Georgetown University Hospital
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Florida
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Gainesville, Florida, États-Unis, 32610-3008
- UF Health Rheumatology
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Jacksonville, Florida, États-Unis, 32224
- Mayo Clinic
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Tampa, Florida, États-Unis, 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, États-Unis, 30322
- Emory University Hospital, The Emory Clinic
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Augusta, Georgia, États-Unis, 30312
- Augusta University
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern Memorial Hospital
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- University Of Kansas Medical Center
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Maryland
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Baltimore, Maryland, États-Unis, 21224
- Johns Hopkins Medicine - Johns Hopkins Myositis Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 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, États-Unis, 48824
- Michigan State University - Neurology
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Minnesota
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Saint Paul, Minnesota, États-Unis, 55121
- St. Paul Rheumatology, PA
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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New York
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Great Neck, New York, États-Unis, 11021
- Northwell Health
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New York, New York, États-Unis, 10021
- Hospital for Special Surgery
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27514-4220
- University of North Carolina (UNC) School of Medicine
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Wilmington, North Carolina, États-Unis, 28401
- Carolina Arthritis Associates
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic - Main Campus
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Columbus, Ohio, États-Unis, 43201
- The Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73120
- Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
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Oregon
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Portland, Oregon, États-Unis, 97239
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15261
- University of Pittsburg Medical Center
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Tennessee
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Nashville, Tennessee, États-Unis, 37232-0028
- Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
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Texas
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Austin, Texas, États-Unis, 78759
- Austin Neuromuscular Center
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Houston, Texas, États-Unis, 77030
- McGovern Medical School -The University of Texas Health Science Center at Houston
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Houston, Texas, États-Unis, 77030
- Nerve And Muscle Center Of Texas
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Vermont
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Burlington, Vermont, États-Unis, 05401
- University of Vermont Medical Center - Main Campus
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Washington
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Seattle, Washington, États-Unis, 98195
- University of Washington Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: EFG PH20 SC
participants receiving efgartigimod PH20 SC on top of background treatment |
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer |
|
Comparateur placebo: PBO PH20 SC
participants receiving placebo PH20 SC on top of background treatment |
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean TIS
Délai: phase 2: 24 weeks; phase 3: 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: 24 weeks; phase 3: 52 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to reach TIS ≥ 20 (first "minimal clinical improvement")
Délai: 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
Délai: 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")
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: Phase 3: up to 52 weeks
|
CK: creatine kinase |
Phase 3: up to 52 weeks
|
|
Change in CDASI activity score at week 52
Délai: 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
|
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 octobre 2022
Achèvement primaire (Réel)
2 juillet 2026
Achèvement de l'étude (Réel)
2 juillet 2026
Dates d'inscription aux études
Première soumission
30 août 2022
Première soumission répondant aux critères de contrôle qualité
30 août 2022
Première publication (Réel)
31 août 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 septembre 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ARGX-113-2007
- 2024-512785-33-00 (Ctis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .