Uno studio per indagare l'efficacia e la sicurezza di Efgartigimod PH20 SC nei partecipanti adulti con miopatia infiammatoria idiopatica attiva. (ALKIVIA)
18 settembre 2026 aggiornato da: argenx
Uno studio di fase 2/3, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, a 2 bracci, multicentrico, operativamente senza soluzione di continuità per valutare l'efficacia, la sicurezza, la tollerabilità, la farmacodinamica, la farmacocinetica e l'immunogenicità di Efgartigimod PH20 SC nei partecipanti Di età pari o superiore a 18 anni con miopatia infiammatoria idiopatica attiva
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).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
265
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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, Australia, 4066
- The Wesley Medical Research
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Murdoch, Australia, 6150
- Fiona Stanley Hospital
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Innsbruck, Austria, 6020
- Medical University Innsbruck
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Vienna, Austria, 1090
- Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
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Charleroi, Belgio, 6042
- Centre Hospitalier Universitaire de Charleroi
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Ghent, Belgio, 9000
- AZ Sint Lucas Gent-Campus Sint Lucas
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Leuven, Belgio, 3000
- Universitair Ziekenhuis Leuven Gasthuisberg Campus
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Liège, Belgio, 4000
- Centre Hospitalier Universitaire Sart Tilman
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Plovdiv, Bulgaria, 4002
- Multiprofile hospital for active treatment Kaspela EOOD
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Plovdiv, Bulgaria, 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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Prague, Cechia, 128 00
- Revmatologicky ustav
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Beijing, Cina, 100730
- Peking Union Medical College Hospital
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Beijing, Cina, 100191
- Peking University Third Hospital
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Beijing, Cina, 100034
- Peking University First Hospital
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Changchun, Cina, 130021
- The First Hospital of Jilin University
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Changsha, Cina, 410008
- Xiangya Hospital Central South University
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Changsha, Cina, 410011
- The Second Xiangya Hospital of Central South University
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Chengdu, Cina, 610072
- Sichuan Provincial Peoples Hospital
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Guangzhou, Cina, 510515
- Nanfang Hospital, Southern Medical University
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Guangzhou, Cina, 510000
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Hangzhou, Cina, 310003
- The First Affiliated Hospital - School of Medicine - ZheJiang University
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Hefei, Cina, 230001
- Anhui Provincial Hospital
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Nanchang, Cina, 330000
- The Second Affiliated Hospital Of Nanchang University
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Nanjing, Cina, 210008
- Nanjing Drum Tower Hospital
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Shanghai, Cina, 200025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai, Cina, 200127
- Shanghai Renji Hospital
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Shanghai, Cina, 200000
- Huashan Hospital Affiliated to Fudan University
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Shanxi, Cina, 30001
- First Affiliated Hospital of Shanxi Medical College
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Shenyang, Cina, 110001
- China Medical University (CMU) - First Affiliated Hospital
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Wuhan, Cina, 430030
- Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
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Zhengzhou, Cina, 450052
- First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
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Nicosia, Cipro, 2371
- Cyprus Institute of Neurology and Genetics
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Daejeon, Corea del Sud, 35015
- Chungnam National University Hospital (CNUH)
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Incheon, Corea del Sud, 21565
- Gachon University Gil Medical Center
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Seoul, Corea del Sud, 03080
- Seoul National University Hospital
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Seoul, Corea del Sud, 02447
- Kyung Hee University Medical Center
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Seoul, Corea del Sud, 04763
- Hanyang University Seoul Hospital
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Suwon, Corea del Sud, 16499
- Ajou University Hospital
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Copenhagen, Danimarca, 2100
- Copenhagen University Hospital-Rigshospitalet University Hospital
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Lyon, Francia, 69003
- Hopital Edouard Herriot
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Paris, Francia, 75013
- Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
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Rouen, Francia, 76031
- Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
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Strasbourg, Francia, 67098
- Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
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Tbilisi, Georgia, 0160
- Aversi Clinic
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Tbilisi, Georgia, 0180
- The First Medical Center
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Tbilisi, Georgia, 0114
- LTD New Hospitals
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Tbilisi, Georgia, 0186
- LTD Tbilisi Heart Center
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Tbilisi, Georgia, 0102
- American Hospital Network
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Tbilisi, Georgia, 0179
- LLC MediClub Georgia
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Berlin, Germania, 10117
- Charite - Universitaetsmedizin Berlin
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Düsseldorf, Germania, 40225
- Universitaetsklinikum Duesseldorf
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Göttingen, Germania, 37075
- Universitatsmedizin Gottingen - Georg-August-Universitat
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Hamburg, Germania, 20246
- Universitaetsklinikum Hamburg-Eppendorf
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Herne, Germania, 44649
- Rheumazentrum Ruhrgebiet
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Mannheim, Germania, 68167
- Universitatsmedizin Mannheim
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München, Germania, 80336
- Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik
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Sendenhorst, Germania, 48324
- St. Josef-Stift Sendenhorst
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Tübingen, Germania, 72076
- Universitaetsklinikum Tuebingen (UKT)
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Ulm, Germania, 89081
- Universitatsklinikum Ulm - Standort Oberer Eselsberg
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Bunkyō City, Giappone, 113-8519
- Tokyo Medical And Dental University Hospital, Faculty of Medicine
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Bunkyō City, Giappone, 113-8603
- Nippon Medical School - Nippon Medical School Hospital
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Kawasaki, Giappone, 216-8511
- St. Marianna University School of Medicine Hospital
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Kurume, Giappone, 830-0011
- Kurume University Hospital
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Matsudo-shi, Giappone, 270-2251
- Chiba-Nishi General Hospital
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Nagoya, Giappone, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
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Sagamihara-shi, Giappone, 252-0375
- Kitasato University Hospital (KUH)
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Sapporo, Giappone, 060-8604
- Sapporo City Hospital
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Sapporo, Giappone, 060-8648
- Hokkaido University Hospital - Rheumatology
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Sasebo-shi, Giappone, 857-1165
- Sasebo Chuo Hospital
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Sendai, Giappone, 980-8574
- Tohoku University Hospital
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Tokushima, Giappone, 770-8503
- Tokushima University Hospital
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Tokyo, Giappone, 160-8582
- Keio University Hospital
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Tokyo, Giappone, 113-8655
- The University of Tokyo Hospital
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Tokyo, Giappone, 113-8431
- Juntendo University Hospital - Rheumatology
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Tsukuba, Giappone, 305-8576
- University of Tsukuba Hospital - Rheumatology
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Ube-shi, Giappone, 755-8505
- Yamaguchi University Hospital
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Wakayama, Giappone, 641-8509
- Wakayama Medical University Hospital - Dermatology
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Athens, Grecia, 115 27
- National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
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Athens, Grecia, 115 28
- National and Kapodistrian University of Athens - Eginition Hospital
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Athens, Grecia, 151 25
- Athens Medical Center
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Athens, Grecia, 12462
- Attikon General University Hospital
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Ioannina, Grecia, 45110
- University of Ioannina Medical School
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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, Israele, 3109601
- Rambam Health Care Campus
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Haifa, Israele, 31048
- Bnai Zion Medical Center
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Kfar Saba, Israele, 44281
- Meir Medical Center
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Petah Tikva, Israele, 49100
- Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
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Ramat Gan, Israele, 52621
- Sheba Medical Center - Rheumatology
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Bari, Italia, 70124
- Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology
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Florence, Italia, 50139
- Azienda Ospedaliero Universitaria Careggi
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Milan, Italia, 20132
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
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Pavia, Italia, 27100
- San Matteo Hospital
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Pisa, Italia, 56126
- A.O. Universitaria Pisana
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Reggio Emilia, Italia, 42123
- IRCCS Arcispedale Santa Maria Nuova
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Roma, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
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Roma, Italia, 00189
- Azienda Ospedaliero Universitaria Sant'Andrea
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Rozzano, Italia, 20089
- IRCCS Istituto Clinico Humanitas - Rheumatology
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Torino, Italia, 10126
- Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
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Udine, Italia, 33100
- ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia
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Verona, Italia, 37134
- Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
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Kaunas, Lituania, 50161
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
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Vilnius, Lituania, 08661
- Vilnius University Hospital Santaros Klinikos
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Mexico City, Messico, 06700
- CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
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Mérida, Messico, 97000
- Centro Peninsular De Investigacion Clinica
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Amsterdam, Olanda, 1105 AZ
- Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
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Utrecht, Olanda, 3584 CX
- Universitair Medisch Centrum Utrecht (UMC Utrecht)
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Arequipa, Perù, 4018
- Hogar Clinica San Juan de Dios
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Lima, Perù, 31
- Hospital Nacional Cayetano Heredia
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Lima, Perù, 15023
- Investigaciones Clinicas S.A.C.
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Lima, Perù, 27
- Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar
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Bydgoszcz, Polonia, 85-168
- Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
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Lodz, Polonia, 90-549
- USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113
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Szczecin, Polonia, 71-252
- Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie
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Lisbon, Portogallo, 1649-035
- Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria
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Porto, Portogallo, 4099-001
- Centro Hospitalar Universitario de Santo Antonio
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Bath, Regno Unito, BA1 3NG
- Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
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Doncaster, Regno Unito, DN2 5LT
- Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
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Leeds, Regno Unito, LS7 4SA
- Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds
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Liverpool, Regno Unito, L9 7AL
- Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
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London, Regno Unito, SE5 9RS
- Kings College Hospital NHS Foundation Trust
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London, Regno Unito, WC1N 3BG
- The National Hospital for Neurology and Neurosurgery
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London, Regno Unito, NW3 2QG
- The Royal Free Hospital - Royal Free London NHS Foundation Trust
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Middlesbrough, Regno Unito, TS4 3BW
- James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
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Salford, Regno Unito, M6 8HD
- Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
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Belgrade, Serbia, 11000
- Clinical Center of Serbia
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Belgrade, Serbia, 11000
- Institute of Rheumatology
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Piešťany, Slovacchia, 92112
- Narodny ustav reumatickych chorob
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Alicante, Spagna, 03010
- Hospital General Universitario de Alicante
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Barcelona, Spagna, 08036
- Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology
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Barcelona, Spagna, 08041
- Hospital de la Santa Creu i Sant Pau
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Madrid, Spagna, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Spagna, 28046
- Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
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Madrid, Spagna, 451086
- Hospital Universitario 12 de Octubre
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Seville, Spagna, 9-41014
- Hospital De Valme
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Valencia, Spagna, 46026
- Hospital Universitario y Politecnico La Fe
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Vigo, Spagna, 36200
- Hospital Do Meixoeiro
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Arizona
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Phoenix, Arizona, Stati Uniti, 85028
- Neuromuscular Research Center
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Scottsdale, Arizona, Stati Uniti, 85251
- HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
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California
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Beverly Hills, California, Stati Uniti, 90039
- Attune Health Research, Inc
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Los Angeles, California, Stati Uniti, 90033
- University of Southern California Norris Comprehensive Cancer Center
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Oceanside, California, Stati Uniti, 92056
- Profound Research LLC - Oceanside
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Orange, California, Stati Uniti, 92868
- University of California, Irvine
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Rancho Mirage, California, Stati Uniti, 92270
- Eisenhower Medical Center
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Redwood City, California, Stati Uniti, 94063-3132
- Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
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San Francisco, California, Stati Uniti, 94109
- California Pacific Medical Center - Sutter Health
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San Francisco, California, Stati Uniti, 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, Stati Uniti, 80230
- Denver Arthritis Clinic
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Connecticut
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New Haven, Connecticut, Stati Uniti, 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, Stati Uniti, 20007
- Georgetown University Hospital
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Florida
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Gainesville, Florida, Stati Uniti, 32610-3008
- UF Health Rheumatology
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Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic
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Tampa, Florida, Stati Uniti, 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, Stati Uniti, 30322
- Emory University Hospital, The Emory Clinic
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Augusta, Georgia, Stati Uniti, 30312
- Augusta University
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern Memorial Hospital
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- University Of Kansas Medical Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21224
- Johns Hopkins Medicine - Johns Hopkins Myositis Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 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, Stati Uniti, 48824
- Michigan State University - Neurology
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Minnesota
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Saint Paul, Minnesota, Stati Uniti, 55121
- St. Paul Rheumatology, PA
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Missouri
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St Louis, Missouri, Stati Uniti, 63110
- Washington University School of Medicine
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New York
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Great Neck, New York, Stati Uniti, 11021
- Northwell Health
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New York, New York, Stati Uniti, 10021
- Hospital for Special Surgery
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27514-4220
- University of North Carolina (UNC) School of Medicine
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Wilmington, North Carolina, Stati Uniti, 28401
- Carolina Arthritis Associates
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic - Main Campus
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Columbus, Ohio, Stati Uniti, 43201
- The Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73120
- Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15261
- University of Pittsburg Medical Center
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232-0028
- Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
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Texas
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Austin, Texas, Stati Uniti, 78759
- Austin Neuromuscular Center
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Houston, Texas, Stati Uniti, 77030
- McGovern Medical School -The University of Texas Health Science Center at Houston
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Houston, Texas, Stati Uniti, 77030
- Nerve And Muscle Center Of Texas
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Vermont
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Burlington, Vermont, Stati Uniti, 05401
- University of Vermont Medical Center - Main Campus
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Washington
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Seattle, Washington, Stati Uniti, 98195
- University of Washington Medical Center
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Stockholm, Svezia, 17164
- Karolinska Universitestssjukhus Solna
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Lugano, Svizzera, 6900
- Neurocenter of Southern Switzerland
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Bangkok, Tailandia, 10400
- Phramongkutklao Hospital
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Bangkok, Tailandia, 10700
- Siriraj Hospital, Mahidol University of Internal medicine
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Bangkok, Tailandia, 10300
- Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
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Bangkok, Tailandia, 10400
- Ramathibodi hospital
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Chiang Mai, Tailandia, 50200
- Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
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Khon Kaen, Tailandia, 40000
- Khon Kaen University
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Pathum Thani, Tailandia, 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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Ankara, Turchia (Türkiye), 06800
- Ankara City Hospital
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Ankara, Turchia (Türkiye), 06230
- Ankara University Medical Faculty
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Konya, Turchia (Türkiye), 42090
- Necmettin Erbakan University Meram Medical Faculty
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Budapest, Ungheria, 1083
- Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
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Debrecen, Ungheria, 4032
- Debreceni Egyetem - University of Debrecen
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: EFG PH20 SC
participants receiving efgartigimod PH20 SC on top of background treatment |
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer |
|
Comparatore placebo: PBO PH20 SC
participants receiving placebo PH20 SC on top of background treatment |
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean TIS
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to reach TIS ≥ 20 (first "minimal clinical improvement")
Lasso di tempo: 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
Lasso di tempo: 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")
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Phase 3: up to 52 weeks
|
CK: creatine kinase |
Phase 3: up to 52 weeks
|
|
Change in CDASI activity score at week 52
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
12 ottobre 2022
Completamento primario (Effettivo)
2 luglio 2026
Completamento dello studio (Effettivo)
2 luglio 2026
Date di iscrizione allo studio
Primo inviato
30 agosto 2022
Primo inviato che soddisfa i criteri di controllo qualità
30 agosto 2022
Primo Inserito (Effettivo)
31 agosto 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 settembre 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ARGX-113-2007
- 2024-512785-33-00 (Ctis)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .