En studie for å undersøke effektiviteten og sikkerheten til Efgartigimod PH20 SC hos voksne deltakere med aktiv idiopatisk inflammatorisk myopati. (ALKIVIA)
18. september 2026 oppdatert av: argenx
En fase 2/3, randomisert, dobbeltblindet, placebokontrollert, parallellgruppe, 2-arm, multisenter, operasjonell sømløs studie for å evaluere effektiviteten, sikkerheten, tolerabiliteten, farmakodynamikken, farmakokinetikken og immunogenisiteten til Efgartigimod PH20 SC hos deltakerne 18 år og eldre med aktiv idiopatisk inflammatorisk myopati
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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
265
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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Charleroi, Belgia, 6042
- Centre Hospitalier Universitaire de Charleroi
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Ghent, Belgia, 9000
- AZ Sint Lucas Gent-Campus Sint Lucas
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Leuven, Belgia, 3000
- Universitair Ziekenhuis Leuven Gasthuisberg Campus
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Liège, Belgia, 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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Copenhagen, Danmark, 2100
- Copenhagen University Hospital-Rigshospitalet University Hospital
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Arizona
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Phoenix, Arizona, Forente stater, 85028
- Neuromuscular Research Center
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Scottsdale, Arizona, Forente stater, 85251
- HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
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California
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Beverly Hills, California, Forente stater, 90039
- Attune Health Research, Inc
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Los Angeles, California, Forente stater, 90033
- University of Southern California Norris Comprehensive Cancer Center
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Oceanside, California, Forente stater, 92056
- Profound Research LLC - Oceanside
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Orange, California, Forente stater, 92868
- University of California, Irvine
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Rancho Mirage, California, Forente stater, 92270
- Eisenhower Medical Center
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Redwood City, California, Forente stater, 94063-3132
- Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
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San Francisco, California, Forente stater, 94109
- California Pacific Medical Center - Sutter Health
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San Francisco, California, Forente stater, 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, Forente stater, 80230
- Denver Arthritis Clinic
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Connecticut
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New Haven, Connecticut, Forente stater, 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, Forente stater, 20007
- Georgetown University Hospital
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Florida
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Gainesville, Florida, Forente stater, 32610-3008
- UF Health Rheumatology
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Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic
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Tampa, Florida, Forente stater, 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, Forente stater, 30322
- Emory University Hospital, The Emory Clinic
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Augusta, Georgia, Forente stater, 30312
- Augusta University
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern Memorial Hospital
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- University Of Kansas Medical Center
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Maryland
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Baltimore, Maryland, Forente stater, 21224
- Johns Hopkins Medicine - Johns Hopkins Myositis Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 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, Forente stater, 48824
- Michigan State University - Neurology
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Minnesota
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Saint Paul, Minnesota, Forente stater, 55121
- St. Paul Rheumatology, PA
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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New York
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Great Neck, New York, Forente stater, 11021
- Northwell Health
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New York, New York, Forente stater, 10021
- Hospital for Special Surgery
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27514-4220
- University of North Carolina (UNC) School of Medicine
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Wilmington, North Carolina, Forente stater, 28401
- Carolina Arthritis Associates
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic - Main Campus
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Columbus, Ohio, Forente stater, 43201
- The Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73120
- Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15261
- University of Pittsburg Medical Center
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Tennessee
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Nashville, Tennessee, Forente stater, 37232-0028
- Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
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Texas
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Austin, Texas, Forente stater, 78759
- Austin Neuromuscular Center
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Houston, Texas, Forente stater, 77030
- McGovern Medical School -The University of Texas Health Science Center at Houston
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Houston, Texas, Forente stater, 77030
- Nerve And Muscle Center Of Texas
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Vermont
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Burlington, Vermont, Forente stater, 05401
- University of Vermont Medical Center - Main Campus
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Washington
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Seattle, Washington, Forente stater, 98195
- University of Washington Medical Center
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Lyon, Frankrike, 69003
- Hopital Edouard Herriot
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Paris, Frankrike, 75013
- Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
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Rouen, Frankrike, 76031
- Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
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Strasbourg, Frankrike, 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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Athens, Hellas, 115 27
- National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
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Athens, Hellas, 115 28
- National and Kapodistrian University of Athens - Eginition Hospital
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Athens, Hellas, 151 25
- Athens Medical Center
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Athens, Hellas, 12462
- Attikon General University Hospital
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Ioannina, Hellas, 45110
- University of Ioannina Medical School
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Dublin, Irland, D04 T6F4
- St. Vincents University Hospital
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Dublin, Irland, D15 X40D
- Connolly Hospital Blanchardstown
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Manorhamilton, Irland, 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, 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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Bunkyō City, Japan, 113-8519
- Tokyo Medical And Dental University Hospital, Faculty of Medicine
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Bunkyō City, Japan, 113-8603
- Nippon Medical School - Nippon Medical School Hospital
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Kawasaki, Japan, 216-8511
- St. Marianna University School of Medicine Hospital
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Kurume, Japan, 830-0011
- Kurume University Hospital
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Matsudo-shi, Japan, 270-2251
- Chiba-Nishi General Hospital
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Nagoya, Japan, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
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Sagamihara-shi, Japan, 252-0375
- Kitasato University Hospital (KUH)
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Sapporo, Japan, 060-8604
- Sapporo City Hospital
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Sapporo, Japan, 060-8648
- Hokkaido University Hospital - Rheumatology
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Sasebo-shi, Japan, 857-1165
- Sasebo Chuo Hospital
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Sendai, Japan, 980-8574
- Tohoku University Hospital
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Tokushima, Japan, 770-8503
- Tokushima University Hospital
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Tokyo, Japan, 160-8582
- Keio University Hospital
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Tokyo, Japan, 113-8655
- The University of Tokyo Hospital
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Tokyo, Japan, 113-8431
- Juntendo University Hospital - Rheumatology
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Tsukuba, Japan, 305-8576
- University of Tsukuba Hospital - Rheumatology
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Ube-shi, Japan, 755-8505
- Yamaguchi University Hospital
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Wakayama, Japan, 641-8509
- Wakayama Medical University Hospital - Dermatology
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Beijing, Kina, 100730
- Peking Union Medical College Hospital
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Beijing, Kina, 100191
- Peking University Third Hospital
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Beijing, Kina, 100034
- Peking University First Hospital
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Changchun, Kina, 130021
- The First Hospital of Jilin University
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Changsha, Kina, 410008
- Xiangya Hospital Central South University
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Changsha, Kina, 410011
- The Second Xiangya Hospital of Central South University
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Chengdu, Kina, 610072
- Sichuan Provincial Peoples Hospital
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Guangzhou, Kina, 510515
- Nanfang Hospital, Southern Medical University
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Guangzhou, Kina, 510000
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Hangzhou, Kina, 310003
- The First Affiliated Hospital - School of Medicine - ZheJiang University
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Hefei, Kina, 230001
- Anhui Provincial Hospital
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Nanchang, Kina, 330000
- The Second Affiliated Hospital Of Nanchang University
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Nanjing, Kina, 210008
- Nanjing Drum Tower Hospital
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Shanghai, Kina, 200025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai, Kina, 200127
- Shanghai Renji Hospital
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Shanghai, Kina, 200000
- Huashan Hospital Affiliated to Fudan University
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Shanxi, Kina, 30001
- First Affiliated Hospital of Shanxi Medical College
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Shenyang, Kina, 110001
- China Medical University (CMU) - First Affiliated Hospital
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Wuhan, Kina, 430030
- Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
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Zhengzhou, Kina, 450052
- First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
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Nicosia, Kypros, 2371
- Cyprus Institute of Neurology and Genetics
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Kaunas, Litauen, 50161
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
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Vilnius, Litauen, 08661
- Vilnius University Hospital Santaros Klinikos
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Mexico City, Mexico, 06700
- CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
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Mérida, Mexico, 97000
- Centro Peninsular De Investigacion Clinica
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Amsterdam, Nederland, 1105 AZ
- Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
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Utrecht, Nederland, 3584 CX
- Universitair Medisch Centrum Utrecht (UMC Utrecht)
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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, Polen, 85-168
- Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
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Lodz, Polen, 90-549
- USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113
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Szczecin, Polen, 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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Belgrade, Serbia, 11000
- Clinical Center of Serbia
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Belgrade, Serbia, 11000
- Institute of Rheumatology
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Piešťany, Slovakia, 92112
- Narodny ustav reumatickych chorob
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Alicante, Spania, 03010
- Hospital General Universitario de Alicante
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Barcelona, Spania, 08036
- Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology
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Barcelona, Spania, 08041
- Hospital de la Santa Creu i Sant Pau
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Madrid, Spania, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Spania, 28046
- Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
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Madrid, Spania, 451086
- Hospital Universitario 12 de Octubre
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Seville, Spania, 9-41014
- Hospital De Valme
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Valencia, Spania, 46026
- Hospital Universitario y Politecnico La Fe
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Vigo, Spania, 36200
- Hospital Do Meixoeiro
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Bath, Storbritannia, BA1 3NG
- Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
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Doncaster, Storbritannia, DN2 5LT
- Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
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Leeds, Storbritannia, LS7 4SA
- Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds
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Liverpool, Storbritannia, L9 7AL
- Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
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London, Storbritannia, SE5 9RS
- Kings College Hospital NHS Foundation Trust
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London, Storbritannia, WC1N 3BG
- The National Hospital for Neurology and Neurosurgery
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London, Storbritannia, NW3 2QG
- The Royal Free Hospital - Royal Free London NHS Foundation Trust
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Middlesbrough, Storbritannia, TS4 3BW
- James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
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Salford, Storbritannia, M6 8HD
- Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
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Lugano, Sveits, 6900
- Neurocenter of Southern Switzerland
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Stockholm, Sverige, 17164
- Karolinska Universitestssjukhus Solna
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Daejeon, Sør -Korea, 35015
- Chungnam National University Hospital (CNUH)
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Incheon, Sør -Korea, 21565
- Gachon University Gil Medical Center
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Seoul, Sør -Korea, 03080
- Seoul National University Hospital
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Seoul, Sør -Korea, 02447
- Kyung Hee University Medical Center
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Seoul, Sør -Korea, 04763
- Hanyang University Seoul Hospital
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Suwon, Sør -Korea, 16499
- Ajou 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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Bangkok, Thailand, 10400
- Phramongkutklao Hospital
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Bangkok, Thailand, 10700
- Siriraj Hospital, Mahidol University of Internal medicine
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Bangkok, Thailand, 10300
- Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
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Bangkok, Thailand, 10400
- Ramathibodi hospital
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Chiang Mai, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
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Khon Kaen, Thailand, 40000
- Khon Kaen University
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Pathum Thani, Thailand, 12120
- Thammasat University Hospital
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Prague, Tsjekkia, 128 00
- Revmatologicky ustav
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Ankara, Tyrkia (Türkiye), 06800
- Ankara City Hospital
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Ankara, Tyrkia (Türkiye), 06230
- Ankara University Medical Faculty
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Konya, Tyrkia (Türkiye), 42090
- Necmettin Erbakan University Meram Medical Faculty
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Berlin, Tyskland, 10117
- Charite - Universitaetsmedizin Berlin
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Düsseldorf, Tyskland, 40225
- Universitaetsklinikum Duesseldorf
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Göttingen, Tyskland, 37075
- Universitatsmedizin Gottingen - Georg-August-Universitat
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Hamburg, Tyskland, 20246
- Universitaetsklinikum Hamburg-Eppendorf
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Herne, Tyskland, 44649
- Rheumazentrum Ruhrgebiet
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Mannheim, Tyskland, 68167
- Universitatsmedizin Mannheim
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München, Tyskland, 80336
- Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik
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Sendenhorst, Tyskland, 48324
- St. Josef-Stift Sendenhorst
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Tübingen, Tyskland, 72076
- Universitaetsklinikum Tuebingen (UKT)
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Ulm, Tyskland, 89081
- Universitatsklinikum Ulm - Standort Oberer Eselsberg
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Budapest, Ungarn, 1083
- Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
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Debrecen, Ungarn, 4032
- Debreceni Egyetem - University of Debrecen
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Innsbruck, Østerrike, 6020
- Medical University Innsbruck
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Vienna, Østerrike, 1090
- Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: EFG PH20 SC
participants receiving efgartigimod PH20 SC on top of background treatment |
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer |
|
Placebo komparator: PBO PH20 SC
participants receiving placebo PH20 SC on top of background treatment |
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean TIS
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to reach TIS ≥ 20 (first "minimal clinical improvement")
Tidsramme: 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
Tidsramme: 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")
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Phase 3: up to 52 weeks
|
CK: creatine kinase |
Phase 3: up to 52 weeks
|
|
Change in CDASI activity score at week 52
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. oktober 2022
Primær fullføring (Faktiske)
2. juli 2026
Studiet fullført (Faktiske)
2. juli 2026
Datoer for studieregistrering
Først innsendt
30. august 2022
Først innsendt som oppfylte QC-kriteriene
30. august 2022
Først lagt ut (Faktiske)
31. august 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. september 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ARGX-113-2007
- 2024-512785-33-00 (Ctis)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .