Studie ke zkoumání účinnosti a bezpečnosti Efgartigimodu PH20 SC u dospělých účastníků s aktivní idiopatickou zánětlivou myopatií. (ALKIVIA)
18. září 2026 aktualizováno: argenx
Fáze 2/3, randomizovaná, dvojitě zaslepená, placebem kontrolovaná, paralelní skupinová, 2ramenná, multicentrická, provozně bezproblémová studie k vyhodnocení účinnosti, bezpečnosti, snášenlivosti, farmakodynamiky, farmakokinetiky a imunogenicity efgartigimodu PH20 SC u účastníků Ve věku 18 let a starší s aktivní idiopatickou zánětlivou myopatií
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).
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
265
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Córdoba, Argentina, 5000
- Consultora Integral de Salud
-
La Plata, Argentina, B1902COS
- Framingham Centro Medico
-
Ramos Mejía, Argentina, B1704ETD
- Dim Clinica Privada
-
San Miguel, Argentina, B1663GKT
- Centro Dermatologico Schejtman
-
San Miguel de Tucumán, Argentina, T4000AXL
- Centro de Investigaciones Medicas Tucuman
-
-
-
-
-
Auchenflower, Austrálie, 4066
- The Wesley Medical Research
-
Murdoch, Austrálie, 6150
- Fiona Stanley Hospital
-
-
-
-
-
Charleroi, Belgie, 6042
- Centre Hospitalier Universitaire de Charleroi
-
Ghent, Belgie, 9000
- AZ Sint Lucas Gent-Campus Sint Lucas
-
Leuven, Belgie, 3000
- Universitair Ziekenhuis Leuven Gasthuisberg Campus
-
Liège, Belgie, 4000
- Centre Hospitalier Universitaire Sart Tilman
-
-
-
-
-
Plovdiv, Bulharsko, 4002
- Multiprofile hospital for active treatment Kaspela EOOD
-
Plovdiv, Bulharsko, 4002
- Medical Centre Artmed
-
-
-
-
-
Copenhagen, Dánsko, 2100
- Copenhagen University Hospital-Rigshospitalet University Hospital
-
-
-
-
-
Lyon, Francie, 69003
- Hopital Edouard Herriot
-
Paris, Francie, 75013
- Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
-
Rouen, Francie, 76031
- Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
-
Strasbourg, Francie, 67098
- Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
-
-
-
-
-
Tbilisi, Gruzie, 0160
- Aversi Clinic
-
Tbilisi, Gruzie, 0180
- The First Medical Center
-
Tbilisi, Gruzie, 0114
- LTD New Hospitals
-
Tbilisi, Gruzie, 0186
- LTD Tbilisi Heart Center
-
Tbilisi, Gruzie, 0102
- American Hospital Network
-
Tbilisi, Gruzie, 0179
- LLC MediClub Georgia
-
-
-
-
-
Amsterdam, Holandsko, 1105 AZ
- Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
-
Utrecht, Holandsko, 3584 CX
- Universitair Medisch Centrum Utrecht (UMC Utrecht)
-
-
-
-
-
Dublin, Irsko, D04 T6F4
- St. Vincents University Hospital
-
Dublin, Irsko, D15 X40D
- Connolly Hospital Blanchardstown
-
Manorhamilton, Irsko, F91 X012
- North West Rheumatology Unit - Our Lady's Hospital
-
-
-
-
-
Bari, Itálie, 70124
- Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology
-
Florence, Itálie, 50139
- Azienda Ospedaliero Universitaria Careggi
-
Milan, Itálie, 20132
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
-
Pavia, Itálie, 27100
- San Matteo Hospital
-
Pisa, Itálie, 56126
- A.O. Universitaria Pisana
-
Reggio Emilia, Itálie, 42123
- IRCCS Arcispedale Santa Maria Nuova
-
Roma, Itálie, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
-
Roma, Itálie, 00189
- Azienda Ospedaliero Universitaria Sant'Andrea
-
Rozzano, Itálie, 20089
- IRCCS Istituto Clinico Humanitas - Rheumatology
-
Torino, Itálie, 10126
- Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
-
Udine, Itálie, 33100
- ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia
-
Verona, Itálie, 37134
- Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
-
-
-
-
-
Haifa, Izrael, 3109601
- Rambam Health Care Campus
-
Haifa, Izrael, 31048
- Bnai Zion Medical Center
-
Kfar Saba, Izrael, 44281
- Meir Medical Center
-
Petah Tikva, Izrael, 49100
- Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
-
Ramat Gan, Izrael, 52621
- Sheba Medical Center - Rheumatology
-
-
-
-
-
Bunkyō City, Japonsko, 113-8519
- Tokyo Medical And Dental University Hospital, Faculty of Medicine
-
Bunkyō City, Japonsko, 113-8603
- Nippon Medical School - Nippon Medical School Hospital
-
Kawasaki, Japonsko, 216-8511
- St. Marianna University School of Medicine Hospital
-
Kurume, Japonsko, 830-0011
- Kurume University Hospital
-
Matsudo-shi, Japonsko, 270-2251
- Chiba-Nishi General Hospital
-
Nagoya, Japonsko, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
-
Sagamihara-shi, Japonsko, 252-0375
- Kitasato University Hospital (KUH)
-
Sapporo, Japonsko, 060-8604
- Sapporo City Hospital
-
Sapporo, Japonsko, 060-8648
- Hokkaido University Hospital - Rheumatology
-
Sasebo-shi, Japonsko, 857-1165
- Sasebo Chuo Hospital
-
Sendai, Japonsko, 980-8574
- Tohoku University Hospital
-
Tokushima, Japonsko, 770-8503
- Tokushima University Hospital
-
Tokyo, Japonsko, 160-8582
- Keio University Hospital
-
Tokyo, Japonsko, 113-8655
- The University of Tokyo Hospital
-
Tokyo, Japonsko, 113-8431
- Juntendo University Hospital - Rheumatology
-
Tsukuba, Japonsko, 305-8576
- University of Tsukuba Hospital - Rheumatology
-
Ube-shi, Japonsko, 755-8505
- Yamaguchi University Hospital
-
Wakayama, Japonsko, 641-8509
- Wakayama Medical University Hospital - Dermatology
-
-
-
-
-
Daejeon, Jižní Korea, 35015
- Chungnam National University Hospital (CNUH)
-
Incheon, Jižní Korea, 21565
- Gachon University Gil Medical Center
-
Seoul, Jižní Korea, 03080
- Seoul National University Hospital
-
Seoul, Jižní Korea, 02447
- Kyung Hee University Medical Center
-
Seoul, Jižní Korea, 04763
- Hanyang University Seoul Hospital
-
Suwon, Jižní Korea, 16499
- Ajou University Hospital
-
-
-
-
-
Montreal, Kanada, H4A 3T2
- Genge Partners
-
Ottawa, Kanada, K1Y 4E9
- Ottawa Hospital Research Institute-Civic Campus
-
-
-
-
-
Nicosia, Kypr, 2371
- Cyprus Institute of Neurology and Genetics
-
-
-
-
-
Kaunas, Litva, 50161
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
-
Vilnius, Litva, 08661
- Vilnius University Hospital Santaros Klinikos
-
-
-
-
-
Budapest, Maďarsko, 1083
- Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
-
Debrecen, Maďarsko, 4032
- Debreceni Egyetem - University of Debrecen
-
-
-
-
-
Mexico City, Mexiko, 06700
- CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
-
Mérida, Mexiko, 97000
- Centro Peninsular De Investigacion Clinica
-
-
-
-
-
Berlin, Německo, 10117
- Charite - Universitaetsmedizin Berlin
-
Düsseldorf, Německo, 40225
- Universitaetsklinikum Duesseldorf
-
Göttingen, Německo, 37075
- Universitatsmedizin Gottingen - Georg-August-Universitat
-
Hamburg, Německo, 20246
- Universitaetsklinikum Hamburg-Eppendorf
-
Herne, Německo, 44649
- Rheumazentrum Ruhrgebiet
-
Mannheim, Německo, 68167
- Universitatsmedizin Mannheim
-
München, Německo, 80336
- Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik
-
Sendenhorst, Německo, 48324
- St. Josef-Stift Sendenhorst
-
Tübingen, Německo, 72076
- Universitaetsklinikum Tuebingen (UKT)
-
Ulm, Německo, 89081
- Universitatsklinikum Ulm - Standort Oberer Eselsberg
-
-
-
-
-
Arequipa, Peru, 4018
- Hogar Clinica San Juan de Dios
-
Lima, Peru, 31
- Hospital Nacional Cayetano Heredia
-
Lima, Peru, 15023
- Investigaciones Clinicas S.A.C.
-
Lima, Peru, 27
- Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar
-
-
-
-
-
Bydgoszcz, Polsko, 85-168
- Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
-
Lodz, Polsko, 90-549
- USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113
-
Szczecin, Polsko, 71-252
- Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie
-
-
-
-
-
Lisbon, Portugalsko, 1649-035
- Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria
-
Porto, Portugalsko, 4099-001
- Centro Hospitalar Universitario de Santo Antonio
-
-
-
-
-
Innsbruck, Rakousko, 6020
- Medical University Innsbruck
-
Vienna, Rakousko, 1090
- Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
-
-
-
-
-
Piešťany, Slovensko, 92112
- Narodny ustav reumatickych chorob
-
-
-
-
-
Bath, Spojené království, BA1 3NG
- Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
-
Doncaster, Spojené království, DN2 5LT
- Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
-
Leeds, Spojené království, LS7 4SA
- Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds
-
Liverpool, Spojené království, L9 7AL
- Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
-
London, Spojené království, SE5 9RS
- Kings College Hospital NHS Foundation Trust
-
London, Spojené království, WC1N 3BG
- The National Hospital for Neurology and Neurosurgery
-
London, Spojené království, NW3 2QG
- The Royal Free Hospital - Royal Free London NHS Foundation Trust
-
Middlesbrough, Spojené království, TS4 3BW
- James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
-
Salford, Spojené království, M6 8HD
- Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
-
-
-
-
Arizona
-
Phoenix, Arizona, Spojené státy, 85028
- Neuromuscular Research Center
-
Scottsdale, Arizona, Spojené státy, 85251
- HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
-
-
California
-
Beverly Hills, California, Spojené státy, 90039
- Attune Health Research, Inc
-
Los Angeles, California, Spojené státy, 90033
- University of Southern California Norris Comprehensive Cancer Center
-
Oceanside, California, Spojené státy, 92056
- Profound Research LLC - Oceanside
-
Orange, California, Spojené státy, 92868
- University of California, Irvine
-
Rancho Mirage, California, Spojené státy, 92270
- Eisenhower Medical Center
-
Redwood City, California, Spojené státy, 94063-3132
- Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
-
San Francisco, California, Spojené státy, 94109
- California Pacific Medical Center - Sutter Health
-
San Francisco, California, Spojené státy, 94143-2202
- Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)
-
-
Colorado
-
Denver, Colorado, Spojené státy, 80230
- Denver Arthritis Clinic
-
-
Connecticut
-
New Haven, Connecticut, Spojené státy, 06520
- Yale Cancer Center-Yale University School Of Medicine
-
-
District of Columbia
-
Washington D.C., District of Columbia, Spojené státy, 20007
- Georgetown University Hospital
-
-
Florida
-
Gainesville, Florida, Spojené státy, 32610-3008
- UF Health Rheumatology
-
Jacksonville, Florida, Spojené státy, 32224
- Mayo Clinic
-
Tampa, Florida, Spojené státy, 33616
- University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
-
-
Georgia
-
Atlanta, Georgia, Spojené státy, 30322
- Emory University Hospital, The Emory Clinic
-
Augusta, Georgia, Spojené státy, 30312
- Augusta University
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60611
- Northwestern Memorial Hospital
-
-
Kansas
-
Kansas City, Kansas, Spojené státy, 66160
- University Of Kansas Medical Center
-
-
Maryland
-
Baltimore, Maryland, Spojené státy, 21224
- Johns Hopkins Medicine - Johns Hopkins Myositis Center
-
-
Massachusetts
-
Boston, Massachusetts, Spojené státy, 02115-6110
- Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC)
-
-
Michigan
-
East Lansing, Michigan, Spojené státy, 48824
- Michigan State University - Neurology
-
-
Minnesota
-
Saint Paul, Minnesota, Spojené státy, 55121
- St. Paul Rheumatology, PA
-
-
Missouri
-
St Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
-
-
New York
-
Great Neck, New York, Spojené státy, 11021
- Northwell Health
-
New York, New York, Spojené státy, 10021
- Hospital for Special Surgery
-
-
North Carolina
-
Chapel Hill, North Carolina, Spojené státy, 27514-4220
- University of North Carolina (UNC) School of Medicine
-
Wilmington, North Carolina, Spojené státy, 28401
- Carolina Arthritis Associates
-
-
Ohio
-
Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic - Main Campus
-
Columbus, Ohio, Spojené státy, 43201
- The Ohio State University
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Spojené státy, 73120
- Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
-
-
Oregon
-
Portland, Oregon, Spojené státy, 97239
- Oregon Health and Science University
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Spojené státy, 15261
- University of Pittsburg Medical Center
-
-
Tennessee
-
Nashville, Tennessee, Spojené státy, 37232-0028
- Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
-
-
Texas
-
Austin, Texas, Spojené státy, 78759
- Austin Neuromuscular Center
-
Houston, Texas, Spojené státy, 77030
- McGovern Medical School -The University of Texas Health Science Center at Houston
-
Houston, Texas, Spojené státy, 77030
- Nerve And Muscle Center Of Texas
-
-
Vermont
-
Burlington, Vermont, Spojené státy, 05401
- University of Vermont Medical Center - Main Campus
-
-
Washington
-
Seattle, Washington, Spojené státy, 98195
- University of Washington Medical Center
-
-
-
-
-
Belgrade, Srbsko, 11000
- Clinical Center of Serbia
-
Belgrade, Srbsko, 11000
- Institute of Rheumatology
-
-
-
-
-
Taichung, Tchaj-wan, 40705
- Taichung Veterans General Hospital
-
Taichung, Tchaj-wan, 402
- Chung Shan Medical University Hospital
-
Taichung, Tchaj-wan, 40402
- China Medical University and Hospital
-
-
-
-
-
Bangkok, Thajsko, 10400
- Phramongkutklao Hospital
-
Bangkok, Thajsko, 10700
- Siriraj Hospital, Mahidol University of Internal medicine
-
Bangkok, Thajsko, 10300
- Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
-
Bangkok, Thajsko, 10400
- Ramathibodi hospital
-
Chiang Mai, Thajsko, 50200
- Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
-
Khon Kaen, Thajsko, 40000
- Khon Kaen University
-
Pathum Thani, Thajsko, 12120
- Thammasat University Hospital
-
-
-
-
-
Ankara, Turecko (Türkiye), 06800
- Ankara City Hospital
-
Ankara, Turecko (Türkiye), 06230
- Ankara University Medical Faculty
-
Konya, Turecko (Türkiye), 42090
- Necmettin Erbakan University Meram Medical Faculty
-
-
-
-
-
Prague, Česko, 128 00
- Revmatologicky ustav
-
-
-
-
-
Beijing, Čína, 100730
- Peking Union Medical College Hospital
-
Beijing, Čína, 100191
- Peking University Third Hospital
-
Beijing, Čína, 100034
- Peking University First Hospital
-
Changchun, Čína, 130021
- The First Hospital of Jilin University
-
Changsha, Čína, 410008
- Xiangya Hospital Central South University
-
Changsha, Čína, 410011
- The Second Xiangya Hospital of Central South University
-
Chengdu, Čína, 610072
- Sichuan Provincial Peoples Hospital
-
Guangzhou, Čína, 510515
- Nanfang Hospital, Southern Medical University
-
Guangzhou, Čína, 510000
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
-
Hangzhou, Čína, 310003
- The First Affiliated Hospital - School of Medicine - ZheJiang University
-
Hefei, Čína, 230001
- Anhui Provincial Hospital
-
Nanchang, Čína, 330000
- The Second Affiliated Hospital Of Nanchang University
-
Nanjing, Čína, 210008
- Nanjing Drum Tower Hospital
-
Shanghai, Čína, 200025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
-
Shanghai, Čína, 200127
- Shanghai Renji Hospital
-
Shanghai, Čína, 200000
- Huashan Hospital Affiliated to Fudan University
-
Shanxi, Čína, 30001
- First Affiliated Hospital of Shanxi Medical College
-
Shenyang, Čína, 110001
- China Medical University (CMU) - First Affiliated Hospital
-
Wuhan, Čína, 430030
- Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
-
Zhengzhou, Čína, 450052
- First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
-
-
-
-
-
Athens, Řecko, 115 27
- National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
-
Athens, Řecko, 115 28
- National and Kapodistrian University of Athens - Eginition Hospital
-
Athens, Řecko, 151 25
- Athens Medical Center
-
Athens, Řecko, 12462
- Attikon General University Hospital
-
Ioannina, Řecko, 45110
- University of Ioannina Medical School
-
-
-
-
-
Alicante, Španělsko, 03010
- Hospital General Universitario de Alicante
-
Barcelona, Španělsko, 08036
- Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology
-
Barcelona, Španělsko, 08041
- Hospital de la Santa Creu i Sant Pau
-
Madrid, Španělsko, 28034
- Hospital Universitario Ramon y Cajal
-
Madrid, Španělsko, 28046
- Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
-
Madrid, Španělsko, 451086
- Hospital Universitario 12 de Octubre
-
Seville, Španělsko, 9-41014
- Hospital De Valme
-
Valencia, Španělsko, 46026
- Hospital Universitario y Politecnico La Fe
-
Vigo, Španělsko, 36200
- Hospital Do Meixoeiro
-
-
-
-
-
Stockholm, Švédsko, 17164
- Karolinska Universitestssjukhus Solna
-
-
-
-
-
Lugano, Švýcarsko, 6900
- Neurocenter of Southern Switzerland
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: EFG PH20 SC
participants receiving efgartigimod PH20 SC on top of background treatment |
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer |
|
Komparátor placeba: PBO PH20 SC
participants receiving placebo PH20 SC on top of background treatment |
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean TIS
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to reach TIS ≥ 20 (first "minimal clinical improvement")
Časové okno: 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
Časové okno: 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")
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: Phase 3: up to 52 weeks
|
CK: creatine kinase |
Phase 3: up to 52 weeks
|
|
Change in CDASI activity score at week 52
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
12. října 2022
Primární dokončení (Aktuální)
2. července 2026
Dokončení studie (Aktuální)
2. července 2026
Termíny zápisu do studia
První předloženo
30. srpna 2022
První předloženo, které splnilo kritéria kontroly kvality
30. srpna 2022
První zveřejněno (Aktuální)
31. srpna 2022
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
21. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. září 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ARGX-113-2007
- 2024-512785-33-00 (Ctis)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .