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Активно (без набиране) Фаза 2/3 NCT05523167

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

Фаза 2/3 – комбинирано изпитване
Заболявания: Active Idiopathic Inflammatory Myopathy Myositis Dermatomyositis Polymyositis Immune-Mediated Necrotizing Myopathy Antisynthetase Syndrome

Спонсор: argenx

Налично на: БГ
Обобщение
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). Additional information can be found on https://myositis-study.com/.
Кой може да участва
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). The full list of inclusion criteria can be found in the protocol. Exclusion Criteria: * A clinically significant active infection at screening * A COVID-19 polymerase chain reaction (PCR)-positive test before enrollment * 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 * Juvenile myositis (JDM) diagnosed \> 5 years from screening or juvenile myositis with extensive calcinosis or severe calcinosis. * 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 * Other inflammatory and noninflammatory myopathies: inclusion body myositis, overlap myositis), metabolic myopathies, muscle dystrophies or a family history of muscle dystrophy, drug-induced or endocrine induced myositis, and juvenile myositis (other than juvenile dermatomyositis (JDM)) * Clinically significant disease, recent major surgery or intends to have surgery during the study, or has any other condition in the opinion of the investigator that could confound the results of the trial or put the patient at undue risk * Known hypersensitivity reaction to investigational medicinal product (IMP) or 1 of its excipients * Received a live or live-attenuated vaccine less than 4 weeks before screening. * Positive serum test at screening for active viral infection with any of the following conditions: Hepatitis B virus (HBV); Hepatitis C virus (HCV); HIV * Participant has previously participated in an efgartigimod clinical trial and received at least 1 dose of investigational medicinal product (IMP). * Participant is concurrently participating in any other clinical study, including a noninterventional study. * Participant has a current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse. * Participant is pregnant or lactating or intends to become pregnant during the study. * Participant has severe renal impairment . * Participant is institutionalized by a court or other governmental order or is in a dependent relationship with the sponsor or investigator. The full list of exclusion criteria can be found in the protocol.
Места на провеждане 32
Argentina (1)
Consultora Integral de Salud
Córdoba
Австралия (1)
The Wesley Medical Research
Auchenflower
Белгия (1)
Centre Hospitalier Universitaire de Charleroi
Charleroi
България (1)
Medical Centre Artmed
Plovdiv
Канада (1)
Genge Partners
Montreal
Китай (1)
Peking University First Hospital
Beijing
Cyprus (1)
Cyprus Institute of Neurology and Genetics
Nicosia
Чехия (1)
Revmatologicky ustav
Prague
Дания (1)
Copenhagen University Hospital-Rigshospitalet University Hospital
Copenhagen
Франция (1)
Hopital Edouard Herriot
Lyon
Georgia (1)
American Hospital Network
Tbilisi
Гърция (1)
National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
Athens
Унгария (1)
Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
Budapest
Ireland (1)
St. Vincents University Hospital
Dublin
Израел (1)
Bnai Zion Medical Center
Haifa
Италия (1)
Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology
Bari
Япония (1)
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Bunkyō City
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas
Mexico (1)
CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
Mexico City
Нидерландия (1)
Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
Amsterdam
Peru (1)
Hogar Clinica San Juan de Dios
Arequipa
Полша (1)
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz
Сърбия (1)
Clinical Center of Serbia
Belgrade
Словакия (1)
Narodny ustav reumatickych chorob
Piešťany
Южна Корея (1)
Chungnam National University Hospital (CNUH)
Daejeon
Испания (1)
Hospital General Universitario de Alicante
Alicante
Швеция (1)
Karolinska Universitestssjukhus Solna
Stockholm
Taiwan (1)
Chung Shan Medical University Hospital
Taichung
Тайланд (1)
Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
Bangkok
Турция (1)
Ankara University Medical Faculty
Ankara
Великобритания (1)
Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
Bath
САЩ (1)
Neuromuscular Research Center
Phoenix , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
12.10.2022
Крайна дата
01.02.2027
Регистрационен номер
NCT05523167
Източник
anzctr
Запитване за медицински туризъм

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