Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in South Korea / NCT05979441
Enrolling by invitation Phase 3

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

NCT05979441 · tracked via the Priya Life Science South Korea tracker
Sponsor
argenx
Phase
Phase 3
Started
2023-09-12
Last updated
2026-09-21

Condition(s) studied

MyositisActive Idiopathic Inflammatory MyopathyDermatomyositisPolymyositisImmune-Mediated Necrotizing MyopathyAntisynthetase Syndrome

Investigational drug(s) / intervention(s)

Efgartigimod PH20 SC →

Efgartigimod PH20 SC: Subcutaneous injection of Efgartigimod PH20 given by vials or prefilled syringe (PFS)

Study summary

The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007.

The study consists of a treatment period where participants will receive efgartigimod PH20 SC for up to 51 months. The treatment period will be followed by a treatment-free safety follow-up period of 56 days.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Has completed trial ARGX-113-2007 * Being capable of providing signed informed consent and complying with protocol requirements * Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug Exclusion Criteria: * Intention to have major surgery during the study period or any other medical condition that has arisen since enrollment in study ARGX-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk * Known hypersensitivity reaction to the study drug or 1 of its excipients * Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness

Primary outcome measure(s)

  • Incidence of AEs, SAEs and AESIs over time — Up to 53 months
    AE : adverse event ; SAE : serious adverse event ; AESI : adverse event of special interest.

Trial sites (92)

FacilityCityRegionStatus
Neuromuscular Clinical and Research Center - Neurology Phoenix Arizona
Attune Health Research, Inc Beverly Hills California
UCI Health - ALS and Neuromuscular Center - Neurology Orange California
UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology San Francisco California
Yale Cancer Center-Yale University School Of Medicine New Haven Connecticut
UF Health - Rheumatology Medical Specialties Medical Plaza Gainesville Florida
Mayo Clinic - Florida - Neurology Jacksonville Florida
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare) Tampa Florida
Emory Healthcare - Emory Clinic - Rheumatology Atlanta Georgia
Northwestern Medicine - Northwestern Memorial Hospital Chicago Illinois
John Hopkins Medicine - Johns Hopkins Myositis Center Baltimore Maryland
Northwell Health Physician Partners Rheumatology Great Neck New York
University of North Carolina (UNC) School of Medicine Chapel Hill North Carolina
The Ohio State University Columbus Ohio
Oregon Health and Science University Portland Oregon
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC) Austin Texas
Nerve And Muscle Center Of Texas Houston Texas
Framingham Centro Medico La Plata Argentina
Centro Dermatologico Schejtman San Miguel Argentina
Centro Medico Privado de Reumatologia San Miguel de Tucumán Argentina
Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck - Neurology Innsbruck Austria
AZ Sint-Lucas - Campus Sint-Lucas - Neurology Ghent Belgium
Universitair Ziekenhuis Leuven Gasthuisberg Campus Leuven Belgium
Medical Centre Artmed Plovdiv Bulgaria
Multiprofile hospital for active treatment Kaspela EOOD Plovdiv Bulgaria
Nanfang Hospital, Southern Medical University Guangzhou Guangdong
Nanjing University Medical School - Taikang Xianlin Drum Tower Hospital (Nanjing Drum Tower Hospital) Nanjing Jingsu
Peking University Third Hospital Beijing China
Peking Union Medical College Hospital Beijing China
Sichuan Provincial Academy of Medical Sciences and Sichuan Provincial People's Hospital Chengdu China
Shanghai Jiao Tong University School of Medicine - Renji Hospital - Shanghai Institute of Digestive Disease (SIDD) Shanghai China
Huashan Hospital Affiliated to Fudan University Shanghai China
China Medical University (CMU) - First Affiliated Hospital Shenyang China
First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University Zhengzhou China
Cyprus Institute of Neurology and Genetics Nicosia Cyprus
Revmatologicky Ustav Prague Czechia
Copenhagen University Hospital-Rigshospitalet University Hospital Copenhagen Denmark
Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix Paris France
Aversi Clinic Tbilisi Georgia

+ 52 more sites — see the full list on the official registry below.

More argenx trials in South Korea

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis Active, not recruiting
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP Recruiting
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP Recruiting
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome Active, not recruiting
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia Active, not recruiting

Other trials for the same condition

Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients With Refractory Polymyositis or Dermatomyositis Starting soon
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies Active, not recruiting
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)] Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05979441 on ClinicalTrials.gov ↗ ← All trials in South Korea