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 USA tracker

Sponsor

argenx

Phase

Phase 3

Started

2023-09-12

Last updated

2026-07-21

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

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)

Facility	City	Region
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.

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 the USA