A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Enrolling by invitation · Phase 3
Conditions studied: Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy, Antisynthetase Syndrome
In brief
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.
Key facts
- Study ID
- NCT05979441
- Run by
- argenx
- People needed
- 240
- Starts
- 2023-09-12
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Attune Health Research, Inc — Beverly Hills, California, United States
- UCI Health - ALS and Neuromuscular Center - Neurology — Orange, California, United States
- UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology — San Francisco, California, United States
- Yale Cancer Center-Yale University School Of Medicine — New Haven, Connecticut, United States
- UF Health - Rheumatology Medical Specialties Medical Plaza — Gainesville, Florida, United States
- Mayo Clinic - Florida - Neurology — Jacksonville, Florida, United States
- University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare) — Tampa, Florida, United States
- Emory Healthcare - Emory Clinic - Rheumatology — Atlanta, Georgia, United States
- Northwestern Medicine - Northwestern Memorial Hospital — Chicago, Illinois, United States
- John Hopkins Medicine - Johns Hopkins Myositis Center — Baltimore, Maryland, United States
- Northwell Health Physician Partners Rheumatology — Great Neck, New York, United States
- University of North Carolina (UNC) School of Medicine — Chapel Hill, North Carolina, United States
- The Ohio State University — Columbus, Ohio, United States
- Oregon Health and Science University — Portland, Oregon, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC) — Austin, Texas, United States
- Nerve And Muscle Center Of Texas — Houston, Texas, United States
- 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
- Neuromuscular Clinical and Research Center - Neurology — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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