ClinicalTrials.gov record NCT05979441
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This phase 3, single-arm, open-label extension studies long-term use of subcutaneous efgartigimod in adults who completed study ARGX-113-2007. Participants receive efgartigimod PH20 SC for up to 51 months, followed by a 56-day treatment-free safety follow-up. The study focuses on measuring long-term safety, tolerability, and measures of disease activity and steroid-related toxicity.
What it is studying. The study is collecting information on adverse events and tolerability during long-term treatment with efgartigimod given by subcutaneous injection. It also tracks disease activity and clinical response, measures related to glucocorticoid (steroid) toxicity, patient and physician global assessments, quality-of-life scores, serum IgG levels, and the development of anti-drug antibodies over time.
What the researchers hope to learn. To learn about the long-term safety and tolerability of efgartigimod when given subcutaneously. To assess effects on glucocorticoid-related toxicity and on clinical measures of myositis activity, patient and physician impressions, quality of life, serum IgG changes, and the occurrence of anti-drug antibodies.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- Efgartigimod PH20 SC
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Receive subcutaneous injections of efgartigimod PH20 (vial or prefilled syringe) during a treatment period lasting up to 51 months, followed by a treatment‑free safety follow-up of 56 days. Attend regular clinic visits for safety monitoring and disease assessments, provide blood samples for tests such as total IgG and anti‑drug antibodies, and complete questionnaires and clinical activity measures used in the study. Report any adverse events to the study team. Comply with pregnancy testing and contraception requirements as applicable.
How the study is structured. Single-group, open-label phase 3 extension: people who completed ARGX-113-2007 receive efgartigimod PH20 by subcutaneous injection (vial or prefilled syringe) on a planned schedule for up to 51 months. There is no blinding or comparison group. After the treatment period participants have a 56-day treatment-free safety follow-up.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in Argentina, Austria, Belgium, Bulgaria, China, Cyprus, Czechia, Denmark, France, Georgia, Germany, Greece, Ireland, Italy, Japan, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Serbia, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on dermatomyositis
This trial is also listed on this site under anti-synthetase syndrome and polymyositis.
Important dates
- Study start
- Sep 12, 2023
- Primary completion
- September 2028 (estimated)
- Study completion
- September 2028 (estimated)
- Target enrollment
- 240 participants (estimated)
- Last updated on registry
- Sep 21, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- argenx
Participating sites (92)
- Neuromuscular Clinical and Research Center - Neurology
Phoenix, Arizona, 85028 · United States
- Attune Health Research, Inc
Beverly Hills, California, 90039 · United States
- UCI Health - ALS and Neuromuscular Center - Neurology
Orange, California, 92868 · United States
- UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology
San Francisco, California, 94143 · United States
- Yale Cancer Center-Yale University School Of Medicine
New Haven, Connecticut, 06520 · United States
- UF Health - Rheumatology Medical Specialties Medical Plaza
Gainesville, Florida, 32610 · United States
- Mayo Clinic - Florida - Neurology
Jacksonville, Florida, 32224 · United States
- University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
Tampa, Florida, 33616 · United States
- Emory Healthcare - Emory Clinic - Rheumatology
Atlanta, Georgia, 30322 · United States
- Northwestern Medicine - Northwestern Memorial Hospital
Chicago, Illinois, 60611 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- safety follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- women of childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- study drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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