A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Public ClinicalTrials.gov record NCT05979441. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05979441
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 240 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 12, 2023 (Actual)
- Primary completion
- Sep 2028 (Estimated)
- Completion
- Sep 2028 (Estimated)
- Last update posted
- Oct 16, 2026
2023 – 2028
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neuromuscular Clinical and Research Center - Neurology | Phoenix | Arizona | 85028 | — |
| Attune Health Research, Inc | Beverly Hills | California | 90039 | — |
| UCI Health - ALS and Neuromuscular Center - Neurology | Orange | California | 92868 | — |
| UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology | San Francisco | California | 94143 | — |
| Yale Cancer Center-Yale University School Of Medicine | New Haven | Connecticut | 06520 | — |
| UF Health - Rheumatology Medical Specialties Medical Plaza | Gainesville | Florida | 32610 | — |
| Mayo Clinic - Florida - Neurology | Jacksonville | Florida | 32224 | — |
| University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare) | Tampa | Florida | 33616 | — |
| Emory Healthcare - Emory Clinic - Rheumatology | Atlanta | Georgia | 30322 | — |
| Northwestern Medicine - Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| John Hopkins Medicine - Johns Hopkins Myositis Center | Baltimore | Maryland | 21224-2734 | — |
| Northwell Health Physician Partners Rheumatology | Great Neck | New York | 11021 | — |
| University of North Carolina (UNC) School of Medicine | Chapel Hill | North Carolina | 27514 | — |
| The Ohio State University | Columbus | Ohio | 43201 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | — |
| Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC) | Austin | Texas | 78759 | — |
| Nerve And Muscle Center Of Texas | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05979441, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05979441 live on ClinicalTrials.gov.