Status:
ENROLLING_BY_INVITATION
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Lead Sponsor:
argenx
Conditions:
Myositis
Active Idiopathic Inflammatory Myopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05979441
Start Date
September 12 2023
End Date
September 1 2028
Last Update
January 8 2026
Active Locations (73)
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1
Neuromuscular Clinical and Research Center - Neurology
Phoenix, Arizona, United States, 85028
2
Attune Health Research, Inc
Beverly Hills, California, United States, 90039
3
UCI Health - ALS and Neuromuscular Center - Neurology
Orange, California, United States, 92868
4
UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology
San Francisco, California, United States, 94143