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A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

NCT05979441

Enrolling By InvitationPhase 3

Sponsor: argenx

Conditions: Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy

Interventions: Efgartigimod PH20 SC

Countries: United States, Argentina, Austria, Belgium, Bulgaria, China, Cyprus, Czechia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (92)
  • Phoenix, Arizona, United States
  • Beverly Hills, California, United States
  • Orange, California, United States
  • San Francisco, California, United States
  • New Haven, Connecticut, United States
  • Gainesville, Florida, United States
  • Jacksonville, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Great Neck, New York, United States
  • Chapel Hill, North Carolina, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Austin, Texas, United States
  • Houston, Texas, United States
  • La Plata, Argentina
  • San Miguel, Argentina
  • San Miguel de Tucumán, Argentina
  • Innsbruck, Austria
  • Ghent, Belgium
  • Leuven, Belgium
  • Plovdiv, Bulgaria
  • Plovdiv, Bulgaria
  • Guangzhou, Guangdong, China
  • Nanjing, Jingsu, China
  • Beijing, China
  • Beijing, China
  • + 62 more on CT.gov