Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.

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

Keywords

Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy, Antisynthetase Syndrome, Muscular Diseases, EFG PH20 SC

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 investigational medicinal product

You CAN'T join 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 investigational medicinal product or 1 of its excipients Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness
  • Permanent discontinuation of IMP in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit
  • Diagnosis with a deselected subtype of myositis based on the analysis of the phase 2 stage data in ARGX-113-2007, unless the investigator determines that the participant is benefiting from IMP as defined by a score of "much better" or "moderately better" on the 'Clinical Global Impression of Change' and 'Patient Global
  • Impression of Change' assessments for at least 12 weeks, and that enrolling in the study is in the participant's best interest

Locations

  • UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology
    San Francisco California 94143 United States
  • Attune Health Research, Inc
    Beverly Hills California 90039 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
argenx
Links
Study website
ID
NCT05979441
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated