This study is accepting new patients by invitation only

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 on Myositis Myopathy Dermatomyositis Polymyositis Antisynthetase Syndrome

Summary

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

Description

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 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.

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, Efgartigimod 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 study drug

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 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

  • 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
ID
NCT05979441
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated