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MyositisSkinImmune and autoimmuneBiologicalPhase 3

What this study is

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.

What's being tested

  • Efgartigimod PH20 SC

    Intervention · BIOLOGICAL

    Subcutaneous injection of Efgartigimod PH20 given by vials or prefilled syringe (PFS)

Study details

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
Sponsor
argenx
Conditions
Myositis · Active Idiopathic Inflammatory Myopathy · Dermatomyositis · Polymyositis · Immune-Mediated Necrotizing Myopathy · Antisynthetase Syndrome
Enrolling
240 people
Starts
2023-09-12
Est. completion
2028-09
Design
Open-label, single group, Phase 3
Record
View on ClinicalTrials.gov ↗