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Trials / Enrolling By Invitation

Enrolling By InvitationNCT05979441

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

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

Status
Enrolling By Invitation
Phase
Phase 3
Study type
Interventional
Enrollment
240 (estimated)
Sponsor
argenx · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALEfgartigimod PH20 SCSubcutaneous injection of Efgartigimod PH20 given by vials or prefilled syringe (PFS)

Timeline

Start date
2023-09-12
Primary completion
2028-09-01
Completion
2028-09-01
First posted
2023-08-07
Last updated
2026-03-10

Locations

80 sites across 29 countries: United States, Argentina, Austria, Belgium, Bulgaria, China, Cyprus, Czechia, Denmark, France, Georgia, Germany, Greece, Ireland, Italy, Japan, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Serbia, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT05979441. Inclusion in this directory is not an endorsement.