Longterm Safety, Tolerability, Efficacy Efgartigimod PH20 SC Active Idiopathic Inflammatory Myopathy
Research type
Research Study
Full 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
IRAS ID
1007732
Contact name
Sabine Coppieters
Contact email
Sponsor organisation
Argenx
Research summary
Myositis is a rare autoimmune disease in which the immune system attacks the muscles. This leads to muscle weakness and may involve other organs of the body. Myositis is a heterogeneous group of diseases including many subtypes.
Myositis can affect people of all ages, both men and women. Myositis is not contagious and cannot be passed from one person to another.
A hallmark of myositis is chronic inflammation of the muscles. The main symptom is muscle weakness, with pain and fatigue, which difficulties in daily life activities and a low health-related quality of life of the patients. Depending on the subtype of myositis patients can also suffer from skin disease, lung disease and arthritis.
Treatment with corticosteroids in combination with other drugs suppressing the immune system is often used to keep the symptoms under control. However, high doses of corticosteroids may be required and they have many side effects when taken at high doses for long periods.
There is 1 licensed treatment for the patients with a myositis subtype, that affects muscles and skin (dermatomyositis). This treatment consists of an intravenous administration of antibodies.
This is an open-label extension (OLE) study following on from the ARGX-113-2007 study and provides participants of the ARGX-113-2007 study the option to receive efgartigimod PH20 SC. The aim of this study is to further look at the effectiveness, safety and tolerability of the study drug (efgartigimod PH20 SC, which is being developed by argenx BV) in people with myositis. It is hoped that the study drug may help improve the symptoms of myositis.
The maximum number of participants in this study will be the number of participants who entered into the preceding study (240 maximum). The study will last up to approximately 60 weeks, including a 52 weeks treatment period and 8 weeks of treatment free follow-up. Participants will undergo procedures such as physical examination, blood samples and electrocardiogram.REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/0533
Date of REC Opinion
4 Oct 2023
REC opinion
Further Information Favourable Opinion