Evaluating the safety and efficacy of a new biologic targeted therapy versus placebo, as add-on to standard treatment, in adults with idiopathic inflammatory myopathies (polymyositis and dermatomyositis)

Overview

Idiopathic inflammatory myopathies (IIM) – including polymyositis and dermatomyositis – are rare autoimmune diseases that cause chronic muscle weakness and may involve multiple organs such as the heart, lungs, and skin. Patients often require long-term treatment with anti-inflammatory and immunosuppressive drugs, but disease frequently relapses and serious side effects are common. There is currently no specific therapy developed solely for this disease group. This study is being conducted to evaluate the efficacy and safety of a new targeted therapy (already approved for the treatment of moderate to severe systemic lupus erythematosus – a disease with a similar mechanism) in patients with moderate to severe IIM, with the expectation of reducing steroid use and lowering the risk of disease flares.

Inclusion Criteria

Men and women aged 18–75 years diagnosed with polymyositis or dermatomyositis, with active disease of at least moderate severity
Body weight 40–100 kg
On stable standard therapy such as corticosteroids or other immunosuppressive drugs

Exclusion Criteria

Prior systemic treatment or TACE (transarterial chemoembolization) (note: reflects wording in original text)
Other forms of myositis such as inclusion body myositis, juvenile myositis, drug-induced myositis, or cancer-associated myositis
Non-inflammatory myopathies (e.g. muscular dystrophy)
Rapidly progressive interstitial lung disease or oxygen dependence
Severe cardiovascular disease or severe dysphagia
Hepatitis B, hepatitis C, or HIV infection

PI

Assoc. Prof, MD Nguyễn Văn Đĩnh – Clinical Allergy–Immunology Center, Vinmec Times City Internation Hospital

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