What side effects are associated with this type of intervention?

Common treatments for Dermatomyositis include glucocorticoids, intravenous immune globulin (IVIG), mycophenolate mofetil, and rituximab. Glucocorticoids can cause side effects such as weight gain, osteoporosis, hypertension, and increased risk of infections. IVIG is associated with headaches, thromboembolic events, and infusion-related reactions. Mycophenolate mofetil may lead to gastrointestinal issues and increased susceptibility to infections. Rituximab can cause infusion reactions, infections, and potential reactivation of hepatitis B. While specific side effects of FcRn inhibitors like Efgartigimod PH20 SC are not detailed, they may share similar immunomodulatory risks, including increased infection susceptibility.

What prior FDA approvals exist?

There are no specific mentions of FDA-approved treatments for Dermatomyositis that involve FcRn inhibition like Efgartigimod PH20 SC in the provided context. However, treatments for resistant Dermatomyositis often include immunosuppressive agents such as mycophenolate mofetil, calcineurin inhibitors (cyclosporine and tacrolimus), and biologics like rituximab. These treatments aim to modulate the immune response and reduce inflammation in patients with Dermatomyositis.

What other types of research exist?

Promising novel alternatives to Efgartigimod PH20 SC for Dermatomyositis patients include: 1) Eculizumab, a complement inhibitor, which has shown efficacy in refractory myasthenia gravis and may have potential in Dermatomyositis. 2) Rituximab, a B-cell depleting agent, which has demonstrated efficacy in various autoimmune conditions, including myasthenia gravis and idiopathic inflammatory myopathies. 3) Janus kinase (JAK) inhibitors, such as tofacitinib, which have shown promise in treating systemic autoimmune diseases like systemic sclerosis and may be beneficial for Dermatomyositis. Patients should discuss these options with their healthcare provider to determine the best course of treatment.

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Monoclonal Antibodies

Efgartigimod SC for Myositis (ALKIVIA+ Trial)

Phase 3

Waitlist Available

Research Sponsored by argenx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 52 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to check the safety and effectiveness of an injectable medication called efgartigimod PH20 SC in adults with muscle inflammation who participated in an earlier phase. The medication works by reducing harmful proteins that cause muscle problems.

Who is the study for?

This trial is for adults with active Idiopathic Inflammatory Myopathy (IIM) who completed the ARGX-113-2007 study. Participants must be able to consent, follow the study plan, and use contraception if of childbearing potential. Exclusions include planned major surgery, new medical conditions that risk safety or skew results, known drug hypersensitivity, any cancer except basal cell skin carcinoma, or previous discontinuation from the related trial.

What is being tested?

The trial tests long-term safety and effectiveness of a subcutaneous injection called efgartigimod PH20 SC in those with IIM. It's for people who've had it before in an earlier phase of research and looks at how well they tolerate it over time as well as its ongoing benefits.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to efgartigimod PH20 SC based on their history with the treatment in the prior ARGX-113-2007 study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Individual core set measures (CSMs) of the TIS

Total improvement score (TIS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EFG PH20 SCExperimental Treatment1 Intervention

participants receiving efgartigimod PH20 SC on top of background treatment

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Dermatomyositis include glucocorticoids, which reduce inflammation by suppressing the immune system; immunosuppressive agents like mycophenolate mofetil, which inhibit the proliferation of immune cells; and biologics such as rituximab, which target specific immune cells (B cells) to reduce inflammation. Efgartigimod PH20 SC, an FcRn inhibitor, works by reducing the levels of pathogenic autoantibodies. This is particularly important for Dermatomyositis patients as it directly targets the underlying autoimmune process, potentially offering a more specific and effective treatment option with fewer side effects compared to broad immunosuppression.

Therapeutic approaches in myositis.Inflammatory myopathies: clinical, diagnostic and therapeutic aspects.Advances in the therapy of idiopathic inflammatory myopathies.