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Monoclonal Antibodies

Efgartigimod SC for Myositis (ALKIVIA+ Trial)

Phase 3
Recruiting
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 60 weeks
Awards & highlights

Summary

This trial tests a drug to treat IIM with long-term safety & tolerability. It may also measure efficacy & is for adults who took ARGX-113-2007.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 60 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence treatment-emergent adverse events and adverse event of special interest
Secondary outcome measures
Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS)
Individual core set measures (CSMs) of the TIS
Percentage of participants with clinically inactive disease
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: EFG PH20 SCExperimental Treatment1 Intervention
participants receiving efgartigimod PH20 SC on top of background treatment

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.

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Who is running the clinical trial?

argenxLead Sponsor
64 Previous Clinical Trials
9,956 Total Patients Enrolled
1 Trials studying Dermatomyositis
80 Patients Enrolled for Dermatomyositis
~160 spots leftby Sep 2027