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Monoclonal Antibodies

Empasiprubart for Dermatomyositis (empacific Trial)

Phase 2
Recruiting
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a clinical diagnosis of idiopathic inflammatory myopathy (IIM) fulfilling criteria for dermatomyositis (DM) or juvenile dermatomyositis (JDM).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 25 weeks

Summary

This trial will test a new drug called empasiprubart to see if it is safe and effective for treating dermatomyositis in adults. Participants will be randomly assigned to receive either empas

Who is the study for?
Adults with dermatomyositis who can consent, are at least 18 years old, agree to use contraception, and have active muscle disease. They must meet specific lab test criteria or show signs of inflammation on an MRI or biopsy. Participants should be vaccinated against certain infections before starting the trial.
What is being tested?
The study tests Empasiprubart IV against a placebo in adults with dermatomyositis over approximately 92 weeks. Participants will be randomly assigned in a 2:1 ratio to receive either the drug or placebo for 25 weeks followed by a safety follow-up period of 65 weeks.
What are the potential side effects?
While not specified here, potential side effects may include reactions at the infusion site, general discomfort, immune system responses, and any other symptoms related to changes in muscle inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with dermatomyositis or juvenile dermatomyositis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 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
Mean TIS

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EmpasiprubartExperimental Treatment1 Intervention
Patients receiving Empasiprubart IV
Group II: PlaceboPlacebo Group1 Intervention
Patients receiving Placebo IV

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
72 Previous Clinical Trials
11,074 Total Patients Enrolled
2 Trials studying Dermatomyositis
480 Patients Enrolled for Dermatomyositis
~25 spots leftby Jul 2025
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