Empasiprubart for Dermatomyositis
(empacific Trial)
Trial Summary
What is the purpose of this trial?
This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must comply with the permitted background dermatomyositis treatment requirements at screening.
Eligibility Criteria
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.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either empasiprubart or placebo for 25 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Empasiprubart
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Who Is Running the Clinical Trial?
argenx
Lead Sponsor
Tim Van Hauwermeiren
argenx
Chief Executive Officer since 2008
B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management
Dr. Peter Ulrichts
argenx
Chief Medical Officer since 2023
MD from Maastricht University, PhD in Molecular Immunology from Maastricht University