Clinical Trial

A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis

Study acronym: empacific
Active, Not Recruiting Phase 2
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Summary
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).
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2024-02-22; most recent amendment 2025-09-22.
Status change: Recruiting → Active, Not Recruiting 2025-09-22
Status change: Not Yet Recruiting → Recruiting 2024-08-23
Trial Details
NCT Number NCT06284954
Lead Sponsor argenx
Conditions Dermatomyositis, Myositis
Enrollment 3 participants
Start Date 2024-08-20
Primary Completion 2026-11 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2025-09-25