NCT06284954

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

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart in Adults With Dermatomyositis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dermatomyositis
• Myositis

Interventions

Type	Name	Description
BIOLOGICAL	Empasiprubart IV	Intravenous infusion with Empasiprubart IV
OTHER	Placebo IV	Intravenous infusion with Placebo IV

Timeline

• Start date: 2024-08-20
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-02-29
• Last updated: 2025-09-25

Locations

28 sites across 7 countries: United States, Georgia, Greece, Italy, Moldova, Poland, Spain

Regulatory

• FDA-regulated drug study