drugset / Trial / NCT06284954

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

NCT06284954

Phase 2 Active not recruiting 3 enrolled argenx
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2024-08-20
Primary completion
2026-11
Completion
2026-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Empasiprubart Monoclonal antibody Intravenous

Indications