drugset / Trial / NCT05523167

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

NCT05523167

Phase 2/3 Active not recruiting 265 enrolled argenx
RandomizedParallel-groupDouble-blindTreatment

Summary

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome \[ASyS\]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

Timeline

Start
2022-10-12
Primary completion
2026-12-01
Completion
2027-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Efgartigimod Alfa Protein / enzyme biologic Subcutaneous
Background rHuPH20 Protein / enzyme biologic Subcutaneous