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

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).

Timeline

Start

2022-10-12

Primary completion

2026-07-02

Completion

2026-07-02

Outcome

Met primary endpoint

release “The Phase 3 ALKIVIA results demonstrate a clinically meaningful and statistically significant treatment benefit in the overall study population” zailaboratory.com ↗

release “Study met its primary endpoint (p=0.0011)” argenx.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efgartigimod Alfa	Protein / enzyme biologic	—	Subcutaneous
Background	rHuPH20	Protein / enzyme biologic	—	Subcutaneous

Indications