Clinical Trial

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

Study acronym: ALKIVIA

Completed Phase 2/3

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).

Protocol Amendment History 4 changes

critical Trial completed 2026-07-25

critical Primary endpoint(s) modified 2026-07-25

notable Primary completion moved earlier: 2026-12-01 -> 2026-07-02 2026-07-25

minor Completion moved earlier: 2027-02-01 -> 2026-07-02 2026-07-25

Trial Details

NCT Number	NCT05523167
Lead Sponsor	argenx
Conditions	Active Idiopathic Inflammatory Myopathy, Myositis, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy, Antisynthetase Syndrome
Enrollment	265 participants
Start Date	2022-10-12
Primary Completion	2026-07-02 (estimated)
Study Completion	2026-07-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-24