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ALKIVIA: Efgartigimod PH20 SC in Idiopathic Inflammatory Myopathy
NCT05523167Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2022
- Primary completion
- Jul 2026
- Countries
- 36
- Sponsor
- argenx
- Modality
- Antibody Fragments
- Drugs
- efgartigimod alfa
- Conditions
- idiopathic inflammatory myopathy (IIM)
01
Overview
Phase 3, randomised, double-blind trial of efgartigimod alfa in idiopathic inflammatory myopathy (IIM), sponsored by argenx. Primary endpoint: Total Improvement Score at 52 weeks. Started Oct 2022; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adults with a definite or probable clinical diagnosis of active idiopathic inflammatory myopathy (including dermatomyositis, polymyositis, or immune-mediated necrotizing myopathy) with muscle weakness, receiving permitted background treatment, and without severe muscle damage or other confounding autoimmune diseases.
04
Endpoints
Primary
Total Improvement Score
Secondary
Time to reach Total Improvement Score >= 20
Percentage of participants with Total Improvement Score >= 20
Time to reach Total Improvement Score >= 40
Percentage of participants with Total Improvement Score >= 40
Manual Muscle Testing-8
Patient Global Assessment of Disease Activity
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