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Efgartigimod add-on to IV methylprednisolone for acute CNS demyelinating attacks
2025-523654-13-00Phase 3Authorised
- Sponsor
- Medizinische Hochschule Hannover
- Start
- Jun 2026
- Modality
- Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics
- Countries
- 2
01
Overview
Phase 3, randomised, double-blind trial in central nervous system demyelinating disease, clinically isolated syndrome (CIS), multiple sclerosis (MS) and 2 more comparing Efgartigimod alfa + IV methylprednisolone with Placebo + IV methylprednisolone (2 arms). Primary endpoint: Complete remission of target neurologic deficits by day 84 without rescue therapy. Planned start Jun 2026; status: authorised.
02
Drugs
efgartigimod alfa
03
Conditions
central nervous system demyelinating diseaseclinically isolated syndrome (CIS)multiple sclerosis (MS)Neuromyelitis Optica Spectrum Disorder (NMOSD)myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)
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