Empasiprubart vs Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: EMVIGORATE Phase Three Study Design
Simon Rinaldi1, Thomas Brannagan2, Pietro Emiliano Doneddu3, Karissa Gable4, Mark Stettner5, Olivier Van de Steen6, Kevin Budding6, Inge Van de Walle6, Susan Ellor6, Martin Markov6, Jeffrey Allen7
1Nuffield Department of Clinical Neurosciences, University of Oxford, 2Department of Neurology, Columbia University, 3Neuromuscular and Neuroimmunology Unit, IRCCS Humanitas Research Hospital, 4Neuromuscular Division, Department of Neurology, Duke University, 5Department of Neurology and Center for Translational Neuro- and Behavioral Sciences (C-TNBS), University Medicine Essen, 6argenx, 7Department of Neurology, University of Minnesota
Objective:
EMVIGORATE will compare intravenous (IV) empasiprubart and IV immunoglobulin (IVIg) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Background:
CIDP is a rare, immune-mediated neuropathy characterised by progressive muscle weakness and sensory dysfunction. The complement system plays a key role in promoting macrophage-mediated demyelination. Empasiprubart binds C2, blocking activation of classical and lectin complement pathways.
Design/Methods:
This Phase 3, randomised, double-blinded, double-dummy study will randomise ~218 adults on stable maintenance IVIg to receive either empasiprubart IV or continue the stable IVIg dose in a 24-week double-blind treatment period (Part A), followed by a 24-month open-label period (Part B) and a 15-month safety follow-up. In Part A, participants will receive either empasiprubart IV plus IVIg placebo or empasiprubart IV placebo plus IVIg. In Part B, all participants will receive empasiprubart IV, while IVIg treatment will not be permitted. No study treatment will be administered during the safety follow-up period.
Results:
The primary endpoint is the percentage of participants achieving ≥1-point improvement versus baseline in adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) score at Week 24. Secondary endpoints (Week 24) include changes from baseline in Inflammatory Rasch-Built Overall Disability Scale score, Medical Research Council sum score, dominant hand grip strength and Timed Up and Go, time to decrease of ≥1 point in aINCAT score, and Patient Global Impression of Change actual values.
Conclusions:
This Phase 3 study will compare the efficacy and safety of empasiprubart IV and IVIg in CIDP, focusing on functional ability, muscle strength/function, gait performance, and patient-reported outcomes.
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