Abstract Details

Title Empasiprubart vs Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: EMVIGORATE Phase Three Study Design

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) P1 - Poster Session 1 (8:00 AM-9:00 AM)

Poster/Presentation
Number 9-022

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.

Authors/Disclosures
Simon Rinaldi, PhD, MBChB PRESENTER	Dr. Rinaldi has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aregnx. Dr. Rinaldi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hansa. Dr. Rinaldi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Annexon. Dr. Rinaldi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Rinaldi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for CSL Behring. The institution of Dr. Rinaldi has received research support from MRC. The institution of Dr. Rinaldi has received research support from BMA. The institution of Dr. Rinaldi has received research support from GBS/CIDP Foundation International.
Thomas Brannagan III, MD, FAAN (Columbia University)	Dr. Brannagan has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Brannagan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Intellia. Dr. Brannagan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Astra Zenica. Dr. Brannagan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Annexon. The institution of Dr. Brannagan has received research support from Alnylam. The institution of Dr. Brannagan has received research support from Abcuro. The institution of Dr. Brannagan has received research support from Ionis. The institution of Dr. Brannagan has received research support from Vertex. The institution of Dr. Brannagan has received research support from NMD Pharma.
Pietro E. Doneddu, MD	The institution of Dr. Doneddu has received research support from GBS CIDP foundation.
Karissa Gable, MD, FAAN	Dr. Gable has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Accordant. Dr. Gable has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunovant. Dr. Gable has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Gable has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Gable has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Argenx. Dr. Gable has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astrazenca. Dr. Gable has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint. Dr. Gable has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for CSL Behring. Dr. Gable has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Grifols . Dr. Gable has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for annexon. Dr. Gable has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Gable has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Gable has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx.
Mark Stettner, MD (University of Duesseldorf)	No disclosure on file
Olivier Van de Steen (argenx)	No disclosure on file
Kevin Budding (argenx)	No disclosure on file
Inge Van de Walle	No disclosure on file
Susan V. Ellor, MD, PhD (UC Health)	No disclosure on file
Martin Markov (argenx)	No disclosure on file
Jeffrey A. Allen, MD (University of Minnesota)	Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for csl behring. Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alnylam. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson and Johnson. Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Annexon. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunovant. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Dianthus. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CSL Behring. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Annexon. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Allen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dianthus. Dr. Allen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for CSL behring. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Takeda. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alnylam. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Allen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Johnson and Johnson.

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