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Abstract Details

Riliprubart Phase Three MOBILIZE and VITALIZE Trials for CIDP are Actively Enrolling Globally
Neuromuscular and Clinical Neurophysiology (EMG)
P1 - Poster Session 1 (8:00 AM-9:00 AM)
9-020
To describe the study designs of two riliprubart Phase-3 trials for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), MOBILIZE (NCT06290128) and VITALIZE (NCT06290141), and provide an update on recruitment status.
Despite standard-of-care (SoC) therapies people living with CIDP may experience failure/inadequate response to treatment (SoC-Refractory). Riliprubart, a first-in-class, humanized IgG4-monoclonal antibody, selectively inhibits activated-C1s within the classical complement pathway and can be self-administrated subcutaneously via an auto-injector. In an open-label Phase-2 trial (NCT04658472), treatment with riliprubart suggested promising clinical benefits at Week-24 with favourable benefit:risk profile.
MOBILIZE, a randomized, double-blind, placebo-controlled trial, targets participants who are presently not on intravenous immunoglobulin (IVIg), and have a history of no/inadequate response to IVIg/corticosteroids. VITALIZE, a randomized, double-blind, double-dummy, non-inferiority, and superiority design trial with sample size re-estimation will compare riliprubart versus IVIg continuation in IVIg-treated participants, who do not have complete response (i.e. residual disability, even if “stable” on IVIg). Treatment duration in both trials is 48-weeks: 24-week double-blind period (Part-A), followed by 24-week open-label period (Part-B). In Part-A, participants are randomized (1:1) to receive riliprubart/placebo (MOBILIZE; N=up to 140), and riliprubart/IVIg (VITALIZE; N=up to 160). Eligible adults with CIDP diagnosed based on 2021 EAN/PNS guidelines with Inflammatory Neuropathy Cause and Treatment (INCAT)-score 2−9 (score-2 exclusively from legs) are included. Primary-endpoints are percentage of participants responding (Part-A) (≥1-point decrease from baseline in adjusted INCAT-score) and long-term efficacy of riliprubart in adjusted INCAT-score (Part-B). Key secondary-endpoints include additional disability/impairment measures (Part-A)/long-term safety (Part-B).
MOBILIZE and VITALIZE were successfully launched in 2024 and are actively enrolling participants across 28 countries in North and South America, Europe, and Asia.

MOBILIZE and VITALIZE are evaluating efficacy and safety of riliprubart in CIDP. These Phase-3 trials represent innovations in the field by focusing on key unmet-needs (refractory disease/residual disability) and incorporating an active comparator (IVIg).

Authors/Disclosures
Richard A. Lewis, MD, FAAN (Cedars-Sinai Medical Center)
PRESENTER 		Dr. Lewis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Lewis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for CSL Behring. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Takeda. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Nuvig. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Dianthus. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Janssen. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Medscape. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Annexon. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunovant. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BioCryst. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NervoSave. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Annexon. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TGTX. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Boehringer-Ingleheim. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Intellia. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Cartesian. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for CME Outfitters. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PeerVision. Dr. Lewis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Up to Date. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boehringer Ingelheim. Dr. Lewis has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alnylam. Dr. Lewis has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Lewis 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. Lewis has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Shernoff et al. Dr. Lewis has received publishing royalties from a publication relating to health care.
Claudia Sommer, MD, PhD (Neurologische Klinik der Universitat) Dr. Sommer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Akigai. Dr. Sommer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nevro. Dr. Sommer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kedrion. Dr. Sommer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Sommer 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. Sommer has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Dr. Sommer has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Takeda. Dr. Sommer has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Pfizer. Dr. Sommer has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Dr. Sommer has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Wiley. The institution of Dr. Sommer has received research support from DFG. The institution of Dr. Sommer has received research support from BMBf.
Luis Querol, MD, PhD (Hospital de la Santa Creu i Sant Pau) Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL Behring. The institution of Dr. Querol has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. Dr. Querol has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ArgenX. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dianthus. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Annexon. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avilar. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biocryst. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for KPL. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lycia. The institution of Dr. Querol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Querol has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Querol has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Querol has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. The institution of Dr. Querol has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Querol 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. Querol has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Querol has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Grifols. The institution of Dr. Querol has received research support from GBS-CIDP Foundation International. The institution of Dr. Querol has received research support from Grifols. The institution of Dr. Querol has received research support from ISCIII. The institution of Dr. Querol has received research support from CIBERER. The institution of Dr. Querol has received research support from UCB. The institution of Dr. Querol has received research support from ArgenX.
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.
Ingemar S. Merkies, MD No disclosure on file
Pieter Van Doorn, MD (Erasmus University Medical Center) The institution of Dr. Van Doorn has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. The institution of Dr. Van Doorn has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hansa. The institution of Dr. Van Doorn has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. The institution of Dr. Van Doorn has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Octapharma. The institution of Dr. Van Doorn 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. Van Doorn has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Grifols. The institution of Dr. Van Doorn has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Octapharma. The institution of Dr. Van Doorn 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. Van Doorn has received publishing royalties from a publication relating to health care.
Erik Wallstroem, MD, PhD (Sanofi) Dr. Wallstroem has received personal compensation for serving as an employee of Sanofi. Dr. Wallstroem has stock in Sanofi. Dr. Wallstroem has received intellectual property interests from a discovery or technology relating to health care.
Qiang Lu, MD Dr. Lu has nothing to disclose.
Li Xiong, MD, PhD (Sanofi) Dr. Xiong has received personal compensation for serving as an employee of Sanofi.
Miguel Alonso Alonso (Sanofi) Miguel Alonso Alonso has received personal compensation for serving as an employee of Sanofi. Miguel Alonso Alonso has stock in Sanofi.
Nazem Atassi, MD Dr. Atassi has received personal compensation for serving as an employee of Sanofi. Dr. Atassi has stock in Sanofi.