Riliprubart Phase Three MOBILIZE and VITALIZE Trials for CIDP are Actively Enrolling Globally
Claudia Sommer1, Luis Querol2, Jeffrey Allen3, Ingemar S.J. Merkies4, Pieter A. van Doorn5, Erik Wallstroem6, Yi Lu7, Li Xiong6, Miguel Alonso-Alonso6, Nazem Atassi6, Richard A. Lewis8
1Neurologische Klinik und Poliklinik, Universitätsklinikum Würzburg, Würzburg, Germany, 2Neuromuscular Diseases Unit, Department of Neurology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Centro para la Investigación Biomédica en Red en Enfermedades Raras (CIBERER), Madrid, Spain, 3Department of Neurology, Division of Neuromuscular Medicine, University of Minnesota, Minneapolis, Minnesota, USA, 4Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Neurology, Curaçao Medical Center, Willemstad, Curaçao, The Netherlands, 5Erasmus MC, University Medical Center, Rotterdam, The Netherlands, 6Sanofi R&D, Neurology Development, Cambridge, MA, USA, 7Sanofi R&D, Biostatistics and Programming, Cambridge, MA, USA, 8Department of Neurology, Cedars Sinai Medical Center, Los Angeles, California, USA
Objective:
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.
Background:
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.
Design/Methods:
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).
Results:
MOBILIZE and VITALIZE were successfully launched in 2024 and are actively enrolling participants across 28 countries in North and South America, Europe, and Asia.
Conclusions:
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).
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