Outlining Phase 3 VITALIZE and MOBILIZE Trials of Riliprubart in CIDP: Luis Querol, MD, PhD

WATCH TIME: 4 minutes

"These phase 3 trials are ambitious—one targets an underserved population, and the other challenges the standard of care for the first time in CIDP."

An investigational agent, riliprubart (Sanofi) tests the theory whether complement-inhibiting action can have significant therapeutic effect on patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The therapy has shown promise in a phase 2 trial (NCT04658472), with patients experiencing improvements in patient-reported fatigue and quality-of-life measures across a 76-week treatment period. These effects, seen in refractory patients and those on standard-of-care therapies in addition to riliprubart, further highlighted the potential this agent may bring to patients.

A bevy of presentations regarding riliprubart were presented at the 2025 Peripheral Nerve Society (PNS) Annual Meeting, held May 17-20, in Edinburgh, Scotland. Among them included subgroup analyses, biomarker data on the drug’s impact on neurofilament light levels, and the design of 2, phase 3 trials set to test the drug’s efficacy and safety. The studies, dubbed VITALIZE (NCT06290128) and MOBILIZE (NCT06290141), were launched in 2024 and are actively enrolling participants across 28 countries in North and South America, Europe, and Asia.

Treatment duration in both trials is 48 weeks: 24-week double-blind period (Part A), followed by a 24-week open-label period (Part B). To better understand the details behind this trial, NeurologyLive sat down with site investigator Luis Querol, MD, PhD, a neurologist at the Hospital de la Santa Creu, in Barcelona, Spain. Querol, a study author for the phase 2 trial, discussed the rationale behind each trial, how they differ, and the main goals the study investigators are looking to achieve. Furthermore, he also touched on the significance of VITALIZE being one of the first trials to directly compare a novel therapy to intravenous immunoglobulins (IVIg), the long-standing standard of care for CIDP.

Click here for more PNS 2025 coverage.

REFERENCES
1. Sommer C, Querol L, Allen J, et al. Riliprubart Phase 3 MOBILIZE and VITALIZE Trials for CIDP are Actively Enrolling Globally. Presented at: 2025 PNS Annual Meeting; May 17-20. Edinburgh, Scotland. Abstract P280.

Transcript edited below for clarity.

Luis Querol, MD, PhD: These two trials, of course, are a consequence of the encouraging earlier results. If those results hadn’t been as strong, the drug wouldn’t have been eligible to continue in development. But not only is development continuing—it’s moving forward with ambition, for two key reasons.

The first trial, called MOBILIZE, is designed to address an unmet need: how do we treat patients who are refractory? This is a particularly challenging population. The phase 2 results were very encouraging, and having a trial that specifically targets a group often left out of therapeutic strategies is ambitious. The phase 2 data support the use of riliprubart in this difficult-to-treat population.

The second trial, called VITALIZE, is ambitious not because it targets a rare subgroup, but because it aims to compare riliprubart head-to-head with the current standard of care: immunoglobulins. This is the first time a trial has attempted such a comparison. IVIG has long been the standard of care, and no one had previously taken on the challenge of testing against it. But the phase 2 data showed not only safety, but also the possibility of improving patients’ status beyond where they were on IVIG prior to trial entry. That suggested there might be room for riliprubart to outperform standard treatment.

Together, these two trials—once completed—will provide robust evidence that complement-targeted therapies can be effective in CIDP and may benefit patient populations that, until now, haven’t been adequately addressed.