160 Participants Needed

Riliprubart vs IVIg for CIDP (VITALIZE Trial)

(VITALIZE Trial)

Recruiting at 17 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study compares the effectiveness of riliprubart against standard IVIg treatment for the management of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). It is a Phase 3 study representing the final step before regulatory approval.

Why do researchers think this study treatment might be promising?

Riliprubart targets inflammation pathways differently than traditional CIDP therapies by blocking C1s, a part of the immune system that can harm nerves in CIDP. By acting on this specific immune pathway, the study drug may offer more targeted relief with fewer adverse effects than current standards of care.

Timeline

Screening

Participants are evaluated to confirm eligibility

Up to 8 weeks
1 Visit

Treatment

Participants receive regular doses of either riliprubart (with placebo IVIg) or IVIg continuation (with placebo riliprubart).

24 weeks
8 Visits

Open-label Extension

All participants receive open-label riliprubart through Week 48.

24 weeks
6 Visits

Follow-up

Participants are monitored after completing treatment through two clinic visits and some phone calls.

55 weeks
2 Visits

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor