Study Design
DesignRandomized, double-blind, active-comparator (vs IVIg), double-dummy
Randomization1:1
BlindingDouble-blind (double-dummy: both groups get IV + SC, one real one placebo)
Enrollment250
Duration48 weeks
Treatment Arms
Riliprubart + Placebo IVIg 3000 mg IV loading → 600 mg SC Q4W maintenance + matched placebo IVIg infusions n=125
IVIg + Placebo Riliprubart Standard IVIg (dose per investigator) + matched placebo IV loading → placebo SC Q4W n=125
[{"id":"vitalize-irods","name":"Change in I-RODS Score","type":"PRIMARY","unit":"points","results":[],"timepoint":"Week 24","description":"I-RODS score change from baseline, comparing riliprubart to IVIg. This is a head-to-head comparison against the current standard of care — not just \"better than nothing\" (placebo) but \"as good as or better than what doctors already use.\" If riliprubart matches or beats IVIg, it validates the switch to a targeted therapy."}]
OPEN QUESTIONS:
1. What is the exact NI margin? (Critical for interpreting results)
2. Will there be a superiority test if NI is met?
3. What dose of IVIg is the comparator arm receiving?
4. Is there a pre-specified subgroup analysis by complement biomarkers?
INVESTMENT IMPLICATIONS:
- NI MET: Game-changing — first targeted therapy with head-to-head evidence vs IVIg in CIDP. Payers would have strong rationale to cover riliprubart. Major differentiation vs Vyvgart and claseprubart (neither has IVIg comparator data).
- SUPERIORITY: Blockbuster-level result. Would reshape CIDP treatment paradigm.
- NI FAILED: Significant setback for riliprubart in CIDP. May still get approved via MOBILIZE (placebo-controlled) but market uptake would be slower.
THIS IS UNIQUELY VALUABLE DATA:
- Vyvgart has NO head-to-head IVIg data in CIDP
- Claseprubart has NO head-to-head IVIg data
- Only riliprubart will have this — major differentiation if positive
Source: ClinicalTrials.gov NCT06290141, Sanofi R&D presentations
While MOBILIZE establishes efficacy vs placebo for regulators, physicians and payers need head-to-head data vs the standard of care (IVIg) to justify switching patients. IVIg requires repeated infusion center visits (every 3-4 weeks, 4-6 hour sessions). Riliprubart SC Q4W offers major convenience advantage if efficacy is comparable.