[{"id":"mobilize-irods","name":"Change in I-RODS Score","type":"PRIMARY","unit":"points","results":[],"timepoint":"Week 24","description":"I-RODS (Inflammatory Rasch-built Overall Disability Scale) is a newer, more sensitive patient-reported outcome scale for inflammatory neuropathies than the traditional INCAT scale. Higher scores = better function. I-RODS has better responsiveness to change and is less prone to floor/ceiling effects than INCAT."}]

OPEN QUESTIONS: 1. What is the minimum treatment duration before primary endpoint assessment? 2. How is "refractory" defined specifically (# of prior therapies)? 3. Will subgroup analyses by antibody subclass (IgG1/3 vs IgG4) be pre-specified? INVESTMENT IMPLICATIONS: - POSITIVE: Validates C1s class in hardest patients (refractory), supports SNY's CIDP franchise - NEGATIVE: Refractory population failure could be population-specific (too sick) vs mechanism issue - Parallel-group design success would be very compelling to skeptics of randomized withdrawal designs - Readout ~same time as CAPTIVATE creates a natural "horse race" moment SANOFI STRATEGY: - MOBILIZE = regulatory approval pathway (placebo-controlled, gold standard for FDA) - VITALIZE = market adoption pathway (vs IVIg, gold standard for physicians/payers) - Running both simultaneously is expensive but accelerates overall program by ~1-2 years Source: ClinicalTrials.gov NCT06290128, Sanofi R&D presentations

C1s inhibition blocks classical complement pathway in CIDP. Riliprubart's YTE-engineered half-life (~40-50 days) enables Q4W dosing. Parallel-group design (no run-in) in IVIg-dependent, refractory patients is a harder test than randomized withdrawal.