Chronic Inflammatory Demyelinating Polyneuropathy
Conditions
Brief summary
Percentage of participants experiencing a response, Percentage of participants randomized to riliprubart who responded during part A and had a lasting response during the open-label treatment extension period.
Detailed description
Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score, Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score, Change from baseline in grip strength (kilopascals, dominant hand), Change from baseline in Medical Research Council Sum Score (MRC-SS), Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS), Percentage of participants experiencing a relapse, Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L), Number of participants with TEAEs, including SAEs and AESIs for Part A., Number of participants with treatment-emergent ADA in participants treated with riliprubart, Number of participants with TEAEs, including SAEs and AESIs, Percentage of participants randomized to riliprubart experiencing a relapse, Percentage of participants randomized to IVIg continuation experiencing a relapse, Incidence and titer of anti-drug antibodies (ADA) during open-label treatment and follow-up., Change from baseline in I-RODS, Change from baseline in adjusted INCAT score, Change from baseline in grip strength (kilopascals; dominant hand), Change from baseline in MRC-SS, Change from baseline in RT-FSS, Change from baseline in EQ-5D-5L score, Percentage of participants randomized to riliprubart who experienced a response at Week 48 without prior response in Part A (delayed response), Percentage of participants randomized to IVIg continuation who experience a response
Interventions
DRUG-
DRUGriliprubart
DRUGriliprubart placebo solution for injection in prefilled pen
DRUGplacebo matching IVIg
DRUGriliprubart placebo solution for injection in vial
Sponsors
Sanofi-Aventis Recherche & Developpement
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants experiencing a response, Percentage of participants randomized to riliprubart who responded during part A and had a lasting response during the open-label treatment extension period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score, Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score, Change from baseline in grip strength (kilopascals, dominant hand), Change from baseline in Medical Research Council Sum Score (MRC-SS), Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS), Percentage of participants experiencing a relapse, Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L), Number of participants with TEAEs, including SAEs and AESIs for Part A., Number of participants with treatment-emergent ADA in participants treated with riliprubart, Number of participants with TEAEs, including SAEs and AESIs, Percentage of participants randomized to riliprubart experiencing a relapse, Percentage of participants randomized to IVIg continuation experiencing a relapse, Incidence and titer of anti-drug antibodies (ADA) during open-label treatment a | — |
Countries
Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Norway, Portugal, Spain, Sweden
Outcome results
None listed