Chronic, Inflammatory Demyelinating, Polyneuropathy
Conditions
Brief summary
Percentage of participants experiencing a response, Percentage of participants randomized to riliprubart with lasting response, Percentage of participants randomized to placebo who experience a response
Detailed description
Change from baseline in Inflammatory 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), Percentage of participants refractory to immunoglobulins experiencing a response, Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L), Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS), Number of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) for Part A, Incidence and titer of anti-riliprubart antibodies (ADA), Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) for Part B, Incidence and titer of anti-riliprubart antibodies, Change from baseline in I-RODS score, 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 EQ-5D-5L score, Change from baseline in RT-FSS, Percentage of participants randomized to riliprubart who experience a response at Week 48 without prior response in Part A (delayed response)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants experiencing a response, Percentage of participants randomized to riliprubart with lasting response, Percentage of participants randomized to placebo who experience a response | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Inflammatory 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), Percentage of participants refractory to immunoglobulins experiencing a response, Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L), Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS), Number of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) for Part A, Incidence and titer of anti-riliprubart antibodies (ADA), Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) for Part B, Incidence and titer of anti-riliprubart antibodies, Change fro | — |
Countries
Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden