Chronic inflammatory demyelinating polyradiculoneuropathy
Conditions
Brief summary
Part A, SOC-Treated: Percentage of participants relapsing after withdrawal of SOC and during the SAR445088 treatment period, Part A, SOC-Refractory (initial and low dose group) and SOC-Naïve: Percentage of participants responding during the SAR445088 treatment period, Part B: Number of participants reported with adverse events
Detailed description
Part A: Number of participants reported with adverse events, Part A: Number of participants with incidence and titer of anti-SAR445088 antibodies (ADA), Part A: Percentage of participants in the SOC-Treated group improving during the overlap treatment period, Part B, SOC-Treated (initial dose group): Percentage of participants relapse-free during the treatment extension period, Part B, SOC-Refractory (initial and low dose group) and SOC-Naive: Percentage of participants with sustained response during the treatment extension period, Part B: Long-term immunogenicity
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A, SOC-Treated: Percentage of participants relapsing after withdrawal of SOC and during the SAR445088 treatment period, Part A, SOC-Refractory (initial and low dose group) and SOC-Naïve: Percentage of participants responding during the SAR445088 treatment period, Part B: Number of participants reported with adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Number of participants reported with adverse events, Part A: Number of participants with incidence and titer of anti-SAR445088 antibodies (ADA), Part A: Percentage of participants in the SOC-Treated group improving during the overlap treatment period, Part B, SOC-Treated (initial dose group): Percentage of participants relapse-free during the treatment extension period, Part B, SOC-Refractory (initial and low dose group) and SOC-Naive: Percentage of participants with sustained response during the treatment extension period, Part B: Long-term immunogenicity | — |
Countries
France, Germany, Italy, Netherlands, Poland, Spain