Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. Secondary objective: To assess the safety of I10E in patients with CIDP.
Name: I10E
Description: Patients who meet all eligibility criteria will receive one dose of IMP at 2g/kg over 2-5 days followed by 7 doses of IMP at 1g/kg over 1-2 day(s), every 3 weeks. Duration of treatment period: 21 weeks +/- 7 days.Type: DrugI10E Arm
Description: Responder rate at EOS visit. Responders are defined as patients with a decrease >=1 point in the adjusted INCAT score between baseline and the EOS visit.
Measure: Efficacy endpoint: Responder rate at end of study (EOS) visit Time: 24-27 weeks after first treament injectionDescription: Changes from baseline to 12 weeks and EOS visit in adjusted INCAT score
Measure: Adjusted INCAT score Time: 24-27 weeksDescription: Changes from baseline to 12 weeks and EOS visit in Grip strength
Measure: Grip strength Time: 24-27 weeksDescription: Changes from baseline to 12 weeks and EOS visit in Rasch-built Overall Disability Scale (R-ODS)
Measure: Rasch-built Overall Disability Scale (R-ODS) Time: 24-27 weeksDescription: Changes from baseline to 12 weeks and EOS visit in Medical Research Council (MRC) sum score
Measure: Medical Research Council (MRC) sum score Time: 24-27 weeksSingle Group Assignment
There is one SNP
An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.. Efficacy and Safety Study of I10E in Treatment of Patients With CIDP Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. --- I10E ---
An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.. Efficacy and Safety Study of I10E in Treatment of Patients With CIDP Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. --- I10E --- --- I10E ---
An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.. Efficacy and Safety Study of I10E in Treatment of Patients With CIDP Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. --- I10E --- --- I10E --- --- I10E ---
Secondary objective: To assess the safety of I10E in patients with CIDP. --- I10E ---
9. Any other serious medical condition that would interfere with the clinical assessment of CIDP or use of I10E or prevent the patient from complying with the protocol requirements 10. --- I10E ---