The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.
Male or female, aged ≥18 years.
Written informed consent and authorization to access personal health information obtained independently from participants indicating that they understand the purpose of, and procedures required for, the study and are willing to participate.
Documented diagnosis of CIDP consistent with the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria.
Current or documented history of significant disability, as defined by an overall INCAT disability score between 2 and 9. A score of 2 must be exclusively from the lower extremities.
Patients' incapable of giving informed consent.
Pure sensory and other CIDP variants.
Females who are pregnant, breastfeeding, unwilling to practice effective birth control methods as defined in Appendix C throughout the study, or planning a pregnancy during the study.
IG-experienced participants requiring an IGIV dosage of more than 1.4 g/kg/month OR SCIG pre-treated participants requiring a SCIG dosage of more than 1.6 g/kg/month.
Parallel
Immune globulin (human) 10% solution for intravenous administration
Biological/VaccineKedrion intravenous immunoglobulin (IVIg) 10%
Efficacy of 1.0 g/kg KIg10 in the treatment of adult subjects with active CIDP
The proportion of responders in the 1.0 g/kg KIg10 arm, at week 24 relative to Randomization Baseline week 0, based on the adjusted INCAT disability score. A responder is defined as having a ≥1 point decrease (improvement) in the adjusted INCAT score at week 24 relative to adjusted INCAT score at randomization baseline.
Efficacy of 0.5 g/kg KIg10 in the treatment of adult subjects with active CIDP
The proportion of responders in the 0.5 g/kg KIg10 arm at week 24 relative to randomization baseline, based on the adjusted INCAT disability score. A responder is defined as having a ≥1 point decrease (improvement) in the adjusted INCAT score at week 24 relative to adjusted INCAT score at randomization baseline.
Proportion of responders (Week 24 vs Baseline) in both dose groups
Proportion of responders in both dose groups based on Grip Strength and I-RODs
Proportion of responders in rescued subjects
Proportion of responders in rescued subjects based on grip strength, I-RODS scores, adjusted INCAT disability score
Improvers based on the MRC-sumscore
Improvers by a change of 4 points in both dose groups (week 24 versus baseline) based on MRC-sumscore
Number of adverse events
Assess Safety and Tolerability of KIg10
The proportion of patients experiencing at least one adverse event.
Assess Safety and Tolerability of KIg10
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