A Double-blind, Randomized, Multi-Center Study Investigating Efficacy and Safety of Two Different Dosages of Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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 subjects indicating that they understand the purpose of, and procedures required for, the study and are willing to participate.
• Documented diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) consistent with the 2021 EAN/PNS criteria.
• Current or documented history of significant disability, as defined by an overall adjusted INCAT disability score between 2 and 9. A score of 2 must be exclusively from the lower extremities.
• Subjects are currently dependent on treatment with immunoglobulins, corticosteroids, or standard of care treatments for CIDP.
• Weakness of at least two limbs.
• Subjects should be clinically stable 12 weeks prior to screening date as defined by:
‣ without a worsening in INCAT score of ≥1 point, AND/OR
⁃ without significant changes in clinical symptoms, AND
⁃ without significant dose changes or requiring additional treatments.