A Double-blind, Randomized Study Comparing Two Dosages of Intravenous Human Immune Globulin (IGIV) 10% in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

What this Trial Is About

Researchers are evaluating the efficacy and safety of KIg10, an intravenous human immune globulin 10%, as maintenance therapy for adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This phase 3, double-blind, randomized study aims to compare two dosages of KIg10 following an initial treatment period, focusing on adults diagnosed with active CIDP who meet specific clinical criteria. Participants will first enter a wash-out phase lasting up to 12 weeks or until their condition shows functional worsening. Those eligible will then be randomly assigned in a 1:2 ratio to receive either 0.5 g/kg or 1.0 g/kg of KIg10 every three weeks for 21 weeks. Should a participant experience a relapse, they will receive a rescue treatment with 2.0 g/kg of KIg10 at the same interval and duration. Initial loading doses of 2.0 g/kg KIg10 are given before maintenance dosing in both groups. Throughout the study, participants will undergo evaluations including the adjusted INCAT disability score to monitor functional status. Researchers will measure treatment efficacy using changes in disability scores and muscle strength, quality of life assessments, and responder rates over 24 weeks. Safety and disease progression will be closely monitored, with follow-up visits scheduled at regular intervals. The total participation duration varies according to treatment and response.

A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)