TAK-411 Treatment Study in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP to Evaluate Safety and Effectiveness

What this Trial Is About

Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP is an autoimmune disease where the immune system attacks the protective covering of nerves, leading to muscle weakness and loss of sensation in the arms and legs. Researchers are studying TAK-411, a special type of immune globulin G derived from human plasma, to see if it can reduce inflammation and improve symptoms in adults with CIDP. This is a Phase 2, open-label study comparing TAK-411 effects with historical placebo data to evaluate physical functioning. Participants receive TAK-411 through intravenous infusions starting with a 400 mgkg induction dose on Day 1, which may be repeated after 3 weeks if needed. Following this, a maintenance dose of 200 mgkg is given every 3 weeks for 24 weeks, with an optional extension of 27 additional weeks. The treatment period can last up to 51 weeks, with a follow-up period of 3 weeks after the last dose. During the study, participants may visit the clinic about 21 times for assessments including physical function tests, questionnaires, and safety monitoring. Researchers will measure improvements in functional ability at various points up to week 54, including changes in nerve function scores and muscle strength. Safety will be monitored by tracking adverse events and immune response markers throughout the study.

A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)