Phase 2 Study Comparing Immunoadsorption and Immunoglobulin Treatments for Adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP

What this Trial Is About

Researchers are evaluating the safety and effectiveness of repeated immunoadsorption compared to immunoglobulin treatment in adults with steroid-refractory Chronic Inflammatory Demyelinating Polyneuropathy CIDP. This phase 2 randomized controlled trial focuses on patients with possible, probable, or definite CIDP, including both typical and atypical forms, who have not responded adequately to methyl-prednisolone treatment or cannot tolerate it. Participants are randomly assigned to receive either immunoadsorption or intravenous immunoglobulins. The immunoadsorption group undergoes three cycles in weeks 1, 7, and 13, each consisting of five consecutive daily sessions processing increasing plasma volumes using a specialized device. The immunoglobulin group receives five cycles at weeks 1, 4, 7, 10, and 13, starting with five daily intravenous applications at 0.4 gkg followed by cycles of two consecutive days at 0.5 gkg per day. Throughout the 15-week study period, participants will undergo multiple assessments including CIDP score, disability INCAT score, muscle strength Oxford MRC, vibration score, pain evaluations, nerve conduction studies, and various immunological and inflammatory biomarkers. Researchers will monitor therapeutic response and quality of life at several time points, ensuring comprehensive evaluation of treatment effects and safety. The study is sponsored by the University of Ulm and is expected to complete by March 2028.

Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)