Evaluating Safety and Blood Levels of XEMBIFY Compared to Gamunex-C in Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy

What this Trial Is About

Researchers are evaluating whether XEMBIFY, given once a week under the skin, provides similar levels of immunoglobulin G IgG in the blood over time as Gamunex-C, administered into a vein once every three weeks, in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP. This Phase 3 study aims to assess the pharmacokinetics and safety of these two treatments in participants diagnosed according to established criteria. Participants will first undergo up to 28 days of screening to confirm eligibility. Those who qualify will enter a 19-week intravenous IV treatment phase receiving Gamunex-C every three weeks, totaling seven doses. Following this, approximately one week after the last IV dose, participants will begin a 16-week subcutaneous SC treatment phase with XEMBIFY once weekly, for a total of 16 doses. Blood samples will be collected during both treatment phases to measure IgG levels. Throughout the study, participants will have regular assessments including blood draws to monitor IgG concentration and safety. The primary outcome measures focus on the steady-state area under the concentration-time curve AUC of total IgG during both the IV and SC treatment phases. Secondary outcomes include the mean trough concentration of IgG. The total study duration includes screening, two sequential treatment periods, and follow-up assessments, with the study completion expected by the end of 2027.

A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy