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- A Multicenter, Randomized, Subject-blinded, Investigator-blinded, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Clinical Trial
A Multicenter, Randomized, Subject-blinded, Investigator-blinded, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
The purpose of this study is to assess how effective an investigational new drug called rozanolixizumab is in treating CIDP; how safe and tolerable (ie, acceptable to you) rozanolixizumab is; how rozanolixizumab acts in your body; and how your body reacts to rozanolixizumab; and to measure the amount of rozanolixizumab in your body. Investigational means that rozanolixizumab has not been approved by the FDA.
Eligibility Criteria
- Inclusion Criteria: You have a documented definite or probable diagnosis of CIDP. You have an Ig-dependency confirmed by clinical examination during you therapy or upon interruption or reduction of you therapy within 18 months before Screening and it is documented in your medical history (ie, a decrease or withdrawal of immunoglobulin was attempted and resulted in a clinically relevant decrease in function) Exclusion Criteria: You have a current diagnosis or has a history of Type 1 or Type 2 diabetes mellitus. You have IgM paraproteinemia
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