A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

CIDP01

The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

2019-03-26

2021-03-31

2021-03-31

Completed

Early phase I

34

Inclusion Criteria: * Subject is ≥ 18 years of age with a minimum body weight of ≥42 kg at Visit 1 (Screening) * Subject has a documented definite or probable diagnosis of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) according to the European Federation of Neurological Societies (EFNS)/ Peripheral Nerve Society (PNS) criteria 2010 * Subject has an immunoglobulin-dependency confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to Screening and documented in medical history * Subject is on a stable dosage (not more than ±20% deviation) for subcutaneous immunoglobulin (SCIg) or intravenous immunoglobulin (IVIg) and a fixed interval for at least 4 months of either treatment * Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their final dose of investigational medicinal product (IMP) * Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the final administration of IMP Exclusion Criteria: * Previously received treatment in this study or subject has previously been exposed to rozanolixizumab * Current diagnosis or has a history of Type 1 or Type 2 diabetes mellitus and/or hemoglobin A1c level \>6.0 % * Known immunoglobulin M (IgM)-mediated neuropathy * Clinical or known evidence of associated systemic diseases that might cause neuropathy or treatment with agents that might lead to neuropathy * History of clinically relevant ongoing chronic infections * Family history of primary immunodeficiency * Received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP * Received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline * Prior treatment with rituximab, ofatumumab, or ocrelizumab in the 6 months prior to the Baseline Visit or subject has had prior treatment with rituximab, ofatumumab, or ocrelizumab in the 12 months prior to Baseline and B cells are not within the normal range * Female subject who is pregnant or lactating

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2023-08-01