NL-OMON48909已完成2 期
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
CB Biopharma SPR0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Subject is >= 18 years of age 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 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
排除标准
- •- 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
研究者
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