NL-OMON54382招募中2 期
A Phase 2, multicenter, open-label, non-randomized, proof-of-concept study evaluating the efficacy, safety, and tolerability of SAR445088 (previously BIVV020) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) - PDY16744
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sanofi B.V.
- 入组人数
- 6
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
- •- Adults >=18 years of age at the time of signing the informed consent.
- •- Documented definite or probable diagnosis of CIDP (typical CIDP, pure motor
- •CIDP, or Lewis-Sumner Syndrome) according to the European Federation of
- •Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) Task Force first
- •- Belonging to one of the following three groups: standard-of-care
- •(SOC)-Treated, SOC-Refractory or SOC-Naïve, as defined in the protocol.
- •- Documented vaccinations against encapsulated bacterial pathogens given within
- •5 years of enrollment or initiated a minimum of 14 days prior to first dose as
- •specified in Section 6.8.1 of the protocol.
- •- Adherence to contraceptive requirements as detailed in the protocol for men
- •- Capable of giving signed informed consent which includes compliance with the
- •requirements and
- •restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •- Polyneuropathy of other causes.
- •- Any other neurological or systemic disease that can cause symptoms and signs
- •interfering with treatment or outcome assessments.
- •- Poorly controlled diabetes (HbA1c >7%).
- •- Serious infections requiring hospitalization within 30 days prior to
- •screening and any active infection requiring treatment during screening.
- •- Clinical diagnosis of SLE.
- •- Treatment with plasma exchange within 12 weeks prior to screening.
- •- Prior treatment with rituximab or ocrelizumab in the 6 months prior to
- •BIVV020 dosing or until return of B-cell counts to normal levels, whichever is
- •- Immunosuppressive/chemotherapeutic medications within 6 months prior to
- •dosing (except for some cases as indicated in the SOC-Refractory group).
- •- Treatment (any time) with highly immunosuppressive/chemotherapeutic
- •medications with sustained effects.
- •- Treatment (any time) with total lymphoid irradiation or bone marrow
- •transplantation.
- •- Use of any specific complement system inhibitor (eg, eculizumab) within 12
- •weeks or 5 times the half-life of the product, whichever is longer, prior to
研究者
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