NL-OMON52460招募中2 期
Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+
Argenx BVBA0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4
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 64（—）
入选标准
- •1. Ability to understand the requirements of the trial, provide written
- •informed consent (including consent for the use and disclosure of
- •research-related health information), willingness and ability to comply with
- •the trial protocol procedures (including required trial visits) of this trial.
- •2.a. Male or female patient with one of the following options:
- •- Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and
- •are considered to be eligible for treatment with efgartigimod PH20 SC; or
- •- Have deteriorated during Stage B of the ARGX-113-1802 trial and are
- •considered to be eligible for treatment with efgartigimod PH20 SC, or
- •- Have been offered the participation in the OLE trial due to early termination
- •of the ARGX-113-1802 trial (because sufficient events for the primary endpoint
- •analysis of the that trial have been reached and it is stopped) and are
- •considered to be eligible for treatment with efgartigimod PH20 SC treatment; or
- •- Have completed the Week-48 visit of the previous cycle of the OLE trial and
- •are considered to be eligible to continue with efgartigimod PH20 SC treatment.
- •Optional Dosing Frequency Substudy: Note that after a minimum period of weekly
- •dosing in this OLE trial, as specified in a separate protocol appendix for a
- •dosing frequency substudy, patients who have a stable clinical condition for at
- •least 12 weeks will be offered the option to receive less frequent dosing to
- •evaluate the maintenance of the clinical condition by administration of
- •efgartigimod PH20 SC 1000 mg at 2 lower dosing frequencies.
- •3. Women of childbearing potential who have a negative urine pregnancy test at
- •baseline before IMP administration.
- •4.a. Women of childbearing potential must use an acceptable method of
- •contraception from signing the ICF untul the date of the last dose of IMP.
- •5. Inclusion criterion removed via protocol amendment #4.
排除标准
- •1. Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the
- •previous OLE participation occurred more than 14 days prior to SD1 of the OLE
- •trial or the start of a new treatment cycle in the OLE trial and more than 21
- •days since the last dose of IMP.
- •2. Pregnant and lactating women and those intending to become pregnant during
- •3. a. Patients with clinical evidence of other significant serious disease or
- •patients who underwent a recent or have a planned major surgery, or patients
- •who (intend to) use prohibited medications and therapies during the trial, or
- •any other reason which could confound the results of the trial or put the
- •patient at undue risk.
研究者
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