A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARGX-117-2003

Argenx0 个研究点目标入组 53 人开始时间: 2023年12月11日最近更新: 2024年7月22日

适应症

试验速览

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•Participants are eligible to be included in the trial only if all of the following criteria apply: 1. Capable of providing signed informed consent, and complying with protocol requirements. Participants must be able to read and write. 2. Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117 3. Agrees to use contraceptive measures consistent with local regulations and the following: a. Male participants: must use an acceptable contraceptive method that should be maintained at minimum until 15 months after last dose of Investigational Medicinal Product (IMP). b. Female participants (women) of childbearing potential must have a negative urine pregnancy test at baseline before IMP can be administered.

•Participants will be excluded from the trial if any of the following criteria apply: 1. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection 2. Clinical evidence of other significant serious diseases, have had a recent major surgery, or who have any other condition, in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk. a. Germany only: A SARS-CoV-2 rapid antigen test must be completed or a negative rapid antigen test not older than 48 hours (depending on local requirements) must be presented upon site entry during DV1. Rapid antigen testing will only be mandatory if required locally. 3. Currently participating in another interventional clinical study 4. Pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the IMP.

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