A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults with Multifocal Motor Neuropathy

Launched by ARGENX · Jun 1, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called ARGX-117 for adults with a condition known as Multifocal Motor Neuropathy (MMN), which affects muscle strength and movement. The trial aims to find out how safe and well-tolerated this treatment is over a longer period, as well as how effective it is and how the body processes it. It involves different phases, including a part where participants receive the treatment without knowing whether they are getting the actual medication or a placebo, followed by a period where everyone knows they are getting the treatment, plus a follow-up to check on their health.

To be eligible for this trial, participants need to have completed a previous study related to ARGX-117 and be able to provide informed consent, meaning they understand the trial and agree to participate. They also must not have certain serious infections or other major health issues that could interfere with the trial results. Participants can expect close monitoring of their health and regular check-ups throughout the study. It's important for potential participants to be aware that there are specific guidelines about contraception for both men and women during the trial and for a period after receiving the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 1. 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).
• • 2. Female participants (women) of childbearing potential must have a negative urine pregnancy test at baseline before Investigational Medicinal Product can be administered.
• Exclusion Criteria:
• • 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.
• • 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 Investigational Medicinal Product.