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
- Conditions
- Multifocal Motor NeuropathyMedDRA version: 21.1Level: PTClassification code: 10065579Term: Multifocal motor neuropathy Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-507052-69-00
- Lead Sponsor
- Argenx
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 53
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method