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

Phase 2

Recruiting

• Conditions: Multifocal Motor Neuropathy; Muscle disease; 10003816

• Registration Number: NL-OMON53633
• Lead Sponsor: argenx BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

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.

Exclusion Criteria

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.
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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety outcomes based on AE monitoring and other safety assessments (clinical<br /><br>laboratory tests)</p><br>