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

Phase 1

Conditions: Multifocal Motor Neuropathy
MedDRA version: 21.1Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2021-004998-32-DE

Lead Sponsor: argenx BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 48

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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.
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
Main Objective: To evaluate the long-term safety and tolerability of ARGX-117 in adult participants with MMN;Secondary Objective: • To evaluate the long-term efficacy of ARGX-117 on muscle strength and/or motor function in adult participants with MMN<br>• To evaluate the long-term efficacy of ARGX-117 on functional ability, arm and hand function, quality of life (QOL), and fatigue in adult participants with MMN<br>• To evaluate the long-term effect of ARGX-117 on health-related productivity and work productivity<br>• To assess the PK, PD, and immunogenicity of ARGX-117;Primary end point(s): • Safety outcomes based on AE monitoring and other safety assessments ;Timepoint(s) of evaluation of this end point: continuously

Secondary Outcome Measures

Name	Time	Method

Related Trials