ARGX-117 for Multifocal Motor Neuropathy

(ARDA Trial)

Recruiting at80 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: argenx

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing ARGX-117, a new treatment, in people with a nerve condition called MMN who are already using IVIg. The goal is to see if ARGX-117 can better manage their nerve function.

Research Team

Eligibility Criteria

Adults with Multifocal Motor Neuropathy (MMN) who are stable on IVIg treatment can join this trial. They must be at least 18, have been vaccinated against certain infections, and use approved contraception methods. People with severe psychiatric issues, other serious diseases, recent major surgery, drug abuse history or certain medication use in the last 3 months cannot participate.

Inclusion Criteria

My need for IVIg treatment has been confirmed by the MMN Committee.

I have been on a stable IVIg treatment for at least 3 months.

Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria

Known hypersensitivity reaction to 1 of the components of the IMP or any of its excipients

Any coexisting condition which may interfere with the outcome assessments

I do not have any serious ongoing infections.

Treatment Details

Interventions

• ARGX-117 (Monoclonal Antibodies)
• Placebo (Other)

Trial Overview The trial is testing two different doses of a new drug called ARGX-117 compared to a placebo in people with MMN. It's designed to see if ARGX-117 is safe and works well when added to their regular IVIg therapy. Participants will be randomly assigned to one of the groups without knowing which one they're in.

Participant Groups

Group I: ARGX-117 Experimental Treatment 1 Intervention

Intravenous administration of ARGX-117

Group II: Placebo Placebo Group 1 Intervention

Intravenous administration of placebo

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University