ARGX-117 for Multifocal Motor Neuropathy

(ARDA Trial)

Recruiting at 80 trial locations

Overseen By Sabine s Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: argenx

Must be taking: IVIg

Must not be taking: Cyclophosphamide, Rituximab, Eculizumab, others

Disqualifiers: Severe psychiatric disorder, Autoimmune disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

54 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have been on a stable IVIg regimen for at least 3 months before screening. Some medications like cyclophosphamide, rituximab, eculizumab, and mycophenolate mofetil should not have been used within 3 months prior to screening.

What data supports the effectiveness of the drug ARGX-117 for treating multifocal motor neuropathy?

The research highlights the effectiveness of intravenous immunoglobulin (IVIg) in treating multifocal motor neuropathy, suggesting that similar treatments like ARGX-117, which may work in a comparable way, could also be effective. ^{1 2 3 4 5}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous administration of ARGX-117 or placebo

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ARGX-117
• Placebo

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Correlates of outcome and response to IVIg in 88 patients with multifocal motor neuropathy. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Intravenous immunoglobulin as short- and long-term therapy of multifocal motor neuropathy: a retrospective study of response to IVIg and of its predictive criteria in 40 patients. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Use of human intravenous immunoglobulin in lower motor neuron syndromes. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Multifocal motor neuropathy: the diagnostic spectrum and response to treatment. [2007]

5. Japan pubmed.ncbi.nlm.nih.gov

[Clinical features of 8 patients with multifocal motor neuropathy in the long-term follow-up]. [2023]