ARGX-117 for Multifocal Motor Neuropathy (ARDA+ Trial)

Phase 2

Waitlist Available

Research Sponsored by argenx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117

Be older than 18 years old

Must not have

Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of argx-117, assessed up to 70 months or treatment discontinuation

Summary

This trialis designed to assess the safety & effectiveness of ARGX-117 for adults with MMN. It will include double-blind & open-label treatment + safety follow-up.

Who is the study for?

Adults with Multifocal Motor Neuropathy who completed the ARGX-117-2002 trial can join. They must be able to consent, follow the study plan, and use effective contraception. Excluded are those with serious diseases, recent major surgery, other clinical study participation, pregnancy or lactation.

What is being tested?

The trial tests long-term safety and effectiveness of ARGX-117 for MMN patients. It includes a double-blinded period where some get ARGX-117 and others a placebo, followed by an open-label period where all receive ARGX-117.

What are the potential side effects?

While specific side effects aren't listed here, common ones may include reactions at the infusion site, potential infections due to immune response changes from treatment with monoclonal antibodies like ARGX-117.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I finished the ARGX-117-2002 trial and can be treated with ARGX-117.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any serious ongoing infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of argx-117, assessed up to 70 months or treatment discontinuation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of argx-117, assessed up to 70 months or treatment discontinuation

This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 1, 8, 15, 22 followed by every 4 weeks during 12 weeks followed by every 8 weeks until market authorization of argx-117, assessed up to 70 months or treatment discontinuation for reporting.