ARGX-117 for Multifocal Motor Neuropathy

(ARDA+ Trial)

Recruiting at 49 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: argenx

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN). The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.

Eligibility Criteria

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.

Inclusion Criteria

I will use birth control until 15 months after my last treatment dose.

Capable of providing signed informed consent and complying with protocol requirements. Participants must be able to read and write.

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

Exclusion Criteria

I do not have any serious ongoing infections.

I do not have any serious health conditions that could interfere with the trial.

Pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the Investigational Medicinal Product

Treatment Details

Interventions

• ARGX-117 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Dose regimen 2 or Dose regimen 3 Experimental Treatment 2 Interventions

ARGX-117/Placebo IV

Group II: Dose regimen 1 Experimental Treatment 2 Interventions

ARGX-117/Placebo IV

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