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 (ARDA+)

argenx

Status and phase: Invitation-only; Phase 2

Conditions: Multifocal Motor Neuropathy (MMN)

Treatments: Other: Placebo; Biological: ARGX-117

Study type: Interventional

Funder types: Industry

Identifiers

NCT05405361

ARGX-117-2003

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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:

   1. 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).
   2. Female participants (women) of childbearing potential must have a negative urine pregnancy test at baseline before Investigational Medicinal Product can be administered.

Exclusion criteria

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.
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 Investigational Medicinal Product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Dose regimen 1

Experimental group

Description:

ARGX-117/Placebo IV

Treatment:

Biological: ARGX-117

Other: Placebo

Dose regimen 2 or Dose regimen 3

Experimental group

Description:

ARGX-117/Placebo IV

Treatment:

Biological: ARGX-117

Other: Placebo