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: Active, not recruiting; Phase 2

Conditions: Multifocal Motor Neuropathy (MMN)

Treatments: Biological: ARGX-117; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05405361

2023-507052-69-00 (EU Trial (CTIS) Number)

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: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Capable of providing signed informed consent and complying with protocol requirements. Participants must be able to read and write.
• Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117.

Exclusion criteria

• Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
• 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.
• Currently participating in another interventional clinical study.
• Pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the study drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 2 patient groups

ARGX-117

Experimental group

Description:

Participants receiving ARGX-117 during the double-blinded treatment period (DTP) and the open-label treatment period (OLTP)

Treatment:

Biological: ARGX-117

Placebo

Experimental group

Description:

Participants receiving placebo during the double-blinded treatment period (DTP) and receiving ARGX-117 during the open-label treatment period (OLTP)

Treatment:

Other: Placebo

Biological: ARGX-117