A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Multifocal Motor Neuropathy

In brief

This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with MMN previously stabilized with IVIg (intravenous immunoglobulin).

Key facts

Study ID

NCT05225675

Run by

argenx

People needed

54

Starts

2022-03-31

Expected to finish

2024-06-04

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of giving signed informed consent form (ICF)
• Male/female at least 18 years of age at the time the informed consent form (ICF) is signed
• Probable or definite MMN according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) (EFNS/PNS) 2010 guidelines at screening confirmed by the MMN Confirmation Committee (MCC)
• Receiving a stable IVIg regimen for at least 3 months before screening or recently initiated IVIg treatment
• IVIg treatment dependency confirmation by the MMN Confirmation Committee (MCC)
• Immunization with the first meningococcal vaccine and pneumococcal vaccine, and the single Haemophilus influenza type B vaccine must be performed at least 14 days before IMP administration at V1 according to local country-specific immunization schedules. A documented history of vaccination against Neisseria meningitides, Haemophilus influenza type B, and streptococcus pneumonia will be permitted
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

You may not qualify if…

• Any coexisting condition which may interfere with the outcome assessments
• Clinical signs or symptoms suggestive for neuropathies other than MMN such as motor neuron disease or other inflammatory neuropathies
• Severe psychiatric disorder, history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the participant or could affect adherence with the trial protocol.
• Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection during the screening and/or IVIg monitoring period (IVMP).
• Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of MMN or put the participant at undue risk (eg, SLE).
• History of malignancy unless resolved by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Participants with the following carcinomas will be eligible:
• Adequately treated basal cell or squamous cell skin cancer
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Incidental histological finding of prostate cancer
• Clinical evidence of other significant serious diseases, have had a recent major surgery (including a splenectomy at any time), 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
• Prior/concomitant therapy
• Cyclophosphamide and/or rituximab and/or eculizumab and/or mycophenolate mofetil within 3 months prior to screening
• Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the IMP.
• Positive serum test at screening for an active viral infection with any of the following conditions:
• Hepatitis B virus (HBV) that is indicative of an acute or chronic infection
• Hepatitis C virus (HCV) based on HCV antibody assay
• HIV based on test results that are associated with an AIDS-defining condition
• Current or history of (ie, within 12 months of screening) alcohol, drug, or medication abuse
• Known hypersensitivity reaction to 1 of the components of the IMP or any of its excipients
• Female participants with a positive serum or urine pregnancy test, lactating females, and those who intend to become pregnant during the trial or within 15 months after last dose of the IMP
• ALT or AST ≥2 × upper limit of normal and total bilirubin ≥1.5 × upper limit of normal of the central laboratory reference range
• An estimated glomerular filtration rate of ≤60 mL/min/1.73m2

Where it is running

• HonorHealth Research Institute-Neuroscience Research — Scottsdate, Arizona, United States
• California Pacific Medical Center-Forbes Norris MDA/ALS Research Center — San Francisco, California, United States
• George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States
• HonorHealth Research Institute-Neuroscience Research — Maitland, Florida, United States
• University of South Florida Carol and Frank Morsani Center for Advanced Healthcare — Tampa, Florida, United States
• NorthShore University HealthSystem — Glenview, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Minnesota Delware Clinic Research Unit — Minneapolis, Minnesota, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Perelman Center for Advanced Medicine-University of Penssylvania — Philadelphia, Pennsylvania, United States
• Austin Neuromuscular Center — Austin, Texas, United States
• West Virginia University Medicine — Morgantown, West Virginia, United States
• Medizinische Universitat Wien Universitatsklienik fur Neurologie — Vienna, Austria
• AZ Sint-Lucas — Ghent, Belgium
• Genge Partners Montreal — Québec, Canada
• Toronto General Hospital — Toronto, Canada
• CHU de Bordeaux-Hopital Pellegrin — Bordeaux, France
• CHRU de Lille-Hopital Roger Salengro — Lille, France
• CHU de Nice-Hopital Pasteur 2 — Nice, France
• Hopital Pitie Salpetriere — Paris, France
• Katholisches Klinikum Bochum — Bochum, Germany
• Universitatsklinikum Essen — Essen, Germany
• Universitatsmedzin Gottingen, Klinik fur Neurologie — Göttingen, Germany
• Medizinische Hochschule Hannover Klinik Fur Neurologie — Hanover, Germany

Full record on ClinicalTrials.gov

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