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
NCT ID: NCT05225675
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2022-03-31
2024-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ARGX-117
Intravenous administration of ARGX-117
ARGX-117
Intravenous administration of ARGX-117
Placebo
Intravenous administration of placebo
Placebo
Intravenous administration of placebo
Interventions
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ARGX-117
Intravenous administration of ARGX-117
Placebo
Intravenous administration of placebo
Eligibility Criteria
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Inclusion Criteria
2. Male/female at least 18 years of age at the time the informed consent form (ICF) is signed
3. 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)
4. Receiving a stable IVIg regimen for at least 3 months before screening or recently initiated IVIg treatment
5. IVIg treatment dependency confirmation by the MMN Confirmation Committee (MCC)
6. 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
7. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Exclusion Criteria
2. Clinical signs or symptoms suggestive for neuropathies other than MMN such as motor neuron disease or other inflammatory neuropathies
3. 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.
4. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection during the screening and/or IVIg monitoring period (IVMP).
5. 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).
6. 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:
1. Adequately treated basal cell or squamous cell skin cancer
2. Carcinoma in situ of the cervix
3. Carcinoma in situ of the breast
4. Incidental histological finding of prostate cancer
7. 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
8. Prior/concomitant therapy
1. Cyclophosphamide and/or rituximab and/or eculizumab and/or mycophenolate mofetil within 3 months prior to screening
2. Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the IMP.
9. Positive serum test at screening for an active viral infection with any of the following conditions:
1. Hepatitis B virus (HBV) that is indicative of an acute or chronic infection
2. Hepatitis C virus (HCV) based on HCV antibody assay
3. HIV based on test results that are associated with an AIDS-defining condition
10. Current or history of (ie, within 12 months of screening) alcohol, drug, or medication abuse
11. Known hypersensitivity reaction to 1 of the components of the IMP or any of its excipients
12. 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
13. ALT or AST ≥2 × upper limit of normal and total bilirubin ≥1.5 × upper limit of normal of the central laboratory reference range
14. An estimated glomerular filtration rate of ≤60 mL/min/1.73m2
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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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
Universitatsklinikum Munster
Münster, , Germany
IRCCS Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliero Univeritaria Pisana-UOS Neurologia
Pisa, , Italy
Azienda Ospedaliera Sant'Andrea-UOS Malattie Neuromuscolari
Rome, , Italy
Instituto Clinico Humanitas (IRCCS)
Rozzano, , Italy
Amsterdam UMC location AMC, Dep of Neurology
Amsterdam, , Netherlands
University Medical Centre Utrecht
Utrecht, , Netherlands
Michalscy I Partnerzy Lekarze Spolka Partnerska
Krakow, , Poland
Uniwersyteckie centrum kliniczne Warszawskiego
Warsaw, , Poland
Hospital Universitario Vall d'Herbon
Barcelona, , Spain
Hospital de la Santa Creu I Santa Pau -Sevicio Neurologia
Barcelona, , Spain
Hospital Universitari I Politecnic La Fe de Valencia-Servicio Neurologia
Valencia, , Spain
Queen Elisabeth University Hospital
Glasgow, , United Kingdom
University College London Hospital
London, , United Kingdom
Oxford University Hospitals NHS Trust-Jonh Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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ARGX-117-2002
Identifier Type: -
Identifier Source: org_study_id
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