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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).
Enrollment
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Inclusion criteria
Exclusion criteria
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:
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
Positive serum test at screening for an active viral infection with any of the following conditions:
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
Primary purpose
Allocation
Interventional model
Masking
54 participants in 2 patient groups, including a placebo group
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Central trial contact
Sabine Coppieters, MD
Data sourced from clinicaltrials.gov
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