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About
This is a multicenter, open-label study to assess the safety and tolerability of iluzanebart (also referred to as VGL101) in subjects with documentation of a gene mutation in the CSF1R gene for the treatment of adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) and to evaluate the effects of iluzanebart on imaging and biomarkers of disease progression in subjects with ALSP. Participants will receive infusions of iluzanebart approximately every 4 weeks for 1 year. The study includes a 52-week, open-label Core Study, followed by a Long-Term Extension (LTE), which provides subjects who complete the original 52-week study (Core Study) with the option to continue treatment for up to an additional 2 years.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Participants who have documentation of a gene mutation in the CSF1R gene
Participants fulfill both (Parts A and B) of the following criteria:
The participant has more than 2 findings of clinical signs or symptoms in the following categories:
MRI findings consistent with ALSP, specifically, bilateral cerebral white matter lesions with or without thinning of the corpus callosum, on the Screening MRI.
The participant must have a study partner (i.e., caregiver, family member, friend, etc.) who, in the investigator's judgment, has frequent and sufficient contact with the subject so as to be able to provide accurate information about the participant's health and cognitive and functional abilities. The study partner must be willing to sign a study partner ICF.
Key Exclusion Criteria:
Primary purpose
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Interventional model
Masking
20 participants in 1 patient group
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Vigil Clinical Trials
Data sourced from clinicaltrials.gov
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