A Study of VGL101 in Patients With Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia

ALSP Clinical Trial

Official title:
A Phase 2 Safety, Tolerability, and Proof-of-Concept Study of VGL101 in Patients With Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia (ALSP) (The Ignite Study)

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05677659
Study type	Interventional
Source	Vigil Neuroscience, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	December 14, 2022
Completion date	March 31, 2027

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See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT05020743` - Natural History Study in Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia
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	Active, not recruiting	`NCT02699190` - LeukoSEQ: Whole Genome Sequencing as a First-Line Diagnostic Tool for Leukodystrophies
	Recruiting	`NCT03047369` - The Myelin Disorders Biorepository Project