This study will assess iluzanebart (VGL101), a new potential therapy for ALSP. The study will look at the safety of iluzanebart as treatment for ALSP and will also measure the effect of the treatment on the symptoms of ALSP.
If you're interested in participating in the study or would like more information, we'd love to hear from you.
Who can participate?
Each person will need to meet the following main inclusion criteria:
- 18 years of age or older
- Documentation of a gene variant in the CSF1R gene
- Having clinical symptoms of ALSP
- Has a study partner (caregiver, friend, family member, etc.) who will commit to supporting throughout the study
*There are additional inclusion and exclusion criteria for this study, which can be discussed with a study doctor and will be assessed during the screening period.
Where will the study take place?
The study will have sites in the following countries. Travel assistance and stipends for participation are available to participants and caregivers.
United States
Germany
Netherlands
United Kingdom
View the study listing for additional details on study sites and eligibility criteria
Study purpose
The study will evaluate iluzanebart (VGL101) for the treatment of ALSP with the following goals
Safety and Tolerability
The main objective is to evaluate how safe the treatment is and how potential side effects are tolerated.
Brain Imaging and Biomarkers
Magnetic resonate imaging (MRI) of the brain and other tests will measure the effects of iluzanebart (VGL101) on disease severity and progression.
Signs and Symptoms
Cognition, motor skills, and other symptoms will be assessed to measure changes in ALSP symptoms.
Overview of study participation
Study participation will last approximately 60 weeks (around 14 months)
Participants will travel to the study site to receive treatment and participate in assessments to evaluate the study treatment. Study visits will take place about every 4 weeks (around 15 visits total).
Participants will receive treatment with iluzanebart (VGL101) approximately every 28 days during the study. The treatment will be given during clinic visits via an intravenous (IV) infusion lasting about 1 hour.
Vigil Neuroscience believes that study participation should not require a financial investment to the participant. Travel assistance and stipends for participation may be available to participants and caregivers.
Before starting the study, participants (or a partner/guardian) will receive an overview of study details in an informed consent form. It is important to make an informed decision to participate in any clinical study. Interested participants are encouraged to ask questions about the study purpose, schedule, potential risks or benefits, and other topics.
Interested in learning more?
View the study listing and additional details including study sites and eligibility criteria
Answers to the community's questions
At Vigil Neuroscience, we value input from the community and want to provide information that people with ALSP and their families need when considering participation. Please see below for answers to questions we’ve received more frequently from the community.
Do participants have to pay to be in the IGNITE study?
Vigil Neuroscience believes that study participation should not require a financial investment to the participant. Travel assistance and stipends for participation are available to participants and caregivers.
Will all IGNITE study participants receive the treatment, or will some participants receive a placebo?
All participants will receive the investigational treatment iluzanebart (VGL101). There is no placebo involved in the study.
Where can I learn more about whether I am eligible to participate in the IGNITE trial?
More information about inclusion and exclusion criteria are listed on the clinicaltrials.gov website. We recommend speaking with your physician and reviewing this information with them if you are interested in exploring participation in the trial. If you have additional questions, please contact us at trials@vigilneuro.com
If I live outside of the countries where the study is being conducted, am I able to participate?
Decisions about individual enrollment, including enrollment of international participants, is left to the study investigators. You may wish to speak with your physician about your eligibility for the trial based on the inclusion/exclusion criteria and you or your physician may wish to reach out to one of the clinical trial sites to express interest as it may be possible for eligible individuals who are able to travel to join a trial site outside of their country of residence.
If I am in the ILLUMINATE natural history study will I automatically be involved in the IGNITE history?
No, participation in the ILLUMINATE natural history trial does not guarantee enrollment into the IGNITE study. These two studies serve different research purposes and the inclusion/exclusion criteria of the two studies are not the same. It is possible that some ILLUMINATE natural history study participants would be eligible and able to enroll into the IGNITE study. Please speak with your physician/trial investigator for more information.
If I didn’t get into the ILLUMINATE natural history study can I possibly be enrolled into the IGNITE study?
Interested individuals should review the inclusion/exclusion criteria with their physician to assess whether they may be a candidate for the IGNITE study.
Explore resources to facilitate ongoing learning about the natural history study as well as support for individuals and families with ALSP.
If you're interested in participating in the study or would like more information, we'd love to hear from you.