Continuation Study for Latozinemab

Study Overview
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Brief Summary
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Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study

Detailed Description
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This is an open-label continuation study to provide access and assess the safety and tolerability of latozinemab in participants who have completed participation in their parent latozinemab study. All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks (q4w).

Official Title
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A Continuation Study of Latozinemab in Participants With Neurodegenerative Disease

Conditions
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Neurodegenerative Diseases

Intervention / Treatment
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* Drug: Latozinemab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker). Has successfully completed participation in their parent latozinemab study. Female participants must be nonpregnant and nonlactating. Male participants must agree to acceptable contraception use. Exclusion Criteria: Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins. Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>Latozinemab (AL001) administered by IV infusion over 60 minutes, q4w | Drug: Latozinemab<br>* All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks<br>* Other names: AL001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants receiving latozinemab | Number of participants receiving latozinemab | Through study completion, up to 190 weeks | 
| Duration of treatment with latozinemab | Duration of treatment with latozinemab | Through study completion, up to 190 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident of adverse events (AEs) and serious adverse events (SAEs) | Number and percentage of participants of AEs or SAEs | Through study completion, up to 190 weeks | 
| Nature and severity of AEs and SAEs | Severity of AEs and SAEs according to the World Health Organization (WHO) toxicity grading scale | Through study completion, up to 190 weeks | 
| Incidence of ADAs to latozinemab | Number and percentage of participants with anti-Drug Antibodies (ADA) titer over study time points | Through study completion, up to 190 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frontotemporal Dementia (FTD), Amyotrophic Lateral Sclerosis (ALS)