Clinical trial NCT06111014: Continuation Study for Latozinemab
Official title: A Continuation Study of Latozinemab in Participants with Neurodegenerative Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Neurodegenerative Diseases
Keywords: Frontotemporal Dementia (FTD)
Amyotrophic Lateral Sclerosis (ALS)
Lead sponsor: Alector Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label
Primary purpose: TREATMENT

Brief summary: Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants receiving latozinemab
timeFrame: Through study completion, up to 190 weeks
measure: Duration of treatment with latozinemab
timeFrame: Through study completion, up to 190 weeks
Secondary outcomes:
measure: Incident of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Through study completion, up to 190 weeks
measure: Nature and severity of AEs and SAEs
timeFrame: Through study completion, up to 190 weeks
measure: Incidence of ADAs to latozinemab
timeFrame: Through study completion, up to 190 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dignity Health - Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Comprehensive Cancer Center - PPDS
state: Minnesota
city: New York
country: United States
facility: Irving Institute for Clinical and Translational Research
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Gardner Neuroscience Institute
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Leuven
country: Belgium
facility: UZ Leuven
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpétrière
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm - Leimgrubenweg 12-14
city: Brescia
country: Italy
facility: IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Fracesco Sforza 35
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Di Modena Policlinico
city: Rotterdam
country: Netherlands
facility: Erasmus MC-Dr. Molewaterplein 40
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitario de Coimbra EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital de Santa Maria
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: Alector Inc.
name: Study Lead
role: STUDY_DIRECTOR
References: