Continuation Study for Latozinemab

Neurodegenerative Diseases Clinical Trial

Official title:

A Continuation Study of Latozinemab in Participants With Neurodegenerative Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06111014
• Other study ID #: AL001-CS-302
• Secondary ID: 2023-506805-20-0
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: December 8, 2023
• Est. completion date: November 30, 2027

Study information

• Verified date: January 2024
• Source: Alector Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: November 30, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurodegenerative Diseases

Intervention

Drug:
• Latozinemab
All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Canada	Parkwood Institute	London	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
France	CHU de Bordeaux	Bordeaux
France	Groupe Hospitalier Pitié Salpétrière	Paris
Germany	Universitätsklinikum Ulm - Leimgrubenweg 12-14	Ulm
Italy	IRCCS - Centro S. Giovanni di Dio Fatebenefratelli	Brescia
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Fracesco Sforza 35	Milano
Italy	Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3	Milano
Italy	Azienda Ospedaliero Universitaria Di Modena Policlinico	Modena
Netherlands	Erasmus MC-Dr. Molewaterplein 40	Rotterdam
Portugal	Centro Hospitalar E Universitario de Coimbra EPE	Coimbra
Portugal	Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital de Santa Maria	Lisboa
Spain	Hospital Universitario de Donostia	Donostia
Sweden	Karolinska Universitetssjukhuset Huddinge	Huddinge
United Kingdom	University College London	London
United States	John Hopkins University School of Medicine	Baltimore	Maryland
United States	University of Cincinnati Gardner Neuroscience Institute	Cincinnati	Ohio
United States	Irving Institute for Clinical and Translational Research	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Dignity Health - Arizona	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Comprehensive Cancer Center - PPDS	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Alector Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants receiving latozinemab	Number of participants receiving latozinemab	Through study completion, up to 190 weeks
Primary	Duration of treatment with latozinemab	Duration of treatment with latozinemab	Through study completion, up to 190 weeks
Secondary	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
Secondary	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
Secondary	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