Continuation Study for Latozinemab

NCT06111014 | Terminated Phase 3 FDA Drug

• 2 other identifiers: AL001-CS-3022023-506805-20-00
• Study Type: interventional
• Target: 17
• Locations: 10 countries
• Sites: 18

Brief Summary

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

Conditions

Neurodegenerative Diseases

Keywords

Frontotemporal Dementia (FTD); Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Incident of adverse events (AEs) and serious adverse events (SAEs)

  Through study completion, up to 190 weeks

• Nature and severity of AEs and SAEs

  Through study completion, up to 190 weeks

• Incidence of ADAs to latozinemab

  Through study completion, up to 190 weeks

Study Arms (1)

Open Label

EXPERIMENTAL

Latozinemab (AL001) administered by IV infusion over 60 minutes, q4w

Drug: Latozinemab

Interventions

Latozinemab DRUG

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

Also known as: AL001

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alector Inc.: lead

Study Sites (18)

Dignity Health - Arizona

Phoenix, Arizona, 85013, United States

Location

Mayo Comprehensive Cancer Center - PPDS

Rochester, Minnesota, 55905, United States

Location

Irving Institute for Clinical and Translational Research

New York, New York, 10032, United States

Location

University of Cincinnati Gardner Neuroscience Institute

Cincinnati, Ohio, 45219, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Parkwood Institute

London, Ontario, N6C 0A7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Groupe Hospitalier Pitié Salpétrière

Paris, 75013, France

Location

Universitätsklinikum Ulm - Leimgrubenweg 12-14

Ulm, 89075, Germany

Location

IRCCS - Centro S. Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Fracesco Sforza 35

Milan, 20122, Italy

Location

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, 41126, Italy

Location

Erasmus MC-Dr. Molewaterplein 40

Rotterdam, 3015 GD, Netherlands

Location

Centro Hospitalar E Universitario de Coimbra EPE

Coimbra, 3000-075, Portugal

Location

Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital de Santa Maria

Lisbon, 1649-028, Portugal

Location

Karolinska Universitetssjukhuset Huddinge

Huddinge, SE-14186, Sweden

Location

University College London

London, WC1NAR, United Kingdom

Location

MeSH Terms

Conditions

Neurodegenerative Diseases; Frontotemporal Dementia; Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders; Spinal Cord Diseases; Motor Neuron Disease; Neuromuscular Diseases

Study Officials

• Study Lead

  Alector Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label continuation study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 1, 2023
• Study Start: December 8, 2023
• Primary Completion: September 1, 2025
• Study Completion: January 7, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (5); BE (1); FR (1); SE (1); PT (2); CA (2); IT (3); NL (1); DE (1)