Continuation Study for Latozinemab
- Registration Number
- NCT06111014
- Lead Sponsor
- Alector Inc.
- 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).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open Label Latozinemab Latozinemab (AL001) administered by IV infusion over 60 minutes, q4w
- Primary Outcome Measures
Name Time Method Duration of treatment with latozinemab Through study completion, up to 190 weeks Duration of treatment with latozinemab
Number of participants receiving latozinemab Through study completion, up to 190 weeks Number of participants receiving latozinemab
- Secondary Outcome Measures
Name Time Method Incident of adverse events (AEs) and serious adverse events (SAEs) Through study completion, up to 190 weeks Number and percentage of participants of AEs or SAEs
Nature and severity of AEs and SAEs Through study completion, up to 190 weeks Severity of AEs and SAEs according to the World Health Organization (WHO) toxicity grading scale
Incidence of ADAs to latozinemab Through study completion, up to 190 weeks Number and percentage of participants with anti-Drug Antibodies (ADA) titer over study time points
Trial Locations
- Locations (23)
Erasmus MC-Dr. Molewaterplein 40
🇳🇱Rotterdam, Netherlands
Centro Hospitalar E Universitario de Coimbra EPE
🇵🇹Coimbra, Portugal
Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
University College London
🇬🇧London, United Kingdom
Dignity Health - Arizona
🇺🇸Phoenix, Arizona, United States
Mayo Comprehensive Cancer Center - PPDS
🇺🇸Rochester, Minnesota, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
John Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Cincinnati Gardner Neuroscience Institute
🇺🇸Cincinnati, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Irving Institute for Clinical and Translational Research
🇺🇸New York, New York, United States
Hospital Universitario de Donostia
🇪🇸Donostia, Spain
UZ Leuven
🇧🇪Leuven, Belgium
Parkwood Institute
🇨🇦London, Ontario, Canada
CHU de Bordeaux
🇫🇷Bordeaux, France
Groupe Hospitalier Pitié Salpétrière
🇫🇷Paris, France
Universitätsklinikum Ulm - Leimgrubenweg 12-14
🇩🇪Ulm, Germany
IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
🇮🇹Brescia, Italy
Fondazione IRCCS CÃ 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, Italy
Karolinska Universitetssjukhuset Huddinge
🇸🇪Huddinge, Sweden