Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks
Dignity Health - Arizona
Phoenix, Arizona, United States
Mayo Comprehensive Cancer Center - PPDS
Rochester, Minnesota, United States
Number of participants receiving latozinemab
Number of participants receiving latozinemab
Time frame: Through study completion, up to 190 weeks
Duration of treatment with latozinemab
Duration of treatment with latozinemab
Time frame: Through study completion, up to 190 weeks
Incident of adverse events (AEs) and serious adverse events (SAEs)
Number and percentage of participants of AEs or SAEs
Time frame: 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
Time frame: 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
Time frame: Through study completion, up to 190 weeks
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Irving Institute for Clinical and Translational Research
New York, New York, United States
University of Cincinnati Gardner Neuroscience Institute
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UZ Leuven
Leuven, Belgium
Parkwood Institute
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Groupe Hospitalier Pitié Salpétrière
Paris, France
Universitätsklinikum Ulm - Leimgrubenweg 12-14
Ulm, Germany
...and 8 more locations