Clincosm LogoSign in Get a demo

Continuation Study for Latozinemab

Sponsor
Alector Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06111014
Collaborator
GlaxoSmithKline (Industry)
35
Enrollment
2
Locations
1
Arm
49.7
Anticipated Duration (Months)
17.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open-labelOpen-label
Masking:
None (Open Label)
Masking Description:
This is an open label continuation study
Primary Purpose:
Treatment
Official Title:
A Continuation Study of Latozinemab in Participants With Neurodegenerative Disease
Actual Study Start Date :
Oct 9, 2023
Anticipated Primary Completion Date :
Jul 30, 2027
Anticipated Study Completion Date :
Nov 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open Label

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

Drug: Latozinemab
All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks
Other Names:
  • AL001

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants receiving Latozinemab [Through study completion, up to 128 weeks]

      Cumulative number of participants receiving Latozinemab

    2. Duration of treatment with Latozinemab [Through study completion, up to 128 weeks]

      Duration of treatment with Latozinemab in weeks

    Secondary Outcome Measures

    1. Incident of adverse events (AEs) and serious adverse events (SAEs) [Through study completion, up to 128 weeks]

      Total number of AEs and SAEs

    2. Nature and Severity of AEs and SAEs [Through study completion, up to 128 weeks]

      Nature and severity of AEs and SAEs according to the World Health Organization (WHO) toxicity grading scale

    3. Incidence of ADAs to Latozinemab [Through study completion, up to 128 weeks]

      Anti-Drug Antibodies (ADA) titer over study time points

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    • Use of any passive immunotherapy under evaluation to prevent or postpone cognitive decline.

    • Use of any experimental vaccine or gene therapy.

    • Use of systemic immunosuppressive therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    2 Parkwood Institute London Ontario Canada N6C 0A7

    Sponsors and Collaborators

    • Alector Inc.
    • GlaxoSmithKline

    Investigators

    • Study Director: Megan Smithey, Alector Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alector Inc.
    ClinicalTrials.gov Identifier:
    NCT06111014
    Other Study ID Numbers:
    • AL001-CS-302
    First Posted:
    Nov 1, 2023
    Last Update Posted:
    Nov 1, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alector Inc.
    Frontotemporal Dementia (FTD)
    Amyotrophic Lateral Sclerosis (ALS)
    Additional relevant MeSH terms:
    Neurodegenerative Diseases

    Study Results

    No Results Posted as of Nov 1, 2023