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Safety and Efficacy of ABX-101 in Participants Aged 18 to 50 Years of Age With Moderate to Severe Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury, Cerebral Edema

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ABX-101 1mg
ABX-101 2mg
Sponsored by
Abalonex, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic brain injury

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent from patient, patient's legal guardian or legal representative, or deferred consent procedure, according to local requirements 18 - 50 years of age, inclusive Expected to survive more than 24 hours after admission Clearly defined time of injury no more than 12 hours before administration of study drug/placebo o Subjects stratified 1:1 (in each arm) by treatment administered 0-12 hrs TBI with Glasgow Coma Score (GCS) 4-12 requiring intracranial pressure (ICP) monitoring according to the assessment of the treating physician o Subjects stratified 1:1 (in each arm) by GCS 4-8 and GCS 9-12 Catheter placement (intraventricular or intraparenchymal, only) for monitoring and management of increased ICP [Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable] Exclusion Criteria: Penetrating head injury (e.g. missile, stab wound) Concurrent, but not pre-existing, spinal cord injury Not expected to survive more than 24 hours after admission Pregnant, or a positive pregnancy test Coma due to an exclusive epidural hematoma (lucid interval and absence of structural brain damage on CT scan) Patient pupils are unresponsive (dilation) in both eyes The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors. Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose intoxication, drowning/near drowning Known or CT scan evidence of pre-existing major cerebral damage Any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission Known to have received an experimental drug within 4 weeks prior to current injury Patients who cannot be monitored with regard to their recovery (GOS-E and QOLIBRI)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Experimental: ABX-101 1mg

    Experimental: ABX-101 2mg

    Placebo Comparator: Saline

    Arm Description

    Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown). Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other). The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX 101 (1 mg OR 2 mg) intramuscular injections, is seven days.

    Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown). Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other). The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX 101 (1 mg OR 2 mg) intramuscular injections, is seven days.

    Placebo to the ABX-101 will be administered to patients.

    Outcomes

    Primary Outcome Measures

    Glasgow Outcome Scale-Extended (GOS-E)
    To demonstrate superiority of ABX-101 vs placebo on the Glasgow Outcome Scale-Extended (GOS-E) at 90-days in participants with TBI

    Secondary Outcome Measures

    Glasgow Outcome Scale-Extended (GOS-E)
    To demonstrate superiority of ABX-101 vs placebo on the GOS-E at 30 days in participants with TBI
    Glasgow Coma Score (GSC) improvement
    To demonstrate superiority of ABX-101 vs placebo on the GCS improvement (vs. baseline) at days 3 and 7 in participants with TBI
    ICP Maintenance
    To demonstrate superiority of ABX-101 vs placebo on the ICP maintenance at 3 days and 7 days in participants with TBI
    Midline Shift
    To demonstrate superiority of ABX-101 vs placebo on the degree of midline shift as assessed by CT scan at 1 day and 3 days in participants with TBI
    Therapeutic Intensity Level
    To demonstrate superiority of ABX-101 vs placebo on the Therapeutic Intensity Level over 3 days and over 7 days in participants with TBI
    Neuroworsening
    To demonstrate superiority of ABX-101 vs placebo on the Neuroworsening at 3 days and 7 days in participants with TBI
    Mortality
    To demonstrate superiority of ABX-101 vs placebo on the mortality at 3 days, 7 days, 28 days, and 90 days in participants with TBI
    Quality of life- (QOLIBRI)
    To demonstrate superiority of ABX-101 vs placebo on the Quality of Life after Brain Injury at 90 days in participants with TBI
    GFAP Inflammatory Biomarker Analysis
    To compare ABX-101 vs placebo on Glial fibrillary acidic protein (GFAP) levels at 1 day, 3 days, and 7 days in participants with TBI. The detection range for GFAP biomarker is 0.31 - 20 ng/ml using ELAB Science GFAP Kit.
    Adverse Events
    To compare ABX-101 vs placebo in terms of AEs assessed over 7 days of treatment and through the duration of follow-up in participants with TBI

    Full Information

    First Posted
    May 2, 2023
    Last Updated
    October 20, 2023
    Sponsor
    Abalonex, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06096415
    Brief Title
    Safety and Efficacy of ABX-101 in Participants Aged 18 to 50 Years of Age With Moderate to Severe Traumatic Brain Injury
    Official Title
    A Parallel Group Treatment, Phase 2A, Double-blind, 3-arm Study to Investigate Safety and Efficacy of ABX-101 Compared With Placebo in Male and Female Participants, Aged 18 to 50 Years, With Moderate-to-severe Traumatic Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abalonex, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the clinical improvement measured by the Glasgow Outcome Scale Extended (GOS-E) with ABX-101 compared with Placebo intramuscular injection in participants with moderate to severe TBI.
    Detailed Description
    Study details include: The study duration will be up to 180 days per participant. The treatment duration will be up to 7 days. The visits post-treatment will be on day 30 and day 180 of the study. Number of Participants: A maximum of 45 participants will be enrolled into the study and randomized to each treatment arm in a ratio of 1:1:1. i.e., fifteen participants per arm. Study Arms and Duration: Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult. Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other). The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX-101 (1 mg OR 2 mg) intramuscular injections, is seven days. Enrolled participant will continue with the in-hospital standard of care, as decided by the external treating physician, and will be followed up by the study team on days 30 and days 180. The ABX-101 1 mg and 2 mg arm will be enrolled simultaneously.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury, Cerebral Edema
    Keywords
    Traumatic brain injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: ABX-101 1mg
    Arm Type
    Experimental
    Arm Description
    Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown). Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other). The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX 101 (1 mg OR 2 mg) intramuscular injections, is seven days.
    Arm Title
    Experimental: ABX-101 2mg
    Arm Type
    Experimental
    Arm Description
    Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown). Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other). The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX 101 (1 mg OR 2 mg) intramuscular injections, is seven days.
    Arm Title
    Placebo Comparator: Saline
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo to the ABX-101 will be administered to patients.
    Intervention Type
    Drug
    Intervention Name(s)
    ABX-101 1mg
    Intervention Description
    ABX-101 1mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)
    Intervention Type
    Drug
    Intervention Name(s)
    ABX-101 2mg
    Intervention Description
    ABX-101 2mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)
    Primary Outcome Measure Information:
    Title
    Glasgow Outcome Scale-Extended (GOS-E)
    Description
    To demonstrate superiority of ABX-101 vs placebo on the Glasgow Outcome Scale-Extended (GOS-E) at 90-days in participants with TBI
    Time Frame
    180 days
    Secondary Outcome Measure Information:
    Title
    Glasgow Outcome Scale-Extended (GOS-E)
    Description
    To demonstrate superiority of ABX-101 vs placebo on the GOS-E at 30 days in participants with TBI
    Time Frame
    30 days
    Title
    Glasgow Coma Score (GSC) improvement
    Description
    To demonstrate superiority of ABX-101 vs placebo on the GCS improvement (vs. baseline) at days 3 and 7 in participants with TBI
    Time Frame
    7 days
    Title
    ICP Maintenance
    Description
    To demonstrate superiority of ABX-101 vs placebo on the ICP maintenance at 3 days and 7 days in participants with TBI
    Time Frame
    7 days
    Title
    Midline Shift
    Description
    To demonstrate superiority of ABX-101 vs placebo on the degree of midline shift as assessed by CT scan at 1 day and 3 days in participants with TBI
    Time Frame
    3 days
    Title
    Therapeutic Intensity Level
    Description
    To demonstrate superiority of ABX-101 vs placebo on the Therapeutic Intensity Level over 3 days and over 7 days in participants with TBI
    Time Frame
    7 days
    Title
    Neuroworsening
    Description
    To demonstrate superiority of ABX-101 vs placebo on the Neuroworsening at 3 days and 7 days in participants with TBI
    Time Frame
    7 days
    Title
    Mortality
    Description
    To demonstrate superiority of ABX-101 vs placebo on the mortality at 3 days, 7 days, 28 days, and 90 days in participants with TBI
    Time Frame
    180 days
    Title
    Quality of life- (QOLIBRI)
    Description
    To demonstrate superiority of ABX-101 vs placebo on the Quality of Life after Brain Injury at 90 days in participants with TBI
    Time Frame
    180 days
    Title
    GFAP Inflammatory Biomarker Analysis
    Description
    To compare ABX-101 vs placebo on Glial fibrillary acidic protein (GFAP) levels at 1 day, 3 days, and 7 days in participants with TBI. The detection range for GFAP biomarker is 0.31 - 20 ng/ml using ELAB Science GFAP Kit.
    Time Frame
    7 days
    Title
    Adverse Events
    Description
    To compare ABX-101 vs placebo in terms of AEs assessed over 7 days of treatment and through the duration of follow-up in participants with TBI
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written informed consent from patient, patient's legal guardian or legal representative, or deferred consent procedure, according to local requirements 18 - 50 years of age, inclusive Expected to survive more than 24 hours after admission Clearly defined time of injury no more than 12 hours before administration of study drug/placebo o Subjects stratified 1:1 (in each arm) by treatment administered 0-12 hrs TBI with Glasgow Coma Score (GCS) 4-12 requiring intracranial pressure (ICP) monitoring according to the assessment of the treating physician o Subjects stratified 1:1 (in each arm) by GCS 4-8 and GCS 9-12 Catheter placement (intraventricular or intraparenchymal, only) for monitoring and management of increased ICP [Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable] Exclusion Criteria: Penetrating head injury (e.g. missile, stab wound) Concurrent, but not pre-existing, spinal cord injury Not expected to survive more than 24 hours after admission Pregnant, or a positive pregnancy test Coma due to an exclusive epidural hematoma (lucid interval and absence of structural brain damage on CT scan) Patient pupils are unresponsive (dilation) in both eyes The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors. Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose intoxication, drowning/near drowning Known or CT scan evidence of pre-existing major cerebral damage Any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission Known to have received an experimental drug within 4 weeks prior to current injury Patients who cannot be monitored with regard to their recovery (GOS-E and QOLIBRI)

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of ABX-101 in Participants Aged 18 to 50 Years of Age With Moderate to Severe Traumatic Brain Injury

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