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An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis

Primary Purpose

Infection, Bacterial, Anthrax

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Collection of samples
Obiltoxaximab
Sponsored by
Elusys Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection, Bacterial focused on measuring Anthim®, Obiltoxaximab, anthrax, anti-toxin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women (including pregnant and lactating women) and children of all ages who receive obiltoxaximab as part of their clinical care for anthrax infection and are willing and able to give written informed consent themselves or through legally acceptable representative (for minors, unconscious adults or deceased subjects) to participate in the study

Exclusion Criteria:

  • There are no exclusion criteria defined for this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Obiltoxaximab

    Arm Description

    This is an open label, 24-week, single arm field study that will be implemented for subjects who receive FDA-approved obiltoxaximab as part of their medical treatment for inhalational anthrax infection in the United States. Adult subjects will be administered a single, intravenous (IV) dose of 16 mg/kg obiltoxaximab given as part of their medical care. Children will receive a weight-adjusted dose. The primary purpose of the study is to collect data from subjects who have been treated with obiltoxaximab as part of their medical care for inhalational anthrax and to collect additional blood samples for measurement of obiltoxaximab concentrations and presence of anti-therapeutic antibodies (ATA).

    Outcomes

    Primary Outcome Measures

    Overall survival in suspected, probable, or confirmed cases of inhalational anthrax at Week 24
    Overall survival will be summarized by frequency of subjects who completed the study at Week 24, and subjects who died before that visit. Population survival distribution function (SDF) will be estimated using the Kaplan-Meier (KM) method.

    Secondary Outcome Measures

    Survival at Day 14 and Day 28
    Population survival rates at 14 and 28 days will be estimated using the KM method.
    Duration of survival (to Week 24)
    The KM method will be used to estimate duration of survival.
    Disease progression and associated complications rates of anthrax (meningitis, pleural effusion, ventilator support) (to Week 24)
    The progression to systemic anthrax infection and complication rates will be summarized using KM estimates associated with time to disease progression and time to complication of anthrax. The population SDFs of time to progression to systemic anthrax infection and of time to complication will be estimated using the KM method. Summary statistics of subjects with disease progression and complication rates will be provided.
    Modified SOFA score (to Week 24)
    Modified sequential organ failure assessment (SOFA) scores will be assessed using 5 organ systems (respiratory, liver, cardiovascular, central nervous system, renal).
    Incidence and duration of B. anthracis bacteremia
    Incidence and duration of B. anthracis bacteremia will be summarized by total incidence across time points of subjects with bacteremia and time from study drug administration to onset of bacteremia.

    Full Information

    First Posted
    March 17, 2017
    Last Updated
    July 12, 2023
    Sponsor
    Elusys Therapeutics
    Collaborators
    Centers for Disease Control and Prevention, APCER Life Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03088111
    Brief Title
    An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis
    Official Title
    A Phase 4, Open Label Field Study to Evaluate the Clinical Benefit, Safety, and Pharmacokinetics of Anthim (Obiltoxaximab) When Used in the Treatment of Suspected, Probable, or Confirmed Cases of Inhalational Anthrax Due to B. Anthracis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Elusys Therapeutics
    Collaborators
    Centers for Disease Control and Prevention, APCER Life Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This field study is a post-marketing requirement from the FDA to evaluate the clinical benefit (course of illness and survival), safety and pharmacokinetics of obiltoxaximab administered to patients as part of their medical care for treatment or prophylaxis of inhalational anthrax infection following exposure to Bacillus anthracis (B. anthracis). The protocol can be implemented for any individual who receives obiltoxaximab for a suspected, probable, or confirmed case of inhalational anthrax due to B. anthracis in the United States, including sporadic cases, small incidents and/or a mass event. In case of a small anthrax incident, to the extent possible, the information will be collected prospectively at prespecified time points, except where it would interfere with management of the subject's illness. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study are anticipated to be collected retrospectively. Both retrospective and prospective data collection are allowed to maximize information collection. This study will collect data on the use of obiltoxaximab in anthrax infected or exposed subjects and the data collected will inform the understanding of the clinical benefit and safety of obiltoxaximab.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infection, Bacterial, Anthrax
    Keywords
    Anthim®, Obiltoxaximab, anthrax, anti-toxin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Model Description
    Open label
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Obiltoxaximab
    Arm Type
    Other
    Arm Description
    This is an open label, 24-week, single arm field study that will be implemented for subjects who receive FDA-approved obiltoxaximab as part of their medical treatment for inhalational anthrax infection in the United States. Adult subjects will be administered a single, intravenous (IV) dose of 16 mg/kg obiltoxaximab given as part of their medical care. Children will receive a weight-adjusted dose. The primary purpose of the study is to collect data from subjects who have been treated with obiltoxaximab as part of their medical care for inhalational anthrax and to collect additional blood samples for measurement of obiltoxaximab concentrations and presence of anti-therapeutic antibodies (ATA).
    Intervention Type
    Other
    Intervention Name(s)
    Collection of samples
    Intervention Description
    To the extent possible, blood samples will be collected from all subjects prior to infusion and at specified time points post-infusion to determine serum obiltoxaximab concentrations and ATA titers. Scavenged blood samples can be utilized, if acceptable, to maximize sample analyses for pharmacokinetic and other investigational parameters. Data on other relevant laboratory testing will only be collected and evaluated if available in the subject's record (eg, protective antigen (PA), anti-PA, anti-lethal factor (LF), anti-edema factor, IgG antibodies, anthrax lethal toxin neutralizing activity, presence of anthrax LF, incidence and duration of B. anthracis bacteremia, and demonstration of B. anthracis antigens in tissues).
    Intervention Type
    Biological
    Intervention Name(s)
    Obiltoxaximab
    Other Intervention Name(s)
    Anthim
    Intervention Description
    Obiltoxaximab standard of care
    Primary Outcome Measure Information:
    Title
    Overall survival in suspected, probable, or confirmed cases of inhalational anthrax at Week 24
    Description
    Overall survival will be summarized by frequency of subjects who completed the study at Week 24, and subjects who died before that visit. Population survival distribution function (SDF) will be estimated using the Kaplan-Meier (KM) method.
    Time Frame
    Up to Week 24
    Secondary Outcome Measure Information:
    Title
    Survival at Day 14 and Day 28
    Description
    Population survival rates at 14 and 28 days will be estimated using the KM method.
    Time Frame
    Up to Day 28
    Title
    Duration of survival (to Week 24)
    Description
    The KM method will be used to estimate duration of survival.
    Time Frame
    Up to Week 24
    Title
    Disease progression and associated complications rates of anthrax (meningitis, pleural effusion, ventilator support) (to Week 24)
    Description
    The progression to systemic anthrax infection and complication rates will be summarized using KM estimates associated with time to disease progression and time to complication of anthrax. The population SDFs of time to progression to systemic anthrax infection and of time to complication will be estimated using the KM method. Summary statistics of subjects with disease progression and complication rates will be provided.
    Time Frame
    Up to Week 24
    Title
    Modified SOFA score (to Week 24)
    Description
    Modified sequential organ failure assessment (SOFA) scores will be assessed using 5 organ systems (respiratory, liver, cardiovascular, central nervous system, renal).
    Time Frame
    Up to Week 24
    Title
    Incidence and duration of B. anthracis bacteremia
    Description
    Incidence and duration of B. anthracis bacteremia will be summarized by total incidence across time points of subjects with bacteremia and time from study drug administration to onset of bacteremia.
    Time Frame
    Up to Week 24

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and women (including pregnant and lactating women) and children of all ages who receive obiltoxaximab as part of their clinical care for anthrax infection and are willing and able to give written informed consent themselves or through legally acceptable representative (for minors, unconscious adults or deceased subjects) to participate in the study Exclusion Criteria: There are no exclusion criteria defined for this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vice President Clinical Development
    Phone
    9192407133
    Email
    info@nighthawkbio.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Executive Director, Regulatory
    Email
    info@nighthawkbio.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vice President Clinical Development
    Organizational Affiliation
    NightHawk Biosciences
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Timothy S. Leach, MD, MPH
    Organizational Affiliation
    Contract Medical Monitor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis

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