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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03088111
Recruitment Status : Not yet recruiting
First Posted : March 23, 2017
Last Update Posted : February 7, 2019
Department of Health and Human Services
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Elusys Therapeutics

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.

Condition or disease Intervention/treatment Phase
Infection, Bacterial Anthrax Other: Collection of samples Biological: Obiltoxaximab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anthrax

Arm Intervention/treatment

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).

Other: Collection of samples
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).

Biological: Obiltoxaximab
Obiltoxaximab standard of care
Other Name: Anthim

Primary Outcome Measures :
  1. Overall survival in suspected, probable, or confirmed cases of inhalational anthrax at Week 24 [ Time Frame: Up to 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 :
  1. Survival at Day 14 and Day 28 [ Time Frame: Up to Day 28 ]
    Population survival rates at 14 and 28 days will be estimated using the KM method.

  2. Duration of survival (to Week 24) [ Time Frame: Up to Week 24 ]
    The KM method will be used to estimate duration of survival.

  3. Disease progression and associated complications rates of anthrax (meningitis, pleural effusion, ventilator support) (to Week 24) [ Time Frame: Up 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.

  4. Modified SOFA score (to Week 24) [ Time Frame: Up to Week 24 ]
    Modified sequential organ failure assessment (SOFA) scores will be assessed using 5 organ systems (respiratory, liver, cardiovascular, central nervous system, renal).

  5. Incidence and duration of B. anthracis bacteremia [ Time Frame: Up to Week 24 ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03088111

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Contact: : Angela Williamson 919-558-3660
Contact: Steven Warthan 910-558-6759

Sponsors and Collaborators
Elusys Therapeutics
Department of Health and Human Services
Centers for Disease Control and Prevention
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Study Director: Christa Nagy, PhD Elusys Therapeutics, Inc.
Study Director: Timothy S. Leach, MD, MPH Contract Medical Monitor

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Responsible Party: Elusys Therapeutics Identifier: NCT03088111     History of Changes
Other Study ID Numbers: AH501
HHSO100201100034C ( Other Grant/Funding Number: Biomedical Advanced Research and Development Authority )
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elusys Therapeutics:
Additional relevant MeSH terms:
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Bacterial Infections
Bacillaceae Infections
Gram-Positive Bacterial Infections
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs