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

NCT03088111 | Unknown Phase 4 FDA Drug

• 2 other identifiers: AH501HHSO100201100034C
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infection, Bacterial; Anthrax

Keywords

Anthim®; Obiltoxaximab; anthrax; anti-toxin

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to Week 24

Secondary Outcomes (5)

• Survival at Day 14 and Day 28

  Up to Day 28

• Duration of survival (to Week 24)

  Up to Week 24

• Disease progression and associated complications rates of anthrax (meningitis, pleural effusion, ventilator support) (to Week 24)

  Up to Week 24

• Modified SOFA score (to Week 24)

  Up to Week 24

• Incidence and duration of B. anthracis bacteremia

  Up to Week 24

Study Arms (1)

Obiltoxaximab

OTHER

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; Biological: Obiltoxaximab

Interventions

Collection of samples OTHER

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).

Obiltoxaximab

Obiltoxaximab BIOLOGICAL

Obiltoxaximab standard of care

Also known as: Anthim

Obiltoxaximab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Elusys Therapeutics: lead
• Centers for Disease Control and Prevention: collaborator
• APCER Life Sciences: collaborator

MeSH Terms

Conditions

Bacterial Infections; Anthrax

Interventions

obiltoxaximab

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Bacillaceae Infections; Gram-Positive Bacterial Infections

Study Officials

• Vice President Clinical Development

  NightHawk Biosciences

  STUDY DIRECTOR

• Timothy S. Leach, MD, MPH

  Contract Medical Monitor

  STUDY DIRECTOR

Central Study Contacts

Vice President Clinical Development

CONTACT

9192407133; info@nighthawkbio.com

Executive Director, Regulatory

CONTACT

info@nighthawkbio.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 23, 2017
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: July 14, 2023

Record last verified: 2023-07