NCT03088111

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Elusys Therapeutics · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-01
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2017-03-23
• Last updated: 2023-07-14

Regulatory

• FDA-regulated drug study