Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario

This field study is designed such that it may be implemented for any individual with symptomatic inhalational anthrax who has been administered raxibacumab for treatment of anthrax following a mass exposure scenario. This study is designed to describe the clinical effectiveness (including course of illness and survival) and safety profile from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study is anticipated to be collected retrospectively. During such a mass anthrax event, scavenged blood samples will be utilized where possible to maximize sample analyses and other investigational parameters. Therefore, both retrospective and prospective data collection are allowed in this protocol in order to maximize the amount of information obtained in subjects who have been administered raxibacumab. This field study will be the first opportunity to collect data on B. anthracis-exposed patients treated with raxibacumab, to better understand the clinical benefit and safety of the drug and to further inform patient care and treatment choices for management of anthrax.

NCT Number	NCT02177721
Lead Sponsor	Emergent BioSolutions Collaborators: Centers for Disease Control and Prevention, Biomedical Advanced Research and Development Authority
Conditions	Infections, Bacterial
Enrollment	100 participants
Start Date	2027-01
Primary Completion	2035-05 (estimated)
Study Completion	2035-12 (estimated)
Updated on ClinicalTrials.gov	2026-02-06