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

NCT ID: NCT02177721

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-31
• Study Completion Date: 2035-12-31

Brief Summary

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.

Detailed Description

The protocol is a post-marketing requirement from the FDA to evaluate the clinical benefit and safety of raxibacumab administered to patients with symptomatic inhalational anthrax as part of their medical care following a mass exposure scenario to Bacillus anthracis.

Conditions

Infections, Bacterial

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Raxibacumab arm

This is an open-label, single arm study. The study will be implemented for subjects with symptomatic inhalational anthrax who receive FDA-approved raxibacumab as part of medical treatment of anthrax following a mass exposure scenario.

Intervention: Sampling of subjects or use of subjects salvaged standard of care samples may be considered for the following assessments (if available/applicable): analysis of antibodies to PA (anti-PA), protective antigen (PA), and lethal factor (LF).

Group Type: EXPERIMENTAL

Sample Collection

Intervention Type: BIOLOGICAL

Whenever possible serum samples will be collected from all subjects to determine serum raxibacumab concentrations pre-infusion, and at specific timepoints post-infusion. In the event cerebrospinal fluid (CSF), pleural, ascites, or bronchoalveolar lavage (BAL) fluid are collected for ad hoc clinical laboratory testing, any remaining excess sample will be provided to Sponsor for determination of raxibacumab concentrations.

Any available serum remaining from ad hoc clinical laboratory specimen collections prior to raxibacumab administration will be provided to Sponsor for measurement of serum PA concentrations. In addition, remaining post raxibacumab dose serum specimens may also be analyzed for lethal factor (LF) levels.

Interventions

Sample Collection

Whenever possible serum samples will be collected from all subjects to determine serum raxibacumab concentrations pre-infusion, and at specific timepoints post-infusion. In the event cerebrospinal fluid (CSF), pleural, ascites, or bronchoalveolar lavage (BAL) fluid are collected for ad hoc clinical laboratory testing, any remaining excess sample will be provided to Sponsor for determination of raxibacumab concentrations.

Any available serum remaining from ad hoc clinical laboratory specimen collections prior to raxibacumab administration will be provided to Sponsor for measurement of serum PA concentrations. In addition, remaining post raxibacumab dose serum specimens may also be analyzed for lethal factor (LF) levels.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Symptomatic inhalational anthrax linked to an identified mass exposure to B. anthracis.
• Women, including pregnant and lactating women, men, and children of all ages who receive a dose of raxibacumab from the Strategic National Stockpile (SNS) as part of their clinical care for symptomatic inhalational anthrax will be eligible to enroll in this study.
• Patients willing and able to adhere to the procedures stated in the protocol.
• Patients (or legally acceptable representative of minors and unconscious adults) willing and able to give written informed consent/assent (as applicable) to participate in the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Emergent BioSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bojan Drobic, PhD

Role: STUDY_DIRECTOR

Emergent BioSolutions

Central Contacts

Clinical Development Representative

Role: CONTACT

ct.gov@ebsi.com

(204) 275-4196

Other Identifiers

EBS-RAX-200137a

Identifier Type: -

Identifier Source: org_study_id