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

NCT02177721 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: EBS-RAX-200137a
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infections, Bacterial

Keywords

Raxibacumab; anthrax; anti-toxin

Outcome Measures

Primary Outcomes (1)

• Evaluate Clinical Benefit of Raxibacumab for Patients with Symptomatic Inhalational Anthrax

  Evaluate the clinical benefit of raxibacumab for the treatment of inhalational anthrax disease in a mass exposure scenario such as intentional B. anthracis release during a bioterrorist attack.

  Up to Day 29

Secondary Outcomes (1)

• Evaluate Safety of Raxibacumab for Patients with Symptomatic Inhalational Anthrax

  Up to Day 29

Other Outcomes (1)

• Evaluate the Clinical Course of Disease

  Up to Day 29

Study Arms (1)

Raxibacumab arm

EXPERIMENTAL

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).

Biological: Sample Collection

Interventions

Sample Collection 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.

Raxibacumab arm

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Centers for Disease Control and Prevention: collaborator
• Biomedical Advanced Research and Development Authority: collaborator

MeSH Terms

Conditions

Bacterial Infections; Anthrax

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Bojan Drobic, PhD

  Emergent BioSolutions

  STUDY DIRECTOR

Central Study Contacts

Clinical Development Representative

CONTACT

(204) 275-4196; ct.gov@ebsi.com

Study Design

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

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: June 30, 2014
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): May 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share