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

Infection, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03088111
• Other study ID #: AH501
• Secondary ID: HHSO100201100034
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2023
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Elusys Therapeutics
• Contact: Vice President Clinical Development
• Phone: 9192407133
• Email: info[@]nighthawkbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• There are no exclusion criteria defined for this study

Related Conditions & MeSH terms

• Anthrax
• Bacterial Infections
• Infection, Bacterial

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Elusys Therapeutics	APCER Life Sciences, Centers for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival at Day 14 and Day 28	Population survival rates at 14 and 28 days will be estimated using the KM method.	Up to Day 28
Secondary	Duration of survival (to Week 24)	The KM method will be used to estimate duration of survival.	Up to Week 24
Secondary	Disease progression and associated complications rates of anthrax (meningitis, pleural effusion, ventilator support) (to Week 24)	The progression to systemic anthrax infection and complication rates will be summarized using KM estimates associated with time to disease progression and time to complication of anthrax. The population SDFs of time to progression to systemic anthrax infection and of time to complication will be estimated using the KM method. Summary statistics of subjects with disease progression and complication rates will be provided.	Up to Week 24
Secondary	Modified SOFA score (to Week 24)	Modified sequential organ failure assessment (SOFA) scores will be assessed using 5 organ systems (respiratory, liver, cardiovascular, central nervous system, renal).	Up to Week 24
Secondary	Incidence and duration of B. anthracis bacteremia	Incidence and duration of B. anthracis bacteremia will be summarized by total incidence across time points of subjects with bacteremia and time from study drug administration to onset of bacteremia.	Up to Week 24