Phase 3 N=20 Treatment

An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection

Therapeutic Treatment of Inhalation Anthrax

Bottom Line

View on ClinicalTrials.gov: NCT02016963 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Raxibacumab (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Human Genome Sciences Inc.
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response	—	—
SECONDARY Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period	8; 0	—
SECONDARY Number of Participants With Hematological Toxicities of the Indicated Grade	0; 0; 0; 0; 5; 0	—
SECONDARY Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities	0; 0; 1; 0; 0; 0	—
SECONDARY Number of Participants With Liver Toxicities of the Indicated Grade	2; 0; 0; 0; 1; 1	—
SECONDARY Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities	0; 1; 0; 0; 0	—
SECONDARY Number of Participants With Electrolyte Toxicities of the Indicated Grade	0; 0; 0; 0; 2; 0	—
SECONDARY Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Other Chemistry Toxicities of the Indicated Grade	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities	0; 0; 0; 1; 0; 0	—
SECONDARY Number of Participants With Urinalysis Toxicities of the Indicated Grade	—	—
SECONDARY Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities	—	—
SECONDARY Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose	1.358; 979.078; 865.874; 784.122; 580.068; 418.253	—

Summary

This is an open-label study to evaluate the immunogenicity and safety of raxibacumab in healthy adult male and female subjects. Subjects who have received raxibacumab >= 4 months ago will be enrolled and dosed as follows: A maximum of 25 subjects (to include 3 evaluable female subjects) will receive a second dose of raxibacumab equal to that of the previous dose >= 4 months following the first dose. Subjects will remain in house from Day 0 until Day 1 and will be followed for 70 days after receiving the second dose of raxibacumab. Raxibacumab has been shown to provide improved survival in rabbit and monkey anthrax spore challenge studies. Preliminary data from our rabbit pivotal efficacy study showed significant survival benefit for raxibacumab over placebo. Exposure to anthrax and resulting clinical disease can occur more than once, especially in individuals who do not develop protective immunity. Hence, if clinically indicated for the treatment of anthrax, there may be a requirement for the repeat administration of raxibacumab. The rationale of the study is to evaluate the immunogenicity and safety of repeat administration of raxibacumab with a >= 4 month interval between dosing.

Eligibility Criteria

Inclusion Criteria

Enrolled and treated with raxibacumab in another HGS protocol, >= 4 months ago.
Male or female >= 18 and = 4 months ago), prior treatment for anthrax exposure, or a confirmed anthrax infection.
History of Type I hypersensitivity reaction to food or drugs, intravenous (IV) contrast dye, or history of urticaria.
Previous hypersensitivity to raxibacumab.
Previous serious or Grade 3 or greater raxibacumab related adverse event (AE).
Drug or alcohol addiction within the last 12 months. Subjects who have documented addiction free period of at least 12 months and in the clinical judgement of the investigator are not at risk for relapse may be enrolled in the study.
Evidence of active or suspected malignancy or history of malignancy within the last 5 years (with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix).
Participation in any other clinical trials of an investigational compound within 60 days of initiating study agent or refusal to refrain from participation during this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02016963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.