Who is sponsoring NCT02016963?

NCT02016963 is sponsored by Human Genome Sciences Inc..

What drugs are being tested in NCT02016963?

Interventions in NCT02016963: Raxibacumab.

What condition does NCT02016963 study?

NCT02016963 studies Therapeutic Treatment of Inhalation Anthrax.

Is NCT02016963 still recruiting?

NCT02016963 is currently completed. Last updated 29 November 2018.

Are results published for NCT02016963?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-11-29 · How we verify

NCT02016963

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2, PHASE3 Results posted Last updated 29 November 2018

What this trial tests

Phase 2, PHASE3 trial testing Raxibacumab in Therapeutic Treatment of Inhalation Anthrax in 20 participants. Completed in 31 May 2008.

Timeline

31 January 2008

Primary endpoint
31 May 2008

31 May 2008

Quick facts

Lead sponsor	Human Genome Sciences Inc.
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	31 January 2008
Primary completion	31 May 2008
Estimated completion	31 May 2008

Drugs / interventions tested

Raxibacumab — full drug profile →

Conditions studied

Therapeutic Treatment of Inhalation Anthrax — all drugs for Therapeutic Treatment of Inhalation Anthrax →

Sponsor

Human Genome Sciences Inc. — full company profile →

Who can join

Adults 18 to 64, any sex, with Therapeutic Treatment of Inhalation Anthrax. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response Primary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.

Group	Value	95% CI
Raxibacumab	0

Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Me

Any AE

Group	Value	95% CI
Raxibacumab	8

Any SAE

Group	Value	95% CI
Raxibacumab	0

Number of Participants With Hematological Toxicities of the Indicated Grade Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limita

Leukocytosis, Grade 1

Group	Value	95% CI
Raxibacumab	0

Leukocytosis, Grade 2

Group	Value	95% CI
Raxibacumab	0

Leukocytosis, Grade 3

Group	Value	95% CI
Raxibacumab	0

Leukocytosis, Grade 4

Group	Value	95% CI
Raxibacumab	0

Leukopenia, Grade 1

Group	Value	95% CI
Raxibacumab	5

Leukopenia, Grade 2

Group	Value	95% CI
Raxibacumab	0

Leukopenia, Grade 3

Group	Value	95% CI
Raxibacumab	0

Leukopenia, Grade 4

Group	Value	95% CI
Raxibacumab	0

Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities is presented. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually requ

Leukocytosis, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Leukopenia, any >=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Lymphopenia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	1

Neutropenia, any >=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hemoglobin, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Platelet, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Prothrombin Time, any >=2-grade worsening

Group	Value	95% CI
Raxibacumab	1

Partial Thromboplastin Time, any>=2grade worsening

Group	Value	95% CI
Raxibacumab	1

Number of Participants With Liver Toxicities of the Indicated Grade Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in

Aspartate amino transferase (AST), Grade 1

Group	Value	95% CI
Raxibacumab	2

AST, Grade 2

Group	Value	95% CI
Raxibacumab	0

AST, Grade 3

Group	Value	95% CI
Raxibacumab	0

AST, Grade 4

Group	Value	95% CI
Raxibacumab	0

Alanine amino transferase(ALT), Grade 1

Group	Value	95% CI
Raxibacumab	1

ALT, Grade 2

Group	Value	95% CI
Raxibacumab	1

ALT, Grade 3

Group	Value	95% CI
Raxibacumab	0

ALT, Grade 4

Group	Value	95% CI
Raxibacumab	0

Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

The number of participants with at least a 2-grade worsening from Baseline in liver toxicities is presented. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical in

AST, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

ALT, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	1

GGT, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Alkaline phosphatase, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hyperbilirubinemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Number of Participants With Electrolyte Toxicities of the Indicated Grade Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitati

Hypernatremia, Grade 1

Group	Value	95% CI
Raxibacumab	0

Hypernatremia, Grade 2

Group	Value	95% CI
Raxibacumab	0

Hypernatremia, Grade 3

Group	Value	95% CI
Raxibacumab	0

Hypernatremia, Grade 4

Group	Value	95% CI
Raxibacumab	0

Hyponatremia, Grade 1

Group	Value	95% CI
Raxibacumab	2

Hyponatremia, Grade 2

Group	Value	95% CI
Raxibacumab	0

Hyponatremia, Grade 3

Group	Value	95% CI
Raxibacumab	0

Hyponatremia, Grade 4

Group	Value	95% CI
Raxibacumab	0

Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities is presented. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0.Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required;

Hypernatremia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hyponatremia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hyperkalemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hypokalemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hypomagnesemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hypercalcemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hypocalcemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hypophosphatemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Number of Participants With Other Chemistry Toxicities of the Indicated Grade Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in

Creatinine, Grade 1

Group	Value	95% CI
Raxibacumab	0

Creatinine, Grade 2

Group	Value	95% CI
Raxibacumab	0

Creatinine, Grade 3

Group	Value	95% CI
Raxibacumab	0

Creatinine, Grade 4

Group	Value	95% CI
Raxibacumab	0

Hypoalbuminemia, Grade 1

Group	Value	95% CI
Raxibacumab	0

Hypoalbuminemia, Grade 2

Group	Value	95% CI
Raxibacumab	0

Hypoalbuminemia, Grade 3

Group	Value	95% CI
Raxibacumab	0

Hypoalbuminemia, Grade 4

Group	Value	95% CI
Raxibacumab	0

Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities is presented. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually

Creatinine, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hypoalbuminemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hyperuricemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Hyperglycemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	1

Hypoglycemia, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Amylase, any>=2-grade worsening

Group	Value	95% CI
Raxibacumab	0

Number of Participants With Urinalysis Toxicities of the Indicated Grade Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activ

Group	Value	95% CI
Raxibacumab	0

Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities Secondary · From the date of the dose administration of study agent for this study (Day 0) until Day 70

Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in acti

Group	Value	95% CI
Raxibacumab	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the time the first dose of study agent (Day 0) until Day 70.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Raxibacumab

Serious: 0/20 (0%)

Deaths: —

Other adverse events (7 terms — click to expand)

Reaction	System	Raxibacumab
Headache	Nervous system disorders	—
Upper respiratory tract infection	Infections and infestations	—
Contusion	Injury, poisoning and procedural complications	—
Pain	General disorders	—
Abdominal pain	Gastrointestinal disorders	—
Joint stiffness	Musculoskeletal and connective tissue disorders	—
Dry skin	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT02016963 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Recent Advances in Monoclonal Antibody-Based Approaches in the Management of Bacterial Sepsis.
Kharga K, Kumar L, Patel SKS. · · 2023 · cited 25× · PMID 36979744 · DOI 10.3390/biomedicines11030765
A new dawn for monoclonal antibodies against antimicrobial resistant bacteria.
Troisi M, Marini E, Abbiento V, Stazzoni S, et al · · 2022 · cited 19× · PMID 36590399 · DOI 10.3389/fmicb.2022.1080059

Verify or expand the search:

Other trials of Raxibacumab

Trials testing the same drug.

NCT02339155 — Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02016963 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Human Genome Sciences Inc.
Last refreshed: 29 November 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02016963.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing