Trial · NCT02016963

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

NCT02016963, Phase 2, Phase 3, Completed, Human Genome Sciences Inc.; results first posted 2014-06-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection. Trials, record NCT02016963. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02016963

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection
NCT number: NCT02016963
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 20 participants, actual
Lead sponsor: Human Genome Sciences Inc.
Conditions: Therapeutic Treatment of Inhalation Anthrax
Interventions: Raxibacumab
First posted: 2013-12-20
Last updated: 2018-11-29
Results first posted: 2014-06-25

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response	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.
Secondary	Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period	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. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.
Secondary	Number of Participants With Hematological Toxicities of the Indicated Grade	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 limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Secondary	Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities	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 required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Secondary	Number of Participants With Liver Toxicities of the Indicated Grade	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 activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Secondary	Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities	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 intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Secondary	Number of Participants With Electrolyte Toxicities of the Indicated Grade	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 limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Secondary	Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities	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; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Secondary	Number of Participants With Other Chemistry Toxicities of the Indicated Grade	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 activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Secondary	Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities	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 required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response	From the date of the dose administration of study agent for this study (Day 0) until Day 70	As-treated population : all participants who received 1 dose of study treatment.	Participants	NUMBER
SECONDARY	Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period	From the date of the dose administration of study agent for this study (Day 0) until Day 70	As-treated population	Participants	NUMBER
SECONDARY	Number of Participants With Hematological Toxicities of the Indicated Grade	From the date of the dose administration of study agent for this study (Day 0) until Day 70	As-treated population	Participants	NUMBER
SECONDARY	Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities	From the date of the dose administration of study agent for this study (Day 0) until Day 70	As-treated population	Participants	NUMBER
SECONDARY	Number of Participants With Liver Toxicities of the Indicated Grade	From the date of the dose administration of study agent for this study (Day 0) until Day 70	As-treated population	Participants	NUMBER
SECONDARY	Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities	From the date of the dose administration of study agent for this study (Day 0) until Day 70	As-treated population	Participants	NUMBER
SECONDARY	Number of Participants With Electrolyte Toxicities of the Indicated Grade	From the date of the dose administration of study agent for this study (Day 0) until Day 70	As-treated population	Participants	NUMBER
SECONDARY	Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities	From the date of the dose administration of study agent for this study (Day 0) until Day 70	As-treated population	Participants	NUMBER
SECONDARY	Number of Participants With Other Chemistry Toxicities of the Indicated Grade	From the date of the dose administration of study agent for this study (Day 0) until Day 70	As-treated population	Participants	NUMBER
SECONDARY	Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities	From the date of the dose administration of study agent for this study (Day 0) until Day 70	As-treated population	Participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group151

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response	Raxibacumab		0	Participants
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period	Raxibacumab	Any AE	8	Participants
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period	Raxibacumab	Any SAE	0	Participants
Number of Participants With Hematological Toxicities of the Indicated Grade	Raxibacumab	Leukocytosis, Grade 1	0	Participants
Number of Participants With Hematological Toxicities of the Indicated Grade	Raxibacumab	Leukocytosis, Grade 2	0	Participants
Number of Participants With Hematological Toxicities of the Indicated Grade	Raxibacumab	Leukocytosis, Grade 3	0	Participants
Number of Participants With Hematological Toxicities of the Indicated Grade	Raxibacumab	Leukocytosis, Grade 4	0	Participants
Number of Participants With Hematological Toxicities of the Indicated Grade	Raxibacumab	Leukopenia, Grade 1	5	Participants
Number of Participants With Hematological Toxicities of the Indicated Grade	Raxibacumab	Leukopenia, Grade 2	0	Participants
Number of Participants With Hematological Toxicities of the Indicated Grade	Raxibacumab	Leukopenia, Grade 3	0	Participants

1 to 10 of 151Source ClinicalTrials.gov

See all 151 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Raxibacumab	20
Overall Study	COMPLETED	Raxibacumab	20
Overall Study	NOT COMPLETED	Raxibacumab	0

Source ClinicalTrials.gov

Adverse events7

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Upper respiratory tract infection	Infections and infestations	Raxibacumab	1	20
other	Headache	Nervous system disorders	Raxibacumab	3	20
other	Contusion	Injury, poisoning and procedural complications	Raxibacumab	1	20
other	Pain	General disorders	Raxibacumab	1	20
other	Abdominal pain	Gastrointestinal disorders	Raxibacumab	1	20
other	Joint stiffness	Musculoskeletal and connective tissue disorders	Raxibacumab	1	20
other	Dry skin	Skin and subcutaneous tissue disorders	Raxibacumab	1	20

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Raxibacumab
Total, other adverse events	Raxibacumab	8	20
Total, serious adverse events	Raxibacumab	0	20

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02016963

GET https://conductscience.org/api/trials/v1/NCT02016963/results?page=2

API reference For AI assistants