Trial · NCT00783289
A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma
NCT00783289, Phase 2, Completed, MedImmune LLC; results first posted 2019-12-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma. Trials, record NCT00783289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00783289
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma
- NCT number
- NCT00783289
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Asthma
- Interventions
- Placebo, Benralizumab 25 mg, Benralizumab 100 mg, Benralizumab 200 mg
- First posted
- 2008-10-31
- Last updated
- 2019-12-27
- Results first posted
- 2019-12-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 0 to Day 161 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 161 that were absent before treatment or that worsened relative to pre-treatment state. |
| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab | Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 | |
| Secondary | Maximum Observed Serum Concentration (Cmax) for Benralizumab | Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 | |
| Secondary | Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab | Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 | Area under the serum concentration-time curve from time-zero extrapolated to infinity postdose. |
| Secondary | Terminal Phase Elimination Half-Life (t1/2) for Benralizumab | Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 | Terminal phase elimination half-life (t1/2) is the time measured for the serum concentration to decrease by one half. |
| Secondary | Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at Any Visit | Day 0, 28, 56, 84, 112, and 161 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 0 to Day 161 | Safety population included all participants who received at least 1 dose of the investigational product. | participants | NUMBER |
| SECONDARY | Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab | Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 | Safety population included all participants who received at least 1 dose of the investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | days | MEDIAN |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) for Benralizumab | Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 | Safety population included all participants who received at least 1 dose of the investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | microgram per milliliter (mcg/mL) | MEAN |
| SECONDARY | Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab | Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 | Safety population included all participants who received at least 1 dose of the investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | microgram*day per milliliter | MEAN |
| SECONDARY | Terminal Phase Elimination Half-Life (t1/2) for Benralizumab | Day 0, 1, 7, 28, 35, 56, 84, 112, and 161 | Safety population included all participants who received at least 1 dose of the investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | days | MEAN |
| SECONDARY | Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at Any Visit | Day 0, 28, 56, 84, 112, and 161 | Safety population included all participants who received at least 1 dose of the investigational product. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Placebo | TEAEs | 3 | participants | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Benralizumab 25 mg | TEAEs | 4 | participants | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Benralizumab 100 mg | TEAEs | 4 | participants | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Benralizumab 200 mg | TEAEs | 4 | participants | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Placebo | TESAEs | 0 | participants | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Benralizumab 25 mg | TESAEs | 0 | participants | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Benralizumab 100 mg | TESAEs | 0 | participants | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Benralizumab 200 mg | TESAEs | 0 | participants | |
| Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab | Benralizumab 25 mg | 7.00 | Full Range 7.00 to 28.00 | days | |
| Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab | Benralizumab 100 mg | 7.00 | Full Range 1.00 to 7.00 | days |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | STARTED | Benralizumab 25 mg | 7 | |
| Overall Study | STARTED | Benralizumab 100 mg | 6 | |
| Overall Study | STARTED | Benralizumab 200 mg | 6 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | COMPLETED | Benralizumab 25 mg | 6 | |
| Overall Study | COMPLETED | Benralizumab 100 mg | 6 | |
| Overall Study | COMPLETED | Benralizumab 200 mg | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Benralizumab 25 mg | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events104
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 | Events |
|---|---|---|---|---|---|---|
| other | Pyrexia | General disorders | Placebo | 0 | 6 | 0 |
| other | Pyrexia | General disorders | Benralizumab 25 mg | 0 | 7 | 0 |
| other | Pyrexia | General disorders | Benralizumab 100 mg | 0 | 6 | 0 |
| other | Pyrexia | General disorders | Benralizumab 200 mg | 1 | 6 | 1 |
| other | Bronchitis bacterial | Infections and infestations | Placebo | 0 | 6 | 0 |
| other | Bronchitis bacterial | Infections and infestations | Benralizumab 25 mg | 1 | 7 | 1 |
| other | Bronchitis bacterial | Infections and infestations | Benralizumab 100 mg | 0 | 6 | 0 |
| other | Bronchitis bacterial | Infections and infestations | Benralizumab 200 mg | 0 | 6 | 0 |
| other | Gastrointestinal viral infection | Infections and infestations | Placebo | 0 | 6 | 0 |
| other | Gastrointestinal viral infection | Infections and infestations | Benralizumab 25 mg | 0 | 7 | 0 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Benralizumab 25 mg | ||
| Total, all-cause mortality | Benralizumab 100 mg | ||
| Total, all-cause mortality | Benralizumab 200 mg | ||
| Total, other adverse events | Placebo | 3 | 6 |
| Total, other adverse events | Benralizumab 25 mg | 4 | 7 |
| Total, other adverse events | Benralizumab 100 mg | 4 | 6 |
| Total, other adverse events | Benralizumab 200 mg | 4 | 6 |
| Total, serious adverse events | Placebo | 0 | 6 |
| Total, serious adverse events | Benralizumab 25 mg | 0 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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/NCT00783289
GET https://conductscience.org/api/trials/v1/NCT00783289/results?page=2