Trial · NCT01238861
Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
NCT01238861, Phase 2, Completed, MedImmune LLC; results first posted 2016-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma. Trials, record NCT01238861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01238861
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
- NCT number
- NCT01238861
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 964 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Asthma
- Interventions
- Benralizumab 2 mg, Benralizumab 20 mg, Benralizumab 100 mg, Placebo
- First posted
- 2010-11-11
- Last updated
- 2016-11-17
- Other registries' IDs
- eudract:2010-020126-17
- Results first posted
- 2016-11-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants | Week 1 up to Week 52 | The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1. |
| Secondary | Dose Response in EOS+ Participants | Baseline up to Week 66 | |
| Secondary | Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss) | Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52 | |
| Secondary | Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD) | Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52 | |
| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants | Baseline up to Week 92 | Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer \>=50 at any point in the study. It was observed at baseline and any visit during the study. |
| Secondary | Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52 | Baseline up to Week 52 | Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants. |
| Secondary | Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52 | Baseline up to Week 52 | Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
| Secondary | Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52 | Baseline up to Week 51-52 | Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
| Secondary | Change From Baseline in Rescue Medication Use at Week 51-52 | Baseline up to Week 51-52 | Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores. |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52 | Baseline and Week 52 | FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants | Week 1 up to Week 52 | The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product. | AER events/person-year | NUMBER |
| SECONDARY | Dose Response in EOS+ Participants | Baseline up to Week 66 | Due to change in planned analysis after unblinding of study data, dose response was not performed. | ||
| SECONDARY | Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss) | Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52 | The Pharmacokinetic (PK) Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group. | microgram per milliliter | MEAN |
| SECONDARY | Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD) | Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52 | The PK Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group. | microgram per milliliter | MEAN |
| SECONDARY | Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants | Baseline up to Week 92 | The mITT population included all randomized participants who received any dose of investigational product. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52 | Baseline up to Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52 | Baseline up to Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52 | Baseline up to Week 51-52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Rescue Medication Use at Week 51-52 | Baseline up to Week 51-52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms. | rescue medication per 2 weeks | MEAN |
| SECONDARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52 | Baseline and Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | liters | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants | Eosinophilic Phenotype (EOS+) Placebo | 0.57 | AER events/person-year | ||
| Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants | EOS+ Benralizumab, 2 mg | 0.65 | AER events/person-year | ||
| Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants | EOS+ Benralizumab, 20 mg | 0.37 | AER events/person-year | ||
| Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants | EOS+ Benralizumab, 100 mg | 0.34 | AER events/person-year | ||
| Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss) | EOS+ Benralizumab, 2 mg | 34.7 | Standard Deviation 131 | microgram per milliliter | |
| Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss) | EOS+ Benralizumab, 20 mg | 182 | Standard Deviation 180 | microgram per milliliter | |
| Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss) | Benralizumab, 100 mg | 869 | Standard Deviation 665 | microgram per milliliter | |
| Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD) | EOS+ Benralizumab, 2 mg | 17.3 | Standard Deviation 65.3 | microgram per milliliter | |
| Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD) | EOS+ Benralizumab, 20 mg | 9.10 | Standard Deviation 9.02 | microgram per milliliter | |
| Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD) | Benralizumab, 100 mg | 8.69 | Standard Deviation 6.65 | microgram per milliliter |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eosinophilic Phenotype (EOS+) Placebo | 80 | |
| Overall Study | STARTED | EOS+ Benralizumab, 2 mg | 81 | |
| Overall Study | STARTED | EOS+ Benralizumab, 20 mg | 81 | |
| Overall Study | STARTED | EOS+ Benralizumab, 100 mg | 82 | |
| Overall Study | STARTED | Non-eosinophil Phenotype (EOS-) Placebo | 142 | |
| Overall Study | STARTED | EOS- Benralizumab, 100 mg | 140 | |
| Overall Study | COMPLETED | Eosinophilic Phenotype (EOS+) Placebo | 69 | |
| Overall Study | COMPLETED | EOS+ Benralizumab, 2 mg | 73 | |
| Overall Study | COMPLETED | EOS+ Benralizumab, 20 mg | 70 | |
| Overall Study | COMPLETED | EOS+ Benralizumab, 100 mg | 69 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events438
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 | Injection site erythema | General disorders | EOS POS Placebo | 0 | 80 | 0 |
| other | Injection site erythema | General disorders | EOS POS Benralizumab 2 mg | 2 | 81 | 2 |
| other | Injection site erythema | General disorders | EOS POS Benralizumab 20 mg | 2 | 81 | 4 |
| other | Injection site erythema | General disorders | EOS POS Benralizumab 100 mg | 8 | 82 | 17 |
| other | Injection site erythema | General disorders | EOS NEG Placebo | 0 | 141 | 0 |
| other | Injection site erythema | General disorders | EOS NEG Benralizumab 100 mg | 10 | 141 | 17 |
| other | Influenza | Infections and infestations | EOS POS Placebo | 4 | 80 | 4 |
| other | Influenza | Infections and infestations | EOS POS Benralizumab 2 mg | 3 | 81 | 5 |
| other | Influenza | Infections and infestations | EOS POS Benralizumab 20 mg | 7 | 81 | 7 |
| other | Influenza | Infections and infestations | EOS POS Benralizumab 100 mg | 6 | 82 | 6 |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EOS POS Placebo | ||
| Total, all-cause mortality | EOS POS Benralizumab 2 mg | ||
| Total, all-cause mortality | EOS POS Benralizumab 20 mg | ||
| Total, all-cause mortality | EOS POS Benralizumab 100 mg | ||
| Total, all-cause mortality | EOS NEG Placebo | ||
| Total, all-cause mortality | EOS NEG Benralizumab 100 mg | ||
| Total, other adverse events | EOS POS Placebo | 44 | 80 |
| Total, other adverse events | EOS POS Benralizumab 2 mg | 54 | 81 |
| Total, other adverse events | EOS POS Benralizumab 20 mg | 57 | 81 |
| Total, other adverse events | EOS POS Benralizumab 100 mg | 68 | 82 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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