Trial Outcomes & Findings for A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma (NCT NCT00783289)
NCT ID: NCT00783289
Last Updated: 2019-12-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Day 0 to Day 161
Results posted on
2019-12-27
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
|
Benralizumab 25 mg
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
|
Benralizumab 100 mg
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
|
Benralizumab 200 mg
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
|
Benralizumab 25 mg
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
|
Benralizumab 100 mg
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
|
Benralizumab 200 mg
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
|
Benralizumab 25 mg
n=7 Participants
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
|
Benralizumab 100 mg
n=6 Participants
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
|
Benralizumab 200 mg
n=6 Participants
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 11.2 • n=93 Participants
|
50.4 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
45.5 years
STANDARD_DEVIATION 13.4 • n=27 Participants
|
40.2 years
STANDARD_DEVIATION 12.5 • n=483 Participants
|
45.6 years
STANDARD_DEVIATION 12.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 161Population: Safety population included all participants who received at least 1 dose of the investigational product.
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.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
|
Benralizumab 25 mg
n=7 Participants
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
|
Benralizumab 100 mg
n=6 Participants
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
|
Benralizumab 200 mg
n=6 Participants
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
3 participants
|
4 participants
|
4 participants
|
4 participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161Population: 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.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
|
Benralizumab 25 mg
n=6 Participants
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
|
Benralizumab 100 mg
n=6 Participants
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
|
Benralizumab 200 mg
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab
|
7.00 days
Interval 7.0 to 28.0
|
7.00 days
Interval 1.0 to 7.0
|
7.00 days
Interval 7.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161Population: 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.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
|
Benralizumab 25 mg
n=6 Participants
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
|
Benralizumab 100 mg
n=6 Participants
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
|
Benralizumab 200 mg
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for Benralizumab
|
1.152 microgram per milliliter (mcg/mL)
Standard Deviation 0.615 • Interval 7.0 to 28.0
|
4.127 microgram per milliliter (mcg/mL)
Standard Deviation 1.775 • Interval 1.0 to 7.0
|
15.637 microgram per milliliter (mcg/mL)
Standard Deviation 8.062 • Interval 7.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161Population: 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.
Area under the serum concentration-time curve from time-zero extrapolated to infinity postdose.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
|
Benralizumab 25 mg
n=4 Participants
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
|
Benralizumab 100 mg
n=4 Participants
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
|
Benralizumab 200 mg
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
|
|---|---|---|---|---|
|
Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab
|
118.335 microgram*day per milliliter
Standard Deviation 69.640 • Interval 7.0 to 28.0
|
405.868 microgram*day per milliliter
Standard Deviation 205.856 • Interval 1.0 to 7.0
|
1157.013 microgram*day per milliliter
Standard Deviation 86.444 • Interval 7.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161Population: 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.
Terminal phase elimination half-life (t1/2) is the time measured for the serum concentration to decrease by one half.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
|
Benralizumab 25 mg
n=4 Participants
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
|
Benralizumab 100 mg
n=4 Participants
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
|
Benralizumab 200 mg
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
|
|---|---|---|---|---|
|
Terminal Phase Elimination Half-Life (t1/2) for Benralizumab
|
17.163 days
Standard Deviation 2.368 • Interval 7.0 to 28.0
|
18.610 days
Standard Deviation 3.905 • Interval 1.0 to 7.0
|
18.315 days
Standard Deviation 3.484 • Interval 7.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Day 0, 28, 56, 84, 112, and 161Population: Safety population included all participants who received at least 1 dose of the investigational product.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
|
Benralizumab 25 mg
n=7 Participants
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
|
Benralizumab 100 mg
n=6 Participants
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
|
Benralizumab 200 mg
n=6 Participants
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
|
|---|---|---|---|---|
|
Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at Any Visit
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Benralizumab 25 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Benralizumab 100 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Benralizumab 200 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
|
Benralizumab 25 mg
n=7 participants at risk
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
|
Benralizumab 100 mg
n=6 participants at risk
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
|
Benralizumab 200 mg
n=6 participants at risk
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/6 • Day 0 to Day 161
|
14.3%
1/7 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
|
Infections and infestations
Oral candidiasis
|
33.3%
2/6 • Number of events 2 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/6 • Day 0 to Day 161
|
14.3%
1/7 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
33.3%
2/6 • Number of events 2 • Day 0 to Day 161
|
|
Infections and infestations
Viral infection
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Injury, poisoning and procedural complications
Muscle strain
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • Day 0 to Day 161
|
14.3%
1/7 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
14.3%
1/7 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • Day 0 to Day 161
|
14.3%
1/7 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Investigations
Troponin i increased
|
0.00%
0/6 • Day 0 to Day 161
|
14.3%
1/7 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Day 0 to Day 161
|
14.3%
1/7 • Number of events 2 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
33.3%
2/6 • Number of events 2 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Day 0 to Day 161
|
28.6%
2/7 • Number of events 3 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
16.7%
1/6 • Number of events 2 • Day 0 to Day 161
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Day 0 to Day 161
|
14.3%
1/7 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
16.7%
1/6 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/7 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Day 0 to Day 161
|
14.3%
1/7 • Number of events 1 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
0.00%
0/6 • Day 0 to Day 161
|
Additional Information
Rene van der Merwe, MBChB/Senior Director, Clinical Development
MedImmune, LLC.
Phone: 301-398-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER