Trial Outcomes & Findings for Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics (NCT NCT02821416)
NCT ID: NCT02821416
Last Updated: 2021-01-07
Results Overview
To evaluate the effect of benralizumab on allergen-induced increases in eosinophils in induced sputum
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
46 participants
Primary outcome timeframe
From prechallenge to 7 hours post allergen challenge during week 9
Results posted on
2021-01-07
Participant Flow
Participant milestones
| Measure |
Benra 30mg q.4 Week
Benralizumab 30mg every 4 Weeks
|
Placebo
Placebo every 4 Weeks
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Benra 30mg q.4 Week
Benralizumab 30mg every 4 Weeks
|
Placebo
Placebo every 4 Weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
Baseline characteristics by cohort
| Measure |
Benra 30mg q.4 Week
n=23 Participants
Benralizumab 30mg every 4 Weeks
|
Placebo
n=23 Participants
Placebo every 4 Weeks
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.4 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
31.5 Years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
30.9 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Age, Customized
>=18 - <=50
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Customized
>50 - <=65
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Customized
>65 - <=75
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From prechallenge to 7 hours post allergen challenge during week 9Population: Primary Efficacy Analysis
To evaluate the effect of benralizumab on allergen-induced increases in eosinophils in induced sputum
Outcome measures
| Measure |
Benra 30mg q.4 Weeks
n=23 Participants
Benralizumab 30 mg every 4 Weeks
|
Placebo
n=22 Participants
Placebo every 4 Weeks
|
|---|---|---|
|
Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge
|
0.822 Percent
Standard Deviation 4.054
|
6.468 Percent
Standard Deviation 9.560
|
PRIMARY outcome
Timeframe: From prechallenge to 3 to 7 hours post allergen challenge during week 9Population: Primary Efficacy Analysis
To evaluate the effect of benralizumab on the allergen-induced late (3-7 hours post challenge) asthmatic response (LAR)
Outcome measures
| Measure |
Benra 30mg q.4 Weeks
n=23 Participants
Benralizumab 30 mg every 4 Weeks
|
Placebo
n=22 Participants
Placebo every 4 Weeks
|
|---|---|---|
|
Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge
|
15.152 Percent
Standard Deviation 8.834
|
16.275 Percent
Standard Deviation 10.235
|
Adverse Events
Benra 30mg q.4 Week
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Benra 30mg q.4 Week
n=23 participants at risk
Benralizumab 30mg every 4 Weeks
|
Placebo
n=23 participants at risk
Placebo every 4 Weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
General disorders
Catheter site haematoma
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
General disorders
Injection site pain
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
General disorders
Malaise
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Hepatobiliary disorders
Nonalcoholic fatty liver disease
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • From Visit 1a to Visit 17
|
8.7%
2/23 • Number of events 3 • From Visit 1a to Visit 17
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Infections and infestations
Influenza
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
13.0%
3/23 • Number of events 3 • From Visit 1a to Visit 17
|
|
Infections and infestations
Periodontitis
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Infections and infestations
Tooth infection
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Infections and infestations
Viral infection
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
13.0%
3/23 • Number of events 3 • From Visit 1a to Visit 17
|
|
Nervous system disorders
Migraine
|
4.3%
1/23 • Number of events 2 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Nervous system disorders
Presyncope
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 3 • From Visit 1a to Visit 17
|
|
Nervous system disorders
Syncope
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/23 • From Visit 1a to Visit 17
|
8.7%
2/23 • Number of events 2 • From Visit 1a to Visit 17
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 3 • From Visit 1a to Visit 17
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
1/23 • Number of events 2 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
Vascular disorders
Flushing
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
0.00%
0/23 • From Visit 1a to Visit 17
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/23 • From Visit 1a to Visit 17
|
4.3%
1/23 • Number of events 1 • From Visit 1a to Visit 17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60