Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma
ALIZE
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma.
1 other identifier
interventional
103
1 country
24
Brief Summary
This is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab administered subcutaneously (SC) on antibody responses following seasonal influenza virus vaccination
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Jul 2016
Shorter than P25 for phase_3 asthma
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
June 28, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2017
CompletedResults Posted
Study results publicly available
March 1, 2018
CompletedOctober 24, 2018
October 1, 2018
7 months
June 15, 2016
December 12, 2017
October 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12
To compare the geometric mean fold rises in influenza strain-specific hemagglutination-inhibition responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo. Geometric mean fold rise was defined as antilog(z) (mean \[log(z) x\]), where "x" is the postdose HAI antibody titer fold rise from Week 8 and "z" is the natural logarithm.
4 weeks
Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12
To compare the geometric mean titers of hemagglutination-inhibition antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
12 weeks
Proportion of Patients Who Experienced a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Hemagglutination-inhibition Antibody Titer From Week 8 to Week 12
To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in hemagglutination-inhibition antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
4 weeks
Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12
To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥40-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
12 weeks
Secondary Outcomes (5)
Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12
12 weeks
Postdose Strain-specific Microneutralization Antibody Geometric Mean Fold Rise From Week 8 to Week 12
4 weeks
Postdose Strain-specific Serum Microneutralization Antibody Geometric Mean Titers Obtained at Week 12
12 weeks
Proportion of Patients Who Experience a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Microneutralization Antibody Titer From Week 8 to Week 12
4 weeks
Change From Baseline in Mean Asthma Control Questionnaire 6 (ACQ-6) Score at Week 12
12 weeks
Study Arms (2)
Benralizumab
EXPERIMENTAL1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Placebo
PLACEBO COMPARATOR1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Interventions
Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Eligibility Criteria
You may qualify if:
- Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1
- Weight of ≥40 kg
- Documented history of current treatment with Inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA)
- Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of \>50% predicted at Visit 1 or Visit 2.
- Airway reversibility (FEV1 \>12% and 200 ml) demonstrated at Visit 1 or Visit 2 using the Maximum Post-bronchodilator Procedure OR
- Airway reversibility documented in the previous 12 months prior to Visit 1
- An exacerbation, 1 or more, that required oral corticosteroids in the previous year OR
- Any condition assessed by patient recall over the previous 2-4 weeks
You may not qualify if:
- Clinically important pulmonary disease other than asthma
- Known history of allergy or reaction to the Investigational Product formulation or influenza vaccine
- Receipt of an influenza vaccine within 90 days prior to randomization
- Poorly controlled asthma during the screening period that requires treatment with oral corticosteroids or a hospitalization/emergency room visit for the treatment of asthma
- Acute illness or evidence of significant active infection or known influenza infection during the current flu season
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (24)
Research Site
Birmingham, Alabama, 35209, United States
Research Site
Mesa, Arizona, 85206, United States
Research Site
Huntington Beach, California, 92647, United States
Research Site
Newport Beach, California, 92663, United States
Research Site
Aurora, Colorado, 80012-4016, United States
Research Site
Colorado Springs, Colorado, 80907, United States
Research Site
Denver, Colorado, 80230, United States
Research Site
Aventura, Florida, 33180, United States
Research Site
Miami, Florida, 33135, United States
Research Site
Miami, Florida, 33173, United States
Research Site
Minneapolis, Minnesota, 55402, United States
Research Site
Bellevue, Nebraska, 68123, United States
Research Site
Northfield, New Jersey, 08225, United States
Research Site
Edmond, Oklahoma, 73034, United States
Research Site
Oklahoma City, Oklahoma, 73103, United States
Research Site
Medford, Oregon, 97504, United States
Research Site
North Charleston, South Carolina, 29420, United States
Research Site
Arlington, Texas, 76018, United States
Research Site
El Paso, Texas, 79903, United States
Research Site
New Braunfels, Texas, 78130, United States
Research Site
San Antonio, Texas, 78221, United States
Research Site
San Antonio, Texas, 78251, United States
Research Site
Waco, Texas, 76712, United States
Research Site
Clinton, Utah, 84015, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mitchell Goldman MD, PhD
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela L Zeitlin, M.D. Ph.D.
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2016
First Posted
June 28, 2016
Study Start
July 1, 2016
Primary Completion
January 24, 2017
Study Completion
January 24, 2017
Last Updated
October 24, 2018
Results First Posted
March 1, 2018
Record last verified: 2018-10