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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)

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ClinicalTrials.gov Identifier: NCT02814643
Recruitment Status : Completed
First Posted : June 28, 2016
Results First Posted : March 1, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Asthma
Interventions Drug: Benralizumab
Drug: Benralizumab Placebo
Drug: Seasonal influenza virus vaccine
Enrollment 103
Recruitment Details This study was conducted at 30 study centers in the United States between 01 July 2016 and 24 January 2017
Pre-assignment Details The study duration was up to 23 weeks, consisting of an initial screening period lasting up to 3 weeks, a 12-week treatment period, and a follow-up visit 8 weeks after the last dose of study drug
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description Benralizumab 30mg/day subcutaneous Placebo to benralizumab subcutaneous
Period Title: Overall Study
Started 51 52
Completed 50 49
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             1             2
Arm/Group Title Benralizumab 30mg Placebo Total
Hide Arm/Group Description Benralizumab 30mg/day subcutaneous Placebo to benralizumab subcutaneous Total of all reporting groups
Overall Number of Baseline Participants 51 52 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 52 participants 103 participants
16.0  (2.65) 15.7  (2.99) 15.9  (2.82)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
≥12 to ≤17 36 36 72
≥18 to ≤21 15 16 31
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
Female 21 21 42
Male 30 31 61
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
American Indian Or Alaska Native 0 1 1
Black Or African American 13 13 26
Other 0 2 2
White 38 36 74
1.Primary Outcome
Title Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine immunogenicity analysis set included all randomized patients who received ≥1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or microneutralization antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description:
Benralizumab 30mg/day subcutaneous
Placebo to benralizumab subcutaneous
Overall Number of Participants Analyzed 50 49
Geometric Least Squares Mean (Standard Error)
Unit of Measure: Fold change
Influenza A H1N1 3.60  (1.22) 3.13  (1.22)
Influenza A H3N2 3.25  (1.18) 3.85  (1.18)
Influenza B Yamagata lineage 3.42  (1.16) 3.17  (1.16)
Influenza B Victoria lineage 4.08  (1.19) 3.27  (1.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg, Placebo
Comments Influenza A H1N1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.
Method of Estimation Estimation Parameter Geometric least-square mean ratio
Estimated Value 0.87
Confidence Interval (2-Sided) 90%
0.56 to 1.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg, Placebo
Comments Influenza A H3N2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.
Method of Estimation Estimation Parameter Geometric least-square mean ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 90%
0.82 to 1.71
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg, Placebo
Comments Influenza B Yamagata lineage
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.
Method of Estimation Estimation Parameter Geometric least-square mean ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 90%
0.67 to 1.29
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg, Placebo
Comments Influenza B Victoria lineage
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.
Method of Estimation Estimation Parameter Geometric least-square mean ratio
Estimated Value 0.80
Confidence Interval (2-Sided) 90%
0.54 to 1.19
Estimation Comments [Not Specified]
2.Primary Outcome
Title Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description:
Benralizumab 30mg/day subcutaneous
Placebo to benralizumab subcutaneous
Overall Number of Participants Analyzed 50 49
Geometric Least Squares Mean (Standard Error)
Unit of Measure: Antibody titer
Influenza A H1N1 521.06  (1.13) 518.60  (1.13)
Influenza A H3N2 170.73  (1.15) 219.35  (1.15)
Influenza B Yamagata lineage 61.47  (1.13) 63.15  (1.13)
Influenza B Victoria lineage 53.10  (1.14) 66.85  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg, Placebo
Comments Influenza A H1N1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.
Method of Estimation Estimation Parameter Geometric least-square mean ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 90%
0.76 to 1.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg, Placebo
Comments Influenza A H3N2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.
Method of Estimation Estimation Parameter Geometric least-square mean ratio
Estimated Value 1.28
Confidence Interval (2-Sided) 90%
0.93 to 1.77
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg, Placebo
Comments Influenza B Yamagata lineage
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.
Method of Estimation Estimation Parameter Geometric least-square mean ratio
Estimated Value 1.03
Confidence Interval 90%
0.79 to 1.34
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg, Placebo
Comments Influenza B Victoria lineage
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.
Method of Estimation Estimation Parameter Geometric least-square mean ratio
Estimated Value 1.26
Confidence Interval 90%
0.93 to 1.70
Estimation Comments [Not Specified]
3.Primary Outcome
Title 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
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description:
Benralizumab 30mg/day subcutaneous
Placebo to benralizumab subcutaneous
Overall Number of Participants Analyzed 50 49
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Proportion of Participants
Influenza A H1N1
0.440
(0.32 to 0.57)
0.306
(0.20 to 0.43)
Influenza A H3N2
0.500
(0.38 to 0.62)
0.490
(0.37 to 0.62)
Influenza B Yamagata lineage
0.480
(0.36 to 0.60)
0.490
(0.37 to 0.62)
Influenza B Victoria lineage
0.560
(0.43 to 0.68)
0.408
(0.29 to 0.54)
4.Primary Outcome
Title Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description:
Benralizumab 30mg/day subcutaneous
Placebo to benralizumab subcutaneous
Overall Number of Participants Analyzed 50 49
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Proportion of Participants
Influenza A H1N1
1.00
(0.94 to 1.00)
1.00
(0.94 to 1.00)
Influenza A H3N2
0.980
(0.91 to 1.00)
0.980
(0.91 to 1.00)
Influenza B Yamagata lineage
0.860
(0.75 to 0.93)
0.796
(0.68 to 0.88)
Influenza B Victoria lineage
0.780
(0.66 to 0.87)
0.878
(0.77 to 0.95)
5.Secondary Outcome
Title Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12
Hide Description To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥320-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description:
Benralizumab 30mg/day subcutaneous
Placebo to benralizumab subcutaneous
Overall Number of Participants Analyzed 50 49
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Proportion of Participants
Influenza A H1N1
0.840
(0.73 to 0.92)
0.857
(0.75 to 0.93)
Influenza A H3N2
0.500
(0.38 to 0.62)
0.612
(0.48 to 0.73)
Influenza B Yamagata lineage
0.020
(0.00 to 0.09)
0.020
(0.00 to 0.09)
Influenza B Victoria lineage
0.080
(0.03 to 0.17)
0.041
(0.01 to 0.12)
6.Secondary Outcome
Title Postdose Strain-specific Microneutralization Antibody Geometric Mean Fold Rise From Week 8 to Week 12
Hide Description To compare the geometric mean fold rises in influenza strain-specific microneutralization antibody 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 microneutralization antibody titer fold rise from Week 8 and "z" is the natural logarithm.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description:
Benralizumab 30mg/day subcutaneous
Placebo to benralizumab subcutaneous
Overall Number of Participants Analyzed 50 49
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Fold change
Influenza A H1N1
5.1
(521.4%)
4.4
(329.4%)
Influenza A H3N2
3.2
(149.8%)
3.6
(210.0%)
Influenza B Yamagata lineage
2.8
(148.9%)
3.2
(141.3%)
Influenza B Victoria lineage
3.8
(224.1%)
3.5
(195.3%)
7.Secondary Outcome
Title Postdose Strain-specific Serum Microneutralization Antibody Geometric Mean Titers Obtained at Week 12
Hide Description To compare the geometric mean titers of microneutralization antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description:
Benralizumab 30mg/day subcutaneous
Placebo to benralizumab subcutaneous
Overall Number of Participants Analyzed 50 49
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Antibody titer
Influenza A H1N1
3774.1
(181.7%)
3969.1
(154.0%)
Influenza A H3N2
4307.5
(169.0%)
4351.3
(171.0%)
Influenza B Yamagata lineage
350.2
(103.6%)
336.2
(114.3%)
Influenza B Victoria lineage
164.5
(178.5%)
234.4
(135.0%)
8.Secondary Outcome
Title 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
Hide Description To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in microneutralization antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description:
Benralizumab 30mg/day subcutaneous
Placebo to benralizumab subcutaneous
Overall Number of Participants Analyzed 50 49
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Proportion of Participants
Influenza A H1N1
0.420
(0.30 to 0.55)
0.408
(0.29 to 0.54)
Influenza A H3N2
0.440
(0.32 to 0.57)
0.429
(0.31 to 0.56)
Influenza B Yamagata lineage
0.280
(0.18 to 0.40)
0.388
(0.27 to 0.52)
Influenza B Victoria lineage
0.400
(0.28 to 0.53)
0.388
(0.27 to 0.52)
9.Secondary Outcome
Title Change From Baseline in Mean Asthma Control Questionnaire 6 (ACQ-6) Score at Week 12
Hide Description To compare the change from baseline at Week 12 in mean ACQ-6 score between patients receiving benralizumab 30mg and patients receiving placebo. The ACQ-6 assesses asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and short-acting β2 agonist use). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses to each question. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma, and a score >1.5 indicates not well controlled asthma
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all patients who were randomized and received any investigational product.
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description:
Benralizumab 30mg/day subcutaneous
Placebo to benralizumab subcutaneous
Overall Number of Participants Analyzed 50 49
Mean (Full Range)
Unit of Measure: Score on a scale
-0.50
(-2.8 to 4.3)
-0.42
(-2.7 to 1.2)
Time Frame All AEs, including SAEs, were collected from the time the patient, parent, or legal guardian signed the informed consent/assent throughout the treatment period and including the follow-up period (through Week 20).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benralizumab 30mg Placebo
Hide Arm/Group Description Benralizumab 30mg/day subcutaneous Placebo to benralizumab subcutaneous
All-Cause Mortality
Benralizumab 30mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/52 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Benralizumab 30mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/51 (0.00%)      2/52 (3.85%)    
Psychiatric disorders     
Suicidal ideation  1  0/51 (0.00%)  0 1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/51 (0.00%)  0 1/52 (1.92%)  1
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Benralizumab 30mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/51 (54.90%)      23/52 (44.23%)    
Gastrointestinal disorders     
Abdominal discomfort  1  2/51 (3.92%)  2 0/52 (0.00%)  0
Nausea  1  1/51 (1.96%)  1 2/52 (3.85%)  2
Infections and infestations     
Gastroenteritis viral  1  3/51 (5.88%)  3 1/52 (1.92%)  1
Nasopharyngitis  1  2/51 (3.92%)  2 4/52 (7.69%)  5
Sinusitis  1  2/51 (3.92%)  2 1/52 (1.92%)  1
Upper respiratory tract infection  1  3/51 (5.88%)  4 1/52 (1.92%)  1
Viral upper respiratory tract infection  1  2/51 (3.92%)  2 0/52 (0.00%)  0
Injury, poisoning and procedural complications     
Ligament sprain  1  2/51 (3.92%)  2 0/52 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Costochondritis  1  2/51 (3.92%)  3 0/52 (0.00%)  0
Nervous system disorders     
Headache  1  2/51 (3.92%)  3 4/52 (7.69%)  4
Respiratory, thoracic and mediastinal disorders     
Asthma  1  3/51 (5.88%)  5 3/52 (5.77%)  3
Cough  1  0/51 (0.00%)  0 3/52 (5.77%)  3
Oropharyngeal pain  1  3/51 (5.88%)  4 2/52 (3.85%)  2
Skin and subcutaneous tissue disorders     
Acne  1  1/51 (1.96%)  1 2/52 (3.85%)  2
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At least 30 days prior to submission for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Institution and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication/presentation.
Results Point of Contact
Name/Title: Mitchell Goldman MD, PhD
Organization: AstraZeneca
Phone: +1 610 457 5585
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02814643     History of Changes
Other Study ID Numbers: D3250C00033
First Submitted: June 15, 2016
First Posted: June 28, 2016
Results First Submitted: December 12, 2017
Results First Posted: March 1, 2018
Last Update Posted: October 24, 2018