Asthma
Conditions
Keywords
Asthma
Brief summary
The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.
Interventions
DRUGPlacebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
DRUGMEDI9929 70 mg
Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
DRUGMEDI9929 210 mg
Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
DRUGMEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Sponsors
Amgen
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 through 75 * Body mass index (BMI) between 18-40 kg/m2 and weight greater than or equal 40 kg * Documented physician-diagnosed asthma - Subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose inhaled corticosteroids (ICS) plus long acting β2 agonist (LABA) -If on asthma controller medications in addition to ICS plus LABA, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ICS, long-acting anti-muscarinics (LAMA), cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -Subjects must have a documented history of at least 2 asthma exacerbation events OR at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit.
Exclusion criteria
* Diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma. * Current smokers or subjects with a smoking history of ≥ 10 pack years * Former smokers with \< 10 pack years must have stopped for at least 1 year to be eligible. * Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome). * Evidence of active liver disease. * History of Cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -Known history of active tuberculosis (TB) * History of anaphylaxis to any biologic therapy * Positive medical history for hepatitis B or C * Subject with human immunodeficiency virus (HIV) or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Asthma Exacerbation Rate (AER) Through Week 52 | Week 0 (Day 1) up to Week 52 | Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 | Baseline (Week 0 [Day 1]) to Week 52 | Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported. |
| Change From Baseline in FEV1 on Subpopulations at Week 52 | Baseline and up to Week 52 | Forced expiratory volume in one second (FEV1) was evaluated in pre-specified subpopulations of asthma. The data presented in the below table for this outcome measure is for pre-bronchodilator FEV1. |
| Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 | Baseline (Week 0 [Day 1]) to Week 52 | Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported. |
| Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Baseline and up to Week 52 | Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Overall symptom score is the average of scores of daytime severity, daytime frequency, and nighttime severity symptoms. The daytime frequency and severity items are scored from 0 to 4, where a higher score indicates greater frequency/severity and nighttime severity item is scored from 0 to 4 , where a higher score indicates greater severity. Overall symptom score ranges from 0 to 4, where lower score indicates better asthma symptom while, higher score indicates worse asthma symptom. |
| Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Baseline (Week 0 [Day 1]) and Week 52 | Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Symptom score values for night time assessment is 0 (no asthma symptom) to 3 (unable to sleep because of asthma) and symptom score values for day time assessment is 0 (no asthma symptom) to 3 (unable to do normal activities due to asthma). Total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. |
| Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52 | Baseline (Week 0 [Day 1]) and Week 52 | The ACQ is a patient-reported questionnaire assessing asthma symptoms (ie, night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use and FEV1. The ACQ-6 is a shortened version of the ACQ that omits the FEV1 measurement from the original ACQ score. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). |
| Rate of Severe Asthma Exacerbation Through Week 52 | Week 0 (Day 1) up to Week 52 | A severe asthma exacerbation is defined as an event that resulted in hospitalization. The severe AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. |
| Time to First Asthma Exacerbation Through Week 52 | Week 0 (Day 1) through Week 52 | Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first asthma exacerbation was reported. |
| Time to First Severe Asthma Exacerbation Through Week 52 | Week 0 (Day 1) through Week 52 | Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first severe asthma exacerbations (hospitalization) were reported. |
| Number of Participants With at Least One Asthma Exacerbations Through Week 52 | Week 0 (Day 1) through Week 52 | Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. |
| Reduction in AER on Subpopulations at Week 52 | Week 52 | Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Reduction in AER was evaluated in pre-specified subpopulations (blood eosinophil count \[eosinophilic and non-eosinophilic\], T helper cell 2 \[Th2\] status \[high and low\], Fraction of exhaled nitric oxide \[FENO\] \[high and low\], serum periostin \[high and low\], current post bronchodilator forced expiratory volume in 1 second \[Post-BD FEV1\] reversibility- yes, allergic and non-allergic) of asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. Also, the high or low was determined using median value. |
| Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52 | Baseline (Week 0 [Day 1]) and Week 52 | The AQLQ(S) +12 is a 32-item questionnaire that measures the health-related quality of life experienced by asthma participants. The questionnaire comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli) scaled on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). |
| Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 | Baseline (Week 0 [Day 1]) and Week 52 | European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a visual analogue scale (VAS) that ranged from 0 to 100, where 0 indicated the worst health you can imagine and 100 indicated the best health you can imagine. |
| Total Amount of Study Drug Exposure | Week 0 (Day 1) through Week 52 | The total amount of study drug exposure (in milligram) for the entire study period was summarized. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Day 1 upto Week 64 | An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any adverse event that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period until and including the follow-up period (Week 64). |
| Number of Participants With TEAEs Related to Vital Sign Parameters | Day 1 upto Week 64 | Adverse events observed in participants with clinically significant vital signs abnormalities were assessed. |
| Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Day 1 upto Week 64 | An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations of blood and urine samples were performed. |
| Number of Participants With TEAEs Related to Electrocardiogram Evaluations | From the start of study drug administration upto Week 64 | Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed. |
| Mean Serum Concentrations of MEDI9929 | Week 0 (Day 1) to Week 64 | The mean serum concentrations of MEDI9929 was observed at specified timepoints. |
| Number of Participants With Positive Antibodies to MEDI9929 | Week 0 (Day 1) to Week 64 | Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The number of participants with positive serum antibodies to MEDI9929 were presented. |
| Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52 | Week 0 (Day 1) through Week 52 | Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Participants with severe asthma exacerbations (hospitalization) were reported. |
Countries
Bulgaria, Czechia, Hungary, Israel, Japan, Latvia, Lithuania, Serbia, Slovakia, South Africa, Ukraine, United States
Participant flow
Recruitment details
The study was conducted from 19Dec2013 to 01Mar2017 across 12 countries (United States, Slovakia, Bulgaria, Czech Republic, Hungary, Israel, Japan, Latvia, Lithuania, Serbia, South Africa, and Ukraine). A total of 918 participants were recruited in the study.
Pre-assignment details
Of 918 participants, 334 were considered screen failures and 584 participants were randomized. Of which, all populations excluded 34 participants from one site due to non-compliance of the principles of Good Clinical Practice.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 138 |
| MEDI9929 70 mg Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. | 138 |
| MEDI9929 210 mg Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. | 137 |
| MEDI9929 280 mg Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 137 |
| Total | 550 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 2 |
| Overall Study | Missed dose | 4 | 6 | 7 | 10 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 7 | 10 |
Baseline characteristics
| Characteristic | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 52.32 Years STANDARD_DEVIATION 11.71 | 50.80 Years STANDARD_DEVIATION 12.36 | 52.66 Years STANDARD_DEVIATION 12.67 | 50.43 Years STANDARD_DEVIATION 12.25 | 51.55 Years STANDARD_DEVIATION 12.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 137 Participants | 138 Participants | 136 Participants | 135 Participants | 546 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 3 Participants | 5 Participants | 5 Participants | 19 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 4 Participants | 3 Participants | 6 Participants | 19 Participants |
| Race/Ethnicity, Customized Multiple Categories Checked | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 123 Participants | 131 Participants | 128 Participants | 122 Participants | 504 Participants |
| Sex: Female, Male Female | 94 Participants | 89 Participants | 87 Participants | 91 Participants | 361 Participants |
| Sex: Female, Male Male | 44 Participants | 49 Participants | 50 Participants | 46 Participants | 189 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 138 | 1 / 138 | 0 / 137 | 0 / 137 |
| other Total, other adverse events | 56 / 138 | 49 / 138 | 44 / 137 | 50 / 137 |
| serious Total, serious adverse events | 18 / 138 | 17 / 138 | 13 / 137 | 18 / 137 |
Outcome results
Primary
Annualized Asthma Exacerbation Rate (AER) Through Week 52
Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
Time frame: Week 0 (Day 1) up to Week 52
Population: Intent-to-treat population included all participants who are randomized and received any study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Annualized Asthma Exacerbation Rate (AER) Through Week 52 | 0.72 events per person-year |
| MEDI9929 70 mg | Annualized Asthma Exacerbation Rate (AER) Through Week 52 | 0.27 events per person-year |
| MEDI9929 210 mg | Annualized Asthma Exacerbation Rate (AER) Through Week 52 | 0.20 events per person-year |
| MEDI9929 280 mg | Annualized Asthma Exacerbation Rate (AER) Through Week 52 | 0.23 events per person-year |
p-value: <0.00195% CI: [0.23, 0.63]Negative binomial regression
p-value: <0.00195% CI: [0.16, 0.51]Negative binomial regression
p-value: <0.00195% CI: [0.2, 0.58]Negative bnomial regression
Secondary
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52
The AQLQ(S) +12 is a 32-item questionnaire that measures the health-related quality of life experienced by asthma participants. The questionnaire comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli) scaled on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment).
Time frame: Baseline (Week 0 [Day 1]) and Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52 | 1.04 Units on a scale | Standard Deviation 1.11 |
| MEDI9929 70 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52 | 1.19 Units on a scale | Standard Deviation 0.9 |
| MEDI9929 210 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52 | 0.93 Units on a scale | Standard Deviation 1.03 |
| MEDI9929 280 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52 | 1.13 Units on a scale | Standard Deviation 1.13 |
Secondary
Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52
The ACQ is a patient-reported questionnaire assessing asthma symptoms (ie, night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use and FEV1. The ACQ-6 is a shortened version of the ACQ that omits the FEV1 measurement from the original ACQ score. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled).
Time frame: Baseline (Week 0 [Day 1]) and Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52 | -0.89 Units on a scale | Standard Deviation 0.91 |
| MEDI9929 70 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52 | -1.24 Units on a scale | Standard Deviation 0.94 |
| MEDI9929 210 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52 | -1.17 Units on a scale | Standard Deviation 1 |
| MEDI9929 280 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52 | -1.19 Units on a scale | Standard Deviation 1 |
Secondary
Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52
Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Symptom score values for night time assessment is 0 (no asthma symptom) to 3 (unable to sleep because of asthma) and symptom score values for day time assessment is 0 (no asthma symptom) to 3 (unable to do normal activities due to asthma). Total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom.
Time frame: Baseline (Week 0 [Day 1]) and Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Daytime Severity | -0.483 Units on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Nighttime Severity | -0.643 Units on a scale | Standard Deviation 0.799 |
| Placebo | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Daytime Frequency | -0.493 Units on a scale | Standard Deviation 0.792 |
| MEDI9929 70 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Daytime Severity | -0.657 Units on a scale | Standard Deviation 0.726 |
| MEDI9929 70 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Nighttime Severity | -0.616 Units on a scale | Standard Deviation 0.687 |
| MEDI9929 70 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Daytime Frequency | -0.598 Units on a scale | Standard Deviation 0.837 |
| MEDI9929 210 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Daytime Frequency | -0.727 Units on a scale | Standard Deviation 0.753 |
| MEDI9929 210 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Daytime Severity | -0.669 Units on a scale | Standard Deviation 0.64 |
| MEDI9929 210 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Nighttime Severity | -0.807 Units on a scale | Standard Deviation 0.699 |
| MEDI9929 280 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Daytime Severity | -0.680 Units on a scale | Standard Deviation 0.688 |
| MEDI9929 280 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Nighttime Severity | -0.662 Units on a scale | Standard Deviation 0.73 |
| MEDI9929 280 mg | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 | Daytime Frequency | -0.754 Units on a scale | Standard Deviation 0.752 |
Secondary
Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a visual analogue scale (VAS) that ranged from 0 to 100, where 0 indicated the worst health you can imagine and 100 indicated the best health you can imagine.
Time frame: Baseline (Week 0 [Day 1]) and Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 | Health State Valuation | 0.1051 Units on a scale | Standard Deviation 0.1511 |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 | Visual Analog Scale | 13.8 Units on a scale | Standard Deviation 17.6 |
| MEDI9929 70 mg | Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 | Visual Analog Scale | 14.0 Units on a scale | Standard Deviation 16.4 |
| MEDI9929 70 mg | Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 | Health State Valuation | 0.0752 Units on a scale | Standard Deviation 0.2179 |
| MEDI9929 210 mg | Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 | Health State Valuation | 0.0729 Units on a scale | Standard Deviation 0.1624 |
| MEDI9929 210 mg | Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 | Visual Analog Scale | 12.0 Units on a scale | Standard Deviation 18 |
| MEDI9929 280 mg | Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 | Health State Valuation | 0.0395 Units on a scale | Standard Deviation 0.1935 |
| MEDI9929 280 mg | Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 | Visual Analog Scale | 12.3 Units on a scale | Standard Deviation 18 |
Secondary
Change From Baseline in FEV1 on Subpopulations at Week 52
Forced expiratory volume in one second (FEV1) was evaluated in pre-specified subpopulations of asthma. The data presented in the below table for this outcome measure is for pre-bronchodilator FEV1.
Time frame: Baseline and up to Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | Allergic | -0.047 Liters | Standard Error 0.073 |
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | Serum Periostin - High | -0.017 Liters | Standard Error 0.088 |
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | FENO - Low | 0.027 Liters | Standard Error 0.074 |
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | Th2 Status - Low | -0.052 Liters | Standard Error 0.085 |
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | -0.045 Liters | Standard Error 0.08 |
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | FENO - High | -0.054 Liters | Standard Error 0.078 |
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | -0.072 Liters | Standard Error 0.105 |
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | Non-Allergic | -0.037 Liters | Standard Error 0.131 |
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility - Yes | -0.081 Liters | Standard Error 0.075 |
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | Serum Periostin - Low | -0.040 Liters | Standard Error 0.09 |
| Placebo | Change From Baseline in FEV1 on Subpopulations at Week 52 | Th2 Status - High | -0.058 Liters | Standard Error 0.101 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Allergic | 0.131 Liters | Standard Error 0.081 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | 0.118 Liters | Standard Error 0.083 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Serum Periostin - Low | 0.060 Liters | Standard Error 0.093 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | -0.030 Liters | Standard Error 0.112 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Th2 Status - High | 0.037 Liters | Standard Error 0.109 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Th2 Status - Low | 0.103 Liters | Standard Error 0.086 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | FENO - High | 0.093 Liters | Standard Error 0.084 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | FENO - Low | 0.115 Liters | Standard Error 0.076 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Serum Periostin - High | 0.147 Liters | Standard Error 0.094 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility - Yes | 0.052 Liters | Standard Error 0.077 |
| MEDI9929 70 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Non-Allergic | 0.050 Liters | Standard Error 0.123 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | 0.008 Liters | Standard Error 0.106 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Non-Allergic | 0.148 Liters | Standard Error 0.129 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility - Yes | 0.049 Liters | Standard Error 0.077 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Serum Periostin - High | 0.207 Liters | Standard Error 0.092 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | FENO - Low | 0.095 Liters | Standard Error 0.073 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Th2 Status - High | 0.052 Liters | Standard Error 0.107 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Serum Periostin - Low | -0.013 Liters | Standard Error 0.093 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Th2 Status - Low | 0.103 Liters | Standard Error 0.088 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Allergic | 0.084 Liters | Standard Error 0.077 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | FENO - High | 0.137 Liters | Standard Error 0.083 |
| MEDI9929 210 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | 0.125 Liters | Standard Error 0.086 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | FENO - High | 0.155 Liters | Standard Error 0.079 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Allergic | 0.065 Liters | Standard Error 0.076 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | FENO - Low | 0.133 Liters | Standard Error 0.075 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Serum Periostin - High | 0.185 Liters | Standard Error 0.089 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | 0.011 Liters | Standard Error 0.108 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Serum Periostin - Low | 0.064 Liters | Standard Error 0.089 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility - Yes | 0.066 Liters | Standard Error 0.073 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | 0.160 Liters | Standard Error 0.08 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Non-Allergic | 0.164 Liters | Standard Error 0.123 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Th2 Status - Low | 0.062 Liters | Standard Error 0.086 |
| MEDI9929 280 mg | Change From Baseline in FEV1 on Subpopulations at Week 52 | Th2 Status - High | 0.182 Liters | Standard Error 0.104 |
Secondary
Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52
Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Overall symptom score is the average of scores of daytime severity, daytime frequency, and nighttime severity symptoms. The daytime frequency and severity items are scored from 0 to 4, where a higher score indicates greater frequency/severity and nighttime severity item is scored from 0 to 4 , where a higher score indicates greater severity. Overall symptom score ranges from 0 to 4, where lower score indicates better asthma symptom while, higher score indicates worse asthma symptom.
Time frame: Baseline and up to Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | -0.57 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Th2 Status - Low | -0.50 Units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Serum Periostin - Low | -0.58 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | -0.49 Units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Serum Periostin - High | -0.48 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | FENO - High | -0.52 Units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Th2 Status - High | -0.54 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Non-Allergic | -0.50 Units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Allergic | -0.53 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | FENO - Low | -0.54 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility - Yes | -0.55 Units on a scale | Standard Error 0.05 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | FENO - Low | -0.55 Units on a scale | Standard Error 0.07 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility - Yes | -0.60 Units on a scale | Standard Error 0.06 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Serum Periostin - High | -0.54 Units on a scale | Standard Error 0.08 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Serum Periostin - Low | -0.63 Units on a scale | Standard Error 0.07 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Th2 Status - High | -0.65 Units on a scale | Standard Error 0.08 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Non-Allergic | -0.60 Units on a scale | Standard Error 0.08 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Th2 Status - Low | -0.57 Units on a scale | Standard Error 0.07 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Allergic | -0.59 Units on a scale | Standard Error 0.07 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | FENO - High | -0.68 Units on a scale | Standard Error 0.07 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | -0.60 Units on a scale | Standard Error 0.08 |
| MEDI9929 70 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | -0.62 Units on a scale | Standard Error 0.07 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Allergic | -0.63 Units on a scale | Standard Error 0.07 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | -0.78 Units on a scale | Standard Error 0.07 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | -0.56 Units on a scale | Standard Error 0.08 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Th2 Status - High | -0.62 Units on a scale | Standard Error 0.08 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Th2 Status - Low | -0.72 Units on a scale | Standard Error 0.08 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | FENO - High | -0.75 Units on a scale | Standard Error 0.08 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | FENO - Low | -0.59 Units on a scale | Standard Error 0.08 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Serum Periostin - High | -0.84 Units on a scale | Standard Error 0.08 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Serum Periostin - Low | -0.47 Units on a scale | Standard Error 0.08 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility - Yes | -0.64 Units on a scale | Standard Error 0.06 |
| MEDI9929 210 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Non-Allergic | -0.72 Units on a scale | Standard Error 0.09 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | FENO - Low | -0.71 Units on a scale | Standard Error 0.07 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Non-Allergic | -0.85 Units on a scale | Standard Error 0.08 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility - Yes | -0.71 Units on a scale | Standard Error 0.06 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | FENO - High | -0.72 Units on a scale | Standard Error 0.08 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Th2 Status - Low | -0.71 Units on a scale | Standard Error 0.08 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Th2 Status - High | -0.75 Units on a scale | Standard Error 0.08 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Allergic | -0.67 Units on a scale | Standard Error 0.07 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | -0.72 Units on a scale | Standard Error 0.08 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | -0.72 Units on a scale | Standard Error 0.07 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Serum Periostin - Low | -0.69 Units on a scale | Standard Error 0.07 |
| MEDI9929 280 mg | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 | Serum Periostin - High | -0.74 Units on a scale | Standard Error 0.08 |
Secondary
Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52
Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported.
Time frame: Baseline (Week 0 [Day 1]) to Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 | Change from Baseline in Post-BD FEV1 | -0.064 Liter | Standard Deviation 0.352 |
| Placebo | Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 | Change from Baseline in Post-BD FVC | -0.092 Liter | Standard Deviation 0.353 |
| MEDI9929 70 mg | Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 | Change from Baseline in Post-BD FVC | 0.088 Liter | Standard Deviation 0.439 |
| MEDI9929 70 mg | Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 | Change from Baseline in Post-BD FEV1 | 0.117 Liter | Standard Deviation 0.389 |
| MEDI9929 210 mg | Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 | Change from Baseline in Post-BD FEV1 | 0.099 Liter | Standard Deviation 0.449 |
| MEDI9929 210 mg | Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 | Change from Baseline in Post-BD FVC | 0.092 Liter | Standard Deviation 0.515 |
| MEDI9929 280 mg | Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 | Change from Baseline in Post-BD FEV1 | 0.128 Liter | Standard Deviation 0.415 |
| MEDI9929 280 mg | Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 | Change from Baseline in Post-BD FVC | 0.083 Liter | Standard Deviation 0.435 |
Secondary
Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52
Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported.
Time frame: Baseline (Week 0 [Day 1]) to Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 | Change from Baseline in Pre-BD FEV1 | 0.071 Liter | Standard Deviation 0.405 |
| Placebo | Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 | Change from Baseline in Pre-BD FVC | 0.068 Liter | Standard Deviation 0.477 |
| MEDI9929 70 mg | Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 | Change from Baseline in Pre-BD FVC | 0.244 Liter | Standard Deviation 0.56 |
| MEDI9929 70 mg | Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 | Change from Baseline in Pre-BD FEV1 | 0.200 Liter | Standard Deviation 0.432 |
| MEDI9929 210 mg | Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 | Change from Baseline in Pre-BD FEV1 | 0.210 Liter | Standard Deviation 0.433 |
| MEDI9929 210 mg | Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 | Change from Baseline in Pre-BD FVC | 0.202 Liter | Standard Deviation 0.616 |
| MEDI9929 280 mg | Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 | Change from Baseline in Pre-BD FEV1 | 0.245 Liter | Standard Deviation 0.411 |
| MEDI9929 280 mg | Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 | Change from Baseline in Pre-BD FVC | 0.197 Liter | Standard Deviation 0.484 |
Secondary
Mean Serum Concentrations of MEDI9929
The mean serum concentrations of MEDI9929 was observed at specified timepoints.
Time frame: Week 0 (Day 1) to Week 64
Population: Pharmacokinetic population included all participants who received MEDI9929 and have a sufficient number of serum concentration measurements. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Serum Concentrations of MEDI9929 | Week 12 | 6215.8 ng/mL | Standard Deviation 3779.2 |
| Placebo | Mean Serum Concentrations of MEDI9929 | Week 40 | 6050.4 ng/mL | Standard Deviation 3296.4 |
| Placebo | Mean Serum Concentrations of MEDI9929 | Week 28 | 6084.1 ng/mL | Standard Deviation 2885.5 |
| Placebo | Mean Serum Concentrations of MEDI9929 | Week 4 | 3933.6 ng/mL | Standard Deviation 3022.7 |
| Placebo | Mean Serum Concentrations of MEDI9929 | Week 64 | 632.8 ng/mL | Standard Deviation 519.5 |
| Placebo | Mean Serum Concentrations of MEDI9929 | Week 52 | 6027.2 ng/mL | Standard Deviation 3024.8 |
| Placebo | Mean Serum Concentrations of MEDI9929 | Week 20 | 6028.3 ng/mL | Standard Deviation 2897.9 |
| MEDI9929 70 mg | Mean Serum Concentrations of MEDI9929 | Week 28 | 19373.4 ng/mL | Standard Deviation 9191.4 |
| MEDI9929 70 mg | Mean Serum Concentrations of MEDI9929 | Week 4 | 10733.1 ng/mL | Standard Deviation 4649.4 |
| MEDI9929 70 mg | Mean Serum Concentrations of MEDI9929 | Week 12 | 16625.4 ng/mL | Standard Deviation 7751.6 |
| MEDI9929 70 mg | Mean Serum Concentrations of MEDI9929 | Week 20 | 18237.1 ng/mL | Standard Deviation 8721.9 |
| MEDI9929 70 mg | Mean Serum Concentrations of MEDI9929 | Week 40 | 18926.1 ng/mL | Standard Deviation 10252.7 |
| MEDI9929 70 mg | Mean Serum Concentrations of MEDI9929 | Week 52 | 18821.9 ng/mL | Standard Deviation 10435.2 |
| MEDI9929 70 mg | Mean Serum Concentrations of MEDI9929 | Week 64 | 1991.2 ng/mL | Standard Deviation 1882.4 |
| MEDI9929 210 mg | Mean Serum Concentrations of MEDI9929 | Week 40 | 64404.0 ng/mL | Standard Deviation 26473 |
| MEDI9929 210 mg | Mean Serum Concentrations of MEDI9929 | Week 12 | 63223.7 ng/mL | Standard Deviation 60627.6 |
| MEDI9929 210 mg | Mean Serum Concentrations of MEDI9929 | Week 64 | 6986.0 ng/mL | Standard Deviation 5289 |
| MEDI9929 210 mg | Mean Serum Concentrations of MEDI9929 | Week 52 | 68899.1 ng/mL | Standard Deviation 71137.2 |
| MEDI9929 210 mg | Mean Serum Concentrations of MEDI9929 | Week 28 | 64659.9 ng/mL | Standard Deviation 24121.6 |
| MEDI9929 210 mg | Mean Serum Concentrations of MEDI9929 | Week 20 | 64442.9 ng/mL | Standard Deviation 22558.3 |
| MEDI9929 210 mg | Mean Serum Concentrations of MEDI9929 | Week 4 | 39722.7 ng/mL | Standard Deviation 15140.7 |
Secondary
Number of Participants With at Least One Asthma Exacerbations Through Week 52
Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.
Time frame: Week 0 (Day 1) through Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least One Asthma Exacerbations Through Week 52 | 43 Participants |
| MEDI9929 70 mg | Number of Participants With at Least One Asthma Exacerbations Through Week 52 | 30 Participants |
| MEDI9929 210 mg | Number of Participants With at Least One Asthma Exacerbations Through Week 52 | 21 Participants |
| MEDI9929 280 mg | Number of Participants With at Least One Asthma Exacerbations Through Week 52 | 25 Participants |
Secondary
Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52
Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Participants with severe asthma exacerbations (hospitalization) were reported.
Time frame: Week 0 (Day 1) through Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52 | 9 Participants |
| MEDI9929 70 mg | Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52 | 5 Participants |
| MEDI9929 210 mg | Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52 | 3 Participants |
| MEDI9929 280 mg | Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52 | 4 Participants |
Secondary
Number of Participants With Positive Antibodies to MEDI9929
Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The number of participants with positive serum antibodies to MEDI9929 were presented.
Time frame: Week 0 (Day 1) to Week 64
Population: As-treated population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Positive Antibodies to MEDI9929 | ADA Positive at Baseline | 7 Participants |
| Placebo | Number of Participants With Positive Antibodies to MEDI9929 | ADA prevalence | 13 Participants |
| Placebo | Number of Participants With Positive Antibodies to MEDI9929 | ADA incidence | 13 Participants |
| Placebo | Number of Participants With Positive Antibodies to MEDI9929 | Neutralizing antibody- ADA Positive | 0 Participants |
| MEDI9929 70 mg | Number of Participants With Positive Antibodies to MEDI9929 | ADA prevalence | 6 Participants |
| MEDI9929 70 mg | Number of Participants With Positive Antibodies to MEDI9929 | ADA incidence | 5 Participants |
| MEDI9929 70 mg | Number of Participants With Positive Antibodies to MEDI9929 | Neutralizing antibody- ADA Positive | 0 Participants |
| MEDI9929 70 mg | Number of Participants With Positive Antibodies to MEDI9929 | ADA Positive at Baseline | 1 Participants |
| MEDI9929 210 mg | Number of Participants With Positive Antibodies to MEDI9929 | ADA incidence | 1 Participants |
| MEDI9929 210 mg | Number of Participants With Positive Antibodies to MEDI9929 | ADA prevalence | 2 Participants |
| MEDI9929 210 mg | Number of Participants With Positive Antibodies to MEDI9929 | Neutralizing antibody- ADA Positive | 0 Participants |
| MEDI9929 210 mg | Number of Participants With Positive Antibodies to MEDI9929 | ADA Positive at Baseline | 2 Participants |
| MEDI9929 280 mg | Number of Participants With Positive Antibodies to MEDI9929 | Neutralizing antibody- ADA Positive | 0 Participants |
| MEDI9929 280 mg | Number of Participants With Positive Antibodies to MEDI9929 | ADA prevalence | 4 Participants |
| MEDI9929 280 mg | Number of Participants With Positive Antibodies to MEDI9929 | ADA Positive at Baseline | 2 Participants |
| MEDI9929 280 mg | Number of Participants With Positive Antibodies to MEDI9929 | ADA incidence | 3 Participants |
Secondary
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations of blood and urine samples were performed.
Time frame: Day 1 upto Week 64
Population: As-treated population included all participants who received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hypokalaemia | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hematuria | 1 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hypercholesterolaemia | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Anaemia | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hyperuricaemia | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Lymphopenia | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Neutropenia | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Leukopenia | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Vitamin D deficiency | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Thrombocytopenia | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Dyslipidaemia | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hepatic enzyme increased | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Leukopenia | 1 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hepatic enzyme increased | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Neutropenia | 1 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hyperuricaemia | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hypokalaemia | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hypercholesterolaemia | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Anaemia | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Dyslipidaemia | 1 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Thrombocytopenia | 1 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Lymphopenia | 1 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hematuria | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Vitamin D deficiency | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hypercholesterolaemia | 1 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Anaemia | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Leukopenia | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Lymphopenia | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Neutropenia | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Thrombocytopenia | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Dyslipidaemia | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hepatic enzyme increased | 1 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hyperuricaemia | 1 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hypokalaemia | 1 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Vitamin D deficiency | 1 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hematuria | 1 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Dyslipidaemia | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Thrombocytopenia | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Anaemia | 1 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hypokalaemia | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Neutropenia | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Lymphopenia | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hematuria | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Vitamin D deficiency | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hypercholesterolaemia | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hepatic enzyme increased | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Leukopenia | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation | Hyperuricaemia | 0 Participants |
Secondary
Number of Participants With TEAEs Related to Electrocardiogram Evaluations
Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed.
Time frame: From the start of study drug administration upto Week 64
Population: As-treated population included all participants who received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Supraventricular extrasystoles | 1 Participants |
| Placebo | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Atrial flutter | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Tachycardia | 1 Participants |
| Placebo | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Bundle branch block left | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Atrial fibrillation | 1 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Bundle branch block left | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Supraventricular extrasystoles | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Tachycardia | 1 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Atrial flutter | 1 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Atrial fibrillation | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Bundle branch block left | 1 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Atrial fibrillation | 2 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Atrial flutter | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Supraventricular extrasystoles | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Tachycardia | 1 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Supraventricular extrasystoles | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Atrial flutter | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Atrial fibrillation | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Bundle branch block left | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Electrocardiogram Evaluations | Tachycardia | 2 Participants |
Secondary
Number of Participants With TEAEs Related to Vital Sign Parameters
Adverse events observed in participants with clinically significant vital signs abnormalities were assessed.
Time frame: Day 1 upto Week 64
Population: As-treated population included all participants who received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With TEAEs Related to Vital Sign Parameters | Blood pressure diastolic increased | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Vital Sign Parameters | Pyrexia | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypertension | 7 Participants |
| Placebo | Number of Participants With TEAEs Related to Vital Sign Parameters | Heart rate increased | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Vital Sign Parameters | Respiratory rate increased | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypotension | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypertensive crisis | 0 Participants |
| Placebo | Number of Participants With TEAEs Related to Vital Sign Parameters | Blood pressure increased | 1 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypertension | 7 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypertensive crisis | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Blood pressure diastolic increased | 1 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Blood pressure increased | 2 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Heart rate increased | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypotension | 0 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Pyrexia | 2 Participants |
| MEDI9929 70 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Respiratory rate increased | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Blood pressure diastolic increased | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Respiratory rate increased | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Pyrexia | 2 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypertension | 5 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypertensive crisis | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Heart rate increased | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypotension | 0 Participants |
| MEDI9929 210 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Blood pressure increased | 1 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Blood pressure increased | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypertension | 6 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Blood pressure diastolic increased | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypertensive crisis | 1 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Respiratory rate increased | 1 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Hypotension | 2 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Pyrexia | 0 Participants |
| MEDI9929 280 mg | Number of Participants With TEAEs Related to Vital Sign Parameters | Heart rate increased | 1 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any adverse event that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period until and including the follow-up period (Week 64).
Time frame: Day 1 upto Week 64
Population: As-treated population included all participants who received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs | 91 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAEs | 18 Participants |
| MEDI9929 70 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAEs | 17 Participants |
| MEDI9929 70 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs | 93 Participants |
| MEDI9929 210 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs | 90 Participants |
| MEDI9929 210 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAEs | 13 Participants |
| MEDI9929 280 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs | 89 Participants |
| MEDI9929 280 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAEs | 18 Participants |
Secondary
Rate of Severe Asthma Exacerbation Through Week 52
A severe asthma exacerbation is defined as an event that resulted in hospitalization. The severe AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
Time frame: Week 0 (Day 1) up to Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Rate of Severe Asthma Exacerbation Through Week 52 | 0.14 events per person-year |
| MEDI9929 70 mg | Rate of Severe Asthma Exacerbation Through Week 52 | 0.04 events per person-year |
| MEDI9929 210 mg | Rate of Severe Asthma Exacerbation Through Week 52 | 0.02 events per person-year |
| MEDI9929 280 mg | Rate of Severe Asthma Exacerbation Through Week 52 | 0.03 events per person-year |
Secondary
Reduction in AER on Subpopulations at Week 52
Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Reduction in AER was evaluated in pre-specified subpopulations (blood eosinophil count \[eosinophilic and non-eosinophilic\], T helper cell 2 \[Th2\] status \[high and low\], Fraction of exhaled nitric oxide \[FENO\] \[high and low\], serum periostin \[high and low\], current post bronchodilator forced expiratory volume in 1 second \[Post-BD FEV1\] reversibility- yes, allergic and non-allergic) of asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. Also, the high or low was determined using median value.
Time frame: Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Reduction in AER on Subpopulations at Week 52 | Serum Periostin - Low | 0.66 events per person-year |
| Placebo | Reduction in AER on Subpopulations at Week 52 | Serum Periostin - High | 0.78 events per person-year |
| Placebo | Reduction in AER on Subpopulations at Week 52 | FENO - High | 0.94 events per person-year |
| Placebo | Reduction in AER on Subpopulations at Week 52 | Non-Allergic | 0.65 events per person-year |
| Placebo | Reduction in AER on Subpopulations at Week 52 | FENO - Low | 0.51 events per person-year |
| Placebo | Reduction in AER on Subpopulations at Week 52 | Th2 Status - High | 0.62 events per person-year |
| Placebo | Reduction in AER on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | 0.65 events per person-year |
| Placebo | Reduction in AER on Subpopulations at Week 52 | Allergic | 0.75 events per person-year |
| Placebo | Reduction in AER on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility-Yes | 0.60 events per person-year |
| Placebo | Reduction in AER on Subpopulations at Week 52 | Th2 Status - Low | 0.86 events per person-year |
| Placebo | Reduction in AER on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | 0.78 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | Non-Allergic | 0.23 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | 0.25 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | Th2 Status - High | 0.33 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | Th2 Status - Low | 0.23 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | FENO - High | 0.32 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | FENO - Low | 0.23 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | Serum Periostin - High | 0.29 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | Serum Periostin - Low | 0.27 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility-Yes | 0.26 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | Allergic | 0.25 events per person-year |
| MEDI9929 70 mg | Reduction in AER on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | 0.29 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | Non-Allergic | 0.26 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | Serum Periostin - High | 0.19 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | Th2 Status - Low | 0.15 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | Serum Periostin - Low | 0.22 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | 0.14 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility-Yes | 0.17 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | Th2 Status - High | 0.25 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | 0.26 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | Allergic | 0.14 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | FENO - High | 0.20 events per person-year |
| MEDI9929 210 mg | Reduction in AER on Subpopulations at Week 52 | FENO - Low | 0.21 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | FENO - Low | 0.28 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | Blood Eosinophil Count -Eosinophilic | 0.21 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | Serum Periostin - High | 0.19 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | Th2 Status - Low | 0.26 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | Non-Allergic | 0.22 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | Allergic | 0.23 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | Serum Periostin - Low | 0.30 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | Th2 Status - High | 0.21 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | Blood Eosinophil Count -Non-Eosinophilic | 0.26 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | FENO - High | 0.20 events per person-year |
| MEDI9929 280 mg | Reduction in AER on Subpopulations at Week 52 | Current Post-BD FEV1 Reversibility-Yes | 0.21 events per person-year |
Secondary
Time to First Asthma Exacerbation Through Week 52
Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first asthma exacerbation was reported.
Time frame: Week 0 (Day 1) through Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to First Asthma Exacerbation Through Week 52 | NA Days |
| MEDI9929 70 mg | Time to First Asthma Exacerbation Through Week 52 | NA Days |
| MEDI9929 210 mg | Time to First Asthma Exacerbation Through Week 52 | NA Days |
| MEDI9929 280 mg | Time to First Asthma Exacerbation Through Week 52 | NA Days |
Secondary
Time to First Severe Asthma Exacerbation Through Week 52
Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first severe asthma exacerbations (hospitalization) were reported.
Time frame: Week 0 (Day 1) through Week 52
Population: Intent-to-treat population included participants who are randomized and received any study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to First Severe Asthma Exacerbation Through Week 52 | NA Days |
| MEDI9929 70 mg | Time to First Severe Asthma Exacerbation Through Week 52 | NA Days |
| MEDI9929 210 mg | Time to First Severe Asthma Exacerbation Through Week 52 | NA Days |
| MEDI9929 280 mg | Time to First Severe Asthma Exacerbation Through Week 52 | NA Days |
Secondary
Total Amount of Study Drug Exposure
The total amount of study drug exposure (in milligram) for the entire study period was summarized.
Time frame: Week 0 (Day 1) through Week 52
Population: As-treated population included all participants who received any study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Amount of Study Drug Exposure | 877.0 Milligram | Standard Deviation 116.9 |
| MEDI9929 70 mg | Total Amount of Study Drug Exposure | 2493.9 Milligram | Standard Deviation 640.4 |
| MEDI9929 210 mg | Total Amount of Study Drug Exposure | 6574.9 Milligram | Standard Deviation 1630.2 |