Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Placebo Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Drug: Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
Experimental: 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. |
Drug: 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.
|
Experimental: 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. |
Drug: 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.
|
Experimental: MEDI9929 280 mg Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Drug: MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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.
- 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.
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Research Site | Los Angeles | California | United States | 90025 |
2 | Research Site | Los Angeles | California | United States | 90048 |
3 | Research Site | Miami | Florida | United States | 33133 |
4 | Research Site | Oviedo | Florida | United States | 32765 |
5 | Research Site | Savannah | Georgia | United States | 31406 |
6 | Research Site | Peoria | Illinois | United States | 61602 |
7 | Research Site | Baltimore | Maryland | United States | 21224 |
8 | Research Site | Rochester | Minnesota | United States | 55905 |
9 | Research Site | New York | New York | United States | 10016 |
10 | Research Site | New York | New York | United States | 10029 |
11 | Research Site | Charlotte | North Carolina | United States | 28207 |
12 | Research Site | Charlotte | North Carolina | United States | 28277 |
13 | Research Site | Dublin | Ohio | United States | 43016 |
14 | Research Site | Oklahoma City | Oklahoma | United States | 73120 |
15 | Research Site | Rock Hill | South Carolina | United States | 29732 |
16 | Research Site | Spartanburg | South Carolina | United States | 29303 |
17 | Research Site | Houston | Texas | United States | 77070 |
18 | Research Site | Richmond | Virginia | United States | 23220 |
19 | Research Site | Plovdiv | Bulgaria | 4002 | |
20 | Research Site | Sofia | Bulgaria | 1202 | |
21 | Research Site | Sofia | Bulgaria | 1233 | |
22 | Research Site | Sofia | Bulgaria | 1431 | |
23 | Research Site | Sofia | Bulgaria | 1606 | |
24 | Research Site | Sofia | Bulgaria | 1750 | |
25 | Research Site | Velingrad | Bulgaria | 4600 | |
26 | Research Site | Brandys nad Labem | Czechia | 250 01 | |
27 | Research Site | Hradec Kralove | Czechia | 500 05 | |
28 | Research Site | Mlada Boleslav | Czechia | 293 01 | |
29 | Research Site | Praha 4 | Czechia | 14059 | |
30 | Research Site | Praha 8 | Czechia | 180 00 | |
31 | Research Site | Praha 8 | Czechia | 180 81 | |
32 | Research Site | Strakonice | Czechia | 38601 | |
33 | Research Site | Balassagyarmat | Hungary | 2660 | |
34 | Research Site | Budapest | Hungary | 1033 | |
35 | Research Site | Budapest | Hungary | 1125 | |
36 | Research Site | Budapest | Hungary | 1529 | |
37 | Research Site | Csorna | Hungary | 9300 | |
38 | Research Site | Debrecen | Hungary | 4032 | |
39 | Research Site | Farkasgyepü | Hungary | 8582 | |
40 | Research Site | Gödöllő | Hungary | 2100 | |
41 | Research Site | Komarom | Hungary | 2900 | |
42 | Research Site | Mateszalka | Hungary | 4700 | |
43 | Research Site | Nagykanizsa | Hungary | 8800 | |
44 | Research Site | Szeged | Hungary | H-6722 | |
45 | Research Site | Százhalombatta | Hungary | 2440 | |
46 | Research Site | Torokbalint | Hungary | 2045 | |
47 | Research Site | Ashkelon | Israel | 78278 | |
48 | Research Site | Haifa | Israel | 34362 | |
49 | Research Site | Jerusalem | Israel | 91120 | |
50 | Research Site | Kfar-Saba | Israel | 44281 | |
51 | Research Site | Petach Tikva | Israel | ||
52 | Research Site | Rehovot | Israel | 7661041 | |
53 | Research Site | Tel Hashomer | Israel | 52621 | |
54 | Research Site | Chuo-ku | Japan | 103-0027 | |
55 | Research Site | Chuo-ku | Japan | 103-0028 | |
56 | Research Site | Chuo-ku | Japan | 104-8560 | |
57 | Research Site | Fujisawa-shi | Japan | 251-8550 | |
58 | Research Site | Kiyose-shi | Japan | 204-8585 | |
59 | Research Site | Kurume-shi | Japan | 830-0011 | |
60 | Research Site | Maebashi-shi | Japan | 371-0054 | |
61 | Research Site | Ora-gun | Japan | 370-0615 | |
62 | Research Site | Sagamihara-shi | Japan | 228-0815 | |
63 | Research Site | Saitama-Ken | Japan | 338-8553 | |
64 | Research Site | Sapporo-shi | Japan | 060-0033 | |
65 | Research Site | Taito-ku | Japan | 111-0051 | |
66 | Research Site | Toshima-ku | Japan | 171-0014 | |
67 | Research Site | Yokkaichi-shi | Japan | 510-8567 | |
68 | Research Site | Daugavpils | Latvia | LV-5401 | |
69 | Research Site | Rezekne | Latvia | LV-4600 | |
70 | Research Site | Riga | Latvia | 1001 | |
71 | Research Site | Riga | Latvia | LV-1038 | |
72 | Research Site | Riga | Latvia | LV1002 | |
73 | Research Site | Riga | Latvia | LV1010 | |
74 | Research Site | Kaunas | Lithuania | LT50009 | |
75 | Research Site | Klaipeda | Lithuania | 92231 | |
76 | Research Site | Klaipeda | Lithuania | 92288 | |
77 | Research Site | Belgrade | Serbia | 11000 | |
78 | Research Site | Kragujevac | Serbia | 34000 | |
79 | Research Site | Sremska Kamenica | Serbia | 21204 | |
80 | Research Site | Bardejov | Slovakia | 085 01 | |
81 | Research Site | Bratislava | Slovakia | 84108 | |
82 | Research Site | Ilava | Slovakia | 01901 | |
83 | Research Site | Kosice | Slovakia | 040 01 | |
84 | Research Site | Levice | Slovakia | 934 01 | |
85 | Research Site | Nove Zamky | Slovakia | 940 01 | |
86 | Research Site | Poprad | Slovakia | 058 01 | |
87 | Research Site | Spisska Nova Ves | Slovakia | 052 01 | |
88 | Research Site | Sturovo | Slovakia | 94301 | |
89 | Research Site | Surany | Slovakia | 94201 | |
90 | Research Site | Topolcany | Slovakia | 95501 | |
91 | Research Site | Zvolen | Slovakia | 96001 | |
92 | Research Site | Durban | South Africa | 4068 | |
93 | Research Site | Middelburg | South Africa | 1055 | |
94 | Research Site | Pretoria | South Africa | 0181 | |
95 | Research Site | Pretoria | South Africa | 0183 | |
96 | Research Site | Dnipropetrovsk | Ukraine | 49051 | |
97 | Research Site | Ivano-Frankivsk | Ukraine | 76012 | |
98 | Research Site | Kyiv | Ukraine | 02091 | |
99 | Research Site | Kyiv | Ukraine | 03680 | |
100 | Research Site | Kyiv | Ukraine | 04050 | |
101 | Research Site | Mykolayiv | Ukraine | 54003 | |
102 | Research Site | Odessa | Ukraine | 65039 | |
103 | Research Site | Poltava | Ukraine | 36038 | |
104 | Research Site | Suprunivka Vil., Poltava Regio | Ukraine | 36028 | |
105 | Research Site | Vinnytsia | Ukraine | 21029 | |
106 | Research Site | Zaporizhzhya | Ukraine | 69035 | |
107 | Research Site | Zaporizhzhya | Ukraine | 69600 |
Sponsors and Collaborators
- MedImmune LLC
- Amgen
Investigators
- Study Director: MedImmune LLC, MedImmune LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- CD-RI-MEDI9929-1146_Protocol_Synopsis_Amendment_3_Redacted_04.03.17
- CD-RI-MEDI9929-1146_Protocol_Synopsis_Redacted_06.23.17
Publications
- CD-RI-MEDI9929-1146
- 2013-003269-33
Study Results
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 Detail | 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. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Period Title: Overall Study | ||||
STARTED | 138 | 138 | 137 | 137 |
COMPLETED | 130 | 127 | 122 | 115 |
NOT COMPLETED | 8 | 11 | 15 | 22 |
Baseline Characteristics
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg | Total |
---|---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | Total of all reporting groups |
Overall Participants | 138 | 138 | 137 | 137 | 550 |
Age (Years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [Years] |
52.32
(11.71)
|
50.80
(12.36)
|
52.66
(12.67)
|
50.43
(12.25)
|
51.55
(12.25)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
94
68.1%
|
89
64.5%
|
87
63.5%
|
91
66.4%
|
361
65.6%
|
Male |
44
31.9%
|
49
35.5%
|
50
36.5%
|
46
33.6%
|
189
34.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||
Hispanic or Latino |
1
0.7%
|
0
0%
|
1
0.7%
|
2
1.5%
|
4
0.7%
|
Not Hispanic or Latino |
137
99.3%
|
138
100%
|
136
99.3%
|
135
98.5%
|
546
99.3%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | |||||
Asian |
6
4.3%
|
3
2.2%
|
5
3.6%
|
5
3.6%
|
19
3.5%
|
Black or African American |
6
4.3%
|
4
2.9%
|
3
2.2%
|
6
4.4%
|
19
3.5%
|
White |
123
89.1%
|
131
94.9%
|
128
93.4%
|
122
89.1%
|
504
91.6%
|
Other |
2
1.4%
|
0
0%
|
0
0%
|
2
1.5%
|
4
0.7%
|
Multiple Categories Checked |
1
0.7%
|
0
0%
|
1
0.7%
|
2
1.5%
|
4
0.7%
|
Outcome Measures
Title | Annualized Asthma Exacerbation Rate (AER) Through Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included all participants who are randomized and received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Number (95% Confidence Interval) [events per person-year] |
0.72
|
0.27
|
0.20
|
0.23
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI9929 70 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Negative binomial regression | |
Comments | ||
Method of Estimation | Estimation Parameter | Rate ratio |
Estimated Value | 0.38 | |
Confidence Interval |
(2-Sided) 95% 0.23 to 0.63 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI9929 210 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Negative binomial regression | |
Comments | ||
Method of Estimation | Estimation Parameter | Rate ratio |
Estimated Value | 0.29 | |
Confidence Interval |
(2-Sided) 95% 0.16 to 0.51 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI9929 280 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Negative bnomial regression | |
Comments | ||
Method of Estimation | Estimation Parameter | Rate ratio |
Estimated Value | 0.34 | |
Confidence Interval |
(2-Sided) 95% 0.20 to 0.58 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Reduction in AER on Subpopulations at Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Blood Eosinophil Count -Eosinophilic |
0.78
|
0.29
|
0.26
|
0.21
|
Blood Eosinophil Count -Non-Eosinophilic |
0.65
|
0.25
|
0.14
|
0.26
|
Th2 Status - High |
0.62
|
0.33
|
0.25
|
0.21
|
Th2 Status - Low |
0.86
|
0.23
|
0.15
|
0.26
|
FENO - High |
0.94
|
0.32
|
0.20
|
0.20
|
FENO - Low |
0.51
|
0.23
|
0.21
|
0.28
|
Serum Periostin - High |
0.78
|
0.29
|
0.19
|
0.19
|
Serum Periostin - Low |
0.66
|
0.27
|
0.22
|
0.30
|
Current Post-BD FEV1 Reversibility-Yes |
0.60
|
0.26
|
0.17
|
0.21
|
Allergic |
0.75
|
0.25
|
0.14
|
0.23
|
Non-Allergic |
0.65
|
0.23
|
0.26
|
0.22
|
Title | Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Change from Baseline in Pre-BD FEV1 |
0.071
(0.405)
|
0.200
(0.432)
|
0.210
(0.433)
|
0.245
(0.411)
|
Change from Baseline in Pre-BD FVC |
0.068
(0.477)
|
0.244
(0.560)
|
0.202
(0.616)
|
0.197
(0.484)
|
Title | Change From Baseline in FEV1 on Subpopulations at Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Blood Eosinophil Count -Eosinophilic |
-0.045
(0.080)
|
0.118
(0.083)
|
0.125
(0.086)
|
0.160
(0.080)
|
Blood Eosinophil Count -Non-Eosinophilic |
-0.072
(0.105)
|
-0.030
(0.112)
|
0.008
(0.106)
|
0.011
(0.108)
|
Th2 Status - High |
-0.058
(0.101)
|
0.037
(0.109)
|
0.052
(0.107)
|
0.182
(0.104)
|
Th2 Status - Low |
-0.052
(0.085)
|
0.103
(0.086)
|
0.103
(0.088)
|
0.062
(0.086)
|
FENO - High |
-0.054
(0.078)
|
0.093
(0.084)
|
0.137
(0.083)
|
0.155
(0.079)
|
FENO - Low |
0.027
(0.074)
|
0.115
(0.076)
|
0.095
(0.073)
|
0.133
(0.075)
|
Serum Periostin - High |
-0.017
(0.088)
|
0.147
(0.094)
|
0.207
(0.092)
|
0.185
(0.089)
|
Serum Periostin - Low |
-0.040
(0.090)
|
0.060
(0.093)
|
-0.013
(0.093)
|
0.064
(0.089)
|
Current Post-BD FEV1 Reversibility - Yes |
-0.081
(0.075)
|
0.052
(0.077)
|
0.049
(0.077)
|
0.066
(0.073)
|
Allergic |
-0.047
(0.073)
|
0.131
(0.081)
|
0.084
(0.077)
|
0.065
(0.076)
|
Non-Allergic |
-0.037
(0.131)
|
0.050
(0.123)
|
0.148
(0.129)
|
0.164
(0.123)
|
Title | Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Change from Baseline in Post-BD FEV1 |
-0.064
(0.352)
|
0.117
(0.389)
|
0.099
(0.449)
|
0.128
(0.415)
|
Change from Baseline in Post-BD FVC |
-0.092
(0.353)
|
0.088
(0.439)
|
0.092
(0.515)
|
0.083
(0.435)
|
Title | Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Blood Eosinophil Count -Eosinophilic |
-0.57
(0.07)
|
-0.62
(0.07)
|
-0.78
(0.07)
|
-0.72
(0.07)
|
Blood Eosinophil Count -Non-Eosinophilic |
-0.49
(0.08)
|
-0.60
(0.08)
|
-0.56
(0.08)
|
-0.72
(0.08)
|
Th2 Status - High |
-0.54
(0.07)
|
-0.65
(0.08)
|
-0.62
(0.08)
|
-0.75
(0.08)
|
Th2 Status - Low |
-0.50
(0.08)
|
-0.57
(0.07)
|
-0.72
(0.08)
|
-0.71
(0.08)
|
FENO - High |
-0.52
(0.08)
|
-0.68
(0.07)
|
-0.75
(0.08)
|
-0.72
(0.08)
|
FENO - Low |
-0.54
(0.07)
|
-0.55
(0.07)
|
-0.59
(0.08)
|
-0.71
(0.07)
|
Serum Periostin - High |
-0.48
(0.07)
|
-0.54
(0.08)
|
-0.84
(0.08)
|
-0.74
(0.08)
|
Serum Periostin - Low |
-0.58
(0.07)
|
-0.63
(0.07)
|
-0.47
(0.08)
|
-0.69
(0.07)
|
Current Post-BD FEV1 Reversibility - Yes |
-0.55
(0.05)
|
-0.60
(0.06)
|
-0.64
(0.06)
|
-0.71
(0.06)
|
Allergic |
-0.53
(0.07)
|
-0.59
(0.07)
|
-0.63
(0.07)
|
-0.67
(0.07)
|
Non-Allergic |
-0.50
(0.09)
|
-0.60
(0.08)
|
-0.72
(0.09)
|
-0.85
(0.08)
|
Title | Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Daytime Severity |
-0.483
(0.700)
|
-0.657
(0.726)
|
-0.669
(0.640)
|
-0.680
(0.688)
|
Daytime Frequency |
-0.493
(0.792)
|
-0.598
(0.837)
|
-0.727
(0.753)
|
-0.754
(0.752)
|
Nighttime Severity |
-0.643
(0.799)
|
-0.616
(0.687)
|
-0.807
(0.699)
|
-0.662
(0.730)
|
Title | Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included participants who are randomized and received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Mean (Standard Deviation) [Units on a scale] |
-0.89
(0.91)
|
-1.24
(0.94)
|
-1.17
(1.00)
|
-1.19
(1.00)
|
Title | Rate of Severe Asthma Exacerbation Through Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included participants who are randomized and received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Number (95% Confidence Interval) [events per person-year] |
0.14
|
0.04
|
0.02
|
0.03
|
Title | Time to First Asthma Exacerbation Through Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included participants who are randomized and received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Median (95% Confidence Interval) [Days] |
NA
|
NA
|
NA
|
NA
|
Title | Time to First Severe Asthma Exacerbation Through Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included participants who are randomized and received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Median (95% Confidence Interval) [Days] |
NA
|
NA
|
NA
|
NA
|
Title | Number of Participants With at Least One Asthma Exacerbations Through Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included participants who are randomized and received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Count of Participants [Participants] |
43
31.2%
|
30
21.7%
|
21
15.3%
|
25
18.2%
|
Title | Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included participants who are randomized and received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Count of Participants [Participants] |
9
6.5%
|
5
3.6%
|
3
2.2%
|
4
2.9%
|
Title | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population included participants who are randomized and received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Mean (Standard Deviation) [Units on a scale] |
1.04
(1.11)
|
1.19
(0.90)
|
0.93
(1.03)
|
1.13
(1.13)
|
Title | Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Health State Valuation |
0.1051
(0.1511)
|
0.0752
(0.2179)
|
0.0729
(0.1624)
|
0.0395
(0.1935)
|
Visual Analog Scale |
13.8
(17.6)
|
14.0
(16.4)
|
12.0
(18.0)
|
12.3
(18.0)
|
Title | Total Amount of Study Drug Exposure |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
As-treated population included all participants who received any study drug. |
Arm/Group Title | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|
Arm/Group Description | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 137 | 137 |
Mean (Standard Deviation) [Milligram] |
877.0
(116.9)
|
2493.9
(640.4)
|
6574.9
(1630.2)
|
Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
As-treated population included all participants who received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
TEAEs |
91
65.9%
|
93
67.4%
|
90
65.7%
|
89
65%
|
TESAEs |
18
13%
|
17
12.3%
|
13
9.5%
|
18
13.1%
|
Title | Number of Participants With TEAEs Related to Vital Sign Parameters |
---|---|
Description | Adverse events observed in participants with clinically significant vital signs abnormalities were assessed. |
Time Frame | Day 1 upto Week 64 |
Outcome Measure Data
Analysis Population Description |
---|
As-treated population included all participants who received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Blood pressure diastolic increased |
0
0%
|
1
0.7%
|
0
0%
|
0
0%
|
Blood pressure increased |
1
0.7%
|
2
1.4%
|
1
0.7%
|
0
0%
|
Heart rate increased |
0
0%
|
0
0%
|
0
0%
|
1
0.7%
|
Hypertension |
7
5.1%
|
7
5.1%
|
5
3.6%
|
6
4.4%
|
Hypertensive crisis |
0
0%
|
0
0%
|
0
0%
|
1
0.7%
|
Hypotension |
0
0%
|
0
0%
|
0
0%
|
2
1.5%
|
Pyrexia |
0
0%
|
2
1.4%
|
2
1.5%
|
0
0%
|
Respiratory rate increased |
0
0%
|
0
0%
|
0
0%
|
1
0.7%
|
Title | Number of Participants With TEAEs Related to Clinical Laboratory Evaluation |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
As-treated population included all participants who received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Anaemia |
0
0%
|
0
0%
|
0
0%
|
1
0.7%
|
Leukopenia |
0
0%
|
1
0.7%
|
0
0%
|
0
0%
|
Lymphopenia |
0
0%
|
1
0.7%
|
0
0%
|
0
0%
|
Neutropenia |
0
0%
|
1
0.7%
|
0
0%
|
0
0%
|
Thrombocytopenia |
0
0%
|
1
0.7%
|
0
0%
|
0
0%
|
Dyslipidaemia |
0
0%
|
1
0.7%
|
0
0%
|
0
0%
|
Hepatic enzyme increased |
0
0%
|
0
0%
|
1
0.7%
|
0
0%
|
Hypercholesterolaemia |
0
0%
|
0
0%
|
1
0.7%
|
0
0%
|
Hyperuricaemia |
0
0%
|
0
0%
|
1
0.7%
|
0
0%
|
Hypokalaemia |
0
0%
|
0
0%
|
1
0.7%
|
0
0%
|
Vitamin D deficiency |
0
0%
|
0
0%
|
1
0.7%
|
0
0%
|
Hematuria |
1
0.7%
|
0
0%
|
1
0.7%
|
0
0%
|
Title | Number of Participants With TEAEs Related to Electrocardiogram Evaluations |
---|---|
Description | Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed. |
Time Frame | From the start of study drug administration upto Week 64 |
Outcome Measure Data
Analysis Population Description |
---|
As-treated population included all participants who received any study drug. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
Atrial fibrillation |
1
0.7%
|
0
0%
|
2
1.5%
|
0
0%
|
Atrial flutter |
0
0%
|
1
0.7%
|
0
0%
|
0
0%
|
Bundle branch block left |
0
0%
|
0
0%
|
1
0.7%
|
0
0%
|
Supraventricular extrasystoles |
1
0.7%
|
0
0%
|
0
0%
|
0
0%
|
Tachycardia |
1
0.7%
|
1
0.7%
|
1
0.7%
|
2
1.5%
|
Title | Mean Serum Concentrations of MEDI9929 |
---|---|
Description | The mean serum concentrations of MEDI9929 was observed at specified timepoints. |
Time Frame | Week 0 (Day 1) to Week 64 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|
Arm/Group Description | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 133 | 128 | 132 |
Week 4 |
3933.6
(3022.7)
|
10733.1
(4649.4)
|
39722.7
(15140.7)
|
Week 12 |
6215.8
(3779.2)
|
16625.4
(7751.6)
|
63223.7
(60627.6)
|
Week 20 |
6028.3
(2897.9)
|
18237.1
(8721.9)
|
64442.9
(22558.3)
|
Week 28 |
6084.1
(2885.5)
|
19373.4
(9191.4)
|
64659.9
(24121.6)
|
Week 40 |
6050.4
(3296.4)
|
18926.1
(10252.7)
|
64404.0
(26473.0)
|
Week 52 |
6027.2
(3024.8)
|
18821.9
(10435.2)
|
68899.1
(71137.2)
|
Week 64 |
632.8
(519.5)
|
1991.2
(1882.4)
|
6986.0
(5289.0)
|
Title | Number of Participants With Positive Antibodies to MEDI9929 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
As-treated population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure. |
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg |
---|---|---|---|---|
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
Measure Participants | 138 | 138 | 137 | 137 |
ADA Positive at Baseline |
7
5.1%
|
1
0.7%
|
2
1.5%
|
2
1.5%
|
ADA prevalence |
13
9.4%
|
6
4.3%
|
2
1.5%
|
4
2.9%
|
ADA incidence |
13
9.4%
|
5
3.6%
|
1
0.7%
|
3
2.2%
|
Neutralizing antibody- ADA Positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
Time Frame | From Day 1 upto Week 64 | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg | ||||
Arm/Group Description | Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | 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. | 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. | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. | ||||
All Cause Mortality |
||||||||
Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/138 (0%) | 1/138 (0.7%) | 0/137 (0%) | 0/137 (0%) | ||||
Serious Adverse Events |
||||||||
Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 18/138 (13%) | 17/138 (12.3%) | 13/137 (9.5%) | 18/137 (13.1%) | ||||
Cardiac disorders | ||||||||
Atrial fibrillation | 1/138 (0.7%) | 1 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Atrial flutter | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Cardiac failure | 1/138 (0.7%) | 1 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Myocardial infarction | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Gastrointestinal disorders | ||||||||
Abdominal pain | 0/138 (0%) | 0 | 1/138 (0.7%) | 2 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Abdominal pain lower | 1/138 (0.7%) | 1 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Hiatus hernia | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Large intestine polyp | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Pancreatitis acute | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
General disorders | ||||||||
Non-cardiac chest pain | 1/138 (0.7%) | 1 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Hepatobiliary disorders | ||||||||
Cholelithiasis | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Immune system disorders | ||||||||
Anaphylactic shock | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Infections and infestations | ||||||||
Bronchitis | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Cellulitis | 1/138 (0.7%) | 1 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Chronic sinusitis | 1/138 (0.7%) | 1 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Erysipelas | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Genitourinary tract infection | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Influenza | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Pneumonia | 1/138 (0.7%) | 1 | 3/138 (2.2%) | 3 | 0/137 (0%) | 0 | 2/137 (1.5%) | 2 |
Pyelonephritis chronic | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Sinusitis | 1/138 (0.7%) | 1 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Staphylococcal infection | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Tooth abscess | 1/138 (0.7%) | 1 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Urinary tract infection | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Viral infection | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||
Cartilage injury | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Concussion | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Foreign body aspiration | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Ligament sprain | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Lower limb fracture | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Lumbar vertebral fracture | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Post procedural complication | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Upper limb fracture | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||
Intervertebral disc protrusion | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Osteoarthritis | 1/138 (0.7%) | 1 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Osteochondrosis | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Rhabdomyolysis | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Adenocarcinoma of colon | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Basal cell carcinoma | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Lipoma | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Pancreatic carcinoma metastatic | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Prostate cancer | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Prostate cancer stage i | 1/138 (0.7%) | 1 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Nervous system disorders | ||||||||
Cerebrovascular accident | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Cervicobrachial syndrome | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Guillain-barre syndrome | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Sciatica | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Pregnancy, puerperium and perinatal conditions | ||||||||
Abortion threatened | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 1/137 (0.7%) | 2 |
Hyperemesis gravidarum | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Renal and urinary disorders | ||||||||
Calculus urinary | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Reproductive system and breast disorders | ||||||||
Cervical leukoplakia | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Ovarian cyst | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Testicular pain | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Asthma | 10/138 (7.2%) | 23 | 5/138 (3.6%) | 5 | 4/137 (2.9%) | 4 | 6/137 (4.4%) | 6 |
Pulmonary embolism | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||
Dermatitis atopic | 1/138 (0.7%) | 1 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Dermatitis contact | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 0/137 (0%) | 0 | 0/137 (0%) | 0 |
Vascular disorders | ||||||||
Deep vein thrombosis | 0/138 (0%) | 0 | 1/138 (0.7%) | 1 | 1/137 (0.7%) | 1 | 0/137 (0%) | 0 |
Hypertensive crisis | 0/138 (0%) | 0 | 0/138 (0%) | 0 | 0/137 (0%) | 0 | 1/137 (0.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
Placebo | MEDI9929 70 mg | MEDI9929 210 mg | MEDI9929 280 mg | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 56/138 (40.6%) | 49/138 (35.5%) | 44/137 (32.1%) | 50/137 (36.5%) | ||||
Infections and infestations | ||||||||
Nasopharyngitis | 16/138 (11.6%) | 26 | 19/138 (13.8%) | 24 | 19/137 (13.9%) | 25 | 15/137 (10.9%) | 30 |
Bronchitis | 7/138 (5.1%) | 11 | 7/138 (5.1%) | 7 | 5/137 (3.6%) | 6 | 9/137 (6.6%) | 11 |
Nervous system disorders | ||||||||
Headache | 6/138 (4.3%) | 11 | 6/138 (4.3%) | 10 | 11/137 (8%) | 21 | 5/137 (3.6%) | 11 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Asthma | 47/138 (34.1%) | 111 | 31/138 (22.5%) | 50 | 23/137 (16.8%) | 37 | 35/137 (25.5%) | 47 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Name/Title | Fred Reid |
---|---|
Organization | MedImmune, LLC |
Phone | +44 (0) 203 749 6512 |
information.center@astrazeneca.com |
- CD-RI-MEDI9929-1146
- 2013-003269-33