Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma (NCT NCT02054130)
NCT ID: NCT02054130
Last Updated: 2018-12-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
584 participants
Primary outcome timeframe
Week 0 (Day 1) up to Week 52
Results posted on
2018-12-04
Participant Flow
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.
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.
Participant milestones
| Measure |
Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
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.
|
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.
|
MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
138
|
138
|
137
|
137
|
|
Overall Study
COMPLETED
|
130
|
127
|
122
|
115
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
15
|
22
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
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.
|
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.
|
MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
7
|
10
|
|
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
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
Total
n=550 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.32 Years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
50.80 Years
STANDARD_DEVIATION 12.36 • n=7 Participants
|
52.66 Years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
50.43 Years
STANDARD_DEVIATION 12.25 • n=4 Participants
|
51.55 Years
STANDARD_DEVIATION 12.25 • n=21 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
361 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
189 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
546 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
123 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
504 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiple Categories Checked
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 0 (Day 1) up to Week 52Population: Intent-to-treat population included all participants who are randomized and received any study drug.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Annualized Asthma Exacerbation Rate (AER) Through Week 52
|
0.72 events per person-year
Interval 0.59 to 0.88
|
0.27 events per person-year
Interval 0.19 to 0.38
|
0.20 events per person-year
Interval 0.13 to 0.3
|
0.23 events per person-year
Interval 0.16 to 0.34
|
SECONDARY outcome
Timeframe: Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Reduction in AER on Subpopulations at Week 52
Blood Eosinophil Count -Eosinophilic
|
0.78 events per person-year
Interval 0.59 to 1.0
|
0.29 events per person-year
Interval 0.18 to 0.43
|
0.26 events per person-year
Interval 0.16 to 0.42
|
0.21 events per person-year
Interval 0.12 to 0.35
|
|
Reduction in AER on Subpopulations at Week 52
Blood Eosinophil Count -Non-Eosinophilic
|
0.65 events per person-year
Interval 0.46 to 0.89
|
0.25 events per person-year
Interval 0.14 to 0.42
|
0.14 events per person-year
Interval 0.06 to 0.27
|
0.26 events per person-year
Interval 0.14 to 0.43
|
|
Reduction in AER on Subpopulations at Week 52
Th2 Status - High
|
0.62 events per person-year
Interval 0.45 to 0.83
|
0.33 events per person-year
Interval 0.2 to 0.5
|
0.25 events per person-year
Interval 0.14 to 0.41
|
0.21 events per person-year
Interval 0.11 to 0.36
|
|
Reduction in AER on Subpopulations at Week 52
Th2 Status - Low
|
0.86 events per person-year
Interval 0.64 to 1.13
|
0.23 events per person-year
Interval 0.14 to 0.37
|
0.15 events per person-year
Interval 0.07 to 0.28
|
0.26 events per person-year
Interval 0.15 to 0.41
|
|
Reduction in AER on Subpopulations at Week 52
FENO - High
|
0.94 events per person-year
Interval 0.72 to 1.2
|
0.32 events per person-year
Interval 0.2 to 0.48
|
0.20 events per person-year
Interval 0.11 to 0.35
|
0.20 events per person-year
Interval 0.1 to 0.35
|
|
Reduction in AER on Subpopulations at Week 52
FENO - Low
|
0.51 events per person-year
Interval 0.36 to 0.72
|
0.23 events per person-year
Interval 0.13 to 0.38
|
0.21 events per person-year
Interval 0.11 to 0.36
|
0.28 events per person-year
Interval 0.16 to 0.44
|
|
Reduction in AER on Subpopulations at Week 52
Serum Periostin - High
|
0.78 events per person-year
Interval 0.59 to 1.02
|
0.29 events per person-year
Interval 0.17 to 0.45
|
0.19 events per person-year
Interval 0.1 to 0.33
|
0.19 events per person-year
Interval 0.1 to 0.32
|
|
Reduction in AER on Subpopulations at Week 52
Serum Periostin - Low
|
0.66 events per person-year
Interval 0.48 to 0.89
|
0.27 events per person-year
Interval 0.16 to 0.42
|
0.22 events per person-year
Interval 0.12 to 0.38
|
0.30 events per person-year
Interval 0.18 to 0.47
|
|
Reduction in AER on Subpopulations at Week 52
Current Post-BD FEV1 Reversibility-Yes
|
0.60 events per person-year
Interval 0.47 to 0.75
|
0.26 events per person-year
Interval 0.18 to 0.37
|
0.17 events per person-year
Interval 0.1 to 0.27
|
0.21 events per person-year
Interval 0.14 to 0.32
|
|
Reduction in AER on Subpopulations at Week 52
Allergic
|
0.75 events per person-year
Interval 0.57 to 0.97
|
0.25 events per person-year
Interval 0.15 to 0.4
|
0.14 events per person-year
Interval 0.07 to 0.26
|
0.23 events per person-year
Interval 0.13 to 0.38
|
|
Reduction in AER on Subpopulations at Week 52
Non-Allergic
|
0.65 events per person-year
Interval 0.44 to 0.91
|
0.23 events per person-year
Interval 0.12 to 0.39
|
0.26 events per person-year
Interval 0.13 to 0.45
|
0.22 events per person-year
Interval 0.11 to 0.38
|
SECONDARY outcome
Timeframe: Baseline (Week 0 [Day 1]) to Week 52Population: 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.
Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
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
|
0.200 Liter
Standard Deviation 0.432
|
0.210 Liter
Standard Deviation 0.433
|
0.245 Liter
Standard Deviation 0.411
|
|
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
|
0.244 Liter
Standard Deviation 0.560
|
0.202 Liter
Standard Deviation 0.616
|
0.197 Liter
Standard Deviation 0.484
|
SECONDARY outcome
Timeframe: Baseline and up to Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
Blood Eosinophil Count -Non-Eosinophilic
|
-0.072 Liters
Standard Error 0.105
|
-0.030 Liters
Standard Error 0.112
|
0.008 Liters
Standard Error 0.106
|
0.011 Liters
Standard Error 0.108
|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
Th2 Status - High
|
-0.058 Liters
Standard Error 0.101
|
0.037 Liters
Standard Error 0.109
|
0.052 Liters
Standard Error 0.107
|
0.182 Liters
Standard Error 0.104
|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
Th2 Status - Low
|
-0.052 Liters
Standard Error 0.085
|
0.103 Liters
Standard Error 0.086
|
0.103 Liters
Standard Error 0.088
|
0.062 Liters
Standard Error 0.086
|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
FENO - High
|
-0.054 Liters
Standard Error 0.078
|
0.093 Liters
Standard Error 0.084
|
0.137 Liters
Standard Error 0.083
|
0.155 Liters
Standard Error 0.079
|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
Blood Eosinophil Count -Eosinophilic
|
-0.045 Liters
Standard Error 0.080
|
0.118 Liters
Standard Error 0.083
|
0.125 Liters
Standard Error 0.086
|
0.160 Liters
Standard Error 0.080
|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
FENO - Low
|
0.027 Liters
Standard Error 0.074
|
0.115 Liters
Standard Error 0.076
|
0.095 Liters
Standard Error 0.073
|
0.133 Liters
Standard Error 0.075
|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
Serum Periostin - High
|
-0.017 Liters
Standard Error 0.088
|
0.147 Liters
Standard Error 0.094
|
0.207 Liters
Standard Error 0.092
|
0.185 Liters
Standard Error 0.089
|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
Serum Periostin - Low
|
-0.040 Liters
Standard Error 0.090
|
0.060 Liters
Standard Error 0.093
|
-0.013 Liters
Standard Error 0.093
|
0.064 Liters
Standard Error 0.089
|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
Current Post-BD FEV1 Reversibility - Yes
|
-0.081 Liters
Standard Error 0.075
|
0.052 Liters
Standard Error 0.077
|
0.049 Liters
Standard Error 0.077
|
0.066 Liters
Standard Error 0.073
|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
Allergic
|
-0.047 Liters
Standard Error 0.073
|
0.131 Liters
Standard Error 0.081
|
0.084 Liters
Standard Error 0.077
|
0.065 Liters
Standard Error 0.076
|
|
Change From Baseline in FEV1 on Subpopulations at Week 52
Non-Allergic
|
-0.037 Liters
Standard Error 0.131
|
0.050 Liters
Standard Error 0.123
|
0.148 Liters
Standard Error 0.129
|
0.164 Liters
Standard Error 0.123
|
SECONDARY outcome
Timeframe: Baseline (Week 0 [Day 1]) to Week 52Population: 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.
Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
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
|
0.117 Liter
Standard Deviation 0.389
|
0.099 Liter
Standard Deviation 0.449
|
0.128 Liter
Standard Deviation 0.415
|
|
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
|
0.088 Liter
Standard Deviation 0.439
|
0.092 Liter
Standard Deviation 0.515
|
0.083 Liter
Standard Deviation 0.435
|
SECONDARY outcome
Timeframe: Baseline and up to Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
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
|
-0.57 Units on a scale
Standard Error 0.07
|
-0.72 Units on a scale
Standard Error 0.08
|
-0.71 Units on a scale
Standard Error 0.08
|
|
Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52
FENO - Low
|
-0.54 Units on a scale
Standard Error 0.07
|
-0.55 Units on a scale
Standard Error 0.07
|
-0.59 Units on a scale
Standard Error 0.08
|
-0.71 Units on a scale
Standard Error 0.07
|
|
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
|
-0.62 Units on a scale
Standard Error 0.07
|
-0.78 Units on a scale
Standard Error 0.07
|
-0.72 Units on a scale
Standard Error 0.07
|
|
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
|
-0.60 Units on a scale
Standard Error 0.08
|
-0.56 Units on a scale
Standard Error 0.08
|
-0.72 Units on a scale
Standard Error 0.08
|
|
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
|
-0.65 Units on a scale
Standard Error 0.08
|
-0.62 Units on a scale
Standard Error 0.08
|
-0.75 Units on a scale
Standard Error 0.08
|
|
Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52
FENO - High
|
-0.52 Units on a scale
Standard Error 0.08
|
-0.68 Units on a scale
Standard Error 0.07
|
-0.75 Units on a scale
Standard Error 0.08
|
-0.72 Units on a scale
Standard Error 0.08
|
|
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
|
-0.54 Units on a scale
Standard Error 0.08
|
-0.84 Units on a scale
Standard Error 0.08
|
-0.74 Units on a scale
Standard Error 0.08
|
|
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
|
-0.63 Units on a scale
Standard Error 0.07
|
-0.47 Units on a scale
Standard Error 0.08
|
-0.69 Units on a scale
Standard Error 0.07
|
|
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
|
-0.60 Units on a scale
Standard Error 0.06
|
-0.64 Units on a scale
Standard Error 0.06
|
-0.71 Units on a scale
Standard Error 0.06
|
|
Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52
Allergic
|
-0.53 Units on a scale
Standard Error 0.07
|
-0.59 Units on a scale
Standard Error 0.07
|
-0.63 Units on a scale
Standard Error 0.07
|
-0.67 Units on a scale
Standard Error 0.07
|
|
Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52
Non-Allergic
|
-0.50 Units on a scale
Standard Error 0.09
|
-0.60 Units on a scale
Standard Error 0.08
|
-0.72 Units on a scale
Standard Error 0.09
|
-0.85 Units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline (Week 0 [Day 1]) and Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52
Daytime Severity
|
-0.483 Units on a scale
Standard Deviation 0.700
|
-0.657 Units on a scale
Standard Deviation 0.726
|
-0.669 Units on a scale
Standard Deviation 0.640
|
-0.680 Units on a scale
Standard Deviation 0.688
|
|
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
|
-0.598 Units on a scale
Standard Deviation 0.837
|
-0.727 Units on a scale
Standard Deviation 0.753
|
-0.754 Units on a scale
Standard Deviation 0.752
|
|
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
|
-0.616 Units on a scale
Standard Deviation 0.687
|
-0.807 Units on a scale
Standard Deviation 0.699
|
-0.662 Units on a scale
Standard Deviation 0.730
|
SECONDARY outcome
Timeframe: Baseline (Week 0 [Day 1]) and Week 52Population: Intent-to-treat population included participants who are randomized and received any study drug.
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).
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
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
|
-1.24 Units on a scale
Standard Deviation 0.94
|
-1.17 Units on a scale
Standard Deviation 1.00
|
-1.19 Units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Week 0 (Day 1) up to Week 52Population: Intent-to-treat population included participants who are randomized and received any study drug.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Rate of Severe Asthma Exacerbation Through Week 52
|
0.14 events per person-year
Interval 0.08 to 0.22
|
0.04 events per person-year
Interval 0.01 to 0.09
|
0.02 events per person-year
Interval 0.0 to 0.07
|
0.03 events per person-year
Interval 0.01 to 0.08
|
SECONDARY outcome
Timeframe: Week 0 (Day 1) through Week 52Population: Intent-to-treat population included participants who are randomized and received any study drug.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Time to First Asthma Exacerbation Through Week 52
|
NA Days
Median survival time was not estimable as less than 50% participants had exacerbations.
|
NA Days
Median survival time was not estimable as less than 50% participants had exacerbations.
|
NA Days
Median survival time was not estimable as less than 50% participants had exacerbations.
|
NA Days
Median survival time was not estimable as less than 50% participants had exacerbations.
|
SECONDARY outcome
Timeframe: Week 0 (Day 1) through Week 52Population: Intent-to-treat population included participants who are randomized and received any study drug.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Time to First Severe Asthma Exacerbation Through Week 52
|
NA Days
Median survival time was not estimable as less than 50% participants had exacerbations.
|
NA Days
Median survival time was not estimable as less than 50% participants had exacerbations.
|
NA Days
Median survival time was not estimable as less than 50% participants had exacerbations.
|
NA Days
Median survival time was not estimable as less than 50% participants had exacerbations.
|
SECONDARY outcome
Timeframe: Week 0 (Day 1) through Week 52Population: Intent-to-treat population included participants who are randomized and received any study drug.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Asthma Exacerbations Through Week 52
|
43 Participants
|
30 Participants
|
21 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Week 0 (Day 1) through Week 52Population: Intent-to-treat population included participants who are randomized and received any study drug.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52
|
9 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0 [Day 1]) and Week 52Population: Intent-to-treat population included participants who are randomized and received any study drug.
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).
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
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
|
1.19 Units on a scale
Standard Deviation 0.90
|
0.93 Units on a scale
Standard Deviation 1.03
|
1.13 Units on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Baseline (Week 0 [Day 1]) and Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
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
|
0.0752 Units on a scale
Standard Deviation 0.2179
|
0.0729 Units on a scale
Standard Deviation 0.1624
|
0.0395 Units on a scale
Standard Deviation 0.1935
|
|
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
|
14.0 Units on a scale
Standard Deviation 16.4
|
12.0 Units on a scale
Standard Deviation 18.0
|
12.3 Units on a scale
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: Week 0 (Day 1) through Week 52Population: As-treated population included all participants who received any study drug.
The total amount of study drug exposure (in milligram) for the entire study period was summarized.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=137 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Total Amount of Study Drug Exposure
|
877.0 Milligram
Standard Deviation 116.9
|
2493.9 Milligram
Standard Deviation 640.4
|
6574.9 Milligram
Standard Deviation 1630.2
|
—
|
SECONDARY outcome
Timeframe: Day 1 upto Week 64Population: As-treated population included all participants who received any study drug.
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).
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
91 Participants
|
93 Participants
|
90 Participants
|
89 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
18 Participants
|
17 Participants
|
13 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 1 upto Week 64Population: As-treated population included all participants who received any study drug.
Adverse events observed in participants with clinically significant vital signs abnormalities were assessed.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Vital Sign Parameters
Respiratory rate increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Related to Vital Sign Parameters
Pyrexia
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Vital Sign Parameters
Blood pressure diastolic increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Vital Sign Parameters
Blood pressure increased
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Vital Sign Parameters
Heart rate increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Related to Vital Sign Parameters
Hypertension
|
7 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With TEAEs Related to Vital Sign Parameters
Hypertensive crisis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Related to Vital Sign Parameters
Hypotension
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 upto Week 64Population: As-treated population included all participants who received any study drug.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Lymphopenia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Neutropenia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Thrombocytopenia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Dyslipidaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Hepatic enzyme increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Hypercholesterolaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Hyperuricaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Hypokalaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Vitamin D deficiency
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Hematuria
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Anaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Leukopenia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the start of study drug administration upto Week 64Population: As-treated population included all participants who received any study drug.
Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Electrocardiogram Evaluations
Atrial fibrillation
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Electrocardiogram Evaluations
Atrial flutter
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Electrocardiogram Evaluations
Bundle branch block left
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Electrocardiogram Evaluations
Supraventricular extrasystoles
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Electrocardiogram Evaluations
Tachycardia
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 0 (Day 1) to Week 64Population: 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.
The mean serum concentrations of MEDI9929 was observed at specified timepoints.
Outcome measures
| Measure |
Placebo
n=133 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=128 Participants
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.
|
MEDI9929 210 mg
n=132 Participants
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.
|
MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Mean Serum Concentrations of MEDI9929
Week 4
|
3933.6 ng/mL
Standard Deviation 3022.7
|
10733.1 ng/mL
Standard Deviation 4649.4
|
39722.7 ng/mL
Standard Deviation 15140.7
|
—
|
|
Mean Serum Concentrations of MEDI9929
Week 12
|
6215.8 ng/mL
Standard Deviation 3779.2
|
16625.4 ng/mL
Standard Deviation 7751.6
|
63223.7 ng/mL
Standard Deviation 60627.6
|
—
|
|
Mean Serum Concentrations of MEDI9929
Week 20
|
6028.3 ng/mL
Standard Deviation 2897.9
|
18237.1 ng/mL
Standard Deviation 8721.9
|
64442.9 ng/mL
Standard Deviation 22558.3
|
—
|
|
Mean Serum Concentrations of MEDI9929
Week 28
|
6084.1 ng/mL
Standard Deviation 2885.5
|
19373.4 ng/mL
Standard Deviation 9191.4
|
64659.9 ng/mL
Standard Deviation 24121.6
|
—
|
|
Mean Serum Concentrations of MEDI9929
Week 40
|
6050.4 ng/mL
Standard Deviation 3296.4
|
18926.1 ng/mL
Standard Deviation 10252.7
|
64404.0 ng/mL
Standard Deviation 26473.0
|
—
|
|
Mean Serum Concentrations of MEDI9929
Week 52
|
6027.2 ng/mL
Standard Deviation 3024.8
|
18821.9 ng/mL
Standard Deviation 10435.2
|
68899.1 ng/mL
Standard Deviation 71137.2
|
—
|
|
Mean Serum Concentrations of MEDI9929
Week 64
|
632.8 ng/mL
Standard Deviation 519.5
|
1991.2 ng/mL
Standard Deviation 1882.4
|
6986.0 ng/mL
Standard Deviation 5289.0
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Day 1) to Week 64Population: As-treated population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.
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.
Outcome measures
| Measure |
Placebo
n=138 Participants
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 Participants
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.
|
MEDI9929 210 mg
n=137 Participants
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.
|
MEDI9929 280 mg
n=137 Participants
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Number of Participants With Positive Antibodies to MEDI9929
ADA Positive at Baseline
|
7 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Positive Antibodies to MEDI9929
ADA prevalence
|
13 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Positive Antibodies to MEDI9929
ADA incidence
|
13 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Positive Antibodies to MEDI9929
Neutralizing antibody- ADA Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 18 serious events
Other events: 56 other events
Deaths: 0 deaths
MEDI9929 70 mg
Serious events: 17 serious events
Other events: 49 other events
Deaths: 1 deaths
MEDI9929 210 mg
Serious events: 13 serious events
Other events: 44 other events
Deaths: 0 deaths
MEDI9929 280 mg
Serious events: 18 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=138 participants at risk
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 participants at risk
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.
|
MEDI9929 210 mg
n=137 participants at risk
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.
|
MEDI9929 280 mg
n=137 participants at risk
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Cardiac disorders
Cardiac failure
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 2 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
General disorders
Non-cardiac chest pain
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Infections and infestations
Bronchitis
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Infections and infestations
Cellulitis
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Infections and infestations
Chronic sinusitis
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Infections and infestations
Erysipelas
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Infections and infestations
Genitourinary tract infection
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Infections and infestations
Influenza
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Infections and infestations
Pneumonia
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
2.2%
3/138 • Number of events 3 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
1.5%
2/137 • Number of events 2 • From Day 1 upto Week 64
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Infections and infestations
Sinusitis
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Infections and infestations
Tooth abscess
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Infections and infestations
Viral infection
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage i
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Nervous system disorders
Sciatica
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 2 • From Day 1 upto Week 64
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Reproductive system and breast disorders
Cervical leukoplakia
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.2%
10/138 • Number of events 23 • From Day 1 upto Week 64
|
3.6%
5/138 • Number of events 5 • From Day 1 upto Week 64
|
2.9%
4/137 • Number of events 4 • From Day 1 upto Week 64
|
4.4%
6/137 • Number of events 6 • From Day 1 upto Week 64
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.72%
1/138 • Number of events 1 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/138 • From Day 1 upto Week 64
|
0.00%
0/137 • From Day 1 upto Week 64
|
0.73%
1/137 • Number of events 1 • From Day 1 upto Week 64
|
Other adverse events
| Measure |
Placebo
n=138 participants at risk
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
MEDI9929 70 mg
n=138 participants at risk
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.
|
MEDI9929 210 mg
n=137 participants at risk
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.
|
MEDI9929 280 mg
n=137 participants at risk
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.6%
16/138 • Number of events 26 • From Day 1 upto Week 64
|
13.8%
19/138 • Number of events 24 • From Day 1 upto Week 64
|
13.9%
19/137 • Number of events 25 • From Day 1 upto Week 64
|
10.9%
15/137 • Number of events 30 • From Day 1 upto Week 64
|
|
Nervous system disorders
Headache
|
4.3%
6/138 • Number of events 11 • From Day 1 upto Week 64
|
4.3%
6/138 • Number of events 10 • From Day 1 upto Week 64
|
8.0%
11/137 • Number of events 21 • From Day 1 upto Week 64
|
3.6%
5/137 • Number of events 11 • From Day 1 upto Week 64
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
34.1%
47/138 • Number of events 111 • From Day 1 upto Week 64
|
22.5%
31/138 • Number of events 50 • From Day 1 upto Week 64
|
16.8%
23/137 • Number of events 37 • From Day 1 upto Week 64
|
25.5%
35/137 • Number of events 47 • From Day 1 upto Week 64
|
|
Infections and infestations
Bronchitis
|
5.1%
7/138 • Number of events 11 • From Day 1 upto Week 64
|
5.1%
7/138 • Number of events 7 • From Day 1 upto Week 64
|
3.6%
5/137 • Number of events 6 • From Day 1 upto Week 64
|
6.6%
9/137 • Number of events 11 • From Day 1 upto Week 64
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER