Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054130
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Placebo
Drug: MEDI9929 70 mg
Drug: MEDI9929 210 mg
Drug: MEDI9929 280 mg
Enrollment 584
Recruitment Details The study was conducted from 19Dec2013 to 01Mar2017 across 12 countries (United States, Slovakia, Bulgaria, Czech Republic, Hungary, Israel, Japan, Latvia, Lithuania, Serbia, South Africa, and Ukraine). A total of 918 participants were recruited in the study.
Pre-assignment Details Of 918 participants, 334 were considered screen failures and 584 participants were randomized. Of which, all populations excluded 34 participants from one site due to non-compliance of the principles of Good Clinical Practice.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Hide 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
Reason Not Completed
Withdrawal by Subject             4             4             7             10
Death             0             1             0             0
Lost to Follow-up             0             0             1             2
Missed dose             4             6             7             10
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg Total
Hide 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 Number of Baseline Participants 138 138 137 137 550
Hide Baseline Analysis Population Description
The intent-to-treat population included participants who are randomized and received any study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 138 participants 138 participants 137 participants 137 participants 550 participants
52.32  (11.71) 50.80  (12.36) 52.66  (12.67) 50.43  (12.25) 51.55  (12.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 138 participants 137 participants 137 participants 550 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 138 participants 137 participants 137 participants 550 participants
Hispanic or Latino
1
   0.7%
0
   0.0%
1
   0.7%
2
   1.5%
4
   0.7%
Not Hispanic or Latino
137
  99.3%
138
 100.0%
136
  99.3%
135
  98.5%
546
  99.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 138 participants 137 participants 137 participants 550 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
   0.0%
2
   1.5%
4
   0.7%
Multiple Categories Checked
1
   0.7%
0
   0.0%
1
   0.7%
2
   1.5%
4
   0.7%
1.Primary Outcome
Title Annualized Asthma Exacerbation Rate (AER) Through Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per person-year
0.72
(0.59 to 0.88)
0.27
(0.19 to 0.38)
0.20
(0.13 to 0.30)
0.23
(0.16 to 0.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI9929 70 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.23 to 0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI9929 210 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.16 to 0.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI9929 280 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Negative bnomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.20 to 0.58
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Reduction in AER on Subpopulations at Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per person-year
Blood Eosinophil Count -Eosinophilic Number Analyzed 78 participants 80 participants 76 participants 76 participants
0.78
(0.59 to 1.00)
0.29
(0.18 to 0.43)
0.26
(0.16 to 0.42)
0.21
(0.12 to 0.35)
Blood Eosinophil Count -Non-Eosinophilic Number Analyzed 60 participants 58 participants 61 participants 61 participants
0.65
(0.46 to 0.89)
0.25
(0.14 to 0.42)
0.14
(0.06 to 0.27)
0.26
(0.14 to 0.43)
Th2 Status - High Number Analyzed 75 participants 62 participants 65 participants 62 participants
0.62
(0.45 to 0.83)
0.33
(0.20 to 0.50)
0.25
(0.14 to 0.41)
0.21
(0.11 to 0.36)
Th2 Status - Low Number Analyzed 62 participants 75 participants 70 participants 74 participants
0.86
(0.64 to 1.13)
0.23
(0.14 to 0.37)
0.15
(0.07 to 0.28)
0.26
(0.15 to 0.41)
FENO - High Number Analyzed 70 participants 72 participants 68 participants 64 participants
0.94
(0.72 to 1.20)
0.32
(0.20 to 0.48)
0.20
(0.11 to 0.35)
0.20
(0.10 to 0.35)
FENO - Low Number Analyzed 67 participants 65 participants 67 participants 69 participants
0.51
(0.36 to 0.72)
0.23
(0.13 to 0.38)
0.21
(0.11 to 0.36)
0.28
(0.16 to 0.44)
Serum Periostin - High Number Analyzed 69 participants 63 participants 73 participants 68 participants
0.78
(0.59 to 1.02)
0.29
(0.17 to 0.45)
0.19
(0.10 to 0.33)
0.19
(0.10 to 0.32)
Serum Periostin - Low Number Analyzed 69 participants 74 participants 63 participants 66 participants
0.66
(0.48 to 0.89)
0.27
(0.16 to 0.42)
0.22
(0.12 to 0.38)
0.30
(0.18 to 0.47)
Current Post-BD FEV1 Reversibility-Yes Number Analyzed 126 participants 123 participants 114 participants 125 participants
0.60
(0.47 to 0.75)
0.26
(0.18 to 0.37)
0.17
(0.10 to 0.27)
0.21
(0.14 to 0.32)
Allergic Number Analyzed 80 participants 68 participants 77 participants 71 participants
0.75
(0.57 to 0.97)
0.25
(0.15 to 0.40)
0.14
(0.07 to 0.26)
0.23
(0.13 to 0.38)
Non-Allergic Number Analyzed 50 participants 60 participants 50 participants 58 participants
0.65
(0.44 to 0.91)
0.23
(0.12 to 0.39)
0.26
(0.13 to 0.45)
0.22
(0.11 to 0.38)
3.Secondary Outcome
Title Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Mean (Standard Deviation)
Unit of Measure: Liter
Change from Baseline in Pre-BD FEV1 Number Analyzed 131 participants 130 participants 121 participants 116 participants
0.071  (0.405) 0.200  (0.432) 0.210  (0.433) 0.245  (0.411)
Change from Baseline in Pre-BD FVC Number Analyzed 131 participants 130 participants 121 participants 116 participants
0.068  (0.477) 0.244  (0.560) 0.202  (0.616) 0.197  (0.484)
4.Secondary Outcome
Title Change From Baseline in FEV1 on Subpopulations at Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Blood Eosinophil Count -Eosinophilic Number Analyzed 76 participants 77 participants 66 participants 63 participants
-0.045  (0.080) 0.118  (0.083) 0.125  (0.086) 0.160  (0.080)
Blood Eosinophil Count -Non-Eosinophilic Number Analyzed 55 participants 53 participants 55 participants 53 participants
-0.072  (0.105) -0.030  (0.112) 0.008  (0.106) 0.011  (0.108)
Th2 Status - High Number Analyzed 73 participants 59 participants 57 participants 53 participants
-0.058  (0.101) 0.037  (0.109) 0.052  (0.107) 0.182  (0.104)
Th2 Status - Low Number Analyzed 57 participants 70 participants 62 participants 62 participants
-0.052  (0.085) 0.103  (0.086) 0.103  (0.088) 0.062  (0.086)
FENO - High Number Analyzed 65 participants 66 participants 60 participants 54 participants
-0.054  (0.078) 0.093  (0.084) 0.137  (0.083) 0.155  (0.079)
FENO - Low Number Analyzed 65 participants 63 participants 59 participants 59 participants
0.027  (0.074) 0.115  (0.076) 0.095  (0.073) 0.133  (0.075)
Serum Periostin - High Number Analyzed 67 participants 61 participants 65 participants 61 participants
-0.017  (0.088) 0.147  (0.094) 0.207  (0.092) 0.185  (0.089)
Serum Periostin - Low Number Analyzed 64 participants 68 participants 55 participants 52 participants
-0.040  (0.090) 0.060  (0.093) -0.013  (0.093) 0.064  (0.089)
Current Post-BD FEV1 Reversibility - Yes Number Analyzed 120 participants 117 participants 102 participants 105 participants
-0.081  (0.075) 0.052  (0.077) 0.049  (0.077) 0.066  (0.073)
Allergic Number Analyzed 75 participants 65 participants 70 participants 57 participants
-0.047  (0.073) 0.131  (0.081) 0.084  (0.077) 0.065  (0.076)
Non-Allergic Number Analyzed 48 participants 56 participants 42 participants 52 participants
-0.037  (0.131) 0.050  (0.123) 0.148  (0.129) 0.164  (0.123)
5.Secondary Outcome
Title Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Mean (Standard Deviation)
Unit of Measure: Liter
Change from Baseline in Post-BD FEV1 Number Analyzed 130 participants 130 participants 121 participants 115 participants
-0.064  (0.352) 0.117  (0.389) 0.099  (0.449) 0.128  (0.415)
Change from Baseline in Post-BD FVC Number Analyzed 130 participants 130 participants 121 participants 115 participants
-0.092  (0.353) 0.088  (0.439) 0.092  (0.515) 0.083  (0.435)
6.Secondary Outcome
Title Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Blood Eosinophil Count -Eosinophilic Number Analyzed 70 participants 72 participants 58 participants 54 participants
-0.57  (0.07) -0.62  (0.07) -0.78  (0.07) -0.72  (0.07)
Blood Eosinophil Count -Non-Eosinophilic Number Analyzed 48 participants 47 participants 47 participants 49 participants
-0.49  (0.08) -0.60  (0.08) -0.56  (0.08) -0.72  (0.08)
Th2 Status - High Number Analyzed 65 participants 54 participants 51 participants 48 participants
-0.54  (0.07) -0.65  (0.08) -0.62  (0.08) -0.75  (0.08)
Th2 Status - Low Number Analyzed 52 participants 64 participants 52 participants 54 participants
-0.50  (0.08) -0.57  (0.07) -0.72  (0.08) -0.71  (0.08)
FENO - High Number Analyzed 59 participants 60 participants 49 participants 44 participants
-0.52  (0.08) -0.68  (0.07) -0.75  (0.08) -0.72  (0.08)
FENO - Low Number Analyzed 59 participants 58 participants 54 participants 56 participants
-0.54  (0.07) -0.55  (0.07) -0.59  (0.08) -0.71  (0.07)
Serum Periostin - High Number Analyzed 63 participants 57 participants 56 participants 54 participants
-0.48  (0.07) -0.54  (0.08) -0.84  (0.08) -0.74  (0.08)
Serum Periostin - Low Number Analyzed 55 participants 61 participants 48 participants 46 participants
-0.58  (0.07) -0.63  (0.07) -0.47  (0.08) -0.69  (0.07)
Current Post-BD FEV1 Reversibility - Yes Number Analyzed 108 participants 106 participants 87 participants 92 participants
-0.55  (0.05) -0.60  (0.06) -0.64  (0.06) -0.71  (0.06)
Allergic Number Analyzed 66 participants 56 participants 60 participants 48 participants
-0.53  (0.07) -0.59  (0.07) -0.63  (0.07) -0.67  (0.07)
Non-Allergic Number Analyzed 46 participants 55 participants 36 participants 47 participants
-0.50  (0.09) -0.60  (0.08) -0.72  (0.09) -0.85  (0.08)
7.Secondary Outcome
Title Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Daytime Severity Number Analyzed 118 participants 119 participants 105 participants 103 participants
-0.483  (0.700) -0.657  (0.726) -0.669  (0.640) -0.680  (0.688)
Daytime Frequency Number Analyzed 118 participants 119 participants 105 participants 103 participants
-0.493  (0.792) -0.598  (0.837) -0.727  (0.753) -0.754  (0.752)
Nighttime Severity Number Analyzed 118 participants 119 participants 105 participants 103 participants
-0.643  (0.799) -0.616  (0.687) -0.807  (0.699) -0.662  (0.730)
8.Secondary Outcome
Title Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.89  (0.91) -1.24  (0.94) -1.17  (1.00) -1.19  (1.00)
9.Secondary Outcome
Title Rate of Severe Asthma Exacerbation Through Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per person-year
0.14
(0.08 to 0.22)
0.04
(0.01 to 0.09)
0.02
(0.00 to 0.07)
0.03
(0.01 to 0.08)
10.Secondary Outcome
Title Time to First Asthma Exacerbation Through Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median survival time was not estimable as less than 50% participants had exacerbations.
11.Secondary Outcome
Title Time to First Severe Asthma Exacerbation Through Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median survival time was not estimable as less than 50% participants had exacerbations.
12.Secondary Outcome
Title Number of Participants With at Least One Asthma Exacerbations Through Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Measure Type: Count of Participants
Unit of Measure: Participants
43
  31.2%
30
  21.7%
21
  15.3%
25
  18.2%
13.Secondary Outcome
Title Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Measure Type: Count of Participants
Unit of Measure: Participants
9
   6.5%
5
   3.6%
3
   2.2%
4
   2.9%
14.Secondary Outcome
Title Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.04  (1.11) 1.19  (0.90) 0.93  (1.03) 1.13  (1.13)
15.Secondary Outcome
Title Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Health State Valuation Number Analyzed 38 participants 41 participants 33 participants 40 participants
0.1051  (0.1511) 0.0752  (0.2179) 0.0729  (0.1624) 0.0395  (0.1935)
Visual Analog Scale Number Analyzed 138 participants 138 participants 137 participants 137 participants
13.8  (17.6) 14.0  (16.4) 12.0  (18.0) 12.3  (18.0)
16.Secondary Outcome
Title Total Amount of Study Drug Exposure
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 137 137
Mean (Standard Deviation)
Unit of Measure: Milligram
877.0  (116.9) 2493.9  (640.4) 6574.9  (1630.2)
17.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
91
  65.9%
93
  67.4%
90
  65.7%
89
  65.0%
TESAEs
18
  13.0%
17
  12.3%
13
   9.5%
18
  13.1%
18.Secondary Outcome
Title Number of Participants With TEAEs Related to Vital Sign Parameters
Hide Description Adverse events observed in participants with clinically significant vital signs abnormalities were assessed.
Time Frame Day 1 upto Week 64
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Measure Type: Count of Participants
Unit of Measure: Participants
Blood pressure diastolic increased
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
Blood pressure increased
1
   0.7%
2
   1.4%
1
   0.7%
0
   0.0%
Heart rate increased
0
   0.0%
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%
0
   0.0%
1
   0.7%
Hypotension
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.5%
Pyrexia
0
   0.0%
2
   1.4%
2
   1.5%
0
   0.0%
Respiratory rate increased
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.7%
19.Secondary Outcome
Title Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Measure Type: Count of Participants
Unit of Measure: Participants
Anaemia
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.7%
Leukopenia
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
Lymphopenia
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
Neutropenia
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
Thrombocytopenia
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
Dyslipidaemia
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
Hepatic enzyme increased
0
   0.0%
0
   0.0%
1
   0.7%
0
   0.0%
Hypercholesterolaemia
0
   0.0%
0
   0.0%
1
   0.7%
0
   0.0%
Hyperuricaemia
0
   0.0%
0
   0.0%
1
   0.7%
0
   0.0%
Hypokalaemia
0
   0.0%
0
   0.0%
1
   0.7%
0
   0.0%
Vitamin D deficiency
0
   0.0%
0
   0.0%
1
   0.7%
0
   0.0%
Hematuria
1
   0.7%
0
   0.0%
1
   0.7%
0
   0.0%
20.Secondary Outcome
Title Number of Participants With TEAEs Related to Electrocardiogram Evaluations
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Measure Type: Count of Participants
Unit of Measure: Participants
Atrial fibrillation
1
   0.7%
0
   0.0%
2
   1.5%
0
   0.0%
Atrial flutter
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
Bundle branch block left
0
   0.0%
0
   0.0%
1
   0.7%
0
   0.0%
Supraventricular extrasystoles
1
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
Tachycardia
1
   0.7%
1
   0.7%
1
   0.7%
2
   1.5%
21.Secondary Outcome
Title Mean Serum Concentrations of MEDI9929
Hide Description The mean serum concentrations of MEDI9929 was observed at specified timepoints.
Time Frame Week 0 (Day 1) to Week 64
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 133 128 132
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 Number Analyzed 129 participants 126 participants 130 participants
3933.6  (3022.7) 10733.1  (4649.4) 39722.7  (15140.7)
Week 12 Number Analyzed 129 participants 121 participants 126 participants
6215.8  (3779.2) 16625.4  (7751.6) 63223.7  (60627.6)
Week 20 Number Analyzed 126 participants 113 participants 116 participants
6028.3  (2897.9) 18237.1  (8721.9) 64442.9  (22558.3)
Week 28 Number Analyzed 127 participants 117 participants 120 participants
6084.1  (2885.5) 19373.4  (9191.4) 64659.9  (24121.6)
Week 40 Number Analyzed 127 participants 117 participants 118 participants
6050.4  (3296.4) 18926.1  (10252.7) 64404.0  (26473.0)
Week 52 Number Analyzed 128 participants 118 participants 116 participants
6027.2  (3024.8) 18821.9  (10435.2) 68899.1  (71137.2)
Week 64 Number Analyzed 123 participants 116 participants 113 participants
632.8  (519.5) 1991.2  (1882.4) 6986.0  (5289.0)
22.Secondary Outcome
Title Number of Participants With Positive Antibodies to MEDI9929
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 138 138 137 137
Measure Type: Count of Participants
Unit of Measure: Participants
ADA Positive at Baseline Number Analyzed 138 participants 137 participants 136 participants 135 participants
7
   5.1%
1
   0.7%
2
   1.5%
2
   1.5%
ADA prevalence Number Analyzed 138 participants 136 participants 131 participants 131 participants
13
   9.4%
6
   4.4%
2
   1.5%
4
   3.1%
ADA incidence Number Analyzed 138 participants 136 participants 131 participants 131 participants
13
   9.4%
5
   3.7%
1
   0.8%
3
   2.3%
Neutralizing antibody- ADA Positive Number Analyzed 138 participants 136 participants 131 participants 131 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame From Day 1 upto Week 64
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/138 (0.00%)      1/138 (0.72%)      0/137 (0.00%)      0/137 (0.00%)    
Hide 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 (13.04%)      17/138 (12.32%)      13/137 (9.49%)      18/137 (13.14%)    
Cardiac disorders         
Atrial fibrillation  1  1/138 (0.72%)  1 0/138 (0.00%)  0 0/137 (0.00%)  0 0/137 (0.00%)  0
Atrial flutter  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Cardiac failure  1  1/138 (0.72%)  1 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Myocardial infarction  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  0/138 (0.00%)  0 1/138 (0.72%)  2 0/137 (0.00%)  0 0/137 (0.00%)  0
Abdominal pain lower  1  1/138 (0.72%)  1 0/138 (0.00%)  0 0/137 (0.00%)  0 0/137 (0.00%)  0
Hiatus hernia  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Large intestine polyp  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Pancreatitis acute  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
General disorders         
Non-cardiac chest pain  1  1/138 (0.72%)  1 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Hepatobiliary disorders         
Cholelithiasis  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Immune system disorders         
Anaphylactic shock  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Infections and infestations         
Bronchitis  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Cellulitis  1  1/138 (0.72%)  1 0/138 (0.00%)  0 0/137 (0.00%)  0 0/137 (0.00%)  0
Chronic sinusitis  1  1/138 (0.72%)  1 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Erysipelas  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Genitourinary tract infection  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Influenza  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Pneumonia  1  1/138 (0.72%)  1 3/138 (2.17%)  3 0/137 (0.00%)  0 2/137 (1.46%)  2
Pyelonephritis chronic  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Sinusitis  1  1/138 (0.72%)  1 0/138 (0.00%)  0 0/137 (0.00%)  0 0/137 (0.00%)  0
Staphylococcal infection  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Tooth abscess  1  1/138 (0.72%)  1 0/138 (0.00%)  0 0/137 (0.00%)  0 0/137 (0.00%)  0
Urinary tract infection  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Viral infection  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Injury, poisoning and procedural complications         
Cartilage injury  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Concussion  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Foreign body aspiration  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Ligament sprain  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Lower limb fracture  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Lumbar vertebral fracture  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Post procedural complication  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Upper limb fracture  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Osteoarthritis  1  1/138 (0.72%)  1 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Osteochondrosis  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Rhabdomyolysis  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of colon  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Basal cell carcinoma  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Lipoma  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Pancreatic carcinoma metastatic  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Prostate cancer  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Prostate cancer stage i  1  1/138 (0.72%)  1 0/138 (0.00%)  0 0/137 (0.00%)  0 0/137 (0.00%)  0
Nervous system disorders         
Cerebrovascular accident  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Cervicobrachial syndrome  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Guillain-barre syndrome  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Sciatica  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion threatened  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 1/137 (0.73%)  2
Hyperemesis gravidarum  1  0/138 (0.00%)  0 0/138 (0.00%)  0 1/137 (0.73%)  1 0/137 (0.00%)  0
Renal and urinary disorders         
Calculus urinary  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Reproductive system and breast disorders         
Cervical leukoplakia  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Ovarian cyst  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
Testicular pain  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  10/138 (7.25%)  23 5/138 (3.62%)  5 4/137 (2.92%)  4 6/137 (4.38%)  6
Pulmonary embolism  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis atopic  1  1/138 (0.72%)  1 0/138 (0.00%)  0 0/137 (0.00%)  0 0/137 (0.00%)  0
Dermatitis contact  1  0/138 (0.00%)  0 1/138 (0.72%)  1 0/137 (0.00%)  0 0/137 (0.00%)  0
Vascular disorders         
Deep vein thrombosis  1  0/138 (0.00%)  0 1/138 (0.72%)  1 1/137 (0.73%)  1 0/137 (0.00%)  0
Hypertensive crisis  1  0/138 (0.00%)  0 0/138 (0.00%)  0 0/137 (0.00%)  0 1/137 (0.73%)  1
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (40.58%)      49/138 (35.51%)      44/137 (32.12%)      50/137 (36.50%)    
Infections and infestations         
Nasopharyngitis  1  16/138 (11.59%)  26 19/138 (13.77%)  24 19/137 (13.87%)  25 15/137 (10.95%)  30
Bronchitis  1  7/138 (5.07%)  11 7/138 (5.07%)  7 5/137 (3.65%)  6 9/137 (6.57%)  11
Nervous system disorders         
Headache  1  6/138 (4.35%)  11 6/138 (4.35%)  10 11/137 (8.03%)  21 5/137 (3.65%)  11
Respiratory, thoracic and mediastinal disorders         
Asthma  1  47/138 (34.06%)  111 31/138 (22.46%)  50 23/137 (16.79%)  37 35/137 (25.55%)  47
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
A non-pre-specified statistical analysis was performed and generated the Measure of Dispersion for Outcome Measures 4 and 6.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Fred Reid
Organization: MedImmune, LLC
Phone: +44 (0) 203 749 6512
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02054130    
Other Study ID Numbers: CD-RI-MEDI9929-1146
2013-003269-33 ( EudraCT Number )
First Submitted: December 4, 2013
First Posted: February 4, 2014
Results First Submitted: June 5, 2018
Results First Posted: December 4, 2018
Last Update Posted: December 4, 2018