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

Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02054130
Collaborator
Amgen (Industry)
584
107
4
38.6
5.5
0.1

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: MEDI9929 70 mg
  • Drug: MEDI9929 210 mg
  • Drug: MEDI9929 280 mg
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
584 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Inadequately Controlled, Severe Asthma
Actual Study Start Date :
Dec 13, 2013
Actual Primary Completion Date :
Dec 12, 2016
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Drug: Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Experimental: MEDI9929 70 mg

Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.

Drug: MEDI9929 70 mg
Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.

Experimental: MEDI9929 210 mg

Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.

Drug: MEDI9929 210 mg
Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.

Experimental: MEDI9929 280 mg

Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Drug: MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Outcome Measures

Primary Outcome Measures

  1. Annualized Asthma Exacerbation Rate (AER) Through Week 52 [Week 0 (Day 1) up to Week 52]

    Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.

Secondary Outcome Measures

  1. Reduction in AER on Subpopulations at Week 52 [Week 52]

    Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Reduction in AER was evaluated in pre-specified subpopulations (blood eosinophil count [eosinophilic and non-eosinophilic], T helper cell 2 [Th2] status [high and low], Fraction of exhaled nitric oxide [FENO] [high and low], serum periostin [high and low], current post bronchodilator forced expiratory volume in 1 second [Post-BD FEV1] reversibility- yes, allergic and non-allergic) of asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. Also, the high or low was determined using median value.

  2. Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 [Baseline (Week 0 [Day 1]) to Week 52]

    Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported.

  3. Change From Baseline in FEV1 on Subpopulations at Week 52 [Baseline and up to Week 52]

    Forced expiratory volume in one second (FEV1) was evaluated in pre-specified subpopulations of asthma. The data presented in the below table for this outcome measure is for pre-bronchodilator FEV1.

  4. Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 [Baseline (Week 0 [Day 1]) to Week 52]

    Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported.

  5. Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 [Baseline and up to Week 52]

    Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Overall symptom score is the average of scores of daytime severity, daytime frequency, and nighttime severity symptoms. The daytime frequency and severity items are scored from 0 to 4, where a higher score indicates greater frequency/severity and nighttime severity item is scored from 0 to 4 , where a higher score indicates greater severity. Overall symptom score ranges from 0 to 4, where lower score indicates better asthma symptom while, higher score indicates worse asthma symptom.

  6. Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 [Baseline (Week 0 [Day 1]) and Week 52]

    Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Symptom score values for night time assessment is 0 (no asthma symptom) to 3 (unable to sleep because of asthma) and symptom score values for day time assessment is 0 (no asthma symptom) to 3 (unable to do normal activities due to asthma). Total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom.

  7. Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52 [Baseline (Week 0 [Day 1]) and Week 52]

    The ACQ is a patient-reported questionnaire assessing asthma symptoms (ie, night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use and FEV1. The ACQ-6 is a shortened version of the ACQ that omits the FEV1 measurement from the original ACQ score. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled).

  8. Rate of Severe Asthma Exacerbation Through Week 52 [Week 0 (Day 1) up to Week 52]

    A severe asthma exacerbation is defined as an event that resulted in hospitalization. The severe AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.

  9. Time to First Asthma Exacerbation Through Week 52 [Week 0 (Day 1) through Week 52]

    Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first asthma exacerbation was reported.

  10. Time to First Severe Asthma Exacerbation Through Week 52 [Week 0 (Day 1) through Week 52]

    Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first severe asthma exacerbations (hospitalization) were reported.

  11. Number of Participants With at Least One Asthma Exacerbations Through Week 52 [Week 0 (Day 1) through Week 52]

    Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.

  12. Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52 [Week 0 (Day 1) through Week 52]

    Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Participants with severe asthma exacerbations (hospitalization) were reported.

  13. Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52 [Baseline (Week 0 [Day 1]) and Week 52]

    The AQLQ(S) +12 is a 32-item questionnaire that measures the health-related quality of life experienced by asthma participants. The questionnaire comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli) scaled on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment).

  14. Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 [Baseline (Week 0 [Day 1]) and Week 52]

    European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a visual analogue scale (VAS) that ranged from 0 to 100, where 0 indicated the worst health you can imagine and 100 indicated the best health you can imagine.

  15. Total Amount of Study Drug Exposure [Week 0 (Day 1) through Week 52]

    The total amount of study drug exposure (in milligram) for the entire study period was summarized.

  16. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [Day 1 upto Week 64]

    An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any adverse event that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period until and including the follow-up period (Week 64).

  17. Number of Participants With TEAEs Related to Vital Sign Parameters [Day 1 upto Week 64]

    Adverse events observed in participants with clinically significant vital signs abnormalities were assessed.

  18. Number of Participants With TEAEs Related to Clinical Laboratory Evaluation [Day 1 upto Week 64]

    An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations of blood and urine samples were performed.

  19. Number of Participants With TEAEs Related to Electrocardiogram Evaluations [From the start of study drug administration upto Week 64]

    Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed.

  20. Mean Serum Concentrations of MEDI9929 [Week 0 (Day 1) to Week 64]

    The mean serum concentrations of MEDI9929 was observed at specified timepoints.

  21. Number of Participants With Positive Antibodies to MEDI9929 [Week 0 (Day 1) to Week 64]

    Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The number of participants with positive serum antibodies to MEDI9929 were presented.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age 18 through 75

  • Body mass index (BMI) between 18-40 kg/m2 and weight greater than or equal 40 kg

  • Documented physician-diagnosed asthma - Subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose inhaled corticosteroids (ICS) plus long acting β2 agonist (LABA) -If on asthma controller medications in addition to ICS plus LABA, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ICS, long-acting anti-muscarinics (LAMA), cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -Subjects must have a documented history of at least 2 asthma exacerbation events OR at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit.

Exclusion Criteria:
  • Diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma.

  • Current smokers or subjects with a smoking history of ≥ 10 pack years

  • Former smokers with < 10 pack years must have stopped for at least 1 year to be eligible.

  • Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome).

  • Evidence of active liver disease.

  • History of Cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -Known history of active tuberculosis (TB)

  • History of anaphylaxis to any biologic therapy

  • Positive medical history for hepatitis B or C

  • Subject with human immunodeficiency virus (HIV) or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Los Angeles California United States 90025
2 Research Site Los Angeles California United States 90048
3 Research Site Miami Florida United States 33133
4 Research Site Oviedo Florida United States 32765
5 Research Site Savannah Georgia United States 31406
6 Research Site Peoria Illinois United States 61602
7 Research Site Baltimore Maryland United States 21224
8 Research Site Rochester Minnesota United States 55905
9 Research Site New York New York United States 10016
10 Research Site New York New York United States 10029
11 Research Site Charlotte North Carolina United States 28207
12 Research Site Charlotte North Carolina United States 28277
13 Research Site Dublin Ohio United States 43016
14 Research Site Oklahoma City Oklahoma United States 73120
15 Research Site Rock Hill South Carolina United States 29732
16 Research Site Spartanburg South Carolina United States 29303
17 Research Site Houston Texas United States 77070
18 Research Site Richmond Virginia United States 23220
19 Research Site Plovdiv Bulgaria 4002
20 Research Site Sofia Bulgaria 1202
21 Research Site Sofia Bulgaria 1233
22 Research Site Sofia Bulgaria 1431
23 Research Site Sofia Bulgaria 1606
24 Research Site Sofia Bulgaria 1750
25 Research Site Velingrad Bulgaria 4600
26 Research Site Brandys nad Labem Czechia 250 01
27 Research Site Hradec Kralove Czechia 500 05
28 Research Site Mlada Boleslav Czechia 293 01
29 Research Site Praha 4 Czechia 14059
30 Research Site Praha 8 Czechia 180 00
31 Research Site Praha 8 Czechia 180 81
32 Research Site Strakonice Czechia 38601
33 Research Site Balassagyarmat Hungary 2660
34 Research Site Budapest Hungary 1033
35 Research Site Budapest Hungary 1125
36 Research Site Budapest Hungary 1529
37 Research Site Csorna Hungary 9300
38 Research Site Debrecen Hungary 4032
39 Research Site Farkasgyepü Hungary 8582
40 Research Site Gödöllő Hungary 2100
41 Research Site Komarom Hungary 2900
42 Research Site Mateszalka Hungary 4700
43 Research Site Nagykanizsa Hungary 8800
44 Research Site Szeged Hungary H-6722
45 Research Site Százhalombatta Hungary 2440
46 Research Site Torokbalint Hungary 2045
47 Research Site Ashkelon Israel 78278
48 Research Site Haifa Israel 34362
49 Research Site Jerusalem Israel 91120
50 Research Site Kfar-Saba Israel 44281
51 Research Site Petach Tikva Israel
52 Research Site Rehovot Israel 7661041
53 Research Site Tel Hashomer Israel 52621
54 Research Site Chuo-ku Japan 103-0027
55 Research Site Chuo-ku Japan 103-0028
56 Research Site Chuo-ku Japan 104-8560
57 Research Site Fujisawa-shi Japan 251-8550
58 Research Site Kiyose-shi Japan 204-8585
59 Research Site Kurume-shi Japan 830-0011
60 Research Site Maebashi-shi Japan 371-0054
61 Research Site Ora-gun Japan 370-0615
62 Research Site Sagamihara-shi Japan 228-0815
63 Research Site Saitama-Ken Japan 338-8553
64 Research Site Sapporo-shi Japan 060-0033
65 Research Site Taito-ku Japan 111-0051
66 Research Site Toshima-ku Japan 171-0014
67 Research Site Yokkaichi-shi Japan 510-8567
68 Research Site Daugavpils Latvia LV-5401
69 Research Site Rezekne Latvia LV-4600
70 Research Site Riga Latvia 1001
71 Research Site Riga Latvia LV-1038
72 Research Site Riga Latvia LV1002
73 Research Site Riga Latvia LV1010
74 Research Site Kaunas Lithuania LT50009
75 Research Site Klaipeda Lithuania 92231
76 Research Site Klaipeda Lithuania 92288
77 Research Site Belgrade Serbia 11000
78 Research Site Kragujevac Serbia 34000
79 Research Site Sremska Kamenica Serbia 21204
80 Research Site Bardejov Slovakia 085 01
81 Research Site Bratislava Slovakia 84108
82 Research Site Ilava Slovakia 01901
83 Research Site Kosice Slovakia 040 01
84 Research Site Levice Slovakia 934 01
85 Research Site Nove Zamky Slovakia 940 01
86 Research Site Poprad Slovakia 058 01
87 Research Site Spisska Nova Ves Slovakia 052 01
88 Research Site Sturovo Slovakia 94301
89 Research Site Surany Slovakia 94201
90 Research Site Topolcany Slovakia 95501
91 Research Site Zvolen Slovakia 96001
92 Research Site Durban South Africa 4068
93 Research Site Middelburg South Africa 1055
94 Research Site Pretoria South Africa 0181
95 Research Site Pretoria South Africa 0183
96 Research Site Dnipropetrovsk Ukraine 49051
97 Research Site Ivano-Frankivsk Ukraine 76012
98 Research Site Kyiv Ukraine 02091
99 Research Site Kyiv Ukraine 03680
100 Research Site Kyiv Ukraine 04050
101 Research Site Mykolayiv Ukraine 54003
102 Research Site Odessa Ukraine 65039
103 Research Site Poltava Ukraine 36038
104 Research Site Suprunivka Vil., Poltava Regio Ukraine 36028
105 Research Site Vinnytsia Ukraine 21029
106 Research Site Zaporizhzhya Ukraine 69035
107 Research Site Zaporizhzhya Ukraine 69600

Sponsors and Collaborators

  • MedImmune LLC
  • Amgen

Investigators

  • Study Director: MedImmune LLC, MedImmune LLC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02054130
Other Study ID Numbers:
  • CD-RI-MEDI9929-1146
  • 2013-003269-33
First Posted:
Feb 4, 2014
Last Update Posted:
Dec 4, 2018
Last Verified:
Nov 1, 2018
Keywords provided by MedImmune LLC
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details The study was conducted from 19Dec2013 to 01Mar2017 across 12 countries (United States, Slovakia, Bulgaria, Czech Republic, Hungary, Israel, Japan, Latvia, Lithuania, Serbia, South Africa, and Ukraine). A total of 918 participants were recruited in the study.
Pre-assignment Detail Of 918 participants, 334 were considered screen failures and 584 participants were randomized. Of which, all populations excluded 34 participants from one site due to non-compliance of the principles of Good Clinical Practice.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Period Title: Overall Study
STARTED 138 138 137 137
COMPLETED 130 127 122 115
NOT COMPLETED 8 11 15 22

Baseline Characteristics

Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg Total
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Total of all reporting groups
Overall Participants 138 138 137 137 550
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
52.32
(11.71)
50.80
(12.36)
52.66
(12.67)
50.43
(12.25)
51.55
(12.25)
Sex: Female, Male (Count of Participants)
Female
94
68.1%
89
64.5%
87
63.5%
91
66.4%
361
65.6%
Male
44
31.9%
49
35.5%
50
36.5%
46
33.6%
189
34.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
1
0.7%
0
0%
1
0.7%
2
1.5%
4
0.7%
Not Hispanic or Latino
137
99.3%
138
100%
136
99.3%
135
98.5%
546
99.3%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
Race/Ethnicity, Customized (Count of Participants)
Asian
6
4.3%
3
2.2%
5
3.6%
5
3.6%
19
3.5%
Black or African American
6
4.3%
4
2.9%
3
2.2%
6
4.4%
19
3.5%
White
123
89.1%
131
94.9%
128
93.4%
122
89.1%
504
91.6%
Other
2
1.4%
0
0%
0
0%
2
1.5%
4
0.7%
Multiple Categories Checked
1
0.7%
0
0%
1
0.7%
2
1.5%
4
0.7%

Outcome Measures

1. Primary Outcome
Title Annualized Asthma Exacerbation Rate (AER) Through Week 52
Description Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
Time Frame Week 0 (Day 1) up to Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included all participants who are randomized and received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Number (95% Confidence Interval) [events per person-year]
0.72
0.27
0.20
0.23
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI9929 70 mg
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method Negative binomial regression
Comments
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.23 to 0.63
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI9929 210 mg
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method Negative binomial regression
Comments
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.16 to 0.51
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI9929 280 mg
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method Negative bnomial regression
Comments
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.20 to 0.58
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Reduction in AER on Subpopulations at Week 52
Description Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Reduction in AER was evaluated in pre-specified subpopulations (blood eosinophil count [eosinophilic and non-eosinophilic], T helper cell 2 [Th2] status [high and low], Fraction of exhaled nitric oxide [FENO] [high and low], serum periostin [high and low], current post bronchodilator forced expiratory volume in 1 second [Post-BD FEV1] reversibility- yes, allergic and non-allergic) of asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. Also, the high or low was determined using median value.
Time Frame Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Blood Eosinophil Count -Eosinophilic
0.78
0.29
0.26
0.21
Blood Eosinophil Count -Non-Eosinophilic
0.65
0.25
0.14
0.26
Th2 Status - High
0.62
0.33
0.25
0.21
Th2 Status - Low
0.86
0.23
0.15
0.26
FENO - High
0.94
0.32
0.20
0.20
FENO - Low
0.51
0.23
0.21
0.28
Serum Periostin - High
0.78
0.29
0.19
0.19
Serum Periostin - Low
0.66
0.27
0.22
0.30
Current Post-BD FEV1 Reversibility-Yes
0.60
0.26
0.17
0.21
Allergic
0.75
0.25
0.14
0.23
Non-Allergic
0.65
0.23
0.26
0.22
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
Description Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported.
Time Frame Baseline (Week 0 [Day 1]) to Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Change from Baseline in Pre-BD FEV1
0.071
(0.405)
0.200
(0.432)
0.210
(0.433)
0.245
(0.411)
Change from Baseline in Pre-BD FVC
0.068
(0.477)
0.244
(0.560)
0.202
(0.616)
0.197
(0.484)
4. Secondary Outcome
Title Change From Baseline in FEV1 on Subpopulations at Week 52
Description Forced expiratory volume in one second (FEV1) was evaluated in pre-specified subpopulations of asthma. The data presented in the below table for this outcome measure is for pre-bronchodilator FEV1.
Time Frame Baseline and up to Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Blood Eosinophil Count -Eosinophilic
-0.045
(0.080)
0.118
(0.083)
0.125
(0.086)
0.160
(0.080)
Blood Eosinophil Count -Non-Eosinophilic
-0.072
(0.105)
-0.030
(0.112)
0.008
(0.106)
0.011
(0.108)
Th2 Status - High
-0.058
(0.101)
0.037
(0.109)
0.052
(0.107)
0.182
(0.104)
Th2 Status - Low
-0.052
(0.085)
0.103
(0.086)
0.103
(0.088)
0.062
(0.086)
FENO - High
-0.054
(0.078)
0.093
(0.084)
0.137
(0.083)
0.155
(0.079)
FENO - Low
0.027
(0.074)
0.115
(0.076)
0.095
(0.073)
0.133
(0.075)
Serum Periostin - High
-0.017
(0.088)
0.147
(0.094)
0.207
(0.092)
0.185
(0.089)
Serum Periostin - Low
-0.040
(0.090)
0.060
(0.093)
-0.013
(0.093)
0.064
(0.089)
Current Post-BD FEV1 Reversibility - Yes
-0.081
(0.075)
0.052
(0.077)
0.049
(0.077)
0.066
(0.073)
Allergic
-0.047
(0.073)
0.131
(0.081)
0.084
(0.077)
0.065
(0.076)
Non-Allergic
-0.037
(0.131)
0.050
(0.123)
0.148
(0.129)
0.164
(0.123)
5. Secondary Outcome
Title Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52
Description Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported.
Time Frame Baseline (Week 0 [Day 1]) to Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Change from Baseline in Post-BD FEV1
-0.064
(0.352)
0.117
(0.389)
0.099
(0.449)
0.128
(0.415)
Change from Baseline in Post-BD FVC
-0.092
(0.353)
0.088
(0.439)
0.092
(0.515)
0.083
(0.435)
6. Secondary Outcome
Title Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52
Description Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Overall symptom score is the average of scores of daytime severity, daytime frequency, and nighttime severity symptoms. The daytime frequency and severity items are scored from 0 to 4, where a higher score indicates greater frequency/severity and nighttime severity item is scored from 0 to 4 , where a higher score indicates greater severity. Overall symptom score ranges from 0 to 4, where lower score indicates better asthma symptom while, higher score indicates worse asthma symptom.
Time Frame Baseline and up to Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Blood Eosinophil Count -Eosinophilic
-0.57
(0.07)
-0.62
(0.07)
-0.78
(0.07)
-0.72
(0.07)
Blood Eosinophil Count -Non-Eosinophilic
-0.49
(0.08)
-0.60
(0.08)
-0.56
(0.08)
-0.72
(0.08)
Th2 Status - High
-0.54
(0.07)
-0.65
(0.08)
-0.62
(0.08)
-0.75
(0.08)
Th2 Status - Low
-0.50
(0.08)
-0.57
(0.07)
-0.72
(0.08)
-0.71
(0.08)
FENO - High
-0.52
(0.08)
-0.68
(0.07)
-0.75
(0.08)
-0.72
(0.08)
FENO - Low
-0.54
(0.07)
-0.55
(0.07)
-0.59
(0.08)
-0.71
(0.07)
Serum Periostin - High
-0.48
(0.07)
-0.54
(0.08)
-0.84
(0.08)
-0.74
(0.08)
Serum Periostin - Low
-0.58
(0.07)
-0.63
(0.07)
-0.47
(0.08)
-0.69
(0.07)
Current Post-BD FEV1 Reversibility - Yes
-0.55
(0.05)
-0.60
(0.06)
-0.64
(0.06)
-0.71
(0.06)
Allergic
-0.53
(0.07)
-0.59
(0.07)
-0.63
(0.07)
-0.67
(0.07)
Non-Allergic
-0.50
(0.09)
-0.60
(0.08)
-0.72
(0.09)
-0.85
(0.08)
7. Secondary Outcome
Title Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52
Description Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Symptom score values for night time assessment is 0 (no asthma symptom) to 3 (unable to sleep because of asthma) and symptom score values for day time assessment is 0 (no asthma symptom) to 3 (unable to do normal activities due to asthma). Total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom.
Time Frame Baseline (Week 0 [Day 1]) and Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Daytime Severity
-0.483
(0.700)
-0.657
(0.726)
-0.669
(0.640)
-0.680
(0.688)
Daytime Frequency
-0.493
(0.792)
-0.598
(0.837)
-0.727
(0.753)
-0.754
(0.752)
Nighttime Severity
-0.643
(0.799)
-0.616
(0.687)
-0.807
(0.699)
-0.662
(0.730)
8. Secondary Outcome
Title Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52
Description The ACQ is a patient-reported questionnaire assessing asthma symptoms (ie, night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use and FEV1. The ACQ-6 is a shortened version of the ACQ that omits the FEV1 measurement from the original ACQ score. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled).
Time Frame Baseline (Week 0 [Day 1]) and Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Mean (Standard Deviation) [Units on a scale]
-0.89
(0.91)
-1.24
(0.94)
-1.17
(1.00)
-1.19
(1.00)
9. Secondary Outcome
Title Rate of Severe Asthma Exacerbation Through Week 52
Description A severe asthma exacerbation is defined as an event that resulted in hospitalization. The severe AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
Time Frame Week 0 (Day 1) up to Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Number (95% Confidence Interval) [events per person-year]
0.14
0.04
0.02
0.03
10. Secondary Outcome
Title Time to First Asthma Exacerbation Through Week 52
Description Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first asthma exacerbation was reported.
Time Frame Week 0 (Day 1) through Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Median (95% Confidence Interval) [Days]
NA
NA
NA
NA
11. Secondary Outcome
Title Time to First Severe Asthma Exacerbation Through Week 52
Description Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first severe asthma exacerbations (hospitalization) were reported.
Time Frame Week 0 (Day 1) through Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Median (95% Confidence Interval) [Days]
NA
NA
NA
NA
12. Secondary Outcome
Title Number of Participants With at Least One Asthma Exacerbations Through Week 52
Description Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.
Time Frame Week 0 (Day 1) through Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Count of Participants [Participants]
43
31.2%
30
21.7%
21
15.3%
25
18.2%
13. Secondary Outcome
Title Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52
Description Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Participants with severe asthma exacerbations (hospitalization) were reported.
Time Frame Week 0 (Day 1) through Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Count of Participants [Participants]
9
6.5%
5
3.6%
3
2.2%
4
2.9%
14. Secondary Outcome
Title Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52
Description The AQLQ(S) +12 is a 32-item questionnaire that measures the health-related quality of life experienced by asthma participants. The questionnaire comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli) scaled on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment).
Time Frame Baseline (Week 0 [Day 1]) and Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Mean (Standard Deviation) [Units on a scale]
1.04
(1.11)
1.19
(0.90)
0.93
(1.03)
1.13
(1.13)
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
Description European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a visual analogue scale (VAS) that ranged from 0 to 100, where 0 indicated the worst health you can imagine and 100 indicated the best health you can imagine.
Time Frame Baseline (Week 0 [Day 1]) and Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-treat population included participants who are randomized and received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Health State Valuation
0.1051
(0.1511)
0.0752
(0.2179)
0.0729
(0.1624)
0.0395
(0.1935)
Visual Analog Scale
13.8
(17.6)
14.0
(16.4)
12.0
(18.0)
12.3
(18.0)
16. Secondary Outcome
Title Total Amount of Study Drug Exposure
Description The total amount of study drug exposure (in milligram) for the entire study period was summarized.
Time Frame Week 0 (Day 1) through Week 52

Outcome Measure Data

Analysis Population Description
As-treated population included all participants who received any study drug.
Arm/Group Title MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 137 137
Mean (Standard Deviation) [Milligram]
877.0
(116.9)
2493.9
(640.4)
6574.9
(1630.2)
17. Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Description An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any adverse event that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period until and including the follow-up period (Week 64).
Time Frame Day 1 upto Week 64

Outcome Measure Data

Analysis Population Description
As-treated population included all participants who received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
TEAEs
91
65.9%
93
67.4%
90
65.7%
89
65%
TESAEs
18
13%
17
12.3%
13
9.5%
18
13.1%
18. Secondary Outcome
Title Number of Participants With TEAEs Related to Vital Sign Parameters
Description Adverse events observed in participants with clinically significant vital signs abnormalities were assessed.
Time Frame Day 1 upto Week 64

Outcome Measure Data

Analysis Population Description
As-treated population included all participants who received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Blood pressure diastolic increased
0
0%
1
0.7%
0
0%
0
0%
Blood pressure increased
1
0.7%
2
1.4%
1
0.7%
0
0%
Heart rate increased
0
0%
0
0%
0
0%
1
0.7%
Hypertension
7
5.1%
7
5.1%
5
3.6%
6
4.4%
Hypertensive crisis
0
0%
0
0%
0
0%
1
0.7%
Hypotension
0
0%
0
0%
0
0%
2
1.5%
Pyrexia
0
0%
2
1.4%
2
1.5%
0
0%
Respiratory rate increased
0
0%
0
0%
0
0%
1
0.7%
19. Secondary Outcome
Title Number of Participants With TEAEs Related to Clinical Laboratory Evaluation
Description An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations of blood and urine samples were performed.
Time Frame Day 1 upto Week 64

Outcome Measure Data

Analysis Population Description
As-treated population included all participants who received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Anaemia
0
0%
0
0%
0
0%
1
0.7%
Leukopenia
0
0%
1
0.7%
0
0%
0
0%
Lymphopenia
0
0%
1
0.7%
0
0%
0
0%
Neutropenia
0
0%
1
0.7%
0
0%
0
0%
Thrombocytopenia
0
0%
1
0.7%
0
0%
0
0%
Dyslipidaemia
0
0%
1
0.7%
0
0%
0
0%
Hepatic enzyme increased
0
0%
0
0%
1
0.7%
0
0%
Hypercholesterolaemia
0
0%
0
0%
1
0.7%
0
0%
Hyperuricaemia
0
0%
0
0%
1
0.7%
0
0%
Hypokalaemia
0
0%
0
0%
1
0.7%
0
0%
Vitamin D deficiency
0
0%
0
0%
1
0.7%
0
0%
Hematuria
1
0.7%
0
0%
1
0.7%
0
0%
20. Secondary Outcome
Title Number of Participants With TEAEs Related to Electrocardiogram Evaluations
Description Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed.
Time Frame From the start of study drug administration upto Week 64

Outcome Measure Data

Analysis Population Description
As-treated population included all participants who received any study drug.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
Atrial fibrillation
1
0.7%
0
0%
2
1.5%
0
0%
Atrial flutter
0
0%
1
0.7%
0
0%
0
0%
Bundle branch block left
0
0%
0
0%
1
0.7%
0
0%
Supraventricular extrasystoles
1
0.7%
0
0%
0
0%
0
0%
Tachycardia
1
0.7%
1
0.7%
1
0.7%
2
1.5%
21. Secondary Outcome
Title Mean Serum Concentrations of MEDI9929
Description The mean serum concentrations of MEDI9929 was observed at specified timepoints.
Time Frame Week 0 (Day 1) to Week 64

Outcome Measure Data

Analysis Population Description
Pharmacokinetic population included all participants who received MEDI9929 and have a sufficient number of serum concentration measurements. Here, "N" signifies number of participants analyzed for this outcome measure.
Arm/Group Title MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 133 128 132
Week 4
3933.6
(3022.7)
10733.1
(4649.4)
39722.7
(15140.7)
Week 12
6215.8
(3779.2)
16625.4
(7751.6)
63223.7
(60627.6)
Week 20
6028.3
(2897.9)
18237.1
(8721.9)
64442.9
(22558.3)
Week 28
6084.1
(2885.5)
19373.4
(9191.4)
64659.9
(24121.6)
Week 40
6050.4
(3296.4)
18926.1
(10252.7)
64404.0
(26473.0)
Week 52
6027.2
(3024.8)
18821.9
(10435.2)
68899.1
(71137.2)
Week 64
632.8
(519.5)
1991.2
(1882.4)
6986.0
(5289.0)
22. Secondary Outcome
Title Number of Participants With Positive Antibodies to MEDI9929
Description Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The number of participants with positive serum antibodies to MEDI9929 were presented.
Time Frame Week 0 (Day 1) to Week 64

Outcome Measure Data

Analysis Population Description
As-treated population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Measure Participants 138 138 137 137
ADA Positive at Baseline
7
5.1%
1
0.7%
2
1.5%
2
1.5%
ADA prevalence
13
9.4%
6
4.3%
2
1.5%
4
2.9%
ADA incidence
13
9.4%
5
3.6%
1
0.7%
3
2.2%
Neutralizing antibody- ADA Positive
0
0%
0
0%
0
0%
0
0%

Adverse Events

Time Frame From Day 1 upto Week 64
Adverse Event Reporting Description
Arm/Group Title Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Arm/Group Description Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
All Cause Mortality
Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/138 (0%) 1/138 (0.7%) 0/137 (0%) 0/137 (0%)
Serious Adverse Events
Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 18/138 (13%) 17/138 (12.3%) 13/137 (9.5%) 18/137 (13.1%)
Cardiac disorders
Atrial fibrillation 1/138 (0.7%) 1 0/138 (0%) 0 0/137 (0%) 0 0/137 (0%) 0
Atrial flutter 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Cardiac failure 1/138 (0.7%) 1 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Myocardial infarction 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Gastrointestinal disorders
Abdominal pain 0/138 (0%) 0 1/138 (0.7%) 2 0/137 (0%) 0 0/137 (0%) 0
Abdominal pain lower 1/138 (0.7%) 1 0/138 (0%) 0 0/137 (0%) 0 0/137 (0%) 0
Hiatus hernia 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Large intestine polyp 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Pancreatitis acute 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
General disorders
Non-cardiac chest pain 1/138 (0.7%) 1 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Hepatobiliary disorders
Cholelithiasis 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Immune system disorders
Anaphylactic shock 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Infections and infestations
Bronchitis 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Cellulitis 1/138 (0.7%) 1 0/138 (0%) 0 0/137 (0%) 0 0/137 (0%) 0
Chronic sinusitis 1/138 (0.7%) 1 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Erysipelas 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Genitourinary tract infection 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Influenza 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Pneumonia 1/138 (0.7%) 1 3/138 (2.2%) 3 0/137 (0%) 0 2/137 (1.5%) 2
Pyelonephritis chronic 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Sinusitis 1/138 (0.7%) 1 0/138 (0%) 0 0/137 (0%) 0 0/137 (0%) 0
Staphylococcal infection 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Tooth abscess 1/138 (0.7%) 1 0/138 (0%) 0 0/137 (0%) 0 0/137 (0%) 0
Urinary tract infection 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Viral infection 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Injury, poisoning and procedural complications
Cartilage injury 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Concussion 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Foreign body aspiration 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Ligament sprain 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Lower limb fracture 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Lumbar vertebral fracture 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Post procedural complication 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Upper limb fracture 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Osteoarthritis 1/138 (0.7%) 1 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Osteochondrosis 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Rhabdomyolysis 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Basal cell carcinoma 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Lipoma 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Pancreatic carcinoma metastatic 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Prostate cancer 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Prostate cancer stage i 1/138 (0.7%) 1 0/138 (0%) 0 0/137 (0%) 0 0/137 (0%) 0
Nervous system disorders
Cerebrovascular accident 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Cervicobrachial syndrome 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Guillain-barre syndrome 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Sciatica 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Pregnancy, puerperium and perinatal conditions
Abortion threatened 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 1/137 (0.7%) 2
Hyperemesis gravidarum 0/138 (0%) 0 0/138 (0%) 0 1/137 (0.7%) 1 0/137 (0%) 0
Renal and urinary disorders
Calculus urinary 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Reproductive system and breast disorders
Cervical leukoplakia 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Ovarian cyst 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Testicular pain 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Respiratory, thoracic and mediastinal disorders
Asthma 10/138 (7.2%) 23 5/138 (3.6%) 5 4/137 (2.9%) 4 6/137 (4.4%) 6
Pulmonary embolism 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Skin and subcutaneous tissue disorders
Dermatitis atopic 1/138 (0.7%) 1 0/138 (0%) 0 0/137 (0%) 0 0/137 (0%) 0
Dermatitis contact 0/138 (0%) 0 1/138 (0.7%) 1 0/137 (0%) 0 0/137 (0%) 0
Vascular disorders
Deep vein thrombosis 0/138 (0%) 0 1/138 (0.7%) 1 1/137 (0.7%) 1 0/137 (0%) 0
Hypertensive crisis 0/138 (0%) 0 0/138 (0%) 0 0/137 (0%) 0 1/137 (0.7%) 1
Other (Not Including Serious) Adverse Events
Placebo MEDI9929 70 mg MEDI9929 210 mg MEDI9929 280 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 56/138 (40.6%) 49/138 (35.5%) 44/137 (32.1%) 50/137 (36.5%)
Infections and infestations
Nasopharyngitis 16/138 (11.6%) 26 19/138 (13.8%) 24 19/137 (13.9%) 25 15/137 (10.9%) 30
Bronchitis 7/138 (5.1%) 11 7/138 (5.1%) 7 5/137 (3.6%) 6 9/137 (6.6%) 11
Nervous system disorders
Headache 6/138 (4.3%) 11 6/138 (4.3%) 10 11/137 (8%) 21 5/137 (3.6%) 11
Respiratory, thoracic and mediastinal disorders
Asthma 47/138 (34.1%) 111 31/138 (22.5%) 50 23/137 (16.8%) 37 35/137 (25.5%) 47

Limitations/Caveats

A non-pre-specified statistical analysis was performed and generated the Measure of Dispersion for Outcome Measures 4 and 6.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.

Results Point of Contact

Name/Title Fred Reid
Organization MedImmune, LLC
Phone +44 (0) 203 749 6512
Email information.center@astrazeneca.com
Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02054130
Other Study ID Numbers:
  • CD-RI-MEDI9929-1146
  • 2013-003269-33
First Posted:
Feb 4, 2014
Last Update Posted:
Dec 4, 2018
Last Verified:
Nov 1, 2018