Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of CAT-354 (NCT NCT00873860)
NCT ID: NCT00873860
Last Updated: 2017-03-24
Results Overview
Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
357 participants
Primary outcome timeframe
Day 1 and 92
Results posted on
2017-03-24
Participant Flow
A total of 357 participants were screened in this study, out of which 194 participants me the eligibility criteria and were enrolled and randomized into the study.
Participant milestones
| Measure |
Placebo
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
51
|
48
|
|
Overall Study
Treated
|
47
|
47
|
51
|
48
|
|
Overall Study
COMPLETED
|
44
|
47
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of CAT-354
Baseline characteristics by cohort
| Measure |
Placebo
n=48 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=47 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=48 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
47.3 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 and 92Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued prior to receiving 4 doses due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92
Day 1 (n=46, 46, 50, 47)
|
2.63 units on a scale
Standard Deviation 0.51
|
2.72 units on a scale
Standard Deviation 0.58
|
2.62 units on a scale
Standard Deviation 0.50
|
2.72 units on a scale
Standard Deviation 0.76
|
|
Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92
Change at Day 92 (n= 46, 46, 51, 47)
|
-0.61 units on a scale
Standard Deviation 0.90
|
-0.73 units on a scale
Standard Deviation 1.12
|
-0.70 units on a scale
Standard Deviation 0.93
|
-0.86 units on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Day 1 to Day 92 and Day 169Population: Evaluable population = all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Since, \>50% participants for each arm achieved improvement through Day 92; the median time-to-first observed achievement is identical for data through Day 92 and Day 169.
Time to first asthma control was defined as the number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (\>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled).
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Time to First Observed Asthma Control
Day 1 to 92
|
25.5 days
95% Confidence Interval 5.50 • Interval 15.0 to 71.0
|
22.0 days
95% Confidence Interval 5.21 • Interval 15.0 to 43.0
|
15.0 days
95% Confidence Interval 4.54 • Interval 15.0 to 43.0
|
15.0 days
95% Confidence Interval 4.56 • Interval 15.0 to 36.0
|
|
Time to First Observed Asthma Control
Day 1 to 169
|
25.5 days
95% Confidence Interval 9.97 • Interval 15.0 to 71.0
|
22.0 days
95% Confidence Interval 8.89 • Interval 15.0 to 43.0
|
15.0 days
95% Confidence Interval 7.65 • Interval 15.0 to 43.0
|
15.0 days
95% Confidence Interval 8.07 • Interval 15.0 to 36.0
|
SECONDARY outcome
Timeframe: Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Forced Expiratory Volume in 1 Second (FEV1) is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Data collected on Day 1 prior to dosing was considered as baseline.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Day 1 (n=46,46,51,47)
|
1.949 liters
Standard Deviation 0.479
|
2.178 liters
Standard Deviation 0.661
|
1.907 liters
Standard Deviation 0.586
|
1.977 liters
Standard Deviation 0.646
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change at Day 15 (n=44,46,50,46)
|
0.019 liters
Standard Deviation 0.420
|
0.122 liters
Standard Deviation 0.316
|
0.116 liters
Standard Deviation 0.378
|
0.134 liters
Standard Deviation 0.348
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change at Day 29 (n=46,46,49,47)
|
0.051 liters
Standard Deviation 0.424
|
0.138 liters
Standard Deviation 0.315
|
0.149 liters
Standard Deviation 0.303
|
0.222 liters
Standard Deviation 0.354
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change at Day 43 (n=45,44,47,47)
|
0.125 liters
Standard Deviation 0.399
|
0.131 liters
Standard Deviation 0.380
|
0.164 liters
Standard Deviation 0.358
|
0.147 liters
Standard Deviation 0.373
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change at Day 57 (n=45,46,49,47)
|
0.043 liters
Standard Deviation 0.436
|
0.127 liters
Standard Deviation 0.339
|
0.187 liters
Standard Deviation 0.349
|
0.201 liters
Standard Deviation 0.344
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change at Day 71 (n=45,45,49,47)
|
0.047 liters
Standard Deviation 0.397
|
0.158 liters
Standard Deviation 0.314
|
0.179 liters
Standard Deviation 0.381
|
0.190 liters
Standard Deviation 0.335
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change at Day 85 (n=45,46,48,47)
|
0.087 liters
Standard Deviation 0.397
|
0.135 liters
Standard Deviation 0.342
|
0.286 liters
Standard Deviation 0.393
|
0.265 liters
Standard Deviation 0.473
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change at Day 92 (n=42,44,49,44)
|
0.063 liters
Standard Deviation 0.476
|
0.158 liters
Standard Deviation 0.348
|
0.211 liters
Standard Deviation 0.374
|
0.262 liters
Standard Deviation 0.408
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change at Day 127 (n=44,44,49,47)
|
0.094 liters
Standard Deviation 0.489
|
0.144 liters
Standard Deviation 0.263
|
0.241 liters
Standard Deviation 0.381
|
0.237 liters
Standard Deviation 0.285
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Change at Day 169 (n=42,42,47,47)
|
0.101 liters
Standard Deviation 0.442
|
0.204 liters
Standard Deviation 0.378
|
0.211 liters
Standard Deviation 0.394
|
0.236 liters
Standard Deviation 0.366
|
SECONDARY outcome
Timeframe: Day -7 to 1 (predose), Day 2 to 169Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Day -7 to 1 (n=46,46,51,47)
|
282.63 liters/minute
Standard Deviation 100.65
|
351.06 liters/minute
Standard Deviation 130.41
|
291.54 liters/minute
Standard Deviation 119.46
|
325.23 liters/minute
Standard Deviation 123.90
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 2 to 8 (n=44,46,51,47)
|
-5.77 liters/minute
Standard Deviation 22.74
|
1.91 liters/minute
Standard Deviation 23.81
|
-4.53 liters/minute
Standard Deviation 19.02
|
5.94 liters/minute
Standard Deviation 29.93
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 9 to 15 (n=45,46,51,47)
|
-7.46 liters/minute
Standard Deviation 29.68
|
-4.10 liters/minute
Standard Deviation 28.15
|
-2.83 liters/minute
Standard Deviation 24.40
|
5.75 liters/minute
Standard Deviation 42.34
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 16 to 22 (n=45,46,51,47)
|
-8.94 liters/minute
Standard Deviation 35.72
|
-6.53 liters/minute
Standard Deviation 32.70
|
-0.37 liters/minute
Standard Deviation 33.85
|
10.55 liters/minute
Standard Deviation 51.26
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 23 to 29 (n=44,46,51,47)
|
-10.53 liters/minute
Standard Deviation 40.06
|
-6.61 liters/minute
Standard Deviation 37.95
|
-0.79 liters/minute
Standard Deviation 36.94
|
10.61 liters/minute
Standard Deviation 52.64
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 30 to 36 (n=45,46,51,47)
|
-5.69 liters/minute
Standard Deviation 44.69
|
-5.69 liters/minute
Standard Deviation 41.87
|
-1.98 liters/minute
Standard Deviation 36.06
|
6.52 liters/minute
Standard Deviation 50.15
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 37 to 43 (n=44,46,50,47)
|
-11.08 liters/minute
Standard Deviation 41.52
|
-2.00 liters/minute
Standard Deviation 49.76
|
-4.07 liters/minute
Standard Deviation 39.80
|
5.55 liters/minute
Standard Deviation 54.28
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 44 to 50 (n=44,46,50,47)
|
-6.37 liters/minute
Standard Deviation 41.50
|
-9.02 liters/minute
Standard Deviation 47.51
|
-5.30 liters/minute
Standard Deviation 36.57
|
-0.84 liters/minute
Standard Deviation 50.67
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 51 to 57 (n=45,46,50,47)
|
-7.00 liters/minute
Standard Deviation 41.70
|
-6.01 liters/minute
Standard Deviation 47.36
|
-4.85 liters/minute
Standard Deviation 41.27
|
-3.57 liters/minute
Standard Deviation 52.84
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 58 to 64 (n=45,46,50,46)
|
-9.84 liters/minute
Standard Deviation 38.73
|
-2.83 liters/minute
Standard Deviation 47.42
|
-1.42 liters/minute
Standard Deviation 41.90
|
-0.73 liters/minute
Standard Deviation 55.98
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 65 to 71 (n=45,46,50,46)
|
-11.81 liters/minute
Standard Deviation 43.87
|
-3.98 liters/minute
Standard Deviation 47.20
|
-0.92 liters/minute
Standard Deviation 49.95
|
-1.82 liters/minute
Standard Deviation 49.79
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 72 to 78 (n=44,45,50,47)
|
-3.72 liters/minute
Standard Deviation 44.07
|
-3.42 liters/minute
Standard Deviation 53.55
|
2.54 liters/minute
Standard Deviation 45.58
|
1.78 liters/minute
Standard Deviation 49.45
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 79 to 85 (n=45,45,50,46)
|
-10.83 liters/minute
Standard Deviation 43.99
|
-6.67 liters/minute
Standard Deviation 54.49
|
-0.35 liters/minute
Standard Deviation 40.29
|
5.30 liters/minute
Standard Deviation 60.62
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 86 to 92 (n=45,46,50,47)
|
-3.26 liters/minute
Standard Deviation 47.36
|
-6.66 liters/minute
Standard Deviation 51.23
|
5.04 liters/minute
Standard Deviation 40.52
|
0.31 liters/minute
Standard Deviation 62.86
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 93 to 99 (n=45,46,50,47)
|
-2.52 liters/minute
Standard Deviation 47.94
|
-4.99 liters/minute
Standard Deviation 49.91
|
5.16 liters/minute
Standard Deviation 40.99
|
7.81 liters/minute
Standard Deviation 58.29
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 100 to 106 (n=44,46,49,47)
|
-9.60 liters/minute
Standard Deviation 55.47
|
-7.33 liters/minute
Standard Deviation 52.64
|
1.93 liters/minute
Standard Deviation 43.08
|
2.00 liters/minute
Standard Deviation 62.18
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 107 to 113 (n=44,45,48,47)
|
-7.53 liters/minute
Standard Deviation 56.29
|
-11.29 liters/minute
Standard Deviation 57.33
|
0.53 liters/minute
Standard Deviation 45.60
|
0.39 liters/minute
Standard Deviation 61.52
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 114 to 120 (n=42,45,47,47)
|
-2.19 liters/minute
Standard Deviation 61.74
|
-8.97 liters/minute
Standard Deviation 55.61
|
4.85 liters/minute
Standard Deviation 39.54
|
-3.03 liters/minute
Standard Deviation 59.68
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 121 to 127 (n=42,46,46,46)
|
-3.58 liters/minute
Standard Deviation 65.64
|
-8.99 liters/minute
Standard Deviation 64.60
|
3.61 liters/minute
Standard Deviation 46.18
|
-4.21 liters/minute
Standard Deviation 57.88
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 128 to 134 (n=42,45,45,47)
|
-4.39 liters/minute
Standard Deviation 61.22
|
-14.81 liters/minute
Standard Deviation 61.39
|
4.62 liters/minute
Standard Deviation 44.65
|
-2.64 liters/minute
Standard Deviation 56.87
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 135 to 141 (n=40,45,47,47)
|
-0.26 liters/minute
Standard Deviation 58.83
|
-17.03 liters/minute
Standard Deviation 58.99
|
1.11 liters/minute
Standard Deviation 44.36
|
-6.03 liters/minute
Standard Deviation 63.13
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 142 to 148 (n=40,45,47,47)
|
5.16 liters/minute
Standard Deviation 66.54
|
-11.63 liters/minute
Standard Deviation 61.02
|
-2.69 liters/minute
Standard Deviation 51.65
|
-9.65 liters/minute
Standard Deviation 65.62
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 149 to 155 (n=40,45,46,47)
|
0.43 liters/minute
Standard Deviation 60.53
|
-9.56 liters/minute
Standard Deviation 60.13
|
-7.65 liters/minute
Standard Deviation 47.44
|
-11.07 liters/minute
Standard Deviation 62.16
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 156 to 162 (n=40,45,46,46)
|
-1.38 liters/minute
Standard Deviation 65.53
|
-11.60 liters/minute
Standard Deviation 62.14
|
-10.05 liters/minute
Standard Deviation 43.11
|
-10.68 liters/minute
Standard Deviation 66.86
|
|
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
Change in Day 163 to 169 (n=37,41,42,40)
|
-0.36 liters/minute
Standard Deviation 58.66
|
-5.68 liters/minute
Standard Deviation 60.69
|
-4.71 liters/minute
Standard Deviation 49.29
|
-3.23 liters/minute
Standard Deviation 66.84
|
SECONDARY outcome
Timeframe: Day -7 to 169Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 79 to 85 (n=46,46, 50,46)
|
2.6 puffs per week
Standard Deviation 2.3
|
2.1 puffs per week
Standard Deviation 2.1
|
1.9 puffs per week
Standard Deviation 2.0
|
1.8 puffs per week
Standard Deviation 1.8
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 86 to 92 (n=46,46, 50,47)
|
2.5 puffs per week
Standard Deviation 2.3
|
2.0 puffs per week
Standard Deviation 2.1
|
1.8 puffs per week
Standard Deviation 2.0
|
1.7 puffs per week
Standard Deviation 1.7
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 93 to 99 (n=46,46, 50,47)
|
2.4 puffs per week
Standard Deviation 2.2
|
1.7 puffs per week
Standard Deviation 2.0
|
1.8 puffs per week
Standard Deviation 2.1
|
1.6 puffs per week
Standard Deviation 1.8
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 100 to 106 (n=45,46, 49,47)
|
2.3 puffs per week
Standard Deviation 2.1
|
1.9 puffs per week
Standard Deviation 2.2
|
1.7 puffs per week
Standard Deviation 2.2
|
1.8 puffs per week
Standard Deviation 1.8
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 107 to 113 (n=45,45, 48,47)
|
2.4 puffs per week
Standard Deviation 2.1
|
1.9 puffs per week
Standard Deviation 2.2
|
1.7 puffs per week
Standard Deviation 1.9
|
1.7 puffs per week
Standard Deviation 1.6
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 114 to 120 (n=43,45, 47,47)
|
2.3 puffs per week
Standard Deviation 2.0
|
1.9 puffs per week
Standard Deviation 2.1
|
1.7 puffs per week
Standard Deviation 1.9
|
1.7 puffs per week
Standard Deviation 1.7
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 121 to 127 (n=43,46, 46,47)
|
2.2 puffs per week
Standard Deviation 1.9
|
1.9 puffs per week
Standard Deviation 2.2
|
1.8 puffs per week
Standard Deviation 2.0
|
1.6 puffs per week
Standard Deviation 1.6
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 128 to 134 (n=44,45, 47,47)
|
2.2 puffs per week
Standard Deviation 2.1
|
1.8 puffs per week
Standard Deviation 2.0
|
1.6 puffs per week
Standard Deviation 1.9
|
1.6 puffs per week
Standard Deviation 1.7
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 135 to 141 (n=42,45, 47,47)
|
2.2 puffs per week
Standard Deviation 2.0
|
1.9 puffs per week
Standard Deviation 1.9
|
1.7 puffs per week
Standard Deviation 2.0
|
1.7 puffs per week
Standard Deviation 1.8
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 142 to 148 (n=42,45, 47,47)
|
2.3 puffs per week
Standard Deviation 2.0
|
1.9 puffs per week
Standard Deviation 2.1
|
1.8 puffs per week
Standard Deviation 2.0
|
1.8 puffs per week
Standard Deviation 1.8
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 149 to 155 (n=42,45, 46,47)
|
2.4 puffs per week
Standard Deviation 2.2
|
1.9 puffs per week
Standard Deviation 2.1
|
1.8 puffs per week
Standard Deviation 2.0
|
1.8 puffs per week
Standard Deviation 1.8
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 156 to 162 (n=42,45, 46,46)
|
2.3 puffs per week
Standard Deviation 2.1
|
1.9 puffs per week
Standard Deviation 2.1
|
1.7 puffs per week
Standard Deviation 2.2
|
2.0 puffs per week
Standard Deviation 2.0
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 163 to 169 (n=39,41,42,40)
|
2.7 puffs per week
Standard Deviation 2.6
|
1.9 puffs per week
Standard Deviation 2.1
|
1.6 puffs per week
Standard Deviation 1.8
|
1.7 puffs per week
Standard Deviation 1.9
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day -7 to 1 (n=46,46, 51,47)
|
2.58 puffs per week
Standard Deviation 1.70
|
2.84 puffs per week
Standard Deviation 2.03
|
2.04 puffs per week
Standard Deviation 1.51
|
2.62 puffs per week
Standard Deviation 1.96
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 2 to 8 (n=45,46, 51,47)
|
2.5 puffs per week
Standard Deviation 1.8
|
2.4 puffs per week
Standard Deviation 2.0
|
1.9 puffs per week
Standard Deviation 1.5
|
2.3 puffs per week
Standard Deviation 2.0
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 9 to 15 (n=46,46, 51,47)
|
2.4 puffs per week
Standard Deviation 1.8
|
2.5 puffs per week
Standard Deviation 2.3
|
1.9 puffs per week
Standard Deviation 1.5
|
2.2 puffs per week
Standard Deviation 2.0
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 16 to 22 (n=46,46, 51,47)
|
2.6 puffs per week
Standard Deviation 1.9
|
2.2 puffs per week
Standard Deviation 2.0
|
1.9 puffs per week
Standard Deviation 1.7
|
2.3 puffs per week
Standard Deviation 2.2
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 23 to 29 (n=45,46, 51,47)
|
2.7 puffs per week
Standard Deviation 2.1
|
2.2 puffs per week
Standard Deviation 2.0
|
2.0 puffs per week
Standard Deviation 1.9
|
2.2 puffs per week
Standard Deviation 2.1
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 30 to 36 (n=46,46, 51,47)
|
2.5 puffs per week
Standard Deviation 2.0
|
2.1 puffs per week
Standard Deviation 2.2
|
1.9 puffs per week
Standard Deviation 2.0
|
2.0 puffs per week
Standard Deviation 1.9
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 37 to 43 (n=45,46, 50,47)
|
2.4 puffs per week
Standard Deviation 2.0
|
2.1 puffs per week
Standard Deviation 2.2
|
1.9 puffs per week
Standard Deviation 2.0
|
2.0 puffs per week
Standard Deviation 2.0
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 44 to 50 (n=45,46, 50,47)
|
2.5 puffs per week
Standard Deviation 2.0
|
1.9 puffs per week
Standard Deviation 2.2
|
1.7 puffs per week
Standard Deviation 2.0
|
2.0 puffs per week
Standard Deviation 2.0
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 51 to 57 (n=45,46, 50,47)
|
2.5 puffs per week
Standard Deviation 2.1
|
2.0 puffs per week
Standard Deviation 2.0
|
1.8 puffs per week
Standard Deviation 1.9
|
2.0 puffs per week
Standard Deviation 2.1
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 58 to 64 (n=46,46, 49,46)
|
2.5 puffs per week
Standard Deviation 2.2
|
1.9 puffs per week
Standard Deviation 2.0
|
1.9 puffs per week
Standard Deviation 2.0
|
1.8 puffs per week
Standard Deviation 2.0
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 65 to 71 (n=46,46, 50,47)
|
2.7 puffs per week
Standard Deviation 2.3
|
2.0 puffs per week
Standard Deviation 2.0
|
1.8 puffs per week
Standard Deviation 2.0
|
2.0 puffs per week
Standard Deviation 1.9
|
|
Number of Puffs of Rescue Beta-2 Agonist Per Week
Day 72 to 78 (n=45,45, 50,46)
|
2.5 puffs per week
Standard Deviation 2.2
|
2.0 puffs per week
Standard Deviation 2.0
|
1.8 puffs per week
Standard Deviation 2.1
|
1.9 puffs per week
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Day 1, 29, 57, 92, 127 and 169Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\[S\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Overall : Day 1 (n=41,41,44,39)
|
4.22 units on a scale
Standard Deviation 0.83
|
3.96 units on a scale
Standard Deviation 0.89
|
4.12 units on a scale
Standard Deviation 0.80
|
4.11 units on a scale
Standard Deviation 0.94
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Overall: Day 29 (n=43,41,44,40)
|
4.39 units on a scale
Standard Deviation 1.04
|
4.39 units on a scale
Standard Deviation 1.01
|
4.47 units on a scale
Standard Deviation 0.97
|
4.60 units on a scale
Standard Deviation 0.91
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Overall: Day 57 (n=44,40,43,45)
|
4.57 units on a scale
Standard Deviation 1.03
|
4.56 units on a scale
Standard Deviation 1.15
|
4.47 units on a scale
Standard Deviation 1.05
|
4.73 units on a scale
Standard Deviation 0.96
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Overall: Day 92 (n=40,42,40,38)
|
4.70 units on a scale
Standard Deviation 1.16
|
4.88 units on a scale
Standard Deviation 1.31
|
4.74 units on a scale
Standard Deviation 1.15
|
4.87 units on a scale
Standard Deviation 0.99
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Overall: Day 127 (n=41,42,44,42)
|
4.69 units on a scale
Standard Deviation 1.22
|
4.76 units on a scale
Standard Deviation 1.29
|
4.64 units on a scale
Standard Deviation 1.11
|
4.85 units on a scale
Standard Deviation 1.13
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Overall: Day 169 (n=41,44,45,44)
|
4.72 units on a scale
Standard Deviation 1.29
|
4.73 units on a scale
Standard Deviation 1.26
|
4.61 units on a scale
Standard Deviation 1.27
|
4.76 units on a scale
Standard Deviation 1.13
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Symptom: Day 1 (n=41,41,44,39)
|
4.15 units on a scale
Standard Deviation 0.88
|
3.89 units on a scale
Standard Deviation 0.84
|
4.11 units on a scale
Standard Deviation 0.71
|
4.08 units on a scale
Standard Deviation 1.06
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Symptom: Day 29 (n=43,41,44,40)
|
4.32 units on a scale
Standard Deviation 1.08
|
4.44 units on a scale
Standard Deviation 1.07
|
4.48 units on a scale
Standard Deviation 0.94
|
4.56 units on a scale
Standard Deviation 1.01
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Symptom: Day 57 (n=44,40,43,45)
|
4.61 units on a scale
Standard Deviation 1.02
|
4.68 units on a scale
Standard Deviation 1.23
|
4.49 units on a scale
Standard Deviation 1.05
|
4.73 units on a scale
Standard Deviation 1.05
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Symptom: Day 92 (n=40,42,40,38)
|
4.77 units on a scale
Standard Deviation 1.17
|
4.88 units on a scale
Standard Deviation 1.40
|
4.78 units on a scale
Standard Deviation 1.17
|
4.92 units on a scale
Standard Deviation 1.01
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Symptom: Day 127 (n=41,42,44,42)
|
4.74 units on a scale
Standard Deviation 1.33
|
4.79 units on a scale
Standard Deviation 1.31
|
4.69 units on a scale
Standard Deviation 1.09
|
4.95 units on a scale
Standard Deviation 1.31
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Symptom: Day 169 (n=41,44,45,44)
|
4.82 units on a scale
Standard Deviation 1.30
|
4.76 units on a scale
Standard Deviation 1.29
|
4.63 units on a scale
Standard Deviation 1.26
|
4.77 units on a scale
Standard Deviation 1.31
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Activity Limitation: Day 1 (n=41,41,44,39)
|
4.38 units on a scale
Standard Deviation 0.83
|
4.07 units on a scale
Standard Deviation 0.88
|
4.13 units on a scale
Standard Deviation 0.97
|
4.15 units on a scale
Standard Deviation 0.91
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Activity Limitation: Day 29 (n=43,41,44,40)
|
4.47 units on a scale
Standard Deviation 1.00
|
4.37 units on a scale
Standard Deviation 1.07
|
4.42 units on a scale
Standard Deviation 1.08
|
4.59 units on a scale
Standard Deviation 0.92
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Activity Limitation: Day 57 (n=44,40,43,45)
|
4.57 units on a scale
Standard Deviation 1.03
|
4.42 units on a scale
Standard Deviation 1.09
|
4.41 units on a scale
Standard Deviation 1.14
|
4.74 units on a scale
Standard Deviation 0.99
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Activity Limitation: Day 92 (n=40,42,40,38)
|
4.68 units on a scale
Standard Deviation 1.19
|
4.89 units on a scale
Standard Deviation 1.29
|
4.73 units on a scale
Standard Deviation 1.15
|
4.91 units on a scale
Standard Deviation 1.04
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Activity Limitation: Day 127 (n=41,42,44,42)
|
4.64 units on a scale
Standard Deviation 1.20
|
4.77 units on a scale
Standard Deviation 1.32
|
4.62 units on a scale
Standard Deviation 1.13
|
4.66 units on a scale
Standard Deviation 1.08
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Activity Limitation: Day 169 (n=41,44,45,44)
|
4.68 units on a scale
Standard Deviation 1.28
|
4.76 units on a scale
Standard Deviation 1.26
|
4.54 units on a scale
Standard Deviation 1.31
|
4.70 units on a scale
Standard Deviation 1.14
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Emotional Function: Day 1 (n=41,41,44,39)
|
4.30 units on a scale
Standard Deviation 1.08
|
4.20 units on a scale
Standard Deviation 1.18
|
4.45 units on a scale
Standard Deviation 1.10
|
4.29 units on a scale
Standard Deviation 1.24
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Emotional Function: Day 29 (n=43,41,44,40)
|
4.64 units on a scale
Standard Deviation 1.27
|
4.82 units on a scale
Standard Deviation 1.17
|
4.82 units on a scale
Standard Deviation 1.22
|
4.88 units on a scale
Standard Deviation 1.17
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Emotional Function: Day 57 (n=44,40,43,45)
|
4.85 units on a scale
Standard Deviation 1.36
|
4.98 units on a scale
Standard Deviation 1.42
|
4.87 units on a scale
Standard Deviation 1.24
|
4.99 units on a scale
Standard Deviation 1.13
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Emotional Function: Day 92 (n=40,42,40,38)
|
5.00 units on a scale
Standard Deviation 1.31
|
5.24 units on a scale
Standard Deviation 1.33
|
4.99 units on a scale
Standard Deviation 1.45
|
4.98 units on a scale
Standard Deviation 1.02
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Emotional Function: Day 127 (n=41,42,44,42)
|
5.08 units on a scale
Standard Deviation 1.40
|
5.06 units on a scale
Standard Deviation 1.48
|
4.98 units on a scale
Standard Deviation 1.40
|
5.28 units on a scale
Standard Deviation 1.29
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Emotional Function: Day 169 (n=41,44,45,44)
|
5.05 units on a scale
Standard Deviation 1.56
|
5.00 units on a scale
Standard Deviation 1.50
|
5.06 units on a scale
Standard Deviation 1.39
|
5.13 units on a scale
Standard Deviation 1.28
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Environment stimuli: Day 1 (n=41,41,44,39)
|
3.88 units on a scale
Standard Deviation 1.28
|
3.55 units on a scale
Standard Deviation 1.43
|
3.70 units on a scale
Standard Deviation 1.11
|
3.85 units on a scale
Standard Deviation 1.10
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Environment stimuli: Day 29 (n=43,41,44,40)
|
4.06 units on a scale
Standard Deviation 1.26
|
3.75 units on a scale
Standard Deviation 1.48
|
4.13 units on a scale
Standard Deviation 1.41
|
4.40 units on a scale
Standard Deviation 1.20
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Environment stimuli: Day 57 (n=44,40,43,45)
|
4.07 units on a scale
Standard Deviation 1.34
|
4.04 units on a scale
Standard Deviation 1.36
|
4.09 units on a scale
Standard Deviation 1.43
|
4.37 units on a scale
Standard Deviation 1.49
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Environment stimuli: Day 92 (n=40,42,40,38)
|
4.16 units on a scale
Standard Deviation 1.56
|
4.44 units on a scale
Standard Deviation 1.63
|
4.31 units on a scale
Standard Deviation 1.43
|
4.47 units on a scale
Standard Deviation 1.47
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Environment stimuli: Day 127 (n=41,42,44,42)
|
4.18 units on a scale
Standard Deviation 1.58
|
4.30 units on a scale
Standard Deviation 1.57
|
4.15 units on a scale
Standard Deviation 1.56
|
4.51 units on a scale
Standard Deviation 1.64
|
|
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Environment stimuli: Day 169 (n=41,44,45,44)
|
4.13 units on a scale
Standard Deviation 1.54
|
4.26 units on a scale
Standard Deviation 1.50
|
4.18 units on a scale
Standard Deviation 1.76
|
4.45 units on a scale
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Day 1, 29, 57, 92, 127 and 169Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\[S\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing was considered as baseline
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Overall: Day 29 (n=34,35,37,31)
|
0.32 units on a scale
Standard Deviation 0.65
|
0.38 units on a scale
Standard Deviation 0.64
|
0.39 units on a scale
Standard Deviation 0.88
|
0.66 units on a scale
Standard Deviation 0.76
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Overall: Day 57 (n=33,33,35,34)
|
0.45 units on a scale
Standard Deviation 0.77
|
0.70 units on a scale
Standard Deviation 0.99
|
0.38 units on a scale
Standard Deviation 0.95
|
0.77 units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Overall: Day 92 (n=31,34,35,27)
|
0.63 units on a scale
Standard Deviation 0.88
|
0.94 units on a scale
Standard Deviation 1.21
|
0.52 units on a scale
Standard Deviation 1.07
|
1.05 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Overall: Day 127 (n=32,36,34,31)
|
0.71 units on a scale
Standard Deviation 0.85
|
0.78 units on a scale
Standard Deviation 1.21
|
0.49 units on a scale
Standard Deviation 1.14
|
1.05 units on a scale
Standard Deviation 1.15
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Overall: Day 169 (n=31,37,37,34)
|
0.64 units on a scale
Standard Deviation 1.05
|
0.78 units on a scale
Standard Deviation 1.19
|
0.56 units on a scale
Standard Deviation 1.09
|
0.75 units on a scale
Standard Deviation 1.26
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Symptom: Day 29 (n=34,35,37,31)
|
0.31 units on a scale
Standard Deviation 0.81
|
0.49 units on a scale
Standard Deviation 0.83
|
0.43 units on a scale
Standard Deviation 0.83
|
0.62 units on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Symptom: Day 57 (n=33,33,35,34)
|
0.52 units on a scale
Standard Deviation 0.86
|
0.87 units on a scale
Standard Deviation 1.10
|
0.44 units on a scale
Standard Deviation 0.85
|
0.81 units on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Symptom: Day 92 (n=31,34,35,27)
|
0.76 units on a scale
Standard Deviation 1.00
|
1.00 units on a scale
Standard Deviation 1.32
|
0.61 units on a scale
Standard Deviation 1.11
|
1.14 units on a scale
Standard Deviation 1.39
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Symptom: Day 127 (n=32,36,34,31)
|
0.85 units on a scale
Standard Deviation 1.03
|
0.87 units on a scale
Standard Deviation 1.24
|
0.56 units on a scale
Standard Deviation 1.14
|
1.24 units on a scale
Standard Deviation 1.23
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Symptom: Day 169 (n=31,37,37,34)
|
0.80 units on a scale
Standard Deviation 1.06
|
0.86 units on a scale
Standard Deviation 1.22
|
0.62 units on a scale
Standard Deviation 1.17
|
0.77 units on a scale
Standard Deviation 1.34
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Activity Limitation: Day 29 (n=34,35,37,31)
|
0.21 units on a scale
Standard Deviation 0.64
|
0.25 units on a scale
Standard Deviation 0.69
|
0.32 units on a scale
Standard Deviation 0.96
|
0.57 units on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Activity Limitation: Day 57 (n=33,33,35,34)
|
0.28 units on a scale
Standard Deviation 0.79
|
0.44 units on a scale
Standard Deviation 0.89
|
0.30 units on a scale
Standard Deviation 1.08
|
0.71 units on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Activity Limitation: Day 92 (n=31,34,35,27)
|
0.42 units on a scale
Standard Deviation 0.81
|
0.80 units on a scale
Standard Deviation 1.12
|
0.51 units on a scale
Standard Deviation 1.12
|
1.04 units on a scale
Standard Deviation 1.26
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Activity Limitation: Day 127 (n=32,36,34,31)
|
0.43 units on a scale
Standard Deviation 0.77
|
0.65 units on a scale
Standard Deviation 1.20
|
0.45 units on a scale
Standard Deviation 1.14
|
0.72 units on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Activity Limitation: Day 169 (n=31,37,37,34)
|
0.38 units on a scale
Standard Deviation 1.09
|
0.68 units on a scale
Standard Deviation 1.16
|
0.44 units on a scale
Standard Deviation 1.09
|
0.65 units on a scale
Standard Deviation 1.37
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Emotional Function: Day 29 (n=34,35,37,31)
|
0.50 units on a scale
Standard Deviation 0.93
|
0.57 units on a scale
Standard Deviation 0.76
|
0.36 units on a scale
Standard Deviation 1.04
|
0.86 units on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Emotional Function: Day 57 (n=33,33,35,34)
|
0.69 units on a scale
Standard Deviation 1.15
|
0.95 units on a scale
Standard Deviation 1.16
|
0.42 units on a scale
Standard Deviation 1.15
|
0.86 units on a scale
Standard Deviation 1.21
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Emotional Function: Day 92 (n=31,34,35,27)
|
0.87 units on a scale
Standard Deviation 1.25
|
1.06 units on a scale
Standard Deviation 1.25
|
0.43 units on a scale
Standard Deviation 1.26
|
0.93 units on a scale
Standard Deviation 1.39
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Emotional Function: Day 127 (n=32,36,34,31)
|
1.02 units on a scale
Standard Deviation 1.20
|
0.87 units on a scale
Standard Deviation 1.38
|
0.41 units on a scale
Standard Deviation 1.32
|
1.32 units on a scale
Standard Deviation 1.42
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Emotional Function: Day 169 (n=31,37,37,34)
|
0.88 units on a scale
Standard Deviation 1.42
|
0.88 units on a scale
Standard Deviation 1.36
|
0.63 units on a scale
Standard Deviation 1.20
|
0.95 units on a scale
Standard Deviation 1.40
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Environmental Stimuli: Day 29 (n=34,35,37,31)
|
0.40 units on a scale
Standard Deviation 0.85
|
0.16 units on a scale
Standard Deviation 0.78
|
0.47 units on a scale
Standard Deviation 1.18
|
0.76 units on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Environmental Stimuli: Day 57 (n=33,33,35,34)
|
0.36 units on a scale
Standard Deviation 0.86
|
0.58 units on a scale
Standard Deviation 1.39
|
0.38 units on a scale
Standard Deviation 1.27
|
0.65 units on a scale
Standard Deviation 1.40
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Environmental Stimuli: Day 92 (n=31,34,35,27)
|
0.54 units on a scale
Standard Deviation 0.94
|
0.97 units on a scale
Standard Deviation 1.68
|
0.42 units on a scale
Standard Deviation 1.17
|
0.94 units on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Environmental Stimuli: Day 127 (n=32,36,34,31)
|
0.64 units on a scale
Standard Deviation 1.11
|
0.74 units on a scale
Standard Deviation 1.68
|
0.48 units on a scale
Standard Deviation 1.45
|
1.02 units on a scale
Standard Deviation 1.22
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Environmental Stimuli: Day 169 (n=31,37,37,34)
|
0.52 units on a scale
Standard Deviation 1.17
|
0.75 units on a scale
Standard Deviation 1.55
|
0.58 units on a scale
Standard Deviation 1.30
|
0.74 units on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Day 92 and 169Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better).
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC)
Day 92 (n=40,42,40,38)
|
5.1 units on a scale
Standard Deviation 1.1
|
5.3 units on a scale
Standard Deviation 1.1
|
5.3 units on a scale
Standard Deviation 1.0
|
5.2 units on a scale
Standard Deviation 1.2
|
|
Patient Global Impression of Change (PGIC)
Day 169 (n=42,44,45,44)
|
5.1 units on a scale
Standard Deviation 1.1
|
5.3 units on a scale
Standard Deviation 1.1
|
5.0 units on a scale
Standard Deviation 1.0
|
5.1 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Day 92 and 169Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.
Percentage of participants with mean Asthma Control Questionnaire (ACQ) score less than or equal to (\<=) 0.75 or mean ACQ score greater than (\>) 0.75 and less than (\<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (\<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (\>) 0.75 but less than (\<) 1.5 indicated partly controlled asthma.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5
ACQ score<=0.75: Day 92
|
13.0 percentage of participants
19.6
|
19.6 percentage of participants
|
11.8 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5
ACQ score>0.75 and <1.5: Day 92
|
15.2 percentage of participants
|
13.0 percentage of participants
|
15.7 percentage of participants
|
19.1 percentage of participants
|
|
Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5
ACQ score<=0.75: Day 169
|
13.0 percentage of participants
|
19.6 percentage of participants
|
13.7 percentage of participants
|
19.1 percentage of participants
|
|
Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5
ACQ score>0.75 and <1.5: Day 169
|
21.7 percentage of participants
|
10.9 percentage of participants
|
17.6 percentage of participants
|
19.1 percentage of participants
|
SECONDARY outcome
Timeframe: Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169Population: Pharmacokinetic (PK) population included participants who received CAT-354 and had a sufficient number of serum concentration measurements for computing PK parameters. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=51 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=48 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Serum Concentration for CAT-354
Day 15 (n=46,48,48)
|
14.5 microgram per milliliter (mcg/mL)
Standard Deviation 5.57
|
27.8 microgram per milliliter (mcg/mL)
Standard Deviation 10.3
|
56.4 microgram per milliliter (mcg/mL)
Standard Deviation 16.0
|
—
|
|
Serum Concentration for CAT-354
Day 29 (n=45,51,47)
|
20.8 microgram per milliliter (mcg/mL)
Standard Deviation 7.20
|
40.2 microgram per milliliter (mcg/mL)
Standard Deviation 15.0
|
81.9 microgram per milliliter (mcg/mL)
Standard Deviation 23.5
|
—
|
|
Serum Concentration for CAT-354
Day 43 (n=46,50,47)
|
26.9 microgram per milliliter (mcg/mL)
Standard Deviation 12.7
|
51.0 microgram per milliliter (mcg/mL)
Standard Deviation 16.0
|
98.5 microgram per milliliter (mcg/mL)
Standard Deviation 33.4
|
—
|
|
Serum Concentration for CAT-354
Day 57 (n=46,48,46)
|
28.4 microgram per milliliter (mcg/mL)
Standard Deviation 11.3
|
58.8 microgram per milliliter (mcg/mL)
Standard Deviation 20.2
|
108 microgram per milliliter (mcg/mL)
Standard Deviation 35.8
|
—
|
|
Serum Concentration for CAT-354
Day 71 (n=46,49,47)
|
29.3 microgram per milliliter (mcg/mL)
Standard Deviation 11.9
|
61.0 microgram per milliliter (mcg/mL)
Standard Deviation 21.4
|
112 microgram per milliliter (mcg/mL)
Standard Deviation 41.2
|
—
|
|
Serum Concentration for CAT-354
Day 85 (n=45,49,47)
|
31.1 microgram per milliliter (mcg/mL)
Standard Deviation 12.5
|
62.0 microgram per milliliter (mcg/mL)
Standard Deviation 23.8
|
120 microgram per milliliter (mcg/mL)
Standard Deviation 44.5
|
—
|
|
Serum Concentration for CAT-354
Day 88 (n=46,48,45)
|
43.4 microgram per milliliter (mcg/mL)
Standard Deviation 15.8
|
85.7 microgram per milliliter (mcg/mL)
Standard Deviation 32.7
|
157 microgram per milliliter (mcg/mL)
Standard Deviation 56.5
|
—
|
|
Serum Concentration for CAT-354
Day 92 (n=45,46,45)
|
42.0 microgram per milliliter (mcg/mL)
Standard Deviation 16.3
|
86.8 microgram per milliliter (mcg/mL)
Standard Deviation 33.1
|
156 microgram per milliliter (mcg/mL)
Standard Deviation 46.6
|
—
|
|
Serum Concentration for CAT-354
Day 99 (n=46,50,46)
|
31.3 microgram per milliliter (mcg/mL)
Standard Deviation 13.0
|
69.3 microgram per milliliter (mcg/mL)
Standard Deviation 27.2
|
125 microgram per milliliter (mcg/mL)
Standard Deviation 41.9
|
—
|
|
Serum Concentration for CAT-354
Day 127 (n=47,48,47)
|
11.5 microgram per milliliter (mcg/mL)
Standard Deviation 6.02
|
22.9 microgram per milliliter (mcg/mL)
Standard Deviation 12.0
|
43.7 microgram per milliliter (mcg/mL)
Standard Deviation 20.5
|
—
|
|
Serum Concentration for CAT-354
Day 169 (n=47,48,46)
|
2.94 microgram per milliliter (mcg/mL)
Standard Deviation 2.23
|
5.87 microgram per milliliter (mcg/mL)
Standard Deviation 3.69
|
10.1 microgram per milliliter (mcg/mL)
Standard Deviation 6.71
|
—
|
SECONDARY outcome
Timeframe: Day 1, 92 and 169Population: Safety population included all participants who received any dose of the investigational product. Here, 'N'(number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=47 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=49 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1, 92 and 169Population: Safety population included all participants who received any dose of the investigational product. Here, 'N'(number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=47 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=49 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to 169Population: Safety population included all participants who received any dose of the investigational product.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=47 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=48 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
17 participants
|
20 participants
|
25 participants
|
25 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
3 participants
|
2 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 92 and 169Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. No separate analyses were performed for moderate and severe exacerbations since only 1 participant had a severe exacerbation.
Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \>= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 1 Moderate or Severe Exacerbation
Day 92
|
4.3 Percentage of Participants
|
2.2 Percentage of Participants
|
2.0 Percentage of Participants
|
4.3 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Moderate or Severe Exacerbation
Day 169
|
4.3 Percentage of Participants
|
4.3 Percentage of Participants
|
3.9 Percentage of Participants
|
6.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 92 and Day 169Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.
Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \>=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days\*365 days, where X = 92 or 169).
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Moderate or Severe Asthma Exacerbations Per Person Per Annum
Day 1 to 92
|
0.26 asthma exacerbations/person/annum
Standard Error 0.19
|
0.09 asthma exacerbations/person/annum
Standard Error 0.09
|
0.08 asthma exacerbations/person/annum
Standard Error 0.08
|
0.25 asthma exacerbations/person/annum
Standard Error 0.19
|
|
Moderate or Severe Asthma Exacerbations Per Person Per Annum
Day 1 to 169
|
0.23 asthma exacerbations/person/annum
Standard Error 0.19
|
0.14 asthma exacerbations/person/annum
Standard Error 0.10
|
0.08 asthma exacerbations/person/annum
Standard Error 0.06
|
0.19 asthma exacerbations/person/annum
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Day 1 to Day 92 and Day 169Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.
Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \>=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=46 Participants
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 Participants
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=47 Participants
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Time to First Moderate or Severe Asthma Exacerbation
Day 1 to 92
|
89.67 days
Standard Error 1.56
|
90.43 days
Standard Error 1.32
|
88.16 days
Standard Error 2.12
|
89.94 days
Standard Error 1.36
|
|
Time to First Moderate or Severe Asthma Exacerbation
Day 1 to 169
|
162.24 days
Standard Error 3.79
|
163.50 days
Standard Error 3.24
|
158.29 days
Standard Error 4.41
|
161.21 days
Standard Error 3.71
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
CAT-354 150 mg
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
CAT-354 300 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
CAT-354 600 mg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=47 participants at risk
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 participants at risk
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=48 participants at risk
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Infections and infestations
Sinusitis
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 3 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Injury, poisoning and procedural complications
Overdose
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Nervous system disorders
Brain injury
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Psychiatric disorders
Somatoform disorder
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.3%
2/47 • Number of events 2 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 150 mg
n=47 participants at risk
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 300 mg
n=51 participants at risk
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
CAT-354 600 mg
n=48 participants at risk
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
6.2%
3/48 • Number of events 3 • Day 1 to 169
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.1%
1/47 • Number of events 2 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Blood and lymphatic system disorders
Monocytopenia
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 2 • Day 1 to 169
|
|
Eye disorders
Keratitis
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
10.4%
5/48 • Number of events 6 • Day 1 to 169
|
|
Gastrointestinal disorders
Gastritis
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
4.2%
2/48 • Number of events 2 • Day 1 to 169
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
General disorders
Chest pain
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
General disorders
Influenza like illness
|
4.3%
2/47 • Number of events 2 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
3.9%
2/51 • Number of events 2 • Day 1 to 169
|
6.2%
3/48 • Number of events 4 • Day 1 to 169
|
|
General disorders
Infusion site induration
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
General disorders
Injection site erythema
|
2.1%
1/47 • Number of events 7 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
4.2%
2/48 • Number of events 3 • Day 1 to 169
|
|
General disorders
Injection site induration
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
General disorders
Injection site inflammation
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 2 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
General disorders
Injection site pain
|
0.00%
0/47 • Day 1 to 169
|
4.3%
2/47 • Number of events 3 • Day 1 to 169
|
3.9%
2/51 • Number of events 8 • Day 1 to 169
|
2.1%
1/48 • Number of events 7 • Day 1 to 169
|
|
General disorders
Injection site pruritus
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
General disorders
Injection site rash
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
General disorders
Injection site reaction
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
General disorders
Oedema peripheral
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
General disorders
Pyrexia
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/47 • Day 1 to 169
|
4.3%
2/47 • Number of events 2 • Day 1 to 169
|
3.9%
2/51 • Number of events 2 • Day 1 to 169
|
8.3%
4/48 • Number of events 4 • Day 1 to 169
|
|
Infections and infestations
Bronchitis
|
6.4%
3/47 • Number of events 3 • Day 1 to 169
|
4.3%
2/47 • Number of events 2 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
H1n1 influenza
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Influenza
|
4.3%
2/47 • Number of events 2 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
3.9%
2/51 • Number of events 2 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Infections and infestations
Laryngitis
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
4.2%
2/48 • Number of events 2 • Day 1 to 169
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
4/47 • Number of events 4 • Day 1 to 169
|
6.4%
3/47 • Number of events 5 • Day 1 to 169
|
5.9%
3/51 • Number of events 4 • Day 1 to 169
|
8.3%
4/48 • Number of events 5 • Day 1 to 169
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/47 • Day 1 to 169
|
4.3%
2/47 • Number of events 2 • Day 1 to 169
|
3.9%
2/51 • Number of events 2 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Respiratory tract infection viral
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Rhinitis
|
0.00%
0/47 • Day 1 to 169
|
4.3%
2/47 • Number of events 3 • Day 1 to 169
|
3.9%
2/51 • Number of events 2 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Tooth infection
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/47 • Day 1 to 169
|
6.4%
3/47 • Number of events 3 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
4.2%
2/48 • Number of events 2 • Day 1 to 169
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Infections and infestations
Viral infection
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Investigations
Blood bilirubin
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Investigations
Blood chloride increased
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Investigations
Blood glucose increased
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Investigations
Blood urea increased
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Investigations
Lymphocyte count decreased
|
6.4%
3/47 • Number of events 3 • Day 1 to 169
|
4.3%
2/47 • Number of events 2 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Investigations
Neutrophil count decreased
|
6.4%
3/47 • Number of events 3 • Day 1 to 169
|
6.4%
3/47 • Number of events 3 • Day 1 to 169
|
2.0%
1/51 • Number of events 2 • Day 1 to 169
|
4.2%
2/48 • Number of events 2 • Day 1 to 169
|
|
Investigations
Platelet count decreased
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
4.2%
2/48 • Number of events 2 • Day 1 to 169
|
|
Investigations
Reticulocyte count decreased
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Investigations
White blood cell count decreased
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 2 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/47 • Day 1 to 169
|
4.3%
2/47 • Number of events 2 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 2 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Nervous system disorders
Dizziness
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
4.3%
2/47 • Number of events 2 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Nervous system disorders
Headache
|
4.3%
2/47 • Number of events 3 • Day 1 to 169
|
12.8%
6/47 • Number of events 8 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
12.5%
6/48 • Number of events 7 • Day 1 to 169
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 2 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Nervous system disorders
Lethargy
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Nervous system disorders
Sciatica
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Nervous system disorders
Somnolence
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 5 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Renal and urinary disorders
Crystalluria
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
6.2%
3/48 • Number of events 3 • Day 1 to 169
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Renal and urinary disorders
Nitrituria
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Reproductive system and breast disorders
Menopausal disorder
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.4%
3/47 • Number of events 6 • Day 1 to 169
|
10.6%
5/47 • Number of events 9 • Day 1 to 169
|
9.8%
5/51 • Number of events 6 • Day 1 to 169
|
12.5%
6/48 • Number of events 9 • Day 1 to 169
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
3.9%
2/51 • Number of events 2 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
2.1%
1/47 • Number of events 4 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
2.1%
1/48 • Number of events 2 • Day 1 to 169
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/51 • Day 1 to 169
|
2.1%
1/48 • Number of events 1 • Day 1 to 169
|
|
Vascular disorders
Hypertension
|
0.00%
0/47 • Day 1 to 169
|
2.1%
1/47 • Number of events 1 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
4.2%
2/48 • Number of events 2 • Day 1 to 169
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
|
Vascular disorders
Labile hypertension
|
0.00%
0/47 • Day 1 to 169
|
0.00%
0/47 • Day 1 to 169
|
2.0%
1/51 • Number of events 1 • Day 1 to 169
|
0.00%
0/48 • Day 1 to 169
|
Additional Information
Meena Jain, MB BChir/Associate Medical Director
MedImmune, LLC
Phone: 301-398-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing 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. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER