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Trial record 7 of 11 for:    CAT-354

A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

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ClinicalTrials.gov Identifier: NCT01402986
Recruitment Status : Completed
First Posted : July 27, 2011
Results First Posted : March 6, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Other: Placebo Q2W
Biological: Tralokinumab 300 mg, Q2W
Other: Placebo, Q2/4W
Biological: Tralokinumab 300 mg, Q2/4W
Enrollment 689
Recruitment Details  
Pre-assignment Details A total of 689 participants were screened, out of which 452 participants were randomized into this study
Arm/Group Title Placebo, Q2W - Cohort 1 Tralokinumab 300 mg, Q2W - Cohort 1 Placebo, Q2/4W - Cohort 2 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks. Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks. Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses. Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Period Title: Overall Study
Started 76 150 75 151
Completed 67 135 67 129
Not Completed 9 15 8 22
Reason Not Completed
Withdrawal by Subject             7             10             7             13
Death             0             0             0             2
Lost to Follow-up             0             0             0             1
Other             2             5             1             6
Arm/Group Title Placebo, Q2W - Cohort 1 Tralokinumab 300 mg, Q2W - Cohort 1 Placebo, Q2/4W - Cohort 2 Tralokinumab 300 mg, Q2/4W - Cohort 2 Total
Hide Arm/Group Description Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks. Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks. Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses. Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses. Total of all reporting groups
Overall Number of Baseline Participants 76 150 75 151 452
Hide Baseline Analysis Population Description
The intention-to-treat (ITT) population included all participants who were randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 150 participants 75 participants 151 participants 452 participants
48.8  (12.1) 49.7  (12.2) 51.7  (13.6) 50.5  (11.8) 50.1  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 150 participants 75 participants 151 participants 452 participants
Female
51
  67.1%
100
  66.7%
46
  61.3%
100
  66.2%
297
  65.7%
Male
25
  32.9%
50
  33.3%
29
  38.7%
51
  33.8%
155
  34.3%
1.Primary Outcome
Title Annual Asthma Exacerbation Rate (AER)
Hide Description Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids (OCS) is administered (10 days after administration of an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all participants who were randomized into the study.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
0.90
(0.75 to 1.08)
0.91
(0.76 to 1.08)
0.97
(0.81 to 1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments The 95 percent (%) confidence interval (CI) for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 versus [vs] more than [>] 2 but less than or equal to [=<] 6), atopic asthma status (atopic/non-atopic), chronic oral corticosteroid (OCS) use (presence vs absence) and geographical region as the covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.709
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.67 to 1.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs > 2 but =< 6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.904
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.71 to 1.46
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53
Hide Description Pre- and post-bronchodilator FEV1 at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Baseline and Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Error)
Unit of Measure: liters
Pre-bronchodilator: Baseline (n=147,146,146) 1.926  (0.050) 1.922  (0.056) 1.934  (0.059)
Post-bronchodilator: Baseline (n=147,141,146) 2.153  (0.053) 2.094  (0.061) 2.110  (0.061)
Pre-bronchodilator: Week 53 (n=125,130,122) 0.018  (0.035) 0.128  (0.032) 0.032  (0.026)
Post-bronchodilator: Week 53 (n=125,126,120) -0.058  (0.027) 0.085  (0.029) -0.009  (0.025)
3.Secondary Outcome
Title Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53
Hide Description Pre- and post-bronchodilator FEV6 at clinic visits (morning) were measured. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Baseline and Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Error)
Unit of Measure: liters
Pre-bronchodilator: Baseline (n=147,146,146) 2.830  (0.064) 2.809  (0.072) 2.827  (0.074)
Post-bronchodilator: Baseline (n=147,141,146) 3.055  (0.067) 2.981  (0.075) 2.980  (0.076)
Pre-bronchodilator: Week 53 (n=125,130,122) 0.007  (0.036) 0.117  (0.037) 0.003  (0.031)
Post-bronchodilator: Week 53 (n=125,126,120) -0.057  (0.030) 0.060  (0.033) -0.024  (0.029)
4.Secondary Outcome
Title Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53
Hide Description Pre- and post-bronchodilator FVC at clinic visits (morning) were measured. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Baseline and Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Error)
Unit of Measure: liters
Pre-bronchodilator: Baseline (n=147,146,146) 3.003  (0.069) 2.955  (0.075) 2.993  (0.079)
Post-bronchodilator: Baseline (n=147,141,146) 3.225  (0.072) 3.133  (0.078) 3.125  (0.080)
Pre-bronchodilator: Week 53 (n=125,130,122) -0.001  (0.039) 0.110  (0.042) -0.018  (0.032)
Post-bronchodilator: Week 53 (n=125,126,120) -0.071  (0.032) 0.045  (0.034) -0.030  (0.031)
5.Secondary Outcome
Title Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53
Hide Description Pre- and post-bronchodilator FEV1 and FVC at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Ratio of FEV1/FVC was analysed. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Baseline and Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Error)
Unit of Measure: percentage of ratio
Pre-bronchodilator: Baseline (n=147,146,146) 64.508  (0.986) 65.071  (1.013) 65.008  (1.009)
Post-bronchodilator: Baseline (n=147,141,146) 67.152  (0.997) 66.831  (1.056) 67.883  (1.010)
Pre-bronchodilator: Week 53 (n=125,130,122) 0.320  (0.685) 1.695  (0.517) 1.155  (0.527)
Post-bronchodilator: Week 53 (n=125,126,120) -0.512  (0.513) 1.593  (0.563) 0.032  (0.484)
6.Secondary Outcome
Title Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53
Hide Description Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Baseline and Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Error)
Unit of Measure: liters
Pre-bronchodilator: Baseline (n=140,138,143) 0.022  (0.001) 0.023  (0.001) 0.023  (0.001)
Post-bronchodilator: Baseline (n=140,133,135) 0.024  (0.001) 0.024  (0.001) 0.024  (0.001)
Pre-bronchodilator: Week 53 (n=108,109,103) 0.001  (0.001) 0.000  (0.000) 0.001  (0.001)
Post-bronchodilator: Week 53 (n=108,109,104) 0.000  (0.001) 0.001  (0.001) 0.000  (0.001)
7.Secondary Outcome
Title Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home
Hide Description Pre- and post-bronchodilator FEV1 at home (morning and evening) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Error)
Unit of Measure: liters
Day 1-7: Morning (n=151,149,149) 1.63  (0.05) 1.61  (0.05) 1.66  (0.05)
Change at Day 365-371: Morning (n=124,119,114) -0.12  (0.06) 0.01  (0.04) -0.07  (0.06)
Day 1-7: Evening (n=149,147,148) 1.61  (0.05) 1.68  (0.05) 1.65  (0.05)
Change at Day 365-371: Evening (n=120,116,112) -0.08  (0.05) -0.08  (0.05) -0.12  (0.05)
8.Secondary Outcome
Title Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home
Hide Description The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Error)
Unit of Measure: liters per minute
Day 1-7: Morning (n=151,149,149) 273.7  (8.7) 271.0  (9.7) 281.2  (9.9)
Change at Day 365-371: Morning (n=124,119,114) -23.1  (8.8) -8.0  (7.9) -24.0  (9.6)
Day 1-7: Evening (n=149,147,148) 276.0  (8.9) 287.6  (9.9) 283.8  (10.0)
Change at Day 365-371: Evening (n=120,116,112) -16.4  (8.7) -27.0  (8.2) -36.5  (8.8)
9.Secondary Outcome
Title Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53
Hide Description 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 was 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. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Baseline and Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=149,147,148) 2.52  (0.07) 2.59  (0.09) 2.54  (0.08)
Change at Week 53 (n=118,115,112) -0.82  (0.10) -1.02  (0.10) -0.93  (0.11)
10.Secondary Outcome
Title Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53
Hide Description AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma 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 were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Baseline and Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline: Overall (n=147,142,141) 4.05  (0.09) 3.98  (0.09) 4.08  (0.09)
Week 53: Overall (n=107,109,101) 0.85  (0.10) 1.04  (0.10) 1.00  (0.12)
Baseline: Symptoms (n=147,142,141) 4.10  (0.09) 4.03  (0.09) 4.13  (0.09)
Week 53: Symptoms (n=107,109,101) 0.85  (0.11) 1.14  (0.12) 1.05  (0.13)
Baseline: Activity limitation (n=147,142,141) 4.04  (0.08) 4.04  (0.09) 4.13  (0.09)
Week 53: Activity limitation (n=107,109,101) 0.81  (0.10) 0.96  (0.10) 0.93  (0.12)
Baseline: Emotional Function (n=147,142,141) 4.14  (0.12) 3.91  (0.12) 4.02  (0.11)
Week 53: Emotional Function (n=107,109,101) 0.89  (0.12) 1.10  (0.12) 1.09  (0.15)
Baseline: Environmental stimuli (n=147,142,141) 3.80  (0.11) 3.76  (0.12) 3.89  (0.12)
Week 53: Environmental stimuli (n=107,109,101) 0.88  (0.13) 0.86  (0.14) 0.97  (0.14)
11.Secondary Outcome
Title Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53
Hide Description The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems) that reflects increasing levels of difficulty. The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Unit of Measure: participants
Mobility - No problem 107 118 106
Mobility - Moderate problem 26 18 23
Mobility - Severe Problem 1 0 1
Mobility - Missing 17 14 21
Self-care - No Problem 122 127 122
Self-care - Moderate Problem 12 9 7
Self-care - Severe Problem 0 0 1
Self-care - Missing 17 14 21
Usual activities - No Problem 89 106 100
Usual activities - Moderate Problem 43 30 30
Usual activities - Severe Problem 2 0 0
Usual activities - Missing 17 14 21
Pain/discomfort - No problem 84 100 77
Pain/discomfort - Moderate problem 46 34 51
Pain/discomfort - Severe problem 4 2 2
Pain/discomfort - Missing 17 14 21
Anxiety/depression - No problem 102 101 101
Anxiety/depression - Moderate problem 29 34 29
Anxiety/depression - Severe problem 3 1 0
Anxiety/depression - Missing 17 14 21
12.Secondary Outcome
Title Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53
Hide Description The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Baseline and Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 130 136 127
Mean (Standard Error)
Unit of Measure: units on a scale
8.4  (1.6) 9.3  (1.9) 7.3  (1.8)
13.Secondary Outcome
Title Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53
Hide Description There were 3 symptom questions in the ASMA diary: daytime frequency (question 1), daytime severity (question 2) and nighttime severity (question 6). All symptom questions were scored from 0 to 4 averaged, where a higher score indicated greater frequency or severity. Daily Asthma symptom scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.
Time Frame Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day -7 - Day -1 (Baseline) (n=151,147,145) 1.60  (0.71) 1.49  (0.77) 1.56  (0.69)
Change at Day 365 - Day 371 (n=113,108,108) -0.43  (0.75) -0.42  (0.73) -0.49  (0.78)
14.Secondary Outcome
Title Change From Baseline in Rescue Medication Use at Week 53
Hide Description Rescue medication use was collected from 3 questions: daytime use in response to symptoms (question 3), daytime prophylactic use (question 4) and nighttime use (question 7). Rescue medication use questions were first assessed using a dichotomous response option (YES/NO). If the participants reported YES, there was a subsequent question about the number of times rescue medication was used (questions 3a, 4a, and 7a). Daily average scores were summarized each week for all participants with at least 4 non-missing records each week. Days with no reported rescue medication use were represented as 0 and included in the calculation with participants who reported yes and completed questions 3a, 4a and 7a. The baseline scores were calculated from Day -7 to Day -1. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Deviation)
Unit of Measure: use per day
Day -7 - Day -1 (Baseline) (n=151,147,145) 2.56  (2.73) 2.77  (3.78) 2.38  (2.58)
Change at Day 365 - Day 371 (n=113,108,108) -0.86  (2.20) -0.77  (2.59) -1.02  (2.30)
15.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 administration of study drug and up to Week 75 that were absent before treatment or that worsened relative to pre-treatment state. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Baseline and Week 75
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any investigational product and had safety data available for analysis.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Unit of Measure: participants
TEAEs 129 134 128
TESAEs 21 18 25
16.Secondary Outcome
Title Observed Serum Tralokinumab Concentration at Week 53
Hide Description Tralokinumab concentrations that were below limit of quantification (LOQ) of the pharmacokinetic (PK) assay (LOQ = 0.500 microgram per milliliter [mcg/mL]) were replaced by LOQ/2 = 0.250 mcg/mL; results were reported to 3 significant figures level of precision. Observed serum tralokinumab concentration at Week 53 was reported.
Time Frame Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The PK population included all participants who received at least one dose of tralokinumab and had at least one quantifiable PK observation. Here "N" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 136 128
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter
71.3  (34.2) 25.8  (11.8)
17.Secondary Outcome
Title Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab
Hide Description Immunogenicity assessment included determination of anti-drug (tralokinumab) antibodies in serum samples. ADA positive was defined as a titer greater than or equal to (>=13) at any point in the study. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Baseline and Week 75
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The PK population included all participants who received at least one dose of tralokinumab and had at least one quantifiable PK observation. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (Week 1) (n=151,150,151) 1.3 0.67 1.3
Week 75 (n=151,150,150) 3.3 0.0 4.0
18.Secondary Outcome
Title Severe Annual Asthma Exacerbation Rate (AER)
Hide Description Severe annualized AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids is administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
0.17
(0.10 to 0.25)
0.11
(0.06 to 0.17)
0.10
(0.05 to 0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.293
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.26 to 1.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.270
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.27 to 1.44
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Time to First Exacerbation Through Week 53
Hide Description Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median and lower and upper limits of the 95% Confidence Interval were incalculable due to an insufficient number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.57 to 1.16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.225
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.56 to 1.15
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Time to First Severe Exacerbation Through Week 53
Hide Description Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median and lower and upper limits of the 95% Confidence Interval were incalculable due to an insufficient number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.538
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.37 to 1.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.561
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.37 to 1.71
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin
Hide Description Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline serum periostin greater than or equal to (>=) or less than (<) median, >= or < 25th percentile and >= or < 75th percentile. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
>= median (n=67,81,79)
1.13
(0.88 to 1.43)
0.85
(0.65 to 1.08)
1.27
(1.03 to 1.55)
< median (n=84,69,71)
0.73
(0.55 to 0.95)
0.98
(0.76 to 1.25)
0.63
(0.45 to 0.85)
>= 25th Percentile (n=105,115,119)
0.94
(0.75 to 1.15)
0.84
(0.67 to 1.03)
1.05
(0.87 to 1.25)
< 25th Percentile (n=46,35,31)
0.83
(0.58 to 1.16)
1.14
(0.81 to 1.56)
0.65
(0.38 to 1.05)
>= 75th Percentile (n=32,43,39)
1.13
(0.76 to 1.60)
0.91
(0.65 to 1.25)
2.03
(1.60 to 2.55)
< 75th Percentile (n=119,107,111)
0.85
(0.69 to 1.04)
0.91
(0.73 to 1.11)
0.60
(0.46 to 0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin >= median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.46 to 1.17
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin >= median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.856
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.56 to 1.61
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin < median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.602
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.71 to 1.81
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin < median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.703
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.55 to 1.50
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin >= 25th Percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.455
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.58 to 1.28
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin >= 25th Percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.929
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.66 to 1.57
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin < 25th Percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.507
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.63 to 2.51
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin < 25th Percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.44 to 1.89
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin >= 75th Percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.716
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.44 to 1.75
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin >= 75th Percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
0.66 to 3.43
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin < 75th Percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.804
Comments [Not Specified]
Method Poission regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.64 to 1.41
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin < 75th Percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.47 to 1.05
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
22.Secondary Outcome
Title Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status
Hide Description Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Th2 status. Th2-high included those participants who had immunoglobulin E (IgE) >100 international unit per milliliter (IU/mL) and blood eosinophils >= 0.14 * 10 power 9 per Liter. Th2 low would include those participants who do not meet Th2 high status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
Th2 high (n=70,74,67)
0.96
(0.74 to 1.23)
0.94
(0.73 to 1.20)
1.09
(0.85 to 1.39)
Th2 Low (n=73,61,72)
0.90
(0.69 to 1.16)
0.88
(0.66 to 1.16)
0.85
(0.64 to 1.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Th2 high
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.365
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.50 to 1.29
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Th2 high
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.922
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.56 to 1.68
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Th2 Low
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.67 to 1.84
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Th2 Low
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.813
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.66 to 1.70
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
23.Secondary Outcome
Title Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count
Hide Description Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroups baseline peripheral blood eosinophil counts. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
>= 150 cells/mcgL (n=95,104,92)
0.95
(0.76 to 1.18)
0.84
(0.66 to 1.04)
0.96
(0.77 to 1.19)
< 150 cells/mcgL (n=48,38,52)
0.90
(0.64 to 1.22)
1.09
(0.78 to 1.48)
0.95
(0.69 to 1.27)
>= 300 cells/mcgL (n=54,60,50)
1.00
(0.74 to 1.32)
1.01
(0.76 to 1.31)
1.56
(1.23 to 1.97)
< 300 cells/mcgL (n=89,82,94)
0.89
(0.70 to 1.12)
0.83
(0.64 to 1.06)
0.63
(0.47 to 0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline eosinophil count >=150 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.335
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.56 to 1.22
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline eosinophil count >=150 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.586
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.54 to 1.41
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline eosinophil count <150 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.331
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.73 to 2.52
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline eosinophil count <150 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.311
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
0.73 to 2.71
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline eosinophil count >=300 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.414
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.48 to 1.35
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline eosinophil count >=300 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.463
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.68 to 2.36
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline eosinophil count <300 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.793
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.67 to 1.68
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline eosinophil count <300 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.49 to 1.22
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
24.Secondary Outcome
Title Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility
Hide Description Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup baseline FEV1 reversibility >=12% and <12%. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
Reversibility >=12% (n=57,43,49)
0.88
(0.65 to 1.18)
0.68
(0.45 to 0.99)
1.08
(0.80 to 1.42)
Reversibility <12% (n=91,101,97)
0.93
(0.73 to 1.16)
0.99
(0.80 to 1.21)
0.90
(0.71 to 1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline FEV1 reversibility >=12%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.245
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.33 to 1.32
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline FEV1 reversibility >=12%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.438
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.37 to 1.54
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline FEV1 reversibility <12%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.947
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.66 to 1.57
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline FEV1 reversibility <12%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.916
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.59 to 1.59
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
25.Secondary Outcome
Title Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted
Hide Description Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline FEV1% predicaed. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
FEV1% Predicted <=60% (n=49,45,56)
1.05
(0.77 to 1.40)
0.95
(0.68 to 1.29)
1.67
(1.34 to 2.07)
FEV1% Predicted <=80% (n=119,109,105)
0.93
(0.76 to 1.13)
0.88
(0.71 to 1.08)
1.13
(0.93 to 1.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline FEV1% predicted <=60%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.723
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.52 to 1.56
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline FEV1% predicted <=60%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.852
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.60 to 1.86
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline FEV1% predicted <=80%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.409
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.60 to 1.23
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline FEV1% predicted <=80%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.744
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.72 to 1.58
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
26.Secondary Outcome
Title Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year
Hide Description Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup as asthma exacerbations in the past year. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
2 asthma exacerbations (n=97,96,95)
0.62
(0.47 to 0.81)
0.61
(0.45 to 0.79)
0.45
(0.32 to 0.61)
> 2 but < 6 asthma exacerbations (n=54,54,56)
1.44
(1.12 to 1.82)
1.42
(1.12 to 1.78)
1.88
(1.52 to 2.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments 2 asthma exacerbations in the past year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.802
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.58 to 1.52
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments 2 asthma exacerbations in the past year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.36 to 1.00
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments > 2 but < 6 asthma exacerbations in the past year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.792
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.56 to 1.56
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments > 2 but < 6 asthma exacerbations in the past year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.231
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
0.81 to 2.38
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
27.Secondary Outcome
Title Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin
Hide Description Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER evaluated by subgroup baseline serum periostin. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
>= median (n=67,81,79)
0.25
(0.14 to 0.40)
0.08
(0.03 to 0.17)
0.12
(0.06 to 0.23)
< median (n=84,69,71)
0.10
(0.04 to 0.20)
0.14
(0.06 to 0.26)
0.08
(0.03 to 0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline Serum Periostin >=Median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.06 to 0.98
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline Serum Periostin >=Median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.197
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.15 to 1.48
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline Serum Periostin < Median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.50 to 2.79
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline Serum Periostin < Median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.594
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.48 to 3.57
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
28.Secondary Outcome
Title Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility
Hide Description Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup FEV1 reversibility. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
Reversibility >=12% (n=57,43,49)
0.11
(0.04 to 0.25)
0.13
(0.04 to 0.29)
0.13
(0.05 to 0.28)
Reversibility <12% (n=91,101,97)
0.20
(0.12 to 0.32)
0.10
(0.05 to 0.19)
0.09
(0.04 to 0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline FEV1 reversibility >=12%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.975
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.14 to 7.67
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline FEV1 reversibility >=12%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.66
Confidence Interval (2-Sided) 95%
0.41 to 6.67
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline FEV1 reversibility <12%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.21 to 1.14
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline FEV1 reversibility <12%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.13 to 1.36
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
29.Secondary Outcome
Title Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status
Hide Description Severe AER was assessed based on AER data up to Week 53. An asthma exacerbation is a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 days. It was considered resolved 7 days after last dose of OCS administered (10 days after injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup Th2 status. Th2-high include participants who had IgE >100 IU/mL and blood eosinophils >=0.14*10^9/Liter. Th2 low would include participants who do not meet Th2 high status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
Th2 high (n=70,74,67)
0.12
(0.05 to 0.24)
0.12
(0.05 to 0.23)
0.06
(0.02 to 0.16)
Th2 Low (n=73,61,72)
0.21
(0.11 to 0.35)
0.05
(0.01 to 0.15)
0.12
(0.05 to 0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Th2 high
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.31 to 2.19
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Th2 high
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.299
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.18 to 1.70
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Th2 Low
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.05 to 1.34
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Th2 Low
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.576
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.20 to 2.47
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
30.Secondary Outcome
Title Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count
Hide Description Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup baseline peripheral blood eosinophil count. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AER events/person-year
>= 300 cells/mcgL (n=54,60,50)
0.22
(0.11 to 0.40)
0.16
(0.07 to 0.31)
0.15
(0.06 to 0.31)
< 300 cells/mcgL (n=89,82,94)
0.13
(0.07 to 0.24)
0.08
(0.03 to 0.16)
0.08
(0.03 to 0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline eosinophil count >=300 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.19 to 1.25
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline eosinophil count >=300 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.241
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.13 to 1.67
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline eosinophil count <300 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.12 to 2.84
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline eosinophil count <300 cells/mcgL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.19 to 2.85
Estimation Comments The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.
31.Secondary Outcome
Title Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups
Hide Description Prebronchodilator FEV1 was evaluated by subgroups. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.
Time Frame Week 1 up to Week 53
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized into the study. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
Arm/Group Title Placebo Total Tralokinumab 300 mg, Q2W - Cohort 1 Tralokinumab 300 mg, Q2/4W - Cohort 2
Hide Arm/Group Description:
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Overall Number of Participants Analyzed 151 150 151
Mean (Standard Error)
Unit of Measure: Percent change
Baseline SP >=median (n=54,71,65) 4.17  (2.75) 10.48  (3.01) 4.36  (2.25)
Baseline SP <median (n=71,59,56) 1.23  (2.82) 7.46  (3.00) 1.30  (2.12)
Baseline SP >=25th Percentile (n=88,102,100) 4.10  (2.29) 10.40  (2.43) 2.31  (1.66)
Baseline SP <25th Percentile (n=37,28,21) -1.29  (3.92) 4.40  (4.39) 5.99  (4.22)
Baseline SP >=75th Percentile (n=25,40,32) 2.32  (4.07) 11.05  (4.67) 2.97  (3.33)
Baseline SP <75th Percentile (n=100,90,89) 2.55  (2.28) 8.25  (2.29) 2.94  (1.75)
Th2 high (n=63,62,57) 2.10  (2.62) 11.62  (3.23) 4.52  (2.39)
Th2 low (n=57,55,55) 1.90  (3.09) 3.87  (2.50) 0.13  (1.72)
Baseline PBEC >=150 cells/mcgL (n=81,89,75) 1.98  (2.32) 10.97  (2.71) 4.67  (2.17)
Baseline PBEC <150 cells/mcgL (n=39,34,40) 2.05  (3.89) 5.75  (3.75) -0.40  (2.00)
Baseline PBEC >=300 cells/mcgL (n=45,51,39) 0.59  (2.88) 14.04  (3.88) 4.65  (2.90)
Baseline PBEC <300 cells/mcgL (n=75,72,76) 2.85  (2.71) 6.33  (2.57) 2.01  (1.89)
Baseline FEV1 reversibility >=12% (n=49,36,41) 11.02  (3.85) 22.78  (5.20) 11.80  (3.48)
Baseline FEV1 reversibility <12% (n=76,92,80) -2.99  (1.90) 3.98  (1.97) -1.66  (1.28)
2 asthma exacerbations (n=84,81,82) 0.76  (2.16) 8.99  (2.41) 3.57  (2.04)
> 2 but < 6 asthma exacerbations (n=41,49,40) 6.08  (4.12) 9.32  (4.05) 1.63  (2.17)
Chronic OCS use (n=20,21,16) 3.44  (5.82) 6.96  (6.56) -0.48  (5.31)
Without chronic OCS use (n=105,109,106) 2.32  (2.10) 9.52  (2.22) 3.45  (1.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin >= median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 6.79
Confidence Interval (2-Sided) 95%
-0.21 to 13.79
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin >= median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.874
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
-6.54 to 7.68
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin < median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 7.37
Confidence Interval (2-Sided) 95%
0.80 to 13.95
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin < median
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.745
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
-5.48 to 7.66
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin >= 25th percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 7.12
Confidence Interval (2-Sided) 95%
1.66 to 12.58
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin >= 25th percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.863
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-5.93 to 4.97
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin < 25th percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 6.24
Confidence Interval (2-Sided) 95%
-3.80 to 16.27
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin < 25th percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 8.58
Confidence Interval (2-Sided) 95%
-1.91 to 19.07
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin >= 75th percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 9.89
Confidence Interval (2-Sided) 95%
-1.57 to 21.35
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin >= 75th percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.908
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
-11.19 to 12.59
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline serum periostin < 75th percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 6.52
Confidence Interval (2-Sided) 95%
1.41 to 11.64
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline serum periostin < 75th percentile
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.635
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
-3.84 to 6.29
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Th2 high
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 8.89
Confidence Interval (2-Sided) 95%
1.84 to 15.94
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Th2 high
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.280
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 3.91
Confidence Interval (2-Sided) 95%
-3.19 to 11.02
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Th2 low
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.292
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 3.22
Confidence Interval (2-Sided) 95%
-2.78 to 9.22
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Th2 low
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.691
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value -1.18
Confidence Interval (2-Sided) 95%
-6.99 to 4.64
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline peripheral blood eosinophil count >= 150 cells/μL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 8.83
Confidence Interval (2-Sided) 95%
2.85 to 14.81
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline peripheral blood eosinophil count >= 150 cells/μL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 4.25
Confidence Interval (2-Sided) 95%
-1.92 to 10.43
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2W - Cohort 1
Comments Baseline peripheral blood eosinophil count < 150 cells/μL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value 6.05
Confidence Interval (2-Sided) 95%
-2.39 to 14.50
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo Total, Tralokinumab 300 mg, Q2/4W - Cohort 2
Comments Baseline peripheral blood eosinophil count < 150 cells/μL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.857
Comments [Not Specified]
Method Repeated measure model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS-mean
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-8.63 to 7.18
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview