Trial Outcomes & Findings for A Safety and Efficacy Study of Tralokinumab in Adults With Asthma (NCT NCT01402986)

Last Updated: 2017-04-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

689 participants

Primary outcome timeframe

Week 1 up to Week 53

Results posted on

2017-04-04

Participant Flow

A total of 689 participants were screened, out of which 452 participants were randomized into this study

Participant milestones

Participant milestones
Measure	Placebo, Q2W - Cohort 1 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.	Tralokinumab 300 mg, Q2W - Cohort 1 Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.	Placebo, Q2/4W - Cohort 2 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 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 Study STARTED	76	150	75	151
Overall Study COMPLETED	67	135	67	129
Overall Study NOT COMPLETED	9	15	8	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo, Q2W - Cohort 1 Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.	Tralokinumab 300 mg, Q2W - Cohort 1 Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.	Placebo, Q2/4W - Cohort 2 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 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 Study Withdrawal by Subject	7	10	7	13
Overall Study Death	0	0	0	2
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Other	2	5	1	6

Baseline Characteristics

A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo, Q2W - Cohort 1 n=76 Participants Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.	Tralokinumab 300 mg, Q2W - Cohort 1 n=150 Participants Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.	Placebo, Q2/4W - Cohort 2 n=75 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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 n=452 Participants Total of all reporting groups
Age, Continuous	48.8 years STANDARD_DEVIATION 12.1 • n=5 Participants	49.7 years STANDARD_DEVIATION 12.2 • n=7 Participants	51.7 years STANDARD_DEVIATION 13.6 • n=5 Participants	50.5 years STANDARD_DEVIATION 11.8 • n=4 Participants	50.1 years STANDARD_DEVIATION 12.0 • n=21 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	100 Participants n=7 Participants	46 Participants n=5 Participants	100 Participants n=4 Participants	297 Participants n=21 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	50 Participants n=7 Participants	29 Participants n=5 Participants	51 Participants n=4 Participants	155 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 1 up to Week 53

Population: The intent-to-treat (ITT) population included all participants who were randomized into the study.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Annual Asthma Exacerbation Rate (AER)	0.91 AER events/person-year Interval 0.76 to 1.08	0.90 AER events/person-year Interval 0.75 to 1.08	0.97 AER events/person-year Interval 0.81 to 1.14

SECONDARY outcome

Timeframe: Baseline and Week 53

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 Pre-bronchodilator: Baseline (n=147,146,146)	1.922 liters Standard Error 0.056	1.926 liters Standard Error 0.050	1.934 liters Standard Error 0.059
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 Pre-bronchodilator: Week 53 (n=125,130,122)	0.128 liters Standard Error 0.032	0.018 liters Standard Error 0.035	0.032 liters Standard Error 0.026
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 Post-bronchodilator: Baseline (n=147,141,146)	2.094 liters Standard Error 0.061	2.153 liters Standard Error 0.053	2.110 liters Standard Error 0.061
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 Post-bronchodilator: Week 53 (n=125,126,120)	0.085 liters Standard Error 0.029	-0.058 liters Standard Error 0.027	-0.009 liters Standard Error 0.025

SECONDARY outcome

Timeframe: Baseline and Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 Pre-bronchodilator: Baseline (n=147,146,146)	2.809 liters Standard Error 0.072	2.830 liters Standard Error 0.064	2.827 liters Standard Error 0.074
Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 Post-bronchodilator: Week 53 (n=125,126,120)	0.060 liters Standard Error 0.033	-0.057 liters Standard Error 0.030	-0.024 liters Standard Error 0.029
Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 Post-bronchodilator: Baseline (n=147,141,146)	2.981 liters Standard Error 0.075	3.055 liters Standard Error 0.067	2.980 liters Standard Error 0.076
Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 Pre-bronchodilator: Week 53 (n=125,130,122)	0.117 liters Standard Error 0.037	0.007 liters Standard Error 0.036	0.003 liters Standard Error 0.031

SECONDARY outcome

Timeframe: Baseline and Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53 Pre-bronchodilator: Baseline (n=147,146,146)	2.955 liters Standard Error 0.075	3.003 liters Standard Error 0.069	2.993 liters Standard Error 0.079
Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53 Post-bronchodilator: Baseline (n=147,141,146)	3.133 liters Standard Error 0.078	3.225 liters Standard Error 0.072	3.125 liters Standard Error 0.080
Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53 Pre-bronchodilator: Week 53 (n=125,130,122)	0.110 liters Standard Error 0.042	-0.001 liters Standard Error 0.039	-0.018 liters Standard Error 0.032
Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53 Post-bronchodilator: Week 53 (n=125,126,120)	0.045 liters Standard Error 0.034	-0.071 liters Standard Error 0.032	-0.030 liters Standard Error 0.031

SECONDARY outcome

Timeframe: Baseline and Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53 Pre-bronchodilator: Baseline (n=147,146,146)	65.071 percentage of ratio Standard Error 1.013	64.508 percentage of ratio Standard Error 0.986	65.008 percentage of ratio Standard Error 1.009
Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53 Post-bronchodilator: Baseline (n=147,141,146)	66.831 percentage of ratio Standard Error 1.056	67.152 percentage of ratio Standard Error 0.997	67.883 percentage of ratio Standard Error 1.010
Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53 Pre-bronchodilator: Week 53 (n=125,130,122)	1.695 percentage of ratio Standard Error 0.517	0.320 percentage of ratio Standard Error 0.685	1.155 percentage of ratio Standard Error 0.527
Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53 Post-bronchodilator: Week 53 (n=125,126,120)	1.593 percentage of ratio Standard Error 0.563	-0.512 percentage of ratio Standard Error 0.513	0.032 percentage of ratio Standard Error 0.484

SECONDARY outcome

Timeframe: Baseline and Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53 Pre-bronchodilator: Baseline (n=140,138,143)	0.023 liters Standard Error 0.001	0.022 liters Standard Error 0.001	0.023 liters Standard Error 0.001
Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53 Post-bronchodilator: Baseline (n=140,133,135)	0.024 liters Standard Error 0.001	0.024 liters Standard Error 0.001	0.024 liters Standard Error 0.001
Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53 Pre-bronchodilator: Week 53 (n=108,109,103)	0.000 liters Standard Error 0.000	0.001 liters Standard Error 0.001	0.001 liters Standard Error 0.001
Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53 Post-bronchodilator: Week 53 (n=108,109,104)	0.001 liters Standard Error 0.001	0.000 liters Standard Error 0.001	0.000 liters Standard Error 0.001

SECONDARY outcome

Timeframe: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home Day 1-7: Morning (n=151,149,149)	1.61 liters Standard Error 0.05	1.63 liters Standard Error 0.05	1.66 liters Standard Error 0.05
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home Change at Day 365-371: Morning (n=124,119,114)	0.01 liters Standard Error 0.04	-0.12 liters Standard Error 0.06	-0.07 liters Standard Error 0.06
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home Day 1-7: Evening (n=149,147,148)	1.68 liters Standard Error 0.05	1.61 liters Standard Error 0.05	1.65 liters Standard Error 0.05
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home Change at Day 365-371: Evening (n=120,116,112)	-0.08 liters Standard Error 0.05	-0.08 liters Standard Error 0.05	-0.12 liters Standard Error 0.05

SECONDARY outcome

Timeframe: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home Day 1-7: Morning (n=151,149,149)	271.0 liters per minute Standard Error 9.7	273.7 liters per minute Standard Error 8.7	281.2 liters per minute Standard Error 9.9
Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home Change at Day 365-371: Morning (n=124,119,114)	-8.0 liters per minute Standard Error 7.9	-23.1 liters per minute Standard Error 8.8	-24.0 liters per minute Standard Error 9.6
Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home Day 1-7: Evening (n=149,147,148)	287.6 liters per minute Standard Error 9.9	276.0 liters per minute Standard Error 8.9	283.8 liters per minute Standard Error 10.0
Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home Change at Day 365-371: Evening (n=120,116,112)	-27.0 liters per minute Standard Error 8.2	-16.4 liters per minute Standard Error 8.7	-36.5 liters per minute Standard Error 8.8

SECONDARY outcome

Timeframe: Baseline and Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53 Baseline (n=149,147,148)	2.59 units on a scale Standard Error 0.09	2.52 units on a scale Standard Error 0.07	2.54 units on a scale Standard Error 0.08
Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53 Change at Week 53 (n=118,115,112)	-1.02 units on a scale Standard Error 0.10	-0.82 units on a scale Standard Error 0.10	-0.93 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline and Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 Baseline: Emotional Function (n=147,142,141)	3.91 units on a scale Standard Error 0.12	4.14 units on a scale Standard Error 0.12	4.02 units on a scale Standard Error 0.11
Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 Week 53: Overall (n=107,109,101)	1.04 units on a scale Standard Error 0.10	0.85 units on a scale Standard Error 0.10	1.00 units on a scale Standard Error 0.12
Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 Week 53: Activity limitation (n=107,109,101)	0.96 units on a scale Standard Error 0.10	0.81 units on a scale Standard Error 0.10	0.93 units on a scale Standard Error 0.12
Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 Baseline: Overall (n=147,142,141)	3.98 units on a scale Standard Error 0.09	4.05 units on a scale Standard Error 0.09	4.08 units on a scale Standard Error 0.09
Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 Baseline: Symptoms (n=147,142,141)	4.03 units on a scale Standard Error 0.09	4.10 units on a scale Standard Error 0.09	4.13 units on a scale Standard Error 0.09
Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 Week 53: Symptoms (n=107,109,101)	1.14 units on a scale Standard Error 0.12	0.85 units on a scale Standard Error 0.11	1.05 units on a scale Standard Error 0.13
Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 Baseline: Activity limitation (n=147,142,141)	4.04 units on a scale Standard Error 0.09	4.04 units on a scale Standard Error 0.08	4.13 units on a scale Standard Error 0.09
Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 Week 53: Emotional Function (n=107,109,101)	1.10 units on a scale Standard Error 0.12	0.89 units on a scale Standard Error 0.12	1.09 units on a scale Standard Error 0.15
Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 Baseline: Environmental stimuli (n=147,142,141)	3.76 units on a scale Standard Error 0.12	3.80 units on a scale Standard Error 0.11	3.89 units on a scale Standard Error 0.12
Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 Week 53: Environmental stimuli (n=107,109,101)	0.86 units on a scale Standard Error 0.14	0.88 units on a scale Standard Error 0.13	0.97 units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Week 53

Population: The ITT population included all participants who were randomized into the study.

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Mobility - Moderate problem	18 participants 0.12	26 participants 0.12	23 participants 0.11
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Mobility - Severe Problem	0 participants 0.12	1 participants 0.12	1 participants 0.15
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Usual activities - No Problem	106 participants	89 participants	100 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Pain/discomfort - Moderate problem	34 participants	46 participants	51 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Anxiety/depression - No problem	101 participants	102 participants	101 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Anxiety/depression - Severe problem	1 participants	3 participants	0 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Anxiety/depression - Missing	14 participants	17 participants	21 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Mobility - No problem	118 participants 0.10	107 participants 0.10	106 participants 0.12
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Mobility - Missing	14 participants 0.14	17 participants 0.13	21 participants 0.14
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Self-care - No Problem	127 participants	122 participants	122 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Self-care - Moderate Problem	9 participants	12 participants	7 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Self-care - Severe Problem	0 participants	0 participants	1 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Self-care - Missing	14 participants	17 participants	21 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Usual activities - Moderate Problem	30 participants	43 participants	30 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Usual activities - Severe Problem	0 participants	2 participants	0 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Usual activities - Missing	14 participants	17 participants	21 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Pain/discomfort - No problem	100 participants	84 participants	77 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Pain/discomfort - Severe problem	2 participants	4 participants	2 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Pain/discomfort - Missing	14 participants	17 participants	21 participants
Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 Anxiety/depression - Moderate problem	34 participants	29 participants	29 participants

SECONDARY outcome

Timeframe: Baseline and Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=136 Participants 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.	Placebo Total n=130 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=127 Participants 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.
Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53	9.3 units on a scale Standard Error 1.9	8.4 units on a scale Standard Error 1.6	7.3 units on a scale Standard Error 1.8

SECONDARY outcome

Timeframe: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53 Change at Day 365 - Day 371 (n=113,108,108)	-0.42 units on a scale Standard Deviation 0.73	-0.43 units on a scale Standard Deviation 0.75	-0.49 units on a scale Standard Deviation 0.78
Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53 Day -7 - Day -1 (Baseline) (n=151,147,145)	1.49 units on a scale Standard Deviation 0.77	1.60 units on a scale Standard Deviation 0.71	1.56 units on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Change From Baseline in Rescue Medication Use at Week 53 Day -7 - Day -1 (Baseline) (n=151,147,145)	2.77 use per day Standard Deviation 3.78	2.56 use per day Standard Deviation 2.73	2.38 use per day Standard Deviation 2.58
Change From Baseline in Rescue Medication Use at Week 53 Change at Day 365 - Day 371 (n=113,108,108)	-0.77 use per day Standard Deviation 2.59	-0.86 use per day Standard Deviation 2.20	-1.02 use per day Standard Deviation 2.30

SECONDARY outcome

Timeframe: Baseline and Week 75

Population: The safety population included all participants who received any investigational product and had safety data available for analysis.

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) TEAEs	134 participants 19.83	129 participants 17.12	128 participants 16.98
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) TESAEs	18 participants 1.9	21 participants 1.6	25 participants 1.8

SECONDARY outcome

Timeframe: Week 53

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=128 Participants 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.	Placebo Total n=136 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 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.
Observed Serum Tralokinumab Concentration at Week 53	25.8 microgram per milliliter Standard Deviation 11.8	71.3 microgram per milliliter Standard Deviation 34.2	—

SECONDARY outcome

Timeframe: Baseline and Week 75

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab Baseline (Week 1) (n=151,150,151)	0.67 percentage of participants 19.83	1.3 percentage of participants 17.12	1.3 percentage of participants 16.98
Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab Week 75 (n=151,150,150)	0.0 percentage of participants	3.3 percentage of participants	4.0 percentage of participants

SECONDARY outcome

Timeframe: Week 1 up to Week 53

Population: The ITT population included all participants who were randomized into the study.

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Severe Annual Asthma Exacerbation Rate (AER)	0.11 AER events/person-year Interval 0.06 to 0.17	0.17 AER events/person-year Interval 0.1 to 0.25	0.10 AER events/person-year Interval 0.05 to 0.17

SECONDARY outcome

Timeframe: Week 1 up to Week 53

Population: The ITT population included all participants who were randomized into the study.

Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Time to First Exacerbation Through Week 53	NA days The median and lower and upper limits of the 95% Confidence Interval were incalculable due to an insufficient number of events.	NA days The median and lower and upper limits of the 95% Confidence Interval were incalculable due to an insufficient number of events.	NA days The median and lower and upper limits of the 95% Confidence Interval were incalculable due to an insufficient number of events.

SECONDARY outcome

Timeframe: Week 1 up to Week 53

Population: The ITT population included all participants who were randomized into the study.

Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Time to First Severe Exacerbation Through Week 53	NA days The median and lower and upper limits of the 95% Confidence Interval were incalculable due to an insufficient number of events.	NA days The median and lower and upper limits of the 95% Confidence Interval were incalculable due to an insufficient number of events.	NA days The median and lower and upper limits of the 95% Confidence Interval were incalculable due to an insufficient number of events.

SECONDARY outcome

Timeframe: Week 1 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. 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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin >= median (n=67,81,79)	0.85 AER events/person-year Interval 0.65 to 1.08	1.13 AER events/person-year Interval 0.88 to 1.43	1.27 AER events/person-year Interval 1.03 to 1.55
Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin < median (n=84,69,71)	0.98 AER events/person-year Interval 0.76 to 1.25	0.73 AER events/person-year Interval 0.55 to 0.95	0.63 AER events/person-year Interval 0.45 to 0.85
Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin >= 25th Percentile (n=105,115,119)	0.84 AER events/person-year Interval 0.67 to 1.03	0.94 AER events/person-year Interval 0.75 to 1.15	1.05 AER events/person-year Interval 0.87 to 1.25
Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin < 25th Percentile (n=46,35,31)	1.14 AER events/person-year Interval 0.81 to 1.56	0.83 AER events/person-year Interval 0.58 to 1.16	0.65 AER events/person-year Interval 0.38 to 1.05
Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin >= 75th Percentile (n=32,43,39)	0.91 AER events/person-year Interval 0.65 to 1.25	1.13 AER events/person-year Interval 0.76 to 1.6	2.03 AER events/person-year Interval 1.6 to 2.55
Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin < 75th Percentile (n=119,107,111)	0.91 AER events/person-year Interval 0.73 to 1.11	0.85 AER events/person-year Interval 0.69 to 1.04	0.60 AER events/person-year Interval 0.46 to 0.77

SECONDARY outcome

Timeframe: Week 1 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. 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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status Th2 high (n=70,74,67)	0.94 AER events/person-year Interval 0.73 to 1.2	0.96 AER events/person-year Interval 0.74 to 1.23	1.09 AER events/person-year Interval 0.85 to 1.39
Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status Th2 Low (n=73,61,72)	0.88 AER events/person-year Interval 0.66 to 1.16	0.90 AER events/person-year Interval 0.69 to 1.16	0.85 AER events/person-year Interval 0.64 to 1.11

SECONDARY outcome

Timeframe: Week 1 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. AER evaluated by subgroups baseline peripheral blood eosinophil counts. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count >= 300 cells/mcgL (n=54,60,50)	1.01 AER events/person-year Interval 0.76 to 1.31	1.00 AER events/person-year Interval 0.74 to 1.32	1.56 AER events/person-year Interval 1.23 to 1.97
Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count >= 150 cells/mcgL (n=95,104,92)	0.84 AER events/person-year Interval 0.66 to 1.04	0.95 AER events/person-year Interval 0.76 to 1.18	0.96 AER events/person-year Interval 0.77 to 1.19
Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count < 150 cells/mcgL (n=48,38,52)	1.09 AER events/person-year Interval 0.78 to 1.48	0.90 AER events/person-year Interval 0.64 to 1.22	0.95 AER events/person-year Interval 0.69 to 1.27
Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count < 300 cells/mcgL (n=89,82,94)	0.83 AER events/person-year Interval 0.64 to 1.06	0.89 AER events/person-year Interval 0.7 to 1.12	0.63 AER events/person-year Interval 0.47 to 0.82

SECONDARY outcome

Timeframe: Week 1 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. AER evaluated by subgroup baseline FEV1 reversibility \>=12% and \<12%. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility Reversibility <12% (n=91,101,97)	0.99 AER events/person-year Interval 0.8 to 1.21	0.93 AER events/person-year Interval 0.73 to 1.16	0.90 AER events/person-year Interval 0.71 to 1.12
Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility Reversibility >=12% (n=57,43,49)	0.68 AER events/person-year Interval 0.45 to 0.99	0.88 AER events/person-year Interval 0.65 to 1.18	1.08 AER events/person-year Interval 0.8 to 1.42

SECONDARY outcome

Timeframe: Week 1 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. AER was evaluated by subgroup baseline FEV1% predicaed. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted FEV1% Predicted <=60% (n=49,45,56)	0.95 AER events/person-year Interval 0.68 to 1.29	1.05 AER events/person-year Interval 0.77 to 1.4	1.67 AER events/person-year Interval 1.34 to 2.07
Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted FEV1% Predicted <=80% (n=119,109,105)	0.88 AER events/person-year Interval 0.71 to 1.08	0.93 AER events/person-year Interval 0.76 to 1.13	1.13 AER events/person-year Interval 0.93 to 1.36

SECONDARY outcome

Timeframe: Week 1 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. AER evaluated by subgroup as asthma exacerbations in the past year. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year 2 asthma exacerbations (n=97,96,95)	0.61 AER events/person-year Interval 0.45 to 0.79	0.62 AER events/person-year Interval 0.47 to 0.81	0.45 AER events/person-year Interval 0.32 to 0.61
Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year > 2 but < 6 asthma exacerbations (n=54,54,56)	1.42 AER events/person-year Interval 1.12 to 1.78	1.44 AER events/person-year Interval 1.12 to 1.82	1.88 AER events/person-year Interval 1.52 to 2.3

SECONDARY outcome

Timeframe: Week 1 up to Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin >= median (n=67,81,79)	0.08 AER events/person-year Interval 0.03 to 0.17	0.25 AER events/person-year Interval 0.14 to 0.4	0.12 AER events/person-year Interval 0.06 to 0.23
Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin < median (n=84,69,71)	0.14 AER events/person-year Interval 0.06 to 0.26	0.10 AER events/person-year Interval 0.04 to 0.2	0.08 AER events/person-year Interval 0.03 to 0.18

SECONDARY outcome

Timeframe: Week 1 up to Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility Reversibility >=12% (n=57,43,49)	0.13 AER events/person-year Interval 0.04 to 0.29	0.11 AER events/person-year Interval 0.04 to 0.25	0.13 AER events/person-year Interval 0.05 to 0.28
Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility Reversibility <12% (n=91,101,97)	0.10 AER events/person-year Interval 0.05 to 0.19	0.20 AER events/person-year Interval 0.12 to 0.32	0.09 AER events/person-year Interval 0.04 to 0.18

SECONDARY outcome

Timeframe: Week 1 up to Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status Th2 high (n=70,74,67)	0.12 AER events/person-year Interval 0.05 to 0.23	0.12 AER events/person-year Interval 0.05 to 0.24	0.06 AER events/person-year Interval 0.02 to 0.16
Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status Th2 Low (n=73,61,72)	0.05 AER events/person-year Interval 0.01 to 0.15	0.21 AER events/person-year Interval 0.11 to 0.35	0.12 AER events/person-year Interval 0.05 to 0.24

SECONDARY outcome

Timeframe: Week 1 up to Week 53

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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count >= 300 cells/mcgL (n=54,60,50)	0.16 AER events/person-year Interval 0.07 to 0.31	0.22 AER events/person-year Interval 0.11 to 0.4	0.15 AER events/person-year Interval 0.06 to 0.31
Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count < 300 cells/mcgL (n=89,82,94)	0.08 AER events/person-year Interval 0.03 to 0.16	0.13 AER events/person-year Interval 0.07 to 0.24	0.08 AER events/person-year Interval 0.03 to 0.17

SECONDARY outcome

Timeframe: Week 1 up to Week 53

Prebronchodilator FEV1 was evaluated by subgroups. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline SP >=median (n=54,71,65)	10.48 Percent change Standard Error 3.01 • Interval 0.65 to 1.08	4.17 Percent change Standard Error 2.75 • Interval 0.88 to 1.43	4.36 Percent change Standard Error 2.25 • Interval 1.03 to 1.55
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline SP <median (n=71,59,56)	7.46 Percent change Standard Error 3.00 • Interval 0.76 to 1.25	1.23 Percent change Standard Error 2.82 • Interval 0.55 to 0.95	1.30 Percent change Standard Error 2.12 • Interval 0.45 to 0.85
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline SP >=25th Percentile (n=88,102,100)	10.40 Percent change Standard Error 2.43 • Interval 0.67 to 1.03	4.10 Percent change Standard Error 2.29 • Interval 0.75 to 1.15	2.31 Percent change Standard Error 1.66 • Interval 0.87 to 1.25
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline SP <25th Percentile (n=37,28,21)	4.40 Percent change Standard Error 4.39 • Interval 0.81 to 1.56	-1.29 Percent change Standard Error 3.92 • Interval 0.58 to 1.16	5.99 Percent change Standard Error 4.22 • Interval 0.38 to 1.05
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline PBEC >=150 cells/mcgL (n=81,89,75)	10.97 Percent change Standard Error 2.71	1.98 Percent change Standard Error 2.32	4.67 Percent change Standard Error 2.17
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline PBEC <150 cells/mcgL (n=39,34,40)	5.75 Percent change Standard Error 3.75	2.05 Percent change Standard Error 3.89	-0.40 Percent change Standard Error 2.00
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline PBEC >=300 cells/mcgL (n=45,51,39)	14.04 Percent change Standard Error 3.88	0.59 Percent change Standard Error 2.88	4.65 Percent change Standard Error 2.90
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline PBEC <300 cells/mcgL (n=75,72,76)	6.33 Percent change Standard Error 2.57	2.85 Percent change Standard Error 2.71	2.01 Percent change Standard Error 1.89
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline FEV1 reversibility >=12% (n=49,36,41)	22.78 Percent change Standard Error 5.20	11.02 Percent change Standard Error 3.85	11.80 Percent change Standard Error 3.48
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline FEV1 reversibility <12% (n=76,92,80)	3.98 Percent change Standard Error 1.97	-2.99 Percent change Standard Error 1.90	-1.66 Percent change Standard Error 1.28
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups 2 asthma exacerbations (n=84,81,82)	8.99 Percent change Standard Error 2.41	0.76 Percent change Standard Error 2.16	3.57 Percent change Standard Error 2.04
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups > 2 but < 6 asthma exacerbations (n=41,49,40)	9.32 Percent change Standard Error 4.05	6.08 Percent change Standard Error 4.12	1.63 Percent change Standard Error 2.17
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline SP >=75th Percentile (n=25,40,32)	11.05 Percent change Standard Error 4.67 • Interval 0.65 to 1.25	2.32 Percent change Standard Error 4.07 • Interval 0.76 to 1.6	2.97 Percent change Standard Error 3.33 • Interval 1.6 to 2.55
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Baseline SP <75th Percentile (n=100,90,89)	8.25 Percent change Standard Error 2.29 • Interval 0.73 to 1.11	2.55 Percent change Standard Error 2.28 • Interval 0.69 to 1.04	2.94 Percent change Standard Error 1.75 • Interval 0.46 to 0.77
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Th2 high (n=63,62,57)	11.62 Percent change Standard Error 3.23	2.10 Percent change Standard Error 2.62	4.52 Percent change Standard Error 2.39
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Th2 low (n=57,55,55)	3.87 Percent change Standard Error 2.50	1.90 Percent change Standard Error 3.09	0.13 Percent change Standard Error 1.72
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Chronic OCS use (n=20,21,16)	6.96 Percent change Standard Error 6.56	3.44 Percent change Standard Error 5.82	-0.48 Percent change Standard Error 5.31
Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups Without chronic OCS use (n=105,109,106)	9.52 Percent change Standard Error 2.22	2.32 Percent change Standard Error 2.10	3.45 Percent change Standard Error 1.59

SECONDARY outcome

Timeframe: Week 1 up to Week 53

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline EC >= 150 Cells/UL (n= 77, 78, 70)	-1.07 units on a scale Standard Error 0.13	-0.84 units on a scale Standard Error 0.13	-0.94 units on a scale Standard Error 0.13
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline EC < 150 Cells/UL (n= 37, 31, 37)	-0.92 units on a scale Standard Error 0.16	-0.81 units on a scale Standard Error 0.18	-1.02 units on a scale Standard Error 0.21
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline SP >= 25th Percentile (n= 82, 92, 91)	-1.04 units on a scale Standard Error 0.11 • Interval 0.67 to 1.03	-0.86 units on a scale Standard Error 0.12 • Interval 0.75 to 1.15	-0.93 units on a scale Standard Error 0.13 • Interval 0.87 to 1.25
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline SP < 25th Percentile (n= 36, 23, 21)	-0.95 units on a scale Standard Error 0.24 • Interval 0.81 to 1.56	-0.73 units on a scale Standard Error 0.19 • Interval 0.58 to 1.16	-0.92 units on a scale Standard Error 0.24 • Interval 0.38 to 1.05
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline SP >= 75th Percentile (n= 25, 34, 27)	-1.25 units on a scale Standard Error 0.18 • Interval 0.65 to 1.25	-0.75 units on a scale Standard Error 0.14 • Interval 0.76 to 1.6	-1.01 units on a scale Standard Error 0.23 • Interval 1.6 to 2.55
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Th2 High (n= 59, 56, 55)	-1.10 units on a scale Standard Error 0.15	-0.95 units on a scale Standard Error 0.13	-1.02 units on a scale Standard Error 0.15
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Th2 Low (n= 55, 47, 50)	-0.94 units on a scale Standard Error 0.14	-0.70 units on a scale Standard Error 0.16	-0.87 units on a scale Standard Error 0.17
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline EC < 300 Cells/UL (n= 71, 65, 70)	-0.88 units on a scale Standard Error 0.12	-0.86 units on a scale Standard Error 0.14	-1.00 units on a scale Standard Error 0.15
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups >2 Asthma Exacerbations (n= 39, 43, 37)	-1.15 units on a scale Standard Error 0.15	-0.93 units on a scale Standard Error 0.17	-0.90 units on a scale Standard Error 0.19
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups With Chronic OCS Use (n= 20, 17, 18)	-0.89 units on a scale Standard Error 0.28	-0.39 units on a scale Standard Error 0.25	-0.16 units on a scale Standard Error 0.23
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline SP >= Median (n= 51, 65, 60)	-1.18 units on a scale Standard Error 0.13 • Interval 0.65 to 1.08	-0.88 units on a scale Standard Error 0.15 • Interval 0.88 to 1.43	-0.85 units on a scale Standard Error 0.14 • Interval 1.03 to 1.55
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline SP < Median (n= 67, 50, 52)	-0.81 units on a scale Standard Error 0.15 • Interval 0.76 to 1.25	-0.77 units on a scale Standard Error 0.14 • Interval 0.55 to 0.95	-1.03 units on a scale Standard Error 0.17 • Interval 0.45 to 0.85
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline SP < 75th Percentile (n= 93, 81, 85)	-0.92 units on a scale Standard Error 0.12 • Interval 0.73 to 1.11	-0.84 units on a scale Standard Error 0.12 • Interval 0.69 to 1.04	-0.91 units on a scale Standard Error 0.13 • Interval 0.46 to 0.77
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline EC >= 300 Cells/UL (n= 43, 44, 37)	-1.24 units on a scale Standard Error 0.16	-0.77 units on a scale Standard Error 0.15	-0.91 units on a scale Standard Error 0.17
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline FEV1 Reversibility >= 12% (n= 43, 33, 35)	-0.90 units on a scale Standard Error 0.18	-0.47 units on a scale Standard Error 0.19	-0.76 units on a scale Standard Error 0.20
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Baseline FEV1 Reversibility < 12% (n= 73, 78, 75)	-1.12 units on a scale Standard Error 0.12	-1.03 units on a scale Standard Error 0.11	-1.02 units on a scale Standard Error 0.13
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups 2 Asthma Exacerbations (n= 79, 72, 75)	-0.94 units on a scale Standard Error 0.13	-0.77 units on a scale Standard Error 0.13	-0.95 units on a scale Standard Error 0.14
Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups Without Chronic OCS Use (n= 98, 98, 94)	-1.04 units on a scale Standard Error 0.11	-0.91 units on a scale Standard Error 0.11	-1.08 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Week 1 up to Week 53

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline SP >= Median (n= 46, 63, 56)	1.10 units on a scale Standard Error 0.14 • Interval 0.65 to 1.08	0.89 units on a scale Standard Error 0.15 • Interval 0.88 to 1.43	0.95 units on a scale Standard Error 0.17 • Interval 1.03 to 1.55
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline SP < Median ( n= 61, 46, 45)	0.95 units on a scale Standard Error 0.15 • Interval 0.76 to 1.25	0.82 units on a scale Standard Error 0.14 • Interval 0.55 to 0.95	1.07 units on a scale Standard Error 0.17 • Interval 0.45 to 0.85
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline SP >= 75th Percentile (n= 23, 33, 24)	1.20 units on a scale Standard Error 0.19 • Interval 0.65 to 1.25	0.76 units on a scale Standard Error 0.17 • Interval 0.76 to 1.6	1.13 units on a scale Standard Error 0.28 • Interval 1.6 to 2.55
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Th2 high (n=54,52,50)	1.12 units on a scale Standard Error 0.15	0.88 units on a scale Standard Error 0.13	1.12 units on a scale Standard Error 0.18
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Without Chronic OCS Use (n= 90, 93, 85)	1.07 units on a scale Standard Error 0.11	0.91 units on a scale Standard Error 0.11	1.14 units on a scale Standard Error 0.13
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline SP >= 25th Percentile (n= 73, 88, 82)	1.08 units on a scale Standard Error 0.11 • Interval 0.67 to 1.03	0.87 units on a scale Standard Error 0.12 • Interval 0.75 to 1.15	0.98 units on a scale Standard Error 0.14 • Interval 0.87 to 1.25
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline SP < 25th Percentile (n= 34, 21, 19)	0.84 units on a scale Standard Error 0.24 • Interval 0.81 to 1.56	0.81 units on a scale Standard Error 0.19 • Interval 0.58 to 1.16	1.09 units on a scale Standard Error 0.24 • Interval 0.38 to 1.05
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline SP < 75th Percentile (n= 84, 76, 77)	0.97 units on a scale Standard Error 0.12 • Interval 0.73 to 1.11	0.87 units on a scale Standard Error 0.12 • Interval 0.69 to 1.04	0.96 units on a scale Standard Error 0.13 • Interval 0.46 to 0.77
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Th2 low (n= 49, 45, 44 )	0.88 units on a scale Standard Error 0.15	0.79 units on a scale Standard Error 0.17	0.94 units on a scale Standard Error 0.17
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline EC >= 150 Cells/UL (n=69, 72, 64)	1.06 units on a scale Standard Error 0.13	0.91 units on a scale Standard Error 0.11	1.02 units on a scale Standard Error 0.15
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline EC< 150 Cells/UL (n= 34, 31, 32)	0.93 units on a scale Standard Error 0.13	0.68 units on a scale Standard Error 0.20	1.05 units on a scale Standard Error 0.20
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline EC >= 300 Cells/UL (n= 39, 40, 35)	0.98 units on a scale Standard Error 0.17	0.81 units on a scale Standard Error 0.15	0.82 units on a scale Standard Error 0.20
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline EC < 300 Cells/UL (N= 64, 63, 61)	1.05 units on a scale Standard Error 0.13	0.84 units on a scale Standard Error 0.14	1.15 units on a scale Standard Error 0.15
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline FEV1 Reversibility >= 12% (n= 39, 29, 32)	1.14 units on a scale Standard Error 0.16	0.75 units on a scale Standard Error 0.17	0.95 units on a scale Standard Error 0.22
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups Baseline FEV1 Reversibility < 12% (n= 66, 76, 67)	1.04 units on a scale Standard Error 0.13	0.94 units on a scale Standard Error 0.13	1.04 units on a scale Standard Error 0.14
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups 2 Asthma Exacerbations (n=73, 68, 68)	1.09 units on a scale Standard Error 0.14	0.88 units on a scale Standard Error 0.13	1.14 units on a scale Standard Error 0.15
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups >2 Asthma Exacerbations (n= 34, 41, 33)	0.96 units on a scale Standard Error 0.14	0.78 units on a scale Standard Error 0.16	0.73 units on a scale Standard Error 0.20
Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups With Chronic OCS Use (n= 17, 16, 16)	0.87 units on a scale Standard Error 0.29	0.53 units on a scale Standard Error 0.19	0.26 units on a scale Standard Error 0.26

SECONDARY outcome

Timeframe: Week 1 up to Week 53

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status Atopic asthma (n=96,105,92)	0.90 AER events/person-year Interval 0.73 to 1.11	0.85 AER events/person-year Interval 0.67 to 1.06	0.85 AER events/person-year Interval 0.67 to 1.06
Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status Non-atopic asthma (n=51,42,55)	0.82 AER events/person-year Interval 0.56 to 1.15	1.05 AER events/person-year Interval 0.77 to 1.39	1.10 AER events/person-year Interval 0.82 to 1.44

SECONDARY outcome

Timeframe: Week 1 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. AER evaluated by subgroup chronic OCS use. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use Without chronic OCS use (124,124,127)	0.68 AER events/person-year Interval 0.54 to 0.84	0.81 AER events/person-year Interval 0.66 to 1.0	0.74 AER events/person-year Interval 0.59 to 0.91
Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use With chronic OCS use (n=27,26,24)	2.04 AER events/person-year Interval 1.51 to 2.69	1.37 AER events/person-year Interval 0.93 to 1.94	2.2 AER events/person-year Interval 1.62 to 2.91

SECONDARY outcome

Timeframe: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)

Scores for nighttime awakenings were generated based on the single item (question 5) that had a dichotomous response option (YES/NO). Nighttime awakenings were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated with data from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Change From Baseline in Percentage of Nighttime Awakening at Week 53 Change at Day 365 - Day 371 (n=113,108,108)	-0.18 percentage change Standard Deviation 0.37	-0.22 percentage change Standard Deviation 0.43	-0.23 percentage change Standard Deviation 0.45
Change From Baseline in Percentage of Nighttime Awakening at Week 53 Day -7 - Day -1 (Baseline) (n=151,147,145)	0.42 percentage change Standard Deviation 0.43	0.44 percentage change Standard Deviation 0.42	0.43 percentage change Standard Deviation 0.43

SECONDARY outcome

Timeframe: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)

There were 3 activity limitation questions in the ASMA diary. All activity questions were scored from 0 to 4 and averaged, where the higher score indicated greater limitation. Activity limitation 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.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Change From Baseline in Overall Activity Limitations at Week 53 Day -7 - Day -1 (Baseline) (n=151,147,145)	1.52 units on a scale Standard Deviation 0.90	1.71 units on a scale Standard Deviation 0.86	1.63 units on a scale Standard Deviation 0.85
Change From Baseline in Overall Activity Limitations at Week 53 Change at Day 365 - Day 371 (n=113,108,108)	-0.38 units on a scale Standard Deviation 0.84	-0.45 units on a scale Standard Deviation 0.81	-0.48 units on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline and Week 53

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 Pre-bronchodilator(BD): Baseline (n=147,146,146)	1.922 percentage change in liters Standard Error 0.056	1.926 percentage change in liters Standard Error 0.050	1.934 percentage change in liters Standard Error 0.059
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 Post-BD: Baseline (n=147,141,146)	2.094 percentage change in liters Standard Error 0.061	2.153 percentage change in liters Standard Error 0.053	2.110 percentage change in liters Standard Error 0.061
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 Pre-BD:Change from baseline to W53 (n=125,130,122)	9.11 percentage change in liters Standard Error 2.13	2.50 percentage change in liters Standard Error 1.99	2.94 percentage change in liters Standard Error 1.54
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 Post-BD:Change from baseline to W53(n=125,126,120)	5.98 percentage change in liters Standard Error 1.85	-1.65 percentage change in liters Standard Error 1.39	0.18 percentage change in liters Standard Error 1.25

SECONDARY outcome

Timeframe: Baseline and Week 53

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 Pre-bronchodilator(BD): Baseline (n=147,146,146)	2.809 percentage change in liters Standard Error 0.072	2.830 percentage change in liters Standard Error 0.064	2.827 percentage change in liters Standard Error 0.074
Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 Post-BD: Baseline (n=147,141,146)	2.981 percentage change in liters Standard Error 0.075	3.055 percentage change in liters Standard Error 0.067	2.980 percentage change in liters Standard Error 0.076
Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 Pre-BD:Change from baseline to W53 (n=125,130,122)	5.75 percentage change in liters Standard Error 1.53	1.06 percentage change in liters Standard Error 1.29	1.10 percentage change in liters Standard Error 1.18
Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 Post-BD:Change from baseline to W53(n=125,126,120)	3.27 percentage change in liters Standard Error 1.36	-1.16 percentage change in liters Standard Error 1.04	-0.11 percentage change in liters Standard Error 1.01

SECONDARY outcome

Timeframe: Baseline and Week 53

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53 Post-BD: Baseline (n=147,141,146)	3.133 percentage change in liters Standard Error 0.078	3.225 percentage change in liters Standard Error 0.072	3.125 percentage change in liters Standard Error 0.080
Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53 Pre-bronchodilator(BD): Baseline (n=147,146,146)	2.955 percentage change in liters Standard Error 0.075	3.003 percentage change in liters Standard Error 0.069	2.993 percentage change in liters Standard Error 0.079
Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53 Pre-BD:Change from baseline to W53 (n=125,130,122)	5.43 percentage change in liters Standard Error 1.60	0.87 percentage change in liters Standard Error 1.31	0.46 percentage change in liters Standard Error 1.17
Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53 Post-BD:Change from baseline to W53(n=125,126,120)	2.56 percentage change in liters Standard Error 1.27	-1.51 percentage change in liters Standard Error 1.01	-0.26 percentage change in liters Standard Error 1.03

SECONDARY outcome

Timeframe: Baseline and Week 53

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. Baseline for IC was measured in liters.

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53 Pre-bronchodilator(BD): Baseline (n=140,138,143)	0.023 percentage change in liters Standard Error 0.001	0.022 percentage change in liters Standard Error 0.001	0.023 percentage change in liters Standard Error 0.001
Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53 Post-BD: Baseline (n=140,133,135)	0.024 percentage change in liters Standard Error 0.001	0.024 percentage change in liters Standard Error 0.001	0.024 percentage change in liters Standard Error 0.001
Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53 Pre-BD:Change from baseline to W53 (n=108,109,103)	0.15 percentage change in liters Standard Error 2.21	8.56 percentage change in liters Standard Error 3.42	11.38 percentage change in liters Standard Error 3.71
Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53 Post-BD:Change from baseline to W53(n=108,109,104)	8.33 percentage change in liters Standard Error 3.14	3.64 percentage change in liters Standard Error 3.17	3.17 percentage change in liters Standard Error 2.91

SECONDARY outcome

Timeframe: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home Change at Day 365-371: Morning (n=123,119,113)	1.67 percentage change Standard Error 2.83	-4.96 percentage change Standard Error 3.27	1.70 percentage change Standard Error 5.41
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home Change at Day 365-371: Evening (n=119,116,111)	-2.69 percentage change Standard Error 3.17	-2.83 percentage change Standard Error 3.01	-5.78 percentage change Standard Error 3.63

SECONDARY outcome

Timeframe: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)

Outcome measures

Outcome measures
Measure	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=150 Participants 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.	Placebo Total n=151 Participants 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.	Tralokinumab 300 mg, Q2/4W - Cohort 2 n=151 Participants 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.
Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home Change at Day 365-371: Evening (n=129,116,111)	-6.62 percentage change Standard Error 3.13	-4.95 percentage change Standard Error 2.99	-11.45 percentage change Standard Error 3.33
Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home Change at Day 365-371: Morning (n=123,119,113)	-0.64 percentage change Standard Error 3.26	-6.89 percentage change Standard Error 3.09	-2.80 percentage change Standard Error 5.41

Adverse Events

Placebo Total

Serious events: 21 serious events

Other events: 128 other events

Deaths: 0 deaths

Tralokinumab 300 mg Q2W

Serious events: 18 serious events

Other events: 133 other events

Deaths: 0 deaths

Tralokinumab 300 mg Q2/4W

Serious events: 25 serious events

Other events: 128 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Meena Jain, MB BChir, Director, Clinical Development,

MedImmune, LLC

Phone: 301-398-0000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
Publication restrictions are in place

Restriction type: OTHER