Trial Outcomes & Findings for A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma (NCT NCT02194699)

NCT ID: NCT02194699

Last Updated: 2018-05-15

Results Overview

Asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for \<24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above). * An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. AAER = number of exacerbations\*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

856 participants

Primary outcome timeframe

Baseline (Week 0) up to Week 52

Results posted on

2018-05-15

Participant Flow

First patient enrolled: 30 Oct 2014; Last Patient Last Visit: 21 Sep 2017. Study performed at 242 sites in 13 countries. Patients were maintained on their currently prescribed inhaled corticosteroid long-acting β2-agonist therapy and any additional maintenance asthma controller medications throughout the study period.

1696 patients signed informed consent, 1163 entered screening/run-in period, 856 patients were randomised to receive investigational product (IP) and 849 received treatment. The primary population was the biomarker positive population, defined as all patients with baseline fractional exhaled nitric oxide (FeNO) ≥37 parts per billion (ppb).

Participant milestones

Participant milestones
Measure	Tralo 300 mg Q2W Tralokinumab 300 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) over a 52-week treatment period (up to 26 doses).	Placebo Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Randomised STARTED	428	428
Randomised COMPLETED	420	417
Randomised NOT COMPLETED	8	11
With Potential to Receive 52 Weeks of IP STARTED	420	417
With Potential to Receive 52 Weeks of IP COMPLETED	370	365
With Potential to Receive 52 Weeks of IP NOT COMPLETED	50	52

Reasons for withdrawal

Reasons for withdrawal
Measure	Tralo 300 mg Q2W Tralokinumab 300 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) over a 52-week treatment period (up to 26 doses).	Placebo Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Randomised Did not receive treatment	1	5
Randomised Without potential for 52 weeks of IP	5	5
Randomised Duplicate patient	2	1
With Potential to Receive 52 Weeks of IP Adverse Event	4	3
With Potential to Receive 52 Weeks of IP Death	1	3
With Potential to Receive 52 Weeks of IP Lost to Follow-up	5	8
With Potential to Receive 52 Weeks of IP Protocol Violation	2	2
With Potential to Receive 52 Weeks of IP Withdrawal by Subject	14	20
With Potential to Receive 52 Weeks of IP Other	24	16

Baseline Characteristics

A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tralo 300 mg Q2W n=420 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=417 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Total n=837 Participants Total of all reporting groups
Age, Continuous	47.3 Years STANDARD_DEVIATION 15.6 • n=5 Participants	48.0 Years STANDARD_DEVIATION 15.5 • n=7 Participants	47.6 Years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	276 Participants n=5 Participants	290 Participants n=7 Participants	566 Participants n=5 Participants
Sex: Female, Male Male	144 Participants n=5 Participants	127 Participants n=7 Participants	271 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Asian	83 Participants n=5 Participants	88 Participants n=7 Participants	171 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) White	283 Participants n=5 Participants	281 Participants n=7 Participants	564 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=108 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=121 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=308 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=290 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=420 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=417 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Annualised Asthma Exacerbation Rate (AAER) up to Week 52	0.80 Events/year Interval 0.57 to 1.11	0.95 Events/year Interval 0.68 to 1.31	0.87 Events/year Interval 0.71 to 1.06	0.77 Events/year Interval 0.63 to 0.95	0.84 Events/year Interval 0.71 to 1.0	0.82 Events/year Interval 0.69 to 0.97

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 52

Population: The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.

Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=99 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=103 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=282 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=250 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=384 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=358 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)	18.769 Percent change from baseline Standard Deviation 29.628	16.632 Percent change from baseline Standard Deviation 31.906	13.103 Percent change from baseline Standard Deviation 24.641	8.395 Percent change from baseline Standard Deviation 21.962	14.546 Percent change from baseline Standard Deviation 26.065	10.528 Percent change from baseline Standard Deviation 25.475

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 52

Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=79 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=81 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=215 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=223 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=297 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=309 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)	-1.18 Scores on a scale Standard Deviation 0.98	-1.06 Scores on a scale Standard Deviation 1.25	-0.98 Scores on a scale Standard Deviation 1.04	-1.02 Scores on a scale Standard Deviation 1.24	-1.04 Scores on a scale Standard Deviation 1.04	-1.02 Scores on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 52

The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=77 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=84 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=242 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=230 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=321 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=318 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score	1.35 Scores on a scale Standard Deviation 1.06	1.20 Scores on a scale Standard Deviation 1.22	1.13 Scores on a scale Standard Deviation 1.07	1.23 Scores on a scale Standard Deviation 1.25	1.18 Scores on a scale Standard Deviation 1.07	1.21 Scores on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 52

The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score \>1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=85 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=86 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=254 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=243 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=341 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=334 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score	-1.26 Scores on a scale Standard Deviation 1.01	-1.14 Scores on a scale Standard Deviation 1.12	-1.07 Scores on a scale Standard Deviation 1.02	-1.11 Scores on a scale Standard Deviation 1.13	-1.12 Scores on a scale Standard Deviation 1.02	-1.11 Scores on a scale Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form). AAER = number of exacerbations\*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=108 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=121 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=308 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=290 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=420 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=417 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52	0.06 Events/year Interval 0.03 to 0.14	0.16 Events/year Interval 0.09 to 0.29	0.09 Events/year Interval 0.06 to 0.14	0.11 Events/year Interval 0.07 to 0.17	0.08 Events/year Interval 0.06 to 0.12	0.12 Events/year Interval 0.09 to 0.18

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 52

The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=81 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=85 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=233 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=224 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=317 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=313 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52	14.58 Scores on a scale Standard Deviation 15.21	11.58 Scores on a scale Standard Deviation 17.26	11.67 Scores on a scale Standard Deviation 17.18	12.01 Scores on a scale Standard Deviation 17.43	12.46 Scores on a scale Standard Deviation 16.67	11.66 Scores on a scale Standard Deviation 17.41

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 52

Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2\*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=79 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=81 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=215 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=223 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=297 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=309 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)	-2.86 Puffs/day Standard Deviation 3.26	-1.73 Puffs/day Standard Deviation 4.59	-2.01 Puffs/day Standard Deviation 2.93	-2.08 Puffs/day Standard Deviation 4.28	-2.25 Puffs/day Standard Deviation 3.03	-1.97 Puffs/day Standard Deviation 4.34

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 52

Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=86 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=86 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=233 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=222 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=322 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=313 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52 Evening PEF	18.15 L/min Standard Deviation 69.20	8.88 L/min Standard Deviation 79.72	1.72 L/min Standard Deviation 79.58	0.17 L/min Standard Deviation 73.66	5.72 L/min Standard Deviation 77.01	2.91 L/min Standard Deviation 74.94
Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52 Morning PEF	22.35 L/min Standard Deviation 74.00	18.80 L/min Standard Deviation 86.24	6.72 L/min Standard Deviation 73.82	6.10 L/min Standard Deviation 72.28	10.66 L/min Standard Deviation 73.88	9.43 L/min Standard Deviation 76.01

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 52

The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=94 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=96 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=270 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=247 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=368 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=348 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])	-37.86 Percentage of nights with awakenings Standard Deviation 38.36	-34.06 Percentage of nights with awakenings Standard Deviation 34.96	-34.65 Percentage of nights with awakenings Standard Deviation 34.34	-35.67 Percentage of nights with awakenings Standard Deviation 37.37	-35.60 Percentage of nights with awakenings Standard Deviation 35.40	-35.05 Percentage of nights with awakenings Standard Deviation 36.63

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=108 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=121 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=308 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=290 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=420 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=417 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Number of Patients With ≥1 Asthma Exacerbation up to Week 52	38 Participants	50 Participants	125 Participants	117 Participants	163 Participants	171 Participants

SECONDARY outcome

Timeframe: At Week 52

The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days. The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity. Work Productivity Loss = {Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))x(Q5/10)\]}\*100 (Absenteeism = Q2/(Q2+Q4)\*100; Presenteeism = (Q5/10)\*100). Class Productivity Loss = {Q7/(Q7+Q8) + \[(1-Q7/(Q7+Q8))x(Q9/10)\]}\*100 (Absenteeism = Q7/(Q7+Q8)\*100; Presenteeism = (Q9/10)\*100). Note: QX refers to response to question number X on WPAI+CIQ questionnaire.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=46 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=46 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=105 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=104 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=154 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=151 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52 Productivity loss - currently employed	22.51 Percent productivity loss Standard Deviation 24.47	28.15 Percent productivity loss Standard Deviation 27.39	23.36 Percent productivity loss Standard Deviation 23.39	31.05 Percent productivity loss Standard Deviation 27.20	23.43 Percent productivity loss Standard Deviation 23.66	30.17 Percent productivity loss Standard Deviation 27.08
Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52 Productivity loss - currently in school	28.89 Percent productivity loss Standard Deviation 34.21	37.92 Percent productivity loss Standard Deviation 28.72	25.99 Percent productivity loss Standard Deviation 32.17	19.67 Percent productivity loss Standard Deviation 29.06	28.03 Percent productivity loss Standard Deviation 31.01	28.09 Percent productivity loss Standard Deviation 29.80

SECONDARY outcome

Timeframe: At Week 52

The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days. The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment. Activity impairment = (Q10/10)\*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=50 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=49 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=116 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=110 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=169 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=160 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
WPAI+CIQ: Activity Impairment at Week 52 Activity Impairment - currently employed	20.89 Percent impairment Standard Deviation 18.81	25.28 Percent impairment Standard Deviation 28.63	20.50 Percent impairment Standard Deviation 20.42	26.49 Percent impairment Standard Deviation 23.59	20.68 Percent impairment Standard Deviation 19.82	26.11 Percent impairment Standard Deviation 24.89
WPAI+CIQ: Activity Impairment at Week 52 Activity Impairment - currently in school	20.00 Percent impairment Standard Deviation 18.71	33.85 Percent impairment Standard Deviation 26.63	26.88 Percent impairment Standard Deviation 30.49	23.13 Percent impairment Standard Deviation 30.27	24.55 Percent impairment Standard Deviation 27.38	27.93 Percent impairment Standard Deviation 28.71

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories: * Ambulance transport, * Emergency room visits, * Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit), * Home visits (home visit, physician and/or other healthcare professional), * Telephone calls (telephone calls to physician and/or nurse), and * Advanced pulmonary function test.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=108 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=121 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=308 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=290 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=420 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=417 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Asthma-related Healthcare Encounters by Type up to Week 52 Home visits	10 Encounters	18 Encounters	49 Encounters	26 Encounters	59 Encounters	44 Encounters
Asthma-related Healthcare Encounters by Type up to Week 52 Ambulance transport	14 Encounters	21 Encounters	21 Encounters	20 Encounters	35 Encounters	41 Encounters
Asthma-related Healthcare Encounters by Type up to Week 52 Emergency room visits	20 Encounters	28 Encounters	65 Encounters	70 Encounters	87 Encounters	99 Encounters
Asthma-related Healthcare Encounters by Type up to Week 52 Unscheduled outpatient visits	513 Encounters	579 Encounters	1274 Encounters	1216 Encounters	1798 Encounters	1834 Encounters
Asthma-related Healthcare Encounters by Type up to Week 52 Telephone calls	51 Encounters	76 Encounters	112 Encounters	117 Encounters	163 Encounters	196 Encounters
Asthma-related Healthcare Encounters by Type up to Week 52 Advanced pulmonary function test	16 Encounters	20 Encounters	35 Encounters	26 Encounters	51 Encounters	46 Encounters

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=108 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=121 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=308 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=290 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=420 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=417 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations	82 Days	175 Days	334 Days	414 Days	417 Days	590 Days

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=108 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=121 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=308 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo n=290 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W n=420 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=417 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry	148 Assessments	151 Assessments	284 Assessments	270 Assessments	434 Assessments	426 Assessments

SECONDARY outcome

Timeframe: Blood samples were collected pre-dose at Baseline (Week 0), and at Week 2, Week 8, Week 26, Week 56 (follow-up) and Week 72 (follow-up)

Population: All patients in the FAS who received tralokinumab and who had PK blood samples were included in the PK analysis set. Only patients in the biomarker positive and negative PK populations and with data available at the timepoints of testing were included in the analyses.

To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=108 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=302 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W n=410 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72 Baseline	NA micrograms/millilitre Geometric Coefficient of Variation NA Value was not calculable since below level of detection.	NA micrograms/millilitre Geometric Coefficient of Variation NA Value was not calculable since below level of detection.	NA micrograms/millilitre Geometric Coefficient of Variation NA Value was not calculable since below level of detection.	—	—	—
Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72 Week 2	24.049 micrograms/millilitre Geometric Coefficient of Variation 172.475	20.916 micrograms/millilitre Geometric Coefficient of Variation 280.452	21.690 micrograms/millilitre Geometric Coefficient of Variation 248.876	—	—	—
Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72 Week 8	55.887 micrograms/millilitre Geometric Coefficient of Variation 206.478	52.324 micrograms/millilitre Geometric Coefficient of Variation 226.298	53.272 micrograms/millilitre Geometric Coefficient of Variation 220.301	—	—	—
Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72 Week 26	58.375 micrograms/millilitre Geometric Coefficient of Variation 145.256	47.707 micrograms/millilitre Geometric Coefficient of Variation 319.456	50.332 micrograms/millilitre Geometric Coefficient of Variation 264.686	—	—	—
Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72 Week 56 (follow-up)	12.363 micrograms/millilitre Geometric Coefficient of Variation 591.282	12.513 micrograms/millilitre Geometric Coefficient of Variation 707.267	12.474 micrograms/millilitre Geometric Coefficient of Variation 671.922	—	—	—
Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72 Week 72 (follow-up)	0.325 micrograms/millilitre Geometric Coefficient of Variation 251.436	0.384 micrograms/millilitre Geometric Coefficient of Variation 242.035	0.368 micrograms/millilitre Geometric Coefficient of Variation 244.398	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)

Population: The ADA evaluable population included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.

Assessments of ADA were performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for the presence of neutralising antibodies (nAb). ADA prevalence was defined as proportion of the study population having drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher level following drug administration. Note: 'positive' is denoted by 'pos' in some category titles.

Outcome measures

Outcome measures
Measure	Biomarker Positive - Tralo 300 mg Q2W n=405 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Positive - Placebo n=394 Participants Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker positive population (primary population) had baseline FeNO ≥37 ppb.	Biomarker Negative - Tralo 300 mg Q2W Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Biomarker Negative - Placebo Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Patients in the biomarker negative population (complement population) had baseline FeNO \<37 ppb.	Tralo 300 mg Q2W Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential ADA prevalence	7 Participants	8 Participants	—	—	—	—
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential ADA incidence	5 Participants	3 Participants	—	—	—	—
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential ADA positive at baseline	2 Participants	5 Participants	—	—	—	—
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential ADA positive post-baseline	5 Participants	6 Participants	—	—	—	—
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential ADA pos post-baseline and pos at baseline	0 Participants	3 Participants	—	—	—	—
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential ADA pos post-baseline and not detected at baseline	5 Participants	3 Participants	—	—	—	—
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential ADA not detected post-baseline and pos at baseline	2 Participants	2 Participants	—	—	—	—
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential Persistent Positive	3 Participants	6 Participants	—	—	—	—
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential Transient Positive	2 Participants	0 Participants	—	—	—	—
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential Treatment-boosted ADA	0 Participants	0 Participants	—	—	—	—
Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential nAB positive at any visit	5 Participants	2 Participants	—	—	—	—

Adverse Events

Tralo 300 mg Q2W

Serious events: 35 serious events

Other events: 159 other events

Deaths: 1 deaths

Placebo

Serious events: 39 serious events

Other events: 152 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Tralo 300 mg Q2W n=425 participants at risk Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).	Placebo n=422 participants at risk Placebo administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses).
General disorders Injection site reaction	5.4% 23/425 • Number of events 93 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.	0.71% 3/422 • Number of events 5 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.
Infections and infestations Bronchitis	8.0% 34/425 • Number of events 59 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.	7.3% 31/422 • Number of events 50 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.
Infections and infestations Upper respiratory tract infection	6.8% 29/425 • Number of events 49 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.	7.3% 31/422 • Number of events 39 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.
Infections and infestations Viral upper respiratory tract infection	11.8% 50/425 • Number of events 71 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.	12.3% 52/422 • Number of events 80 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.
Nervous system disorders Headache	9.4% 40/425 • Number of events 76 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.	7.6% 32/422 • Number of events 49 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.
Respiratory, thoracic and mediastinal disorders Asthma	8.2% 35/425 • Number of events 51 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.	11.1% 47/422 • Number of events 79 • 72 weeks Serious and Other (non-serious) adverse event (AE) data is reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + 2 weeks). Patient population was the safety analysis set which included all patients who received at least one dose of IP. All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: +1 301-398-0582

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60