Trial Outcomes & Findings for A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma (NCT NCT02161757)

Last Updated: 2018-08-28

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

1207 participants

Primary outcome timeframe

Baseline (Week 0) up to Week 52

Results posted on

2018-08-28

Participant Flow

First patient enrolled: 13 Jun 2014; Week 52 cut-off: 28 Feb 2017; Last Patient Last Visit Week 72: 18 Jul 2017. Study performed at 254 sites in 14 countries. Patients were maintained on currently prescribed inhaled corticosteroid long-acting β2-agonist therapy + any additional maintenance asthma controller medications throughout the study period.

2248 patients signed informed consent, 1669 entered screening/run-in period, 1207 patients were randomised to receive treatment with tralokinumab 300 milligrams (mg), or placebo, every 2 weeks (Q2W) or every 4 weeks (Q4W). Of the 1207 patients randomised, 1202 received investigational product (IP).

Participant milestones

Participant milestones
Measure	Tralo 300 mg Q2W Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Randomised Through Start Treatment STARTED	401	406	400
Randomised Through Start Treatment COMPLETED	398	404	400
Randomised Through Start Treatment NOT COMPLETED	3	2	0
Treatment Through Study Completion STARTED	398	404	400
Treatment Through Study Completion Completed Treatment for Week 52 Cut-off	332	355	360
Treatment Through Study Completion COMPLETED	341	361	361
Treatment Through Study Completion NOT COMPLETED	57	43	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Tralo 300 mg Q2W Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Randomised Through Start Treatment Did not receive treatment	3	2	0
Treatment Through Study Completion Adverse Event	1	1	0
Treatment Through Study Completion Protocol Violation	0	1	2
Treatment Through Study Completion Withdrawal by Subject	27	19	20
Treatment Through Study Completion Lost to Follow-up	7	2	4
Treatment Through Study Completion Other	20	19	12
Treatment Through Study Completion Death	2	1	1

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=398 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=404 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=400 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.	Total n=1202 Participants Total of all reporting groups
Age, Continuous	49.4 years STANDARD_DEVIATION 14.3 • n=5 Participants	51.1 years STANDARD_DEVIATION 13.9 • n=7 Participants	51.4 years STANDARD_DEVIATION 14.3 • n=5 Participants	50.6 years STANDARD_DEVIATION 14.2 • n=4 Participants
Sex: Female, Male Female	252 Participants n=5 Participants	281 Participants n=7 Participants	265 Participants n=5 Participants	798 Participants n=4 Participants
Sex: Female, Male Male	146 Participants n=5 Participants	123 Participants n=7 Participants	135 Participants n=5 Participants	404 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	21 Participants n=5 Participants	22 Participants n=7 Participants	25 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) Asian	53 Participants n=5 Participants	55 Participants n=7 Participants	55 Participants n=5 Participants	163 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	51 Participants n=4 Participants
Race (NIH/OMB) White	285 Participants n=5 Participants	297 Participants n=7 Participants	288 Participants n=5 Participants	870 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants	49 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Population: The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.

Outcome measures

Outcome measures
Measure	Tralo 300 mg Q2W n=398 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=404 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=400 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Annualised Asthma Exacerbation Rate (AAER) up to Week 52	0.56 Events/year Interval 0.46 to 0.67	0.54 Events/year Interval 0.45 to 0.65	0.60 Events/year Interval 0.5 to 0.72

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 52

Population: The FAS included all randomised patients who received at least one dose of 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 analysis.

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	Tralo 300 mg Q2W n=357 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=373 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=363 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)	16.366 Percent change from baseline Standard Deviation 27.349	12.099 Percent change from baseline Standard Deviation 26.253	10.136 Percent change from baseline Standard Deviation 24.206

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	Tralo 300 mg Q2W n=313 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=313 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=312 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)	-1.09 Scores on a scale Standard Deviation 1.22	-1.00 Scores on a scale Standard Deviation 1.11	-1.03 Scores on a scale Standard Deviation 1.13

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	Tralo 300 mg Q2W n=304 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=321 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=315 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score	1.18 Scores on a scale Standard Deviation 1.17	1.16 Scores on a scale Standard Deviation 1.14	1.03 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	Tralo 300 mg Q2W n=324 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=344 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=329 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score	-1.19 Scores on a scale Standard Deviation 1.06	-1.12 Scores on a scale Standard Deviation 1.03	-1.02 Scores on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Population: The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.

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	Tralo 300 mg Q2W n=398 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=404 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=400 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52	0.04 Events/year Interval 0.02 to 0.06	0.06 Events/year Interval 0.04 to 0.09	0.07 Events/year Interval 0.05 to 0.11

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	Tralo 300 mg Q2W n=306 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=319 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=324 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52	10.68 Scores on a scale Standard Deviation 20.33	9.00 Scores on a scale Standard Deviation 18.99	10.06 Scores on a scale Standard Deviation 18.92

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	Tralo 300 mg Q2W n=313 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=313 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=312 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)	-2.18 Puffs/day Standard Deviation 3.46	-2.15 Puffs/day Standard Deviation 3.69	-2.04 Puffs/day Standard Deviation 3.84

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	Tralo 300 mg Q2W n=321 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=326 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=329 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52 Morning PEF	12.95 L/min Standard Deviation 85.66	7.55 L/min Standard Deviation 74.97	5.23 L/min Standard Deviation 74.10
Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52 Evening PEF	8.89 L/min Standard Deviation 83.02	0.68 L/min Standard Deviation 73.19	-0.28 L/min Standard Deviation 76.05

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	Tralo 300 mg Q2W n=346 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=357 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=357 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])	-37.63 Percentage of nights with awakenings Standard Deviation 37.27	-35.17 Percentage of nights with awakenings Standard Deviation 37.49	-36.00 Percentage of nights with awakenings Standard Deviation 36.69

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Population: The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.

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

Outcome measures

Outcome measures
Measure	Tralo 300 mg Q2W n=398 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=404 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=400 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Number of Patients With ≥1 Asthma Exacerbation up to Week 52	128 Participants	124 Participants	133 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	Tralo 300 mg Q2W n=123 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=130 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=137 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52 Productivity loss - currently employed	27.71 Percent productivity loss Standard Deviation 24.06	28.48 Percent productivity loss Standard Deviation 25.11	31.25 Percent productivity loss Standard Deviation 25.34
Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52 Productivity loss - currently in school	33.13 Percent productivity loss Standard Deviation 28.03	31.79 Percent productivity loss Standard Deviation 34.28	32.31 Percent productivity loss Standard Deviation 28.46

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	Tralo 300 mg Q2W n=134 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=135 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=146 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
WPAI+CIQ: Activity Impairment at Week 52 Activity Impairment - currently employed	23.25 Percent Impairment Standard Deviation 21.31	23.53 Percent Impairment Standard Deviation 22.57	27.01 Percent Impairment Standard Deviation 23.21
WPAI+CIQ: Activity Impairment at Week 52 Activity Impairment - currently in school	29.29 Percent Impairment Standard Deviation 20.56	27.50 Percent Impairment Standard Deviation 29.55	28.95 Percent Impairment Standard Deviation 23.07

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Population: The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.

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	Tralo 300 mg Q2W n=398 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=404 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=400 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Asthma-related Healthcare Encounters by Type up to Week 52 Telephone calls	515 Encounters	463 Encounters	198 Encounters
Asthma-related Healthcare Encounters by Type up to Week 52 Advanced pulmonary function test	84 Encounters	70 Encounters	67 Encounters
Asthma-related Healthcare Encounters by Type up to Week 52 Ambulance transport	5 Encounters	15 Encounters	16 Encounters
Asthma-related Healthcare Encounters by Type up to Week 52 Emergency room visits	59 Encounters	87 Encounters	64 Encounters
Asthma-related Healthcare Encounters by Type up to Week 52 Unscheduled outpatient visits	1750 Encounters	1786 Encounters	1705 Encounters
Asthma-related Healthcare Encounters by Type up to Week 52 Home visits	21 Encounters	5 Encounters	6 Encounters

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Population: The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.

Outcome measures

Outcome measures
Measure	Tralo 300 mg Q2W n=398 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=404 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=400 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations	270 Days	345 Days	482 Days

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Population: The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.

Outcome measures

Outcome measures
Measure	Tralo 300 mg Q2W n=398 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=404 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=400 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry	489 Assessments	520 Assessments	502 Assessments

SECONDARY outcome

Timeframe: Blood samples were collected pre-dose at Baseline (Week 0), and at Week 4, Week 8, Week 26, Week 52 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 with data available at the timepoints of testing were included in the analysis.

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	Tralo 300 mg Q2W n=394 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=401 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72 Week 72 (follow-up)	0.419 micrograms/millilitre Geometric Coefficient of Variation 238.749	0.172 micrograms/millilitre Geometric Coefficient of Variation 171.973	—
Serum Trough Concentration (Ctrough) of Tralokinumab During the Study 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.	—
Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72 Week 4	34.690 micrograms/millilitre Geometric Coefficient of Variation 199.269	13.151 micrograms/millilitre Geometric Coefficient of Variation 188.026	—
Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72 Week 8	55.262 micrograms/millilitre Geometric Coefficient of Variation 159.824	19.243 micrograms/millilitre Geometric Coefficient of Variation 112.830	—
Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72 Week 26	52.766 micrograms/millilitre Geometric Coefficient of Variation 257.341	30.305 micrograms/millilitre Geometric Coefficient of Variation 255.039	—
Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72 Week 52	37.074 micrograms/millilitre Geometric Coefficient of Variation 675.764	14.290 micrograms/millilitre Geometric Coefficient of Variation 437.472	—

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.

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

Outcome measures

Outcome measures
Measure	Tralo 300 mg Q2W n=373 Participants Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=382 Participants Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=374 Participants Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
Number of Patients Positive for Anti-drug Antibodies (ADAs) ADA prevalence	7 Participants	7 Participants	9 Participants
Number of Patients Positive for Anti-drug Antibodies (ADAs) ADA incidence	3 Participants	2 Participants	3 Participants
Number of Patients Positive for Anti-drug Antibodies (ADAs) ADA positive at baseline	4 Participants	5 Participants	7 Participants
Number of Patients Positive for Anti-drug Antibodies (ADAs) ADA positive post-baseline	3 Participants	3 Participants	8 Participants
Number of Patients Positive for Anti-drug Antibodies (ADAs) ADA pos post-baseline and pos at baseline	0 Participants	1 Participants	6 Participants
Number of Patients Positive for Anti-drug Antibodies (ADAs) ADA pos post-baseline and not detected at baseline	3 Participants	2 Participants	2 Participants
Number of Patients Positive for Anti-drug Antibodies (ADAs) ADA not detected post-baseline and pos at baseline	4 Participants	4 Participants	1 Participants
Number of Patients Positive for Anti-drug Antibodies (ADAs) Persistent Positive	2 Participants	2 Participants	7 Participants
Number of Patients Positive for Anti-drug Antibodies (ADAs) Transient Positive	1 Participants	1 Participants	1 Participants
Number of Patients Positive for Anti-drug Antibodies (ADAs) Treatment-boosted ADA	0 Participants	0 Participants	1 Participants
Number of Patients Positive for Anti-drug Antibodies (ADAs) nAB positive at any visit	5 Participants	5 Participants	4 Participants

Adverse Events

Tralo 300 mg Q2W

Serious events: 40 serious events

Other events: 134 other events

Deaths: 2 deaths

Tralo 300 mg Q4W

Serious events: 39 serious events

Other events: 145 other events

Deaths: 1 deaths

Placebo

Serious events: 48 serious events

Other events: 107 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Tralo 300 mg Q2W n=398 participants at risk Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.	Tralo 300 mg Q4W n=404 participants at risk Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.	Placebo n=400 participants at risk Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.
General disorders Injection site erythema	6.0% 24/398 • Number of events 58 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	3.0% 12/404 • Number of events 29 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	0.00% 0/400 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.
Infections and infestations Bronchitis	5.0% 20/398 • Number of events 29 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	5.7% 23/404 • Number of events 27 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	4.5% 18/400 • Number of events 24 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.
Infections and infestations Upper respiratory tract infection	6.5% 26/398 • Number of events 40 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	11.9% 48/404 • Number of events 61 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	9.0% 36/400 • Number of events 73 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.
Infections and infestations Viral upper respiratory tract infection	11.1% 44/398 • Number of events 62 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	11.9% 48/404 • Number of events 67 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	9.2% 37/400 • Number of events 55 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.
Nervous system disorders Headache	5.8% 23/398 • Number of events 35 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	7.7% 31/404 • Number of events 42 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	4.2% 17/400 • Number of events 28 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.
Respiratory, thoracic and mediastinal disorders Asthma	8.8% 35/398 • Number of events 55 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	8.2% 33/404 • Number of events 43 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.	7.0% 28/400 • Number of events 45 • Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72. Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.

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