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Official Title

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A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of
Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

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

This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered
subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma
exacerbations.
Approximately 770 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at
the study site, over a 52-week treatment period.

NCT ID

Therapeutic Area

Research Site

A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

To evaluate the effect of tralokinumab 300 mg administered every 2 weeks compared with placebo on the annualised asthma exacerbation rate in adult and adolescent subjects with asthma that is inadequately controlled with inhaled corticosteroid plus long-acting β2-agonist

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

All patients in the full analysis set (FAS) with the potential to receive 52 weeks of IP and who received any IP (tralokinumab or placebo) were included in the baseline analysis.

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.

Comparison of AAER (rate ratio): Biomarker positive population; Tralo 300 mg Q2W vs placebo.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model.

Comparison of AAER (rate ratio): Biomarker negative population; Tralo 300 mg Q2W vs placebo.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model.

Comparison of AAER (rate reduction): Biomarker positive population; Tralo 300 mg Q2W vs placebo.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model.

Comparison of AAER (rate ratio): FAS population; Tralo 300 mg Q2W vs placebo.

Comparison of AAER (rate reduction): FAS population; Tralo 300 mg Q2W vs placebo.

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.

Annualised asthma exacerbation rate (AAER) up to Week 52

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.

Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.
Restricted maximum likelihood (REML) based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.
REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment

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.

Percent change from baseline to Week 52 in pre-dose/pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)

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.

Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of mean change from baseline in total asthma symptom score at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.

Change from baseline to Week 52 in total asthma symptom score (bi-weekly means)

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.

Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.

Change from baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) total score

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.

Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of change in mean score from baseline for ACQ-6 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.

Change from baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) score

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).

Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker positive population; Tralo 300 mg Q2W vs placebo.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model.

Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker negative population; Tralo 300 mg Q2W vs placebo.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model.

Comparison of AAER associated with an ER/UC visit or hospitalisation: FAS population; Tralo 300 mg Q2W vs placebo.

AAER associated with an ER/UC visit, or a hospitalisation up to 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.

Change from baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) visual analogue scale (VAS) scores at 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.

Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo. 
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo. 
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of mean change from baseline in rescue medication use at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.

Change from baseline in total asthma rescue medication use at Week 52 (bi-weekly means)

Morning PEF

Evening PEF

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.

Comparison of mean change from baseline in morning PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo. 
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of mean change from baseline in morning PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo. 
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of mean change from baseline in evening PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo. 
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of mean change from baseline in evening PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo. 
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of mean change from baseline in morning PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.

Comparison of mean change from baseline in evening PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.

Change from baseline in home peak expiratory flow (PEF) (morning and evening) at 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.

Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo. 
REML based repeated measures analysis.
A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model.

Comparison of mean change from baseline in number (%) of awakenings at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.

Change from baseline in night-time awakenings due to asthma requiring rescue medication use at Week 52 (bi-weekly means [percentage])

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

Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.

Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.

Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: FAS population; Tralo 300 mg Q2W vs placebo.

Number of patients with ≥1 asthma exacerbation up to Week 52

Productivity loss -
currently employed

Productivity loss -
currently in school

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.

Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52

Activity Impairment - currently employed

Activity Impairment - currently in school

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.

WPAI+CIQ: Activity Impairment at Week 52

Ambulance transport

Emergency room visits

Unscheduled outpatient visits

Home visits

Telephone calls

Advanced pulmonary function test

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.

Asthma-related healthcare encounters by type 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 days spent in hospital was calculated across all patients for the following healthcare encounter category:
• Hospitalisations (hospitalisations, intensive care and/or general care).

Asthma-related healthcare encounters by type up to Week 52: Hospitalisations

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 assessments was calculated across all patients for the following healthcare encounter category:
• Spirometry.

Asthma-related healthcare encounters by type up to Week 52: Spirometry

Baseline

Week 2

Week 8

Week 26

Week 56 (follow-up)

Week 72 (follow-up)

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.

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.

Serum trough concentration (Ctrough) of tralokinumab during the
treatment period up to Week 72

ADA prevalence

ADA incidence

ADA positive at baseline

ADA positive post-baseline

ADA pos post-baseline and pos at baseline

ADA pos post-baseline and not detected at baseline

ADA not detected post-baseline and pos at baseline

Persistent Positive

Transient Positive

Treatment-boosted ADA

nAB positive at any visit

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.

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.

Incidence rate of positive anti-drug antibodies (ADAs) including the characterization of their neutralizing potential

Randomised

With potential to receive 52 weeks of IP

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).

Global Clinical Lead

To assess the effect of tralokinumab with regards to lung function

To assess the effect of tralokinumab with regards to asthma symptoms

To assess the effect of tralokinumab with regards to asthma specific health-related quality of life

To assess the effect of tralokinumab with regards to Asthma Control Questionnaire-6 defined asthma control

To assess the effect of tralokinumab compared with placebo with regards to emergency room and urgent care visits and hospitalizations due to
asthma

To assess the effect of tralokinumab compared with placebo with regards to health related quality of life

To assess the effect of tralokinumab compared with placebo with regards to asthma symptoms and asthma control as measured by rescue
medication use

To assess the effect of tralokinumab compared with placebo with regards to asthma symptoms and asthma control as measured by home peak
expiratory flow

To assess the effect of tralokinumab compared with placebo with regards to asthma symptoms and asthma control as measured by night-time
awakenings due to asthma

To assess the effect of tralokinumab compared with placebo with regards to asthma exacerbations as measured by time to first asthma exacerbation

To assess the effect of tralokinumab compared with placebo with regards to asthma exacerbations as measured by the proportion of subjects with at
least one asthma exacerbation

To assess the effect of tralokinumab compared with placebo with regards to productivity loss due to asthma

To assess the effect of tralokinumab compared with placebo with regards to health care resource utilization

To evaluate the pharmacokinetics of tralokinumab

To evaluate the immunogenicity of tralokinumab

Arms	Assigned Interventions
Experimental: Tralokinumab Tralokinumab subcutaneous injection	Biological/Vaccine: Experimental: Tralokinumab Tralokinumab subcutaneous injection
Placebo Comparator: Placebo Placebo subcutaneous injection	Other: Placebo Placebo subcutaneous injection

A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Uncontrolled Asthma - STRATOS2

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