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A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma (STRATOS2)

Primary Purpose

Uncontrolled Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Experimental: Tralokinumab

Placebo

About this trial

This is an interventional treatment trial for Uncontrolled Asthma

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 12 -75
Documented physician-diagnosed asthma.
Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of age) of their PNV.
Post-BD reversibility of ≥12% and ≥200 mL in FEV1
ACQ-6 score ≥1.5

Exclusion Criteria:

Pulmonary disease other than asthma
History of anaphylaxis following any biologic therapy
Hepatitis B, C or HIV
Pregnant or breastfeeding
History of cancer
Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
Previous receipt of tralokinumab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tralokinumab

Placebo

Arm Description

Tralokinumab subcutaneous injection

Placebo subcutaneous injection

Outcomes

Primary Outcome Measures

Annualised Asthma Exacerbation Rate (AAER) up to Week 52

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.

Secondary Outcome Measures

Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)

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.

Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)

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.

Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score

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.

Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) 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.

AAER Associated With an ER/UC Visit, or a Hospitalisation 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).

Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at 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 Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)

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.

Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at 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.

Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])

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.

Number of Patients With ≥1 Asthma Exacerbation up to Week 52

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

Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss 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.

WPAI+CIQ: Activity Impairment 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.

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 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: Hospitalisations

Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry

Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72

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.

Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential

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.

Full Information

NCT ID

NCT02194699

First Posted

July 17, 2014

Last Updated

April 13, 2018

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02194699

Brief Title

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

Acronym

STRATOS2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 30, 2014 (Actual)

Primary Completion Date

May 10, 2017 (Actual)

Study Completion Date

September 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uncontrolled Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

856 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tralokinumab

Arm Type

Experimental

Arm Description

Tralokinumab subcutaneous injection

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo subcutaneous injection

Intervention Type

Biological

Intervention Name(s)

Experimental: Tralokinumab

Intervention Description

Tralokinumab subcutaneous injection

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo subcutaneous injection

Primary Outcome Measure Information:

Title

Annualised Asthma Exacerbation Rate (AAER) up to Week 52

Description

Time Frame

Baseline (Week 0) up to Week 52

Secondary Outcome Measure Information:

Title

Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)

Description

Time Frame

Baseline (Week 0) and Week 52

Title

Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)

Description

Time Frame

Baseline (Week 0) and Week 52

Title

Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score

Description

Time Frame

Baseline (Week 0) and Week 52

Title

Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score

Description

Time Frame

Baseline (Week 0) and Week 52

Title

AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52

Description

Time Frame

Baseline (Week 0) up to Week 52

Title

Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52

Description

Time Frame

Baseline (Week 0) and Week 52

Title

Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)

Description

Time Frame

Baseline (Week 0) and Week 52

Title

Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52

Description

Time Frame

Baseline (Week 0) and Week 52

Title

Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])

Description

Time Frame

Baseline (Week 0) and Week 52

Title

Number of Patients With ≥1 Asthma Exacerbation up to Week 52

Description

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

Time Frame

Baseline (Week 0) up to Week 52

Title

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

Description

Time Frame

At Week 52

Title

WPAI+CIQ: Activity Impairment at Week 52

Description

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.

Time Frame

At Week 52

Title

Asthma-related Healthcare Encounters by Type up to Week 52

Description

Time Frame

Baseline (Week 0) up to Week 52

Title

Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations

Description

Time Frame

Baseline (Week 0) up to Week 52

Title

Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry

Description

Time Frame

Baseline (Week 0) up to Week 52

Title

Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72

Description

Time Frame

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)

Title

Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 12 -75 Documented physician-diagnosed asthma. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of age) of their PNV. Post-BD reversibility of ≥12% and ≥200 mL in FEV1 ACQ-6 score ≥1.5 Exclusion Criteria: Pulmonary disease other than asthma History of anaphylaxis following any biologic therapy Hepatitis B, C or HIV Pregnant or breastfeeding History of cancer Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years Previous receipt of tralokinumab

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Brightling, MD

Organizational Affiliation

Institute for Lung Health, United Kingdom

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Research Site

City

Hoover

State/Province

Alabama

ZIP/Postal Code

35244

Country

United States

Facility Name

Research Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35803

Country

United States

Facility Name

Research Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

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Research Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72209

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United States

Facility Name

Research Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Research Site

City

Buena Park

State/Province

California

ZIP/Postal Code

90620

Country

United States

Facility Name

Research Site

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

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United States

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Research Site

City

Lakewood

State/Province

California

ZIP/Postal Code

90805

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United States

Facility Name

Research Site

City

Lomita

State/Province

California

ZIP/Postal Code

90717

Country

United States

Facility Name

Research Site

City

Northridge

State/Province

California

ZIP/Postal Code

91324

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United States

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Research Site

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Palmdale

State/Province

California

ZIP/Postal Code

93551

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United States

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Research Site

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Roseville

State/Province

California

ZIP/Postal Code

95661

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United States

Facility Name

Research Site

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Sacramento

State/Province

California

ZIP/Postal Code

95819

Country

United States

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Research Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94102

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United States

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Research Site

City

Thousand Oaks

State/Province

California

ZIP/Postal Code

91360

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United States

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Research Site

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Ventura

State/Province

California

ZIP/Postal Code

93003-3099

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United States

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Research Site

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Walnut Creek

State/Province

California

ZIP/Postal Code

94598

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United States

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Centennial

State/Province

Colorado

ZIP/Postal Code

80112

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United States

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Research Site

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Celebration

State/Province

Florida

ZIP/Postal Code

34747

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United States

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Research Site

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

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United States

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Research Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

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United States

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Hialeah

State/Province

Florida

ZIP/Postal Code

33016

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United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

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United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33142

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Research Site

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34653

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United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

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United States

Facility Name

Research Site

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

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United States

Facility Name

Research Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

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United States

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Research Site

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Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33710

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United States

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Tampa

State/Province

Florida

ZIP/Postal Code

33607

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United States

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Winter Park

State/Province

Florida

ZIP/Postal Code

32789

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United States

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Research Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

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United States

Facility Name

Research Site

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Research Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

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United States

Facility Name

Research Site

City

Eagle

State/Province

Idaho

ZIP/Postal Code

83616

Country

United States

Facility Name

Research Site

City

Evergreen Park

State/Province

Illinois

ZIP/Postal Code

60805

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United States

Facility Name

Research Site

City

Kenilworth

State/Province

Illinois

ZIP/Postal Code

60043

Country

United States

Facility Name

Research Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Facility Name

Research Site

City

White Marsh

State/Province

Maryland

ZIP/Postal Code

21162

Country

United States

Facility Name

Research Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

Country

United States

Facility Name

Research Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89503

Country

United States

Facility Name

Research Site

City

Northfield

State/Province

New Jersey

ZIP/Postal Code

08225

Country

United States

Facility Name

Research Site

City

Ocean City

State/Province

New Jersey

ZIP/Postal Code

07712

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United States

Facility Name

Research Site

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

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United States

Facility Name

Research Site

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Research Site

City

Verona

State/Province

New Jersey

ZIP/Postal Code

07044

Country

United States

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10459

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Research Site

City

Larchmont

State/Province

New York

ZIP/Postal Code

10538

Country

United States

Facility Name

Research Site

City

Wappingers Falls

State/Province

New York

ZIP/Postal Code

12590

Country

United States

Facility Name

Research Site

City

Burlington

State/Province

North Carolina

ZIP/Postal Code

27215

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28205

Country

United States

Facility Name

Research Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27410

Country

United States

Facility Name

Research Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Research Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

Research Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Research Site

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Research Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76018

Country

United States

Facility Name

Research Site

City

Baytown

State/Province

Texas

ZIP/Postal Code

77521

Country

United States

Facility Name

Research Site

City

Frisco

State/Province

Texas

ZIP/Postal Code

75034

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77043

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77083

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

Research Site

City

Kingwood

State/Province

Texas

ZIP/Postal Code

77339

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78212

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78251

Country

United States

Facility Name

Research Site

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Research Site

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22030

Country

United States

Facility Name

Research Site

City

Greenfield

State/Province

Wisconsin

ZIP/Postal Code

53228

Country

United States

Facility Name

Research Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Research Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Research Site

City

Sherwood Park

State/Province

Alberta

ZIP/Postal Code

T8L 0N2

Country

Canada

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Research Site

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 2J5

Country

Canada

Facility Name

Research Site

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1Z 0M1

Country

Canada

Facility Name

Research Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

Research Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 1V2

Country

Canada

Facility Name

Research Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5A 3V4

Country

Canada

Facility Name

Research Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G 6C6

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4V 1R2

Country

Canada

Facility Name

Research Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Research Site

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1V 4W2

Country

Canada

Facility Name

Research Site

City

St Charles Borromee

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

Country

Canada

Facility Name

Research Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1G 3Y8

Country

Canada

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7500698

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7750495

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7980378

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8380453

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8910131

Country

Chile

Facility Name

Research Site

City

Talcahuano

ZIP/Postal Code

4270918

Country

Chile

Facility Name

Research Site

City

Brandys nad Labem

ZIP/Postal Code

250 01

Country

Czechia

Facility Name

Research Site

City

Jindrichuv Hradec

ZIP/Postal Code

377 01

Country

Czechia

Facility Name

Research Site

City

Praha 10 - Strasnice

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Research Site

City

Praha

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Research Site

City

Rokycany

ZIP/Postal Code

337 22

Country

Czechia

Facility Name

Research Site

City

Teplice

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Research Site

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Research Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Research Site

City

Legnago

ZIP/Postal Code

37045

Country

Italy

Facility Name

Research Site

City

Messina

ZIP/Postal Code

98124

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Research Site

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Research Site

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Research Site

City

Salerno

ZIP/Postal Code

84131

Country

Italy

Facility Name

Research Site

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

Research Site

City

Asahi-shi

ZIP/Postal Code

289-2511

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Research Site

City

Fukui-shi

ZIP/Postal Code

910-8526

Country

Japan

Facility Name

Research Site

City

Fukushima-shi

ZIP/Postal Code

960-1295

Country

Japan

Facility Name

Research Site

City

Habikino-shi

ZIP/Postal Code

583-8588

Country

Japan

Facility Name

Research Site

City

Himeji-shi

ZIP/Postal Code

672-8064

Country

Japan

Facility Name

Research Site

City

Hiroshima-shi

ZIP/Postal Code

732-0052

Country

Japan

Facility Name

Research Site

City

Itabashi-ku

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Research Site

City

Izumo-shi

ZIP/Postal Code

693-8501

Country

Japan

Facility Name

Research Site

City

Kagoshima-shi

ZIP/Postal Code

890-0064

Country

Japan

Facility Name

Research Site

City

Kanazawa

ZIP/Postal Code

920-8641

Country

Japan

Facility Name

Research Site

City

Kanuma-shi

ZIP/Postal Code

322-0036

Country

Japan

Facility Name

Research Site

City

Kasuga-shi

ZIP/Postal Code

816-0813

Country

Japan

Facility Name

Research Site

City

Kishiwada-shi

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

Research Site

City

Kobe-shi

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

Research Site

City

Kobe-shi

ZIP/Postal Code

653-0013

Country

Japan

Facility Name

Research Site

City

Kochi-shi

ZIP/Postal Code

780-8077

Country

Japan

Facility Name

Research Site

City

Maebashi-shi

ZIP/Postal Code

371-8511

Country

Japan

Facility Name

Research Site

City

Matsue-shi

ZIP/Postal Code

690-8556

Country

Japan

Facility Name

Research Site

City

Matsusaka-shi

ZIP/Postal Code

515-8544

Country

Japan

Facility Name

Research Site

City

Meguro-ku

ZIP/Postal Code

153-8515

Country

Japan

Facility Name

Research Site

City

Minato-ku

ZIP/Postal Code

108-8642

Country

Japan

Facility Name

Research Site

City

Morioka-shi

ZIP/Postal Code

020-8505

Country

Japan

Facility Name

Research Site

City

Nagasaki-shi

ZIP/Postal Code

852-8501

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

467-0001

Country

Japan

Facility Name

Research Site

City

Nishinomiya-shi

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

Research Site

City

Sagamihara-shi

ZIP/Postal Code

228-0815

Country

Japan

Facility Name

Research Site

City

Sakaide-shi

ZIP/Postal Code

762-8550

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

064-0807

Country

Japan

Facility Name

Research Site

City

Sasebo-shi

ZIP/Postal Code

857-8511

Country

Japan

Facility Name

Research Site

City

Seto-shi

ZIP/Postal Code

489-8642

Country

Japan

Facility Name

Research Site

City

Shibuya-ku

ZIP/Postal Code

150-0013

Country

Japan

Facility Name

Research Site

City

Shinagawa-ku

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

162-8655

Country

Japan

Facility Name

Research Site

City

Sumida-ku

ZIP/Postal Code

130-8587

Country

Japan

Facility Name

Research Site

City

Takamatsu-shi

ZIP/Postal Code

760-0018

Country

Japan

Facility Name

Research Site

City

Toshima-ku

ZIP/Postal Code

171-0014

Country

Japan

Facility Name

Research Site

City

Touon-shi

ZIP/Postal Code

791-0281

Country

Japan

Facility Name

Research Site

City

Toyama-shi

ZIP/Postal Code

930-0859

Country

Japan

Facility Name

Research Site

City

Tsu-shi

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

Research Site

City

Tsukubo-gun

ZIP/Postal Code

701-0304

Country

Japan

Facility Name

Research Site

City

Uozu-shi

ZIP/Postal Code

937-0042

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

227-8501

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

232-0024

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

232-0066

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

236-0051

Country

Japan

Facility Name

Research Site

City

Guadalajara

ZIP/Postal Code

44100

Country

Mexico

Facility Name

Research Site

City

Mexico

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

66465

Country

Mexico

Facility Name

Research Site

City

Villahermosa

ZIP/Postal Code

86035

Country

Mexico

Facility Name

Research Site

City

Caloocan City

ZIP/Postal Code

1400

Country

Philippines

Facility Name

Research Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Research Site

City

Lipa City

Country

Philippines

Facility Name

Research Site

City

Pasig City

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Research Site

City

Quezon City

ZIP/Postal Code

1101

Country

Philippines

Facility Name

Research Site

City

Quezon City

ZIP/Postal Code

1109

Country

Philippines

Facility Name

Research Site

City

San Fernando

ZIP/Postal Code

2000

Country

Philippines

Facility Name

Research Site

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620039

Country

Russian Federation

Facility Name

Research Site

City

Izhevsk

ZIP/Postal Code

426035

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115682

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

127473

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

ZIP/Postal Code

630008

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

ZIP/Postal Code

630084

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

ZIP/Postal Code

630117

Country

Russian Federation

Facility Name

Research Site

City

Omsk

ZIP/Postal Code

644043

Country

Russian Federation

Facility Name

Research Site

City

Perm

ZIP/Postal Code

614000

Country

Russian Federation

Facility Name

Research Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Research Site

City

Pyatigorsk

ZIP/Postal Code

357538

Country

Russian Federation

Facility Name

Research Site

City

Saint - Petersburg

ZIP/Postal Code

196211

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

196601

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

Ulyanovsk

ZIP/Postal Code

432009

Country

Russian Federation

Facility Name

Research Site

City

Vladikavkaz

ZIP/Postal Code

362007

Country

Russian Federation

Facility Name

Research Site

City

Volgograd

ZIP/Postal Code

400001

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

ZIP/Postal Code

150002

Country

Russian Federation

Facility Name

Research Site

City

Boksburg North

ZIP/Postal Code

1460

Country

South Africa

Facility Name

Research Site

City

Durban

ZIP/Postal Code

4092

Country

South Africa

Facility Name

Research Site

City

Mount Edgecombe

ZIP/Postal Code

4302

Country

South Africa

Facility Name

Research Site

City

Mowbray

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Research Site

City

Port Elizabeth

ZIP/Postal Code

6001

Country

South Africa

Facility Name

Research Site

City

Stanger

ZIP/Postal Code

4450

Country

South Africa

Facility Name

Research Site

City

Kaohsiung Hsien

ZIP/Postal Code

TAIWAN

Country

Taiwan

Facility Name

Research Site

City

Keelung

Country

Taiwan

Facility Name

Research Site

City

New-Taipei

ZIP/Postal Code

22056

Country

Taiwan

Facility Name

Research Site

City

Cherkasy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

Research Site

City

Dnipropetrovsk

ZIP/Postal Code

49051

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivsk

ZIP/Postal Code

76012

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61035

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61075

Country

Ukraine

Facility Name

Research Site

City

Kremenchuk

ZIP/Postal Code

39617

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Research Site

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Research Site

City

Odesa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Research Site

City

Sumy

ZIP/Postal Code

40000

Country

Ukraine

Facility Name

Research Site

City

Sumy

ZIP/Postal Code

40022

Country

Ukraine

Facility Name

Research Site

City

Uzhgorod

ZIP/Postal Code

88009

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69068

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69114

Country

Ukraine

Facility Name

Research Site

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Research Site

City

Chertsey

ZIP/Postal Code

KT16 0PZ

Country

United Kingdom

Facility Name

Research Site

City

Glasgow

ZIP/Postal Code

G12 OYN

Country

United Kingdom

Facility Name

Research Site

City

Leicester

ZIP/Postal Code

LE3 9QP

Country

United Kingdom

Facility Name

Research Site

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M23 9QZ

Country

United Kingdom

Facility Name

Research Site

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Research Site

City

Sidcup

ZIP/Postal Code

DA14 6LT

Country

United Kingdom

Facility Name

Research Site

City

Wishaw

ZIP/Postal Code

ML2 0DP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

This is commercially sensitive information.

Citations:

PubMed Identifier

31315668

Citation

Gottlow M, Svensson DJ, Lipkovich I, Huhn M, Bowen K, Wessman P, Colice G. Application of structured statistical analyses to identify a biomarker predictive of enhanced tralokinumab efficacy in phase III clinical trials for severe, uncontrolled asthma. BMC Pulm Med. 2019 Jul 17;19(1):129. doi: 10.1186/s12890-019-0889-4.

Results Reference

derived

PubMed Identifier

30649752

Citation

Carlsson M, Braddock M, Li Y, Wang J, Xu W, White N, Megally A, Hunter G, Colice G. Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma. Drug Saf. 2019 Jun;42(6):769-784. doi: 10.1007/s40264-018-00788-w.

Results Reference

derived

PubMed Identifier

29792288

Citation

Panettieri RA Jr, Sjobring U, Peterffy A, Wessman P, Bowen K, Piper E, Colice G, Brightling CE. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med. 2018 Jul;6(7):511-525. doi: 10.1016/S2213-2600(18)30184-X. Epub 2018 May 20.

Results Reference

derived

PubMed Identifier

29536781

Citation

Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.

Results Reference

derived

Learn more about this trial

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

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A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma (STRATOS2)

Uncontrolled Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial