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A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma (STRATOS1)

Primary Purpose

Uncontrolled Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tralokinumab

Placebo

About this trial

This is an interventional treatment trial for Uncontrolled Asthma focused on measuring Asthma, Reactive Airways, Respiratory Tract Disease, Obstructive Lung Disease, Lung Diseases

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 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Tralokinumab Dose Regimen 1

Placebo Dose Regimen 1

Tralokinumab Dose Regimen 2

Placebo Dose Regimen 2

Arm Description

Tralokinumab subcutaneous injection

Placebo subcutaneous injection

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 Study 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.

Number of Patients Positive for Anti-drug Antibodies (ADAs)

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'.

Full Information

NCT ID

NCT02161757

First Posted

June 5, 2014

Last Updated

July 30, 2018

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02161757

Brief Title

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

Acronym

STRATOS1

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

July 2018

Overall Recruitment Status

Completed

Study Start Date

June 13, 2014 (Actual)

Primary Completion Date

February 28, 2017 (Actual)

Study Completion Date

July 18, 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 1140 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

Keywords

Asthma, Reactive Airways, Respiratory Tract Disease, Obstructive Lung Disease, Lung Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tralokinumab Dose Regimen 1

Arm Type

Experimental

Arm Description

Tralokinumab subcutaneous injection

Arm Title

Placebo Dose Regimen 1

Arm Type

Placebo Comparator

Arm Description

Placebo subcutaneous injection

Arm Title

Tralokinumab Dose Regimen 2

Arm Type

Experimental

Arm Description

Tralokinumab subcutaneous injection

Arm Title

Placebo Dose Regimen 2

Arm Type

Placebo Comparator

Arm Description

Placebo subcutaneous injection

Intervention Type

Biological

Intervention Name(s)

Tralokinumab

Intervention Description

Subcutaneous injection

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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 Study Period up to Week 72

Description

Time Frame

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)

Title

Number of Patients Positive for Anti-drug Antibodies (ADAs)

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

Reynold A Panettieri, M.D.

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Research Site

City

Arcadia

State/Province

California

ZIP/Postal Code

91007

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Research Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Research Site

City

Poway

State/Province

California

ZIP/Postal Code

92064

Country

United States

Facility Name

Research Site

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Research Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Research Site

City

Wildomar

State/Province

California

ZIP/Postal Code

92595

Country

United States

Facility Name

Research Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80246

Country

United States

Facility Name

Research Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Facility Name

Research Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Research Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Research Site

City

Cutler Bay

State/Province

Florida

ZIP/Postal Code

33189

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United States

Facility Name

Research Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

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United States

Facility Name

Research Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Research Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33013

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United States

Facility Name

Research Site

City

Homestead

State/Province

Florida

ZIP/Postal Code

33030

Country

United States

Facility Name

Research Site

City

Homestead

State/Province

Florida

ZIP/Postal Code

33130

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32277

Country

United States

Facility Name

Research Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

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

33135

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

33145

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

33166

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Research Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Research Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33029

Country

United States

Facility Name

Research Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Research Site

City

Albany

State/Province

Georgia

ZIP/Postal Code

31707

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Research Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Research Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Research Site

City

Twin Falls

State/Province

Idaho

ZIP/Postal Code

83301

Country

United States

Facility Name

Research Site

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Facility Name

Research Site

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46617

Country

United States

Facility Name

Research Site

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Research Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Research Site

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

2301

Country

United States

Facility Name

Research Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Research Site

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Facility Name

Research Site

City

Flint

State/Province

Michigan

ZIP/Postal Code

48504

Country

United States

Facility Name

Research Site

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

Research Site

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63143

Country

United States

Facility Name

Research Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89123

Country

United States

Facility Name

Research Site

City

Union

State/Province

New Jersey

ZIP/Postal Code

07083

Country

United States

Facility Name

Research Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11229

Country

United States

Facility Name

Research Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Research Site

City

Cornelius

State/Province

North Carolina

ZIP/Postal Code

28031

Country

United States

Facility Name

Research Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

Facility Name

Research Site

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43235

Country

United States

Facility Name

Research Site

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Research Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43617

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73131

Country

United States

Facility Name

Research Site

City

Monroeville

State/Province

Pennsylvania

ZIP/Postal Code

15146

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19115

Country

United States

Facility Name

Research Site

City

Scottdale

State/Province

Pennsylvania

ZIP/Postal Code

15683

Country

United States

Facility Name

Research Site

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15683

Country

United States

Facility Name

Research Site

City

Johnston

State/Province

Rhode Island

ZIP/Postal Code

02919

Country

United States

Facility Name

Research Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02908

Country

United States

Facility Name

Research Site

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Research Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Research Site

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29588

Country

United States

Facility Name

Research Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Research Site

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Research Site

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75225

Country

United States

Facility Name

Research Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Research Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76109

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

77084

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Research Site

City

Lampasas

State/Province

Texas

ZIP/Postal Code

76550

Country

United States

Facility Name

Research Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Research Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Research Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Research Site

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Research Site

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Research Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22203

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23225

Country

United States

Facility Name

Research Site

City

Richland

State/Province

Washington

ZIP/Postal Code

99352

Country

United States

Facility Name

Research Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Research Site

City

Cap. Fed

ZIP/Postal Code

1280

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonomade Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Research Site

City

Concepción del Uruguay

ZIP/Postal Code

3260

Country

Argentina

Facility Name

Research Site

City

Córdoba

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

Research Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Research Site

City

Mendoza

ZIP/Postal Code

M5500GIP

Country

Argentina

Facility Name

Research Site

City

Quilmes

ZIP/Postal Code

B1878FNR

Country

Argentina

Facility Name

Research Site

City

Rosario

ZIP/Postal Code

S2000DEJ

Country

Argentina

Facility Name

Research Site

City

San Miguel de Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Research Site

City

Brussels (Anderlecht)

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Research Site

City

Erpent

ZIP/Postal Code

5101

Country

Belgium

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Research Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Research Site

City

Dupnitsa

ZIP/Postal Code

2600

Country

Bulgaria

Facility Name

Research Site

City

Kozloduy

ZIP/Postal Code

3320

Country

Bulgaria

Facility Name

Research Site

City

Pazardzhik

ZIP/Postal Code

4400

Country

Bulgaria

Facility Name

Research Site

City

Pernik

ZIP/Postal Code

2307

Country

Bulgaria

Facility Name

Research Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Research Site

City

Sliven

ZIP/Postal Code

8800

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1202

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1618

Country

Bulgaria

Facility Name

Research Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Research Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Research Site

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Research Site

City

Vratsa

ZIP/Postal Code

3000

Country

Bulgaria

Facility Name

Research Site

City

Yambol

ZIP/Postal Code

8600

Country

Bulgaria

Facility Name

Research Site

City

Armenia

ZIP/Postal Code

630004

Country

Colombia

Facility Name

Research Site

City

Bogotá

ZIP/Postal Code

110311

Country

Colombia

Facility Name

Research Site

City

Bogotá

Country

Colombia

Facility Name

Research Site

City

Cali

ZIP/Postal Code

76001000

Country

Colombia

Facility Name

Research Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Research Site

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Facility Name

Research Site

City

Bad Lippspringe

ZIP/Postal Code

33175

Country

Germany

Facility Name

Research Site

City

Geesthacht

ZIP/Postal Code

21502

Country

Germany

Facility Name

Research Site

City

Herford

ZIP/Postal Code

32049

Country

Germany

Facility Name

Research Site

City

Landsberg

ZIP/Postal Code

86899

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04357

Country

Germany

Facility Name

Research Site

City

München-Pasing

ZIP/Postal Code

81241

Country

Germany

Facility Name

Research Site

City

Reinfeld

ZIP/Postal Code

23858

Country

Germany

Facility Name

Research Site

City

Rodgau-Dudenhofen

ZIP/Postal Code

63110

Country

Germany

Facility Name

Research Site

City

Warendorf

ZIP/Postal Code

48231

Country

Germany

Facility Name

Research Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Research Site

City

Edelény

ZIP/Postal Code

3780

Country

Hungary

Facility Name

Research Site

City

Farkasgyepü

ZIP/Postal Code

8582

Country

Hungary

Facility Name

Research Site

City

Komárom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Research Site

City

Létavértes

ZIP/Postal Code

4281

Country

Hungary

Facility Name

Research Site

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Research Site

City

Pécs

ZIP/Postal Code

7626

Country

Hungary

Facility Name

Research Site

City

Pécs

ZIP/Postal Code

7635

Country

Hungary

Facility Name

Research Site

City

Százhalombatta

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Research Site

City

Bucheon-si

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

Research Site

City

Cheongju-si

ZIP/Postal Code

362-804

Country

Korea, Republic of

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

42415

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Research Site

City

Jeju-si

ZIP/Postal Code

63241

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

02559

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

150-713

Country

Korea, Republic of

Facility Name

Research Site

City

Suwon-si

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Research Site

City

Cusco

ZIP/Postal Code

CUSCO 01

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

L27

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 1

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 21

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 29

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 32

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 33

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 41

Country

Peru

Facility Name

Research Site

City

Bydgoszcz

ZIP/Postal Code

85-079

Country

Poland

Facility Name

Research Site

City

Będzin

ZIP/Postal Code

42-500

Country

Poland

Facility Name

Research Site

City

Chorzów

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Research Site

City

Gdańsk

ZIP/Postal Code

80-405

Country

Poland

Facility Name

Research Site

City

Gdańsk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

Research Site

City

Grudziądz

ZIP/Postal Code

86-300

Country

Poland

Facility Name

Research Site

City

Kielce

ZIP/Postal Code

25-734

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

31-209

Country

Poland

Facility Name

Research Site

City

Lubin

ZIP/Postal Code

59-300

Country

Poland

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-363

Country

Poland

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-468

Country

Poland

Facility Name

Research Site

City

Mrozy

ZIP/Postal Code

05-320

Country

Poland

Facility Name

Research Site

City

Olsztyn

ZIP/Postal Code

10-357

Country

Poland

Facility Name

Research Site

City

Ostrowiec Świętokrzyski

ZIP/Postal Code

27-400

Country

Poland

Facility Name

Research Site

City

Ostrów Wielkopolski

ZIP/Postal Code

63-400

Country

Poland

Facility Name

Research Site

City

Oświęcim

ZIP/Postal Code

32-600

Country

Poland

Facility Name

Research Site

City

Puławy

ZIP/Postal Code

24-100

Country

Poland

Facility Name

Research Site

City

Racibórz

ZIP/Postal Code

47-400

Country

Poland

Facility Name

Research Site

City

Skierniewice

ZIP/Postal Code

96-100

Country

Poland

Facility Name

Research Site

City

Staszów

ZIP/Postal Code

28-200

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

01-138

Country

Poland

Facility Name

Research Site

City

Wieluń

ZIP/Postal Code

98-300

Country

Poland

Facility Name

Research Site

City

Wołomin

ZIP/Postal Code

05-200

Country

Poland

Facility Name

Research Site

City

Wrocław

ZIP/Postal Code

50-220

Country

Poland

Facility Name

Research Site

City

Wrocław

ZIP/Postal Code

51-162

Country

Poland

Facility Name

Research Site

City

Zamość

ZIP/Postal Code

22-400

Country

Poland

Facility Name

Research Site

City

Zgierz

ZIP/Postal Code

95-100

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Research Site

City

Humenne

ZIP/Postal Code

066 01

Country

Slovakia

Facility Name

Research Site

City

Kezmarok

ZIP/Postal Code

060 01

Country

Slovakia

Facility Name

Research Site

City

Presov

ZIP/Postal Code

08001

Country

Slovakia

Facility Name

Research Site

City

Sabinov

Country

Slovakia

Facility Name

Research Site

City

Topolcany

ZIP/Postal Code

955 01

Country

Slovakia

Facility Name

Research Site

City

Alicante

ZIP/Postal Code

03004

Country

Spain

Facility Name

Research Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Research Site

City

Hospitalet de Llobregat(Barcel

ZIP/Postal Code

08907

Country

Spain

Facility Name

Research Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46015

Country

Spain

Facility Name

Research Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung

Country

Taiwan

Facility Name

Research Site

City

New-Taipei

ZIP/Postal Code

22056

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

235

Country

Taiwan

Facility Name

Research Site

City

Yilan

ZIP/Postal Code

260

Country

Taiwan

Facility Name

Research Site

City

Chernivtsi

ZIP/Postal Code

58000

Country

Ukraine

Facility Name

Research Site

City

Chernivtsi

ZIP/Postal Code

58001

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivsk

ZIP/Postal Code

76012

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61002

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61058

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61093

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

02125

Country

Ukraine

Facility Name

Research Site

City

Lutsk

ZIP/Postal Code

43000

Country

Ukraine

Facility Name

Research Site

City

Lviv

ZIP/Postal Code

79066

Country

Ukraine

Facility Name

Research Site

City

Odesa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Research Site

City

Vinnytsia

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69063

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69065

Country

Ukraine

Facility Name

Research Site

City

Can Tho

ZIP/Postal Code

900000

Country

Vietnam

Facility Name

Research Site

City

Ha Noi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Research Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Research Site

City

Ho Chi Minh

ZIP/Postal Code

700000

Country

Vietnam

Facility Name

Research Site

City

Hochiminh

Country

Vietnam

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 (STRATOS1)

Uncontrolled Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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