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Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dupilumab

Placebo

Inhaled corticosteroid (ICS) therapy

Albuterol/Salbutamol

Levalbuterol/Levosalbutamol

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

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

Inclusion criteria:

-Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:

a) Existing treatment with medium to high dose ICS (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to Visit 1.

i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be ≥100 mcg of fluticasone propionate twice daily or equivalent).

ii) Participants requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to Visit 1.

Exclusion criteria:

Participants <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who are ≥18 years of age).
Weight is less than 30 kilograms.
Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care.
Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) available within 3 months prior to screening to exclude participants with suspected active or untreated latent tuberculosis.
Current smoker or cessation of smoking within 6 months prior to Visit 1.
Previous smoker with a smoking history >10 pack-years.
Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo (for Dupilumab 200 mg) q2w

Dupilumab 200 mg q2w

Placebo (for Dupilumab 300 mg) q2w

Dupilumab 300 mg q2w

Arm Description

2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.

2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.

2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.

2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines . Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.

Outcomes

Primary Outcome Measures

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population

A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.

Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Secondary Outcome Measures

Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L

Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L

Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline

Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population

The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.

Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L

Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population

The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.

Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population

A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations (resulted hospitalization or emergency room visit) that occurred during the treatment period divided by the total number of participant-years treated.

Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.

Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters.

Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF25-75% is defined as the mean forced expiratory flow between the 25% and 75% of the FVC.

Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population

LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.

Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population

The time to first severe exacerbation was defined as follows: date of the first event - randomization date +1. For participants who had no event on or before Visit 18 (Week 52) or last contact date, the time was censored at the date of Visit 18 or the last contact date, whichever was earlier. The median time to first severe exacerbation was not estimated; therefore, the probability of severe exacerbation at Weeks 12, 24, 36, and 52, are presented as the descriptive statistics.

Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population

The time to first LOAC event was defined as follows: date of the first event - first dose date +1. For participants who had no event on or before last dose date + 14 days or last contact date, the time was censored at the last dose date + 14 days or the last contact date, whichever was earlier.

Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population

Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

The ACQ-7 has 7 questions, the first 5 questions assess the most common asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze plus short-acting bronchodilator use, and FEV1 (pre-bronchodilator % predicted). Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). Clinic staff scored the FEV1% predicted on a 7-point scale. The questions were equally weighted and the ACQ-7 total score was mean of the scores of all 7 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.

Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0= No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.

Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.

Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.

Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded daily by the participants in an electronic diary/peak expiratory flow (PEF) meter. In the case that Nebulizer solutions were used as an alternative delivery method, the nebulizer dose was converted to number of puffs as per following conversion factor: salbutamol/albuterol nebulizer solution (2.5 mg) corresponds to 4 puffs.

Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population

Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population

EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population

The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. The anxiety/depression score is the sum of the scores of the 7 related items; one can score between 0 and 21 for either anxiety or depression. And the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains.

Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis

The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.

Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis

RQLQ(S)+12 is a self-administered questionnaire with standardized activities developed to measure health-related quality of life signs and symptoms that are most problematic in those 12 to 75 years of age, as a result of perennial or seasonal allergic rhinitis. There are 28 items on RQLQ(S) in 7 domains: activities (3 items), sleep (3 items), non-nose/eye symptoms (7 items), practical problems (3 items), nasal symptoms (4 items), eye symptoms (4 items) and emotional (4 items). RQLQ(S)+12 responses are based on 7-point likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Individual items within RQLQ(S)+12 are equally weighted. The overall score is calculated as the mean score of all items. Higher scores indicated more health-related quality of life impairment (lower scores better).

Full Information

NCT ID

NCT02414854

First Posted

April 8, 2015

Last Updated

October 19, 2018

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02414854

Brief Title

Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)

Official Title

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

April 27, 2015 (undefined)

Primary Completion Date

July 29, 2017 (Actual)

Study Completion Date

November 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary Objective: To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma. Secondary Objectives: To evaluate the safety and tolerability of dupilumab. To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life. To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.

Detailed Description

The total duration of study period for each participant is 67 to 69 weeks, including a screening period of 3 to 5 weeks, treatment period of 52 weeks, and post-treatment follow-up period of 12 weeks.

6. Conditions and Keywords

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

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1902 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo (for Dupilumab 200 mg) q2w

Arm Type

Placebo Comparator

Arm Description

Arm Title

Dupilumab 200 mg q2w

Arm Type

Experimental

Arm Description

Arm Title

Placebo (for Dupilumab 300 mg) q2w

Arm Type

Placebo Comparator

Arm Description

Arm Title

Dupilumab 300 mg q2w

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

SAR231893, REGN668

Intervention Description

Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

Intervention Type

Drug

Intervention Name(s)

Inhaled corticosteroid (ICS) therapy

Intervention Description

Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)

Intervention Type

Drug

Intervention Name(s)

Albuterol/Salbutamol

Intervention Description

Oral inhalation as needed

Intervention Type

Drug

Intervention Name(s)

Levalbuterol/Levosalbutamol

Intervention Description

Oral inhalation as needed

Primary Outcome Measure Information:

Title

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population

Description

Time Frame

Baseline to Week 52

Title

Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Week 12

Title

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L

Description

Time Frame

Baseline to Week 52

Title

Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Week 12

Title

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L

Description

Time Frame

Baseline to Week 52

Title

Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Week 12

Title

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L

Description

Time Frame

Baseline to Week 52

Title

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline

Description

Time Frame

Baseline to Week 52

Title

Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population

Description

Time Frame

Baseline, Week 24

Title

Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population

Description

A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations (resulted hospitalization or emergency room visit) that occurred during the treatment period divided by the total number of participant-years treated.

Time Frame

Baseline to Week 52

Title

Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Week 12

Title

Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Weeks 2, 4, 8, 24, 36, and 52

Title

Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Weeks 2, 4, 8, 24, 36, and 52

Title

Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52

Title

Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52

Title

Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52

Title

Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52

Title

Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Description

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52

Title

Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population

Description

Time Frame

Baseline to Week 52

Title

Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population

Description

Time Frame

Baseline up to Week 52

Title

Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population

Description

Time Frame

Baseline up to Week 52

Title

Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 36, and 52

Title

Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52

Title

Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52

Title

Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52

Title

Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Description

Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52

Title

Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52

Title

Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 12, 36, and 52

Title

Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 12, 24, 36, and 52

Title

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population

Description

Time Frame

Baseline, Weeks 12, 24, 36, and 52

Title

Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis

Description

Time Frame

Baseline, Weeks 12, 24, 36, and 52

Title

Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis

Description

Time Frame

Baseline, Weeks 12, 24, 36, and 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: -Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria: a) Existing treatment with medium to high dose ICS (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to Visit 1. i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be ≥100 mcg of fluticasone propionate twice daily or equivalent). ii) Participants requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to Visit 1. Exclusion criteria: Participants <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who are ≥18 years of age). Weight is less than 30 kilograms. Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function. A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit). Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care. Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) available within 3 months prior to screening to exclude participants with suspected active or untreated latent tuberculosis. Current smoker or cessation of smoking within 6 months prior to Visit 1. Previous smoker with a smoking history >10 pack-years. Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840047

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Investigational Site Number 840056

City

Flagstaff

State/Province

Arizona

ZIP/Postal Code

86001

Country

United States

Facility Name

Investigational Site Number 840099

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Investigational Site Number 840087

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Investigational Site Number 840132

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72209

Country

United States

Facility Name

Investigational Site Number 840109

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Investigational Site Number 840052

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Investigational Site Number 840116

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Investigational Site Number 840045

City

Long Beach

State/Province

California

ZIP/Postal Code

90720

Country

United States

Facility Name

Investigational Site Number 840011

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Investigational Site Number 840061

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Investigational Site Number 840097

City

Los Angeles

State/Province

California

ZIP/Postal Code

90064

Country

United States

Facility Name

Investigational Site Number 840019

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Investigational Site Number 840125

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Investigational Site Number 840041

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

Investigational Site Number 840036

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

Facility Name

Investigational Site Number 840020

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Investigational Site Number 840074

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Investigational Site Number 840021

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Investigational Site Number 840004

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Investigational Site Number 840025

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Investigational Site Number 840034

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Investigational Site Number 840130

City

Denver

State/Province

Colorado

ZIP/Postal Code

80246

Country

United States

Facility Name

Investigational Site Number 840102

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06504

Country

United States

Facility Name

Investigational Site Number 840037

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Investigational Site Number 840018

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33472

Country

United States

Facility Name

Investigational Site Number 840105

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Investigational Site Number 840092

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Investigational Site Number 840122

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Investigational Site Number 840053

City

Loxahatchee Groves

State/Province

Florida

ZIP/Postal Code

33470

Country

United States

Facility Name

Investigational Site Number 840069

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Investigational Site Number 840123

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Investigational Site Number 840071

City

Ocala

State/Province

Florida

ZIP/Postal Code

34474

Country

United States

Facility Name

Investigational Site Number 840115

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Investigational Site Number 840055

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Investigational Site Number 840114

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Investigational Site Number 840048

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Investigational Site Number 840084

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30506

Country

United States

Facility Name

Investigational Site Number 840044

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Investigational Site Number 840079

City

Twin Falls

State/Province

Idaho

ZIP/Postal Code

83301

Country

United States

Facility Name

Investigational Site Number 840101

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Investigational Site Number 840015

City

River Forest

State/Province

Illinois

ZIP/Postal Code

60305

Country

United States

Facility Name

Investigational Site Number 840089

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Investigational Site Number 840032

City

Fort Mitchell

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

Investigational Site Number 840009

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

Investigational Site Number 840064

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Investigational Site Number 840080

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Investigational Site Number 840017

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Investigational Site Number 840073

City

Gaithersburg

State/Province

Maryland

ZIP/Postal Code

20878

Country

United States

Facility Name

Investigational Site Number 840127

City

White Marsh

State/Province

Maryland

ZIP/Postal Code

21162

Country

United States

Facility Name

Investigational Site Number 840014

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Investigational Site Number 840005

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Investigational Site Number 840013

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Investigational Site Number 840002

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Investigational Site Number 840093

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Investigational Site Number 840026

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

Investigational Site Number 840078

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Investigational Site Number 840003

City

Papillion

State/Province

Nebraska

ZIP/Postal Code

27103

Country

United States

Facility Name

Investigational Site Number 840111

City

Brick

State/Province

New Jersey

ZIP/Postal Code

08723

Country

United States

Facility Name

Investigational Site Number 840068

City

Ocean City

State/Province

New Jersey

ZIP/Postal Code

07712

Country

United States

Facility Name

Investigational Site Number 840016

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

Investigational Site Number 840096

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08775

Country

United States

Facility Name

Investigational Site Number 840031

City

Bronx

State/Province

New York

ZIP/Postal Code

10457

Country

United States

Facility Name

Investigational Site Number 840106

City

Jamaica

State/Province

New York

ZIP/Postal Code

11435

Country

United States

Facility Name

Investigational Site Number 840065

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Investigational Site Number 840076

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Investigational Site Number 840126

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28226

Country

United States

Facility Name

Investigational Site Number 840083

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Investigational Site Number 840108

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Investigational Site Number 840107

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27403

Country

United States

Facility Name

Investigational Site Number 840007

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Investigational Site Number 840046

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45241

Country

United States

Facility Name

Investigational Site Number 840049

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Investigational Site Number 840042

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43617

Country

United States

Facility Name

Investigational Site Number 840112

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Investigational Site Number 840121

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Investigational Site Number 840104

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Investigational Site Number 840040

City

Clackamas

State/Province

Oregon

ZIP/Postal Code

97015

Country

United States

Facility Name

Investigational Site Number 840039

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Investigational Site Number 840001

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

Investigational Site Number 840085

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Investigational Site Number 840081

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102

Country

United States

Facility Name

Investigational Site Number 840010

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Investigational Site Number 840067

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Investigational Site Number 840028

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Investigational Site Number 840091

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Investigational Site Number 840029

City

Lincoln

State/Province

Rhode Island

ZIP/Postal Code

02286

Country

United States

Facility Name

Investigational Site Number 840082

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Investigational Site Number 840117

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Investigational Site Number 840100

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Investigational Site Number 840054

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Investigational Site Number 840062

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Investigational Site Number 840098

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

Investigational Site Number 840038

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Investigational Site Number 840124

City

Cypress

State/Province

Texas

ZIP/Postal Code

77429

Country

United States

Facility Name

Investigational Site Number 840008

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Investigational Site Number 840094

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Investigational Site Number 840023

City

El Paso

State/Province

Texas

ZIP/Postal Code

79903

Country

United States

Facility Name

Investigational Site Number 840022

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76109

Country

United States

Facility Name

Investigational Site Number 840027

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76244

Country

United States

Facility Name

Investigational Site Number 840066

City

Killeen

State/Province

Texas

ZIP/Postal Code

76542

Country

United States

Facility Name

Investigational Site Number 840050

City

Live Oak

State/Province

Texas

ZIP/Postal Code

78233

Country

United States

Facility Name

Investigational Site Number 840070

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Investigational Site Number 840128

City

McKinney

State/Province

Texas

ZIP/Postal Code

75071

Country

United States

Facility Name

Investigational Site Number 840118

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Investigational Site Number 840012

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Investigational Site Number 840129

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78251

Country

United States

Facility Name

Investigational Site Number 840133

City

Sealy

State/Province

Texas

ZIP/Postal Code

77474

Country

United States

Facility Name

Investigational Site Number 840119

City

Spring

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

Investigational Site Number 840035

City

Draper

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

Facility Name

Investigational Site Number 840077

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Investigational Site Number 840057

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Investigational Site Number 840059

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22030

Country

United States

Facility Name

Investigational Site Number 840113

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Investigational Site Number 840051

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98225

Country

United States

Facility Name

Investigational Site Number 840043

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Investigational Site Number 032006

City

Bahia Blanca

ZIP/Postal Code

B8000JRB

Country

Argentina

Facility Name

Investigational Site Number 032002

City

Buenos Aires

ZIP/Postal Code

C1121ABE

Country

Argentina

Facility Name

Investigational Site Number 032011

City

Caba

ZIP/Postal Code

1120

Country

Argentina

Facility Name

Investigational Site Number 032007

City

Caba

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Investigational Site Number 032001

City

Caba

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Investigational Site Number 032003

City

Caba

ZIP/Postal Code

C1425FVH

Country

Argentina

Facility Name

Investigational Site Number 032010

City

Caba

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Investigational Site Number 032005

City

Capital Federal

ZIP/Postal Code

C1425DUC

Country

Argentina

Facility Name

Investigational Site Number 032008

City

La Plata

ZIP/Postal Code

B1900DXM

Country

Argentina

Facility Name

Investigational Site Number 032004

City

Rosario

ZIP/Postal Code

S2000JKR

Country

Argentina

Facility Name

Investigational Site Number 032012

City

San Miguel De Tucuman

ZIP/Postal Code

T4000CHE

Country

Argentina

Facility Name

Investigational Site Number 032009

City

San Miguel De Tucumán

ZIP/Postal Code

T4000IAR

Country

Argentina

Facility Name

Investigational Site Number 036005

City

Campbelltown

ZIP/Postal Code

2560

Country

Australia

Facility Name

Investigational Site Number 036001

City

Clayton

ZIP/Postal Code

3168

Country

Australia

Facility Name

Investigational Site Number 036002

City

Frankston

ZIP/Postal Code

3199

Country

Australia

Facility Name

Investigational Site Number 036006

City

Glen Osmond

ZIP/Postal Code

5064

Country

Australia

Facility Name

Investigational Site Number 036003

City

Murdoch

ZIP/Postal Code

6150

Country

Australia

Facility Name

Investigational Site Number 036004

City

Parkville

ZIP/Postal Code

3050

Country

Australia

Facility Name

Investigational Site Number 076009

City

Florianópolis

ZIP/Postal Code

88040-970

Country

Brazil

Facility Name

Investigational Site Number 076007

City

Porto Alegre

ZIP/Postal Code

90020-090

Country

Brazil

Facility Name

Investigational Site Number 076001

City

Porto Alegre

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Investigational Site Number 076003

City

Salvador

ZIP/Postal Code

41940-455

Country

Brazil

Facility Name

Investigational Site Number 076012

City

Sao Paulo

ZIP/Postal Code

04266-010

Country

Brazil

Facility Name

Investigational Site Number 076008

City

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Investigational Site Number 076006

City

Sao Paulo

ZIP/Postal Code

05437-010

Country

Brazil

Facility Name

Investigational Site Number 076002

City

Sorocaba

ZIP/Postal Code

18040-425

Country

Brazil

Facility Name

Investigational Site Number 076013

City

São Bernardo Do Campo

ZIP/Postal Code

09715-090

Country

Brazil

Facility Name

Investigational Site Number 124019

City

Burlington

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

Investigational Site Number 124009

City

Calgary

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Investigational Site Number 124003

City

Mississauga

ZIP/Postal Code

L5A 3V4

Country

Canada

Facility Name

Investigational Site Number 124001

City

Montreal

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

Investigational Site Number 124012

City

Montreal

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Investigational Site Number 124010

City

Montreal

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Investigational Site Number 124013

City

Ottawa

ZIP/Postal Code

K1G 6C6

Country

Canada

Facility Name

Investigational Site Number 124018

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Investigational Site Number 124014

City

Quebec

ZIP/Postal Code

G1V 4W2

Country

Canada

Facility Name

Investigational Site Number 124008

City

Sherbrooke

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Investigational Site Number 124015

City

Toronto

ZIP/Postal Code

M5G 1E2

Country

Canada

Facility Name

Investigational Site Number 124002

City

Toronto

ZIP/Postal Code

M5T 3A9

Country

Canada

Facility Name

Investigational Site Number 124007

City

Trois-Rivieres

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

Investigational Site Number 124006

City

Vancouver

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Investigational Site Number 152015

City

Concepción

ZIP/Postal Code

Country

Chile

Facility Name

Investigational Site Number 152003

City

Quillota

ZIP/Postal Code

2260877

Country

Chile

Facility Name

Investigational Site Number 152014

City

Santiago

ZIP/Postal Code

7500588

Country

Chile

Facility Name

Investigational Site Number 152001

City

Santiago

ZIP/Postal Code

7500692

Country

Chile

Facility Name

Investigational Site Number 152002

City

Santiago

ZIP/Postal Code

7500698

Country

Chile

Facility Name

Investigational Site Number 152008

City

Santiago

ZIP/Postal Code

7500710

Country

Chile

Facility Name

Investigational Site Number 152017

City

Santiago

ZIP/Postal Code

7560994

Country

Chile

Facility Name

Investigational Site Number 152007

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Investigational Site Number 152005

City

Santiago

ZIP/Postal Code

8380456

Country

Chile

Facility Name

Investigational Site Number 152009

City

Santiago

ZIP/Postal Code

8910131

Country

Chile

Facility Name

Investigational Site Number 152013

City

Talcahuano

ZIP/Postal Code

427918

Country

Chile

Facility Name

Investigational Site Number 152004

City

Talca

ZIP/Postal Code

3460001

Country

Chile

Facility Name

Investigational Site Number 152016

City

Temuco

ZIP/Postal Code

4781156

Country

Chile

Facility Name

Investigational Site Number 152010

City

Valdivia

Country

Chile

Facility Name

Investigational Site Number 152011

City

Viña Del Mar

ZIP/Postal Code

2520594

Country

Chile

Facility Name

Investigational Site Number 152012

City

Viña Del Mar

Country

Chile

Facility Name

Investigational Site Number 170006

City

Bogota

ZIP/Postal Code

110131

Country

Colombia

Facility Name

Investigational Site Number 170001

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Investigational Site Number 170002

City

Bogotá

ZIP/Postal Code

110231

Country

Colombia

Facility Name

Investigational Site Number 170003

City

Bogotá

ZIP/Postal Code

111321

Country

Colombia

Facility Name

Investigational Site Number 250002

City

Brest

ZIP/Postal Code

29609

Country

France

Facility Name

Investigational Site Number 250011

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Investigational Site Number 250013

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Investigational Site Number 250004

City

Lyon

ZIP/Postal Code

69317

Country

France

Facility Name

Investigational Site Number 250010

City

Marseille

ZIP/Postal Code

13015

Country

France

Facility Name

Investigational Site Number 250005

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Investigational Site Number 250003

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number 250012

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Investigational Site Number 250001

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

Investigational Site Number 250008

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Investigational Site Number 250014

City

Vandoeuvre-Les-Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Investigational Site Number 276006

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

Investigational Site Number 276003

City

Bochum

ZIP/Postal Code

44789

Country

Germany

Facility Name

Investigational Site Number 276010

City

Frankfurt Am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Investigational Site Number 276004

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Investigational Site Number 276009

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Investigational Site Number 276007

City

Lübeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Investigational Site Number 276001

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Investigational Site Number 276005

City

Rüdersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Investigational Site Number 348003

City

Gödöllö

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Investigational Site Number 380004

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

Investigational Site Number 380005

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Investigational Site Number 380003

City

Ferrara

ZIP/Postal Code

44124

Country

Italy

Facility Name

Investigational Site Number 380006

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Investigational Site Number 380010

City

Foggia

ZIP/Postal Code

71122

Country

Italy

Facility Name

Investigational Site Number 380002

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Investigational Site Number 380009

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Investigational Site Number 380001

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Investigational Site Number 380014

City

Reggio Emilia

ZIP/Postal Code

42123

Country

Italy

Facility Name

Investigational Site Number 380011

City

Torino

ZIP/Postal Code

10128

Country

Italy

Facility Name

Investigational Site Number 392185

City

Akashi-Shi

Country

Japan

Facility Name

Investigational Site Number 392128

City

Asahikawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392118

City

Chiyoda-Ku

Country

Japan

Facility Name

Investigational Site Number 392112

City

Chuo-Ku

Country

Japan

Facility Name

Investigational Site Number 392157

City

Fukui-Shi

Country

Japan

Facility Name

Investigational Site Number 392137

City

Fukuoka-Shi

Country

Japan

Facility Name

Investigational Site Number 392117

City

Fukuyama-Shi

Country

Japan

Facility Name

Investigational Site Number 392121

City

Habikino-Shi

Country

Japan

Facility Name

Investigational Site Number 392154

City

Higashiosaka-Shi

Country

Japan

Facility Name

Investigational Site Number 392109

City

Himeji-Shi

Country

Japan

Facility Name

Investigational Site Number 392108

City

Hiroshima-Shi

Country

Japan

Facility Name

Investigational Site Number 392158

City

Hiroshima-Shi

Country

Japan

Facility Name

Investigational Site Number 392107

City

Iizuka-Shi

Country

Japan

Facility Name

Investigational Site Number 392101

City

Isesaki-Shi

Country

Japan

Facility Name

Investigational Site Number 392147

City

Itabashi-Ku

Country

Japan

Facility Name

Investigational Site Number 392150

City

Kagoshima-Shi

Country

Japan

Facility Name

Investigational Site Number 392178

City

Kagoshima-Shi

Country

Japan

Facility Name

Investigational Site Number 392110

City

Kanazawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392136

City

Kanazawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392142

City

Kasuga-Shi

Country

Japan

Facility Name

Investigational Site Number 392166

City

Kawaguchi-Shi

Country

Japan

Facility Name

Investigational Site Number 392119

City

Kishiwada-Shi

Country

Japan

Facility Name

Investigational Site Number 392162

City

Kobe-Shi

Country

Japan

Facility Name

Investigational Site Number 392182

City

Kodaira-Shi

Country

Japan

Facility Name

Investigational Site Number 392174

City

Kokubunji-Shi

Country

Japan

Facility Name

Investigational Site Number 392131

City

Koshi-Shi

Country

Japan

Facility Name

Investigational Site Number 392183

City

Koshigaya-Shi

Country

Japan

Facility Name

Investigational Site Number 392129

City

Kurashiki-Shi

Country

Japan

Facility Name

Investigational Site Number 392153

City

Kyoto-Shi

Country

Japan

Facility Name

Investigational Site Number 392176

City

Kyoto-Shi

Country

Japan

Facility Name

Investigational Site Number 392184

City

Kyoto-Shi

Country

Japan

Facility Name

Investigational Site Number 392133

City

Machida-Shi

Country

Japan

Facility Name

Investigational Site Number 392135

City

Matsuyama-Shi

Country

Japan

Facility Name

Investigational Site Number 392172

City

Mibu

Country

Japan

Facility Name

Investigational Site Number 392114

City

Minato-Ku

Country

Japan

Facility Name

Investigational Site Number 392122

City

Minato-Ku

Country

Japan

Facility Name

Investigational Site Number 392144

City

Minato-Ku

Country

Japan

Facility Name

Investigational Site Number 392106

City

Mizunami-Shi

Country

Japan

Facility Name

Investigational Site Number 392164

City

Muroran-Shi

Country

Japan

Facility Name

Investigational Site Number 392161

City

Nagakute-Shi

Country

Japan

Facility Name

Investigational Site Number 392163

City

Nagoya-Shi

Country

Japan

Facility Name

Investigational Site Number 392102

City

Naka-Gun

Country

Japan

Facility Name

Investigational Site Number 392125

City

Nakano-Ku

Country

Japan

Facility Name

Investigational Site Number 392115

City

Naruto-Shi

Country

Japan

Facility Name

Investigational Site Number 392187

City

Obihiro-Shi

Country

Japan

Facility Name

Investigational Site Number 392177

City

Ome-Shi

Country

Japan

Facility Name

Investigational Site Number 392152

City

Osaka Sayama-Shi

Country

Japan

Facility Name

Investigational Site Number 392155

City

Osaka Sayama-Shi

Country

Japan

Facility Name

Investigational Site Number 392170

City

Osaki-Shi

Country

Japan

Facility Name

Investigational Site Number 392120

City

Ota-Ku

Country

Japan

Facility Name

Investigational Site Number 392127

City

Ota-Ku

Country

Japan

Facility Name

Investigational Site Number 392138

City

Ota-Shi

Country

Japan

Facility Name

Investigational Site Number 392123

City

Oura-Gun

Country

Japan

Facility Name

Investigational Site Number 392169

City

Sagamihara-Shi

Country

Japan

Facility Name

Investigational Site Number 392149

City

Sapporo-Shi

Country

Japan

Facility Name

Investigational Site Number 392179

City

Seto-Shi

Country

Japan

Facility Name

Investigational Site Number 392186

City

Shibuya-Ku

Country

Japan

Facility Name

Investigational Site Number 392139

City

Shinagawa-Ku

Country

Japan

Facility Name

Investigational Site Number 392167

City

Shinagawa-Ku

Country

Japan

Facility Name

Investigational Site Number 392130

City

Shinjuku-Ku

Country

Japan

Facility Name

Investigational Site Number 392165

City

Sumida-Ku

Country

Japan

Facility Name

Investigational Site Number 392146

City

Tachikawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392173

City

Tachikawa-Shi

Country

Japan

Facility Name

Investigational Site Number 392103

City

Tokyo

Country

Japan

Facility Name

Investigational Site Number 392113

City

Tomakomai-Shi

Country

Japan

Facility Name

Investigational Site Number 392151

City

Tsu-Shi

Country

Japan

Facility Name

Investigational Site Number 392168

City

Uozu-Shi

Country

Japan

Facility Name

Investigational Site Number 392132

City

Urasoe-Shi

Country

Japan

Facility Name

Investigational Site Number 392134

City

Uruma-Shi

Country

Japan

Facility Name

Investigational Site Number 392116

City

Wakayama-Shi

Country

Japan

Facility Name

Investigational Site Number 392140

City

Yokohama-Shi

Country

Japan

Facility Name

Investigational Site Number 392159

City

Yonago-Shi

Country

Japan

Facility Name

Investigational Site Number 410002

City

Bucheon-Si

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

Investigational Site Number 410015

City

Busan

ZIP/Postal Code

49201

Country

Korea, Republic of

Facility Name

Investigational Site Number 410003

City

Cheongju-Si

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Investigational Site Number 410013

City

Incheon

ZIP/Postal Code

21565

Country

Korea, Republic of

Facility Name

Investigational Site Number 410008

City

Seoul

ZIP/Postal Code

02559

Country

Korea, Republic of

Facility Name

Investigational Site Number 410006

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Investigational Site Number 410004

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Investigational Site Number 410012

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

Investigational Site Number 410005

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Investigational Site Number 410007

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Investigational Site Number 410009

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Investigational Site Number 410010

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Facility Name

Investigational Site Number 410011

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Investigational Site Number 410001

City

Suwon

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Investigational Site Number 410014

City

Uijeongbu-Si

ZIP/Postal Code

11765

Country

Korea, Republic of

Facility Name

Investigational Site Number 484013

City

Chihuahua

ZIP/Postal Code

31020

Country

Mexico

Facility Name

Investigational Site Number 484006

City

Chihuahua

ZIP/Postal Code

31200

Country

Mexico

Facility Name

Investigational Site Number 484014

City

Cuautitlan Izcalli

ZIP/Postal Code

54769

Country

Mexico

Facility Name

Investigational Site Number 484008

City

Durango

ZIP/Postal Code

34080

Country

Mexico

Facility Name

Investigational Site Number 484001

City

Guadalajara

ZIP/Postal Code

44100

Country

Mexico

Facility Name

Investigational Site Number 484004

City

Mexico City

ZIP/Postal Code

64718

Country

Mexico

Facility Name

Investigational Site Number 484003

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Investigational Site Number 484007

City

Monterrey

ZIP/Postal Code

66465

Country

Mexico

Facility Name

Investigational Site Number 484010

City

México

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Investigational Site Number 484012

City

San Juan Del Rio

ZIP/Postal Code

76800

Country

Mexico

Facility Name

Investigational Site Number 484011

City

Veracruz

ZIP/Postal Code

91910

Country

Mexico

Facility Name

Investigational Site Number 484015

City

Zapopan

ZIP/Postal Code

45100

Country

Mexico

Facility Name

Investigational Site Number 616006

City

Bialystok

ZIP/Postal Code

15-010

Country

Poland

Facility Name

Investigational Site Number 616003

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Investigational Site Number 616007

City

Krakow

ZIP/Postal Code

31-159

Country

Poland

Facility Name

Investigational Site Number 616001

City

Lodz

ZIP/Postal Code

90-141

Country

Poland

Facility Name

Investigational Site Number 616005

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Investigational Site Number 616009

City

Lodz

ZIP/Postal Code

90-329

Country

Poland

Facility Name

Investigational Site Number 616002

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Investigational Site Number 616004

City

Sopot

ZIP/Postal Code

81-741

Country

Poland

Facility Name

Investigational Site Number 616008

City

Strzelce Opolskie

ZIP/Postal Code

47-100

Country

Poland

Facility Name

Investigational Site Number 643013

City

Ekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Investigational Site Number 643006

City

Moscow

ZIP/Postal Code

105077

Country

Russian Federation

Facility Name

Investigational Site Number 643003

City

Moscow

ZIP/Postal Code

109240

Country

Russian Federation

Facility Name

Investigational Site Number 643005

City

Moscow

ZIP/Postal Code

115280

Country

Russian Federation

Facility Name

Investigational Site Number 643002

City

Moscow

ZIP/Postal Code

117574

Country

Russian Federation

Facility Name

Investigational Site Number 643004

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Investigational Site Number 643001

City

Moscow

ZIP/Postal Code

125315

Country

Russian Federation

Facility Name

Investigational Site Number 643011

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

Investigational Site Number 643008

City

Saint-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Investigational Site Number 643009

City

Saint-Petersburg

ZIP/Postal Code

195030

Country

Russian Federation

Facility Name

Investigational Site Number 643007

City

St-Petersburg

ZIP/Postal Code

193231

Country

Russian Federation

Facility Name

Investigational Site Number 643010

City

St-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Investigational Site Number 643012

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Investigational Site Number 710009

City

Brandfort

ZIP/Postal Code

9400

Country

South Africa

Facility Name

Investigational Site Number 710011

City

Cape Town

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Investigational Site Number 710004

City

Cape Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Investigational Site Number 710001

City

Cape Town

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Investigational Site Number 710002

City

Cape Town

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Investigational Site Number 710010

City

Cape Town

ZIP/Postal Code

7764

Country

South Africa

Facility Name

Investigational Site Number 710003

City

Cape Town

ZIP/Postal Code

8000

Country

South Africa

Facility Name

Investigational Site Number 710005

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Investigational Site Number 710006

City

Durban

ZIP/Postal Code

4071

Country

South Africa

Facility Name

Investigational Site Number 710007

City

Pretoria

ZIP/Postal Code

0087

Country

South Africa

Facility Name

Investigational Site Number 724002

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Investigational Site Number 724001

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Investigational Site Number 724010

City

Palma De Mallorca

ZIP/Postal Code

07120

Country

Spain

Facility Name

Investigational Site Number 724005

City

Pozuelo De Alarcón

ZIP/Postal Code

28223

Country

Spain

Facility Name

Investigational Site Number 724004

City

Sant Boi De Llobregat

ZIP/Postal Code

08830

Country

Spain

Facility Name

Investigational Site Number 724006

City

Santiago De Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Investigational Site Number 724008

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Investigational Site Number 724007

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Investigational Site Number 158004

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Investigational Site Number 158002

City

Kaohsiung

ZIP/Postal Code

82445

Country

Taiwan

Facility Name

Investigational Site Number 158008

City

New Taipei City

ZIP/Postal Code

23561

Country

Taiwan

Facility Name

Investigational Site Number 158005

City

Taichung

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

Investigational Site Number 158007

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Investigational Site Number 158001

City

Taipei

ZIP/Postal Code

10043

Country

Taiwan

Facility Name

Investigational Site Number 158009

City

Taipei

ZIP/Postal Code

11031

Country

Taiwan

Facility Name

Investigational Site Number 158006

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Investigational Site Number 792004

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Investigational Site Number 792008

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Investigational Site Number 792003

City

Bursa

ZIP/Postal Code

16059

Country

Turkey

Facility Name

Investigational Site Number 792001

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Investigational Site Number 792007

City

Istanbul

ZIP/Postal Code

34668

Country

Turkey

Facility Name

Investigational Site Number 792005

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Investigational Site Number 792010

City

Izmir

ZIP/Postal Code

35110

Country

Turkey

Facility Name

Investigational Site Number 792009

City

Kirikkale

ZIP/Postal Code

71450

Country

Turkey

Facility Name

Investigational Site Number 792011

City

Kocaeli

ZIP/Postal Code

41100

Country

Turkey

Facility Name

Investigational Site Number 792002

City

Mersin

ZIP/Postal Code

33070

Country

Turkey

Facility Name

Investigational Site Number 792006

City

Rize

ZIP/Postal Code

53100

Country

Turkey

Facility Name

Investigational Site Number 804007

City

Chernivtsi

ZIP/Postal Code

58001

Country

Ukraine

Facility Name

Investigational Site Number 804023

City

Dnipro

ZIP/Postal Code

49101

Country

Ukraine

Facility Name

Investigational Site Number 804004

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Investigational Site Number 804009

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Investigational Site Number 804005

City

Kharkiv

ZIP/Postal Code

61058

Country

Ukraine

Facility Name

Investigational Site Number 804021

City

Kharkiv

ZIP/Postal Code

61093

Country

Ukraine

Facility Name

Investigational Site Number 804001

City

Kharkiv

ZIP/Postal Code

61124

Country

Ukraine

Facility Name

Investigational Site Number 804003

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804008

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804011

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804013

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804017

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804016

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Investigational Site Number 804006

City

Odessa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Investigational Site Number 804002

City

Poltava

ZIP/Postal Code

36038

Country

Ukraine

Facility Name

Investigational Site Number 804014

City

Ternopil

ZIP/Postal Code

46000

Country

Ukraine

Facility Name

Investigational Site Number 804012

City

Vinnytsya

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Investigational Site Number 804022

City

Zaporizhia

ZIP/Postal Code

69076

Country

Ukraine

Facility Name

Investigational Site Number 826001

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Investigational Site Number 826002

City

London

ZIP/Postal Code

EC1M 6BQ

Country

United Kingdom

Facility Name

Investigational Site Number 826005

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Investigational Site Number 826007

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Investigational Site Number 826006

City

South Shields

ZIP/Postal Code

NE34 0PL

Country

United Kingdom

Facility Name

Investigational Site Number 826003

City

Sutton-In-Ashfield

ZIP/Postal Code

NG17 4JL

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29782217

Citation

Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, Busse WW, Ford L, Sher L, FitzGerald JM, Katelaris C, Tohda Y, Zhang B, Staudinger H, Pirozzi G, Amin N, Ruddy M, Akinlade B, Khan A, Chao J, Martincova R, Graham NMH, Hamilton JD, Swanson BN, Stahl N, Yancopoulos GD, Teper A. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018 Jun 28;378(26):2486-2496. doi: 10.1056/NEJMoa1804092. Epub 2018 May 21.

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result

PubMed Identifier

36087550

Citation

Bourdin A, Virchow JC, Papi A, Lugogo NL, Bardin P, Antila M, Halpin DMG, Daizadeh N, Djandji M, Ortiz B, Jacob-Nara JA, Gall R, Deniz Y, Rowe PJ. Dupilumab efficacy in subgroups of type 2 asthma with high-dose inhaled corticosteroids at baseline. Respir Med. 2022 Oct;202:106938. doi: 10.1016/j.rmed.2022.106938. Epub 2022 Aug 11.

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derived

PubMed Identifier

35899469

Citation

Papi A, Corren J, Castro M, Domingo C, Rogers L, Chapman KR, Jackson DJ, Daizadeh N, Pandit-Abid N, Gall R, Jacob-Nara JA, Rowe PJ, Deniz Y, Ortiz B. Dupilumab reduced impact of severe exacerbations on lung function in patients with moderate-to-severe type 2 asthma. Allergy. 2023 Jan;78(1):233-243. doi: 10.1111/all.15456. Epub 2022 Aug 9.

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PubMed Identifier

35636689

Citation

Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

Results Reference

derived

PubMed Identifier

35487538

Citation

Rabe KF, Pavord ID, Castro M, Wechsler ME, Daizadeh N, Kapoor U, Ortiz B, Radwan A, Johnson RR, Rowe PJ, Deniz Y, Jacob-Nara JA. Dupilumab efficacy and safety in patients with asthma and blood eosinophils >/=500 cells.microL-1. Eur Respir J. 2022 Jun 23;59(6):2102577. doi: 10.1183/13993003.02577-2021. Print 2022 Jun.

Results Reference

derived

PubMed Identifier

35255536

Citation

Rhee CK, Park JW, Park HW, Cho YS. Effect of Dupilumab in Korean Patients With Uncontrolled Moderate-to-Severe Asthma: A LIBERTY ASTHMA QUEST Sub-analysis. Allergy Asthma Immunol Res. 2022 Mar;14(2):182-195. doi: 10.4168/aair.2022.14.2.182.

Results Reference

derived

PubMed Identifier

34954123

Citation

Geng B, Bachert C, Busse WW, Gevaert P, Lee SE, Niederman MS, Chen Z, Lu X, Khokhar FA, Kapoor U, Pandit-Abid N, Jacob-Nara JA, Rowe PJ, Deniz Y, Ortiz B. Respiratory Infections and Anti-Infective Medication Use From Phase 3 Dupilumab Respiratory Studies. J Allergy Clin Immunol Pract. 2022 Mar;10(3):732-741. doi: 10.1016/j.jaip.2021.12.006. Epub 2021 Dec 22.

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derived

PubMed Identifier

34752208

Citation

Tohda Y, Matsumoto H, Miyata M, Taguchi Y, Ueyama M, Joulain F, Arakawa I. Cost-effectiveness analysis of dupilumab among patients with oral corticosteroid-dependent uncontrolled severe asthma in Japan. J Asthma. 2022 Nov;59(11):2162-2173. doi: 10.1080/02770903.2021.1996596. Epub 2021 Dec 8.

Results Reference

derived

PubMed Identifier

34326187

Citation

Busse WW, Paggiaro P, Munoz X, Casale TB, Castro M, Canonica GW, Douglass JA, Tohda Y, Daizadeh N, Ortiz B, Pandit-Abid N. Impact of baseline patient characteristics on dupilumab efficacy in type 2 asthma. Eur Respir J. 2021 Oct 7;58(4):2004605. doi: 10.1183/13993003.04605-2020. Print 2021 Oct.

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derived

PubMed Identifier

34266940

Citation

Corren J, Katelaris CH, Castro M, Maspero JF, Ford LB, Halpin DMG, Rice MS, Radwan A, Deniz Y, Rowe PJ, Teper A, Djandji M. Effect of exacerbation history on clinical response to dupilumab in moderate-to-severe uncontrolled asthma. Eur Respir J. 2021 Oct 28;58(4):2004498. doi: 10.1183/13993003.04498-2020. Print 2021 Oct.

Results Reference

derived

PubMed Identifier

34181876

Citation

Busse WW, Wenzel SE, Casale TB, FitzGerald JM, Rice MS, Daizadeh N, Deniz Y, Patel N, Harel S, Rowe PJ, Graham NMH, O'Riordan T, Pavord ID. Baseline FeNO as a prognostic biomarker for subsequent severe asthma exacerbations in patients with uncontrolled, moderate-to-severe asthma receiving placebo in the LIBERTY ASTHMA QUEST study: a post-hoc analysis. Lancet Respir Med. 2021 Oct;9(10):1165-1173. doi: 10.1016/S2213-2600(21)00124-7. Epub 2021 Jun 25.

Results Reference

derived

PubMed Identifier

34037993

Citation

Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26.

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PubMed Identifier

33905544

Citation

Maspero JF, FitzGerald JM, Pavord ID, Rice MS, Maroni J, Rowe PJ, Pirozzi G, Amin N, Ruddy M, Graham NMH, Teper A, Hardin M. Dupilumab efficacy in adolescents with uncontrolled, moderate-to-severe asthma: LIBERTY ASTHMA QUEST. Allergy. 2021 Aug;76(8):2621-2624. doi: 10.1111/all.14872. Epub 2021 May 10. No abstract available.

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derived

PubMed Identifier

33481203

Citation

Bansal A, Simpson EL, Paller AS, Siegfried EC, Blauvelt A, de Bruin-Weller M, Corren J, Sher L, Guttman-Yassky E, Chen Z, Daizadeh N, Kamal MA, Shumel B, Mina-Osorio P, Mannent L, Patel N, Graham NMH, Khokhar FA, Ardeleanu M. Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma. Am J Clin Dermatol. 2021 Jan;22(1):101-115. doi: 10.1007/s40257-020-00577-1.

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derived

PubMed Identifier

33010038

Citation

Bourdin A, Papi AA, Corren J, Virchow JC, Rice MS, Deniz Y, Djandji M, Rowe P, Pavord ID. Dupilumab is effective in type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline. Allergy. 2021 Jan;76(1):269-280. doi: 10.1111/all.14611. Epub 2020 Oct 21.

Results Reference

derived

PubMed Identifier

32444306

Citation

Tohda Y, Nakamura Y, Fujisawa T, Ebisawa M, Arima K, Miyata M, Takahashi Y, Rice MS, Deniz Y, Rowe P, Patel N, Graham NMH, Teper A. Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study. Allergol Int. 2020 Oct;69(4):578-587. doi: 10.1016/j.alit.2020.04.002. Epub 2020 May 20.

Results Reference

derived

PubMed Identifier

31521831

Citation

Corren J, Castro M, O'Riordan T, Hanania NA, Pavord ID, Quirce S, Chipps BE, Wenzel SE, Thangavelu K, Rice MS, Harel S, Jagerschmidt A, Khan AH, Kamat S, Maroni J, Rowe P, Lu Y, Amin N, Pirozzi G, Ruddy M, Graham NMH, Teper A. Dupilumab Efficacy in Patients with Uncontrolled, Moderate-to-Severe Allergic Asthma. J Allergy Clin Immunol Pract. 2020 Feb;8(2):516-526. doi: 10.1016/j.jaip.2019.08.050. Epub 2019 Sep 12.

Results Reference

derived

PubMed Identifier

31351189

Citation

Maspero JF, Katelaris CH, Busse WW, Castro M, Corren J, Chipps BE, Peters AT, Pavord ID, Ford LB, Sher L, Rabe KF, Rice MS, Rowe P, Lu Y, Harel S, Jagerschmidt A, Khan AH, Kamat S, Pirozzi G, Amin N, Ruddy M, Graham NMH, Mannent LP, Teper A. Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2020 Feb;8(2):527-539.e9. doi: 10.1016/j.jaip.2019.07.016. Epub 2019 Jul 24.

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PubMed Identifier

30138668

Citation

Corren J, Castro M, Chanez P, Fabbri L, Joish VN, Amin N, Graham NMH, Mastey V, Abbe A, Taniou C, Mahajan P, Teper A, Pirozzi G, Eckert L. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019 Jan;122(1):41-49.e2. doi: 10.1016/j.anai.2018.08.005. Epub 2018 Aug 21.

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PubMed Identifier

29725983

Citation

Busse WW, Maspero JF, Rabe KF, Papi A, Wenzel SE, Ford LB, Pavord ID, Zhang B, Staudinger H, Pirozzi G, Amin N, Akinlade B, Eckert L, Chao J, Graham NMH, Teper A. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018 May;35(5):737-748. doi: 10.1007/s12325-018-0702-4. Epub 2018 May 3.

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PubMed Identifier

29355679

Citation

Weinstein SF, Katial R, Jayawardena S, Pirozzi G, Staudinger H, Eckert L, Joish VN, Amin N, Maroni J, Rowe P, Graham NMH, Teper A. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol. 2018 Jul;142(1):171-177.e1. doi: 10.1016/j.jaci.2017.11.051. Epub 2018 Jan 31.

Results Reference

derived

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/?term=29782217&report=abstract

Description

Related Info

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Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)

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Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)

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