Clinical trial NCT02414854: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2015-04-13
Enrollment: 1902
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population
timeFrame: Baseline to Week 52
measure: Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population
timeFrame: Baseline, Week 12
measure: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L
timeFrame: Baseline to Week 52
measure: Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
timeFrame: Baseline, Week 12
measure: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L
timeFrame: Baseline to Week 52
measure: Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
timeFrame: Baseline, Week 12
measure: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L
timeFrame: Baseline to Week 52
measure: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline
timeFrame: Baseline to Week 52
measure: Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline
timeFrame: Baseline, Week 12
measure: Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population
timeFrame: Baseline, Week 24
measure: Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L
timeFrame: Baseline, Week 24
measure: Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population
timeFrame: Baseline, Week 24
measure: Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population
timeFrame: Baseline to Week 52
measure: Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 24, 36, and 52
measure: Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 24, 36, and 52
measure: Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
measure: Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
measure: Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
measure: Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
measure: Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
measure: Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population
timeFrame: Baseline to Week 52
measure: Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population
timeFrame: Baseline up to Week 52
measure: Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population
timeFrame: Baseline up to Week 52
measure: Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, 36, and 52
measure: 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
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
measure: Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
measure: Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
measure: Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
measure: 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
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
measure: Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 12, 36, and 52
measure: 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
timeFrame: Baseline, Weeks 12, 24, 36, and 52
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population
timeFrame: Baseline, Weeks 12, 24, 36, and 52
measure: 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
timeFrame: Baseline, Weeks 12, 24, 36, and 52
measure: 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
timeFrame: Baseline, Weeks 12, 24, 36, and 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 840047
state: Alabama
city: Flagstaff
country: United States
facility: Investigational Site Number 840056
state: Arizona
city: Gilbert
country: United States
facility: Investigational Site Number 840099
state: Arizona
city: Scottsdale
country: United States
facility: Investigational Site Number 840087
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site Number 840132
state: Arkansas
city: Bakersfield
country: United States
facility: Investigational Site Number 840109
state: California
city: Costa Mesa
country: United States
facility: Investigational Site Number 840052
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840116
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840045
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840011
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840061
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840097
state: California
city: Mission Viejo
country: United States
facility: Investigational Site Number 840019
state: California
city: Newport Beach
country: United States
facility: Investigational Site Number 840125
state: California
city: North Hollywood
country: United States
facility: Investigational Site Number 840041
state: California
city: Redwood City
country: United States
facility: Investigational Site Number 840036
state: California
city: Rolling Hills Estates
country: United States
facility: Investigational Site Number 840020
state: California
city: Roseville
country: United States
facility: Investigational Site Number 840074
state: California
city: San Jose
country: United States
facility: Investigational Site Number 840021
state: California
city: Centennial
country: United States
facility: Investigational Site Number 840004
state: Colorado
city: Colorado Springs
country: United States
facility: Investigational Site Number 840025
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840034
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840130
state: Colorado
city: New Haven
country: United States
facility: Investigational Site Number 840102
state: Connecticut
city: Aventura
country: United States
facility: Investigational Site Number 840037
state: Florida
city: Boynton Beach
country: United States
facility: Investigational Site Number 840018
state: Florida
city: Brandon
country: United States
facility: Investigational Site Number 840105
state: Florida
city: Clearwater
country: United States
facility: Investigational Site Number 840092
state: Florida
city: Hialeah
country: United States
facility: Investigational Site Number 840122
state: Florida
city: Loxahatchee Groves
country: United States
facility: Investigational Site Number 840053
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840069
state: Florida
city: Ocala
country: United States
facility: Investigational Site Number 840123
state: Florida
city: Ocala
country: United States
facility: Investigational Site Number 840071
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 840115
state: Florida
city: Sarasota
country: United States
facility: Investigational Site Number 840055
state: Florida
city: South Miami
country: United States
facility: Investigational Site Number 840114
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 840048
state: Florida
city: Gainesville
country: United States
facility: Investigational Site Number 840084
state: Georgia
city: Savannah
country: United States
facility: Investigational Site Number 840044
state: Georgia
city: Twin Falls
country: United States
facility: Investigational Site Number 840079
state: Idaho
city: Chicago
country: United States
facility: Investigational Site Number 840101
state: Illinois
city: River Forest
country: United States
facility: Investigational Site Number 840015
state: Illinois
city: Iowa City
country: United States
facility: Investigational Site Number 840089
state: Iowa
city: Fort Mitchell
country: United States
facility: Investigational Site Number 840032
state: Kentucky
city: Owensboro
country: United States
facility: Investigational Site Number 840009
state: Kentucky
city: Bangor
country: United States
facility: Investigational Site Number 840064
state: Maine
city: Baltimore
country: United States
facility: Investigational Site Number 840080
state: Maryland
city: Chevy Chase
country: United States
facility: Investigational Site Number 840017
state: Maryland
city: Gaithersburg
country: United States
facility: Investigational Site Number 840073
state: Maryland
city: White Marsh
country: United States
facility: Investigational Site Number 840127
state: Maryland
city: North Dartmouth
country: United States
facility: Investigational Site Number 840014
state: Massachusetts
city: Minneapolis
country: United States
facility: Investigational Site Number 840005
state: Minnesota
city: Kansas City
country: United States
facility: Investigational Site Number 840013
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site Number 840002
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site Number 840093
state: Missouri
city: Missoula
country: United States
facility: Investigational Site Number 840026
state: Montana
city: Omaha
country: United States
facility: Investigational Site Number 840078
state: Nebraska
city: Papillion
country: United States
facility: Investigational Site Number 840003
state: Nebraska
city: Brick
country: United States
facility: Investigational Site Number 840111
state: New Jersey
city: Ocean City
country: United States
facility: Investigational Site Number 840068
state: New Jersey
city: Princeton
country: United States
facility: Investigational Site Number 840016
state: New Jersey
city: Toms River
country: United States
facility: Investigational Site Number 840096
state: New Jersey
city: Bronx
country: United States
facility: Investigational Site Number 840031
state: New York
city: Jamaica
country: United States
facility: Investigational Site Number 840106
state: New York
city: New York
country: United States
facility: Investigational Site Number 840065
state: New York
city: Rochester
country: United States
facility: Investigational Site Number 840076
state: New York
city: Charlotte
country: United States
facility: Investigational Site Number 840126
state: North Carolina
city: Charlotte
country: United States
facility: Investigational Site Number 840083
state: North Carolina
city: Durham
country: United States
facility: Investigational Site Number 840108
state: North Carolina
city: Greensboro
country: United States
facility: Investigational Site Number 840107
state: North Carolina
city: High Point
country: United States
facility: Investigational Site Number 840007
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site Number 840046
state: Ohio
city: Middleburg Heights
country: United States
facility: Investigational Site Number 840049
state: Ohio
city: Toledo
country: United States
facility: Investigational Site Number 840042
state: Ohio
city: Edmond
country: United States
facility: Investigational Site Number 840112
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site Number 840121
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site Number 840104
state: Oklahoma
city: Clackamas
country: United States
facility: Investigational Site Number 840040
state: Oregon
city: Medford
country: United States
facility: Investigational Site Number 840039
state: Oregon
city: Portland
country: United States
facility: Investigational Site Number 840001
state: Oregon
city: Hershey
country: United States
facility: Investigational Site Number 840085
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site Number 840081
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site Number 840010
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site Number 840067
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number 840028
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number 840091
state: Pennsylvania
city: Lincoln
country: United States
facility: Investigational Site Number 840029
state: Rhode Island
city: Charleston
country: United States
facility: Investigational Site Number 840082
state: South Carolina
city: Greenville
country: United States
facility: Investigational Site Number 840117
state: South Carolina
city: Greer
country: United States
facility: Investigational Site Number 840100
state: South Carolina
city: Spartanburg
country: United States
facility: Investigational Site Number 840054
state: South Carolina
city: Amarillo
country: United States
facility: Investigational Site Number 840062
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 840098
state: Texas
city: Boerne
country: United States
facility: Investigational Site Number 840038
state: Texas
city: Cypress
country: United States
facility: Investigational Site Number 840124
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840008
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840094
state: Texas
city: El Paso
country: United States
facility: Investigational Site Number 840023
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840022
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840027
state: Texas
city: Killeen
country: United States
facility: Investigational Site Number 840066
state: Texas
city: Live Oak
country: United States
facility: Investigational Site Number 840050
state: Texas
city: McKinney
country: United States
facility: Investigational Site Number 840070
state: Texas
city: McKinney
country: United States
facility: Investigational Site Number 840128
state: Texas
city: Plano
country: United States
facility: Investigational Site Number 840118
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840012
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840129
state: Texas
city: Sealy
country: United States
facility: Investigational Site Number 840133
state: Texas
city: Spring
country: United States
facility: Investigational Site Number 840119
state: Texas
city: Draper
country: United States
facility: Investigational Site Number 840035
state: Utah
city: Murray
country: United States
facility: Investigational Site Number 840077
state: Utah
city: South Burlington
country: United States
facility: Investigational Site Number 840057
state: Vermont
city: Fairfax
country: United States
facility: Investigational Site Number 840059
state: Virginia
city: Richmond
country: United States
facility: Investigational Site Number 840113
state: Virginia
city: Bellevue
country: United States
facility: Investigational Site Number 840051
state: Washington
city: Spokane
country: United States
facility: Investigational Site Number 840043
state: Washington
city: Bahia Blanca
country: Argentina
facility: Investigational Site Number 032006
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032002
city: Caba
country: Argentina
facility: Investigational Site Number 032011
city: Caba
country: Argentina
facility: Investigational Site Number 032007
city: Caba
country: Argentina
facility: Investigational Site Number 032001
city: Caba
country: Argentina
facility: Investigational Site Number 032003
city: Caba
country: Argentina
facility: Investigational Site Number 032010
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032005
city: La Plata
country: Argentina
facility: Investigational Site Number 032008
city: Rosario
country: Argentina
facility: Investigational Site Number 032004
city: San Miguel De Tucuman
country: Argentina
facility: Investigational Site Number 032012
city: San Miguel De Tucumán
country: Argentina
facility: Investigational Site Number 032009
city: Campbelltown
country: Australia
facility: Investigational Site Number 036005
city: Clayton
country: Australia
facility: Investigational Site Number 036001
city: Frankston
country: Australia
facility: Investigational Site Number 036002
city: Glen Osmond
country: Australia
facility: Investigational Site Number 036006
city: Murdoch
country: Australia
facility: Investigational Site Number 036003
city: Parkville
country: Australia
facility: Investigational Site Number 036004
city: Florianópolis
country: Brazil
facility: Investigational Site Number 076009
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076007
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076001
city: Salvador
country: Brazil
facility: Investigational Site Number 076003
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076012
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076008
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076006
city: Sorocaba
country: Brazil
facility: Investigational Site Number 076002
city: São Bernardo Do Campo
country: Brazil
facility: Investigational Site Number 076013
city: Burlington
country: Canada
facility: Investigational Site Number 124019
city: Calgary
country: Canada
facility: Investigational Site Number 124009
city: Mississauga
country: Canada
facility: Investigational Site Number 124003
city: Montreal
country: Canada
facility: Investigational Site Number 124001
city: Montreal
country: Canada
facility: Investigational Site Number 124012
city: Montreal
country: Canada
facility: Investigational Site Number 124010
city: Ottawa
country: Canada
facility: Investigational Site Number 124013
city: Quebec
country: Canada
facility: Investigational Site Number 124018
city: Quebec
country: Canada
facility: Investigational Site Number 124014
city: Sherbrooke
country: Canada
facility: Investigational Site Number 124008
city: Toronto
country: Canada
facility: Investigational Site Number 124015
city: Toronto
country: Canada
facility: Investigational Site Number 124002
city: Trois-Rivieres
country: Canada
facility: Investigational Site Number 124007
city: Vancouver
country: Canada
facility: Investigational Site Number 124006
city: Concepción
country: Chile
facility: Investigational Site Number 152015
city: Quillota
country: Chile
facility: Investigational Site Number 152003
city: Santiago
country: Chile
facility: Investigational Site Number 152014
city: Santiago
country: Chile
facility: Investigational Site Number 152001
city: Santiago
country: Chile
facility: Investigational Site Number 152002
city: Santiago
country: Chile
facility: Investigational Site Number 152008
city: Santiago
country: Chile
facility: Investigational Site Number 152017
city: Santiago
country: Chile
facility: Investigational Site Number 152007
city: Santiago
country: Chile
facility: Investigational Site Number 152005
city: Santiago
country: Chile
facility: Investigational Site Number 152009
city: Talcahuano
country: Chile
facility: Investigational Site Number 152013
city: Talca
country: Chile
facility: Investigational Site Number 152004
city: Temuco
country: Chile
facility: Investigational Site Number 152016
city: Valdivia
country: Chile
facility: Investigational Site Number 152010
city: Viña Del Mar
country: Chile
facility: Investigational Site Number 152011
city: Viña Del Mar
country: Chile
facility: Investigational Site Number 152012
city: Bogota
country: Colombia
facility: Investigational Site Number 170006
city: Bogota
country: Colombia
facility: Investigational Site Number 170001
city: Bogotá
country: Colombia
facility: Investigational Site Number 170002
city: Bogotá
country: Colombia
facility: Investigational Site Number 170003
city: Brest
country: France
facility: Investigational Site Number 250002
city: Lille Cedex
country: France
facility: Investigational Site Number 250011
city: Lille
country: France
facility: Investigational Site Number 250013
city: Lyon
country: France
facility: Investigational Site Number 250004
city: Marseille
country: France
facility: Investigational Site Number 250010
city: Montpellier
country: France
facility: Investigational Site Number 250005
city: Nantes Cedex 1
country: France
facility: Investigational Site Number 250003
city: Paris
country: France
facility: Investigational Site Number 250012
city: Paris
country: France
facility: Investigational Site Number 250001
city: Strasbourg
country: France
facility: Investigational Site Number 250008
city: Vandoeuvre-Les-Nancy
country: France
facility: Investigational Site Number 250014
city: Berlin
country: Germany
facility: Investigational Site Number 276006
city: Bochum
country: Germany
facility: Investigational Site Number 276003
city: Frankfurt Am Main
country: Germany
facility: Investigational Site Number 276010
city: Hannover
country: Germany
facility: Investigational Site Number 276004
city: Koblenz
country: Germany
facility: Investigational Site Number 276009
city: Lübeck
country: Germany
facility: Investigational Site Number 276007
city: Mainz
country: Germany
facility: Investigational Site Number 276001
city: Rüdersdorf
country: Germany
facility: Investigational Site Number 276005
city: Gödöllö
country: Hungary
facility: Investigational Site Number 348003
city: Ancona
country: Italy
facility: Investigational Site Number 380004
city: Catania
country: Italy
facility: Investigational Site Number 380005
city: Ferrara
country: Italy
facility: Investigational Site Number 380003
city: Firenze
country: Italy
facility: Investigational Site Number 380006
city: Foggia
country: Italy
facility: Investigational Site Number 380010
city: Modena
country: Italy
facility: Investigational Site Number 380002
city: Palermo
country: Italy
facility: Investigational Site Number 380009
city: Pisa
country: Italy
facility: Investigational Site Number 380001
city: Reggio Emilia
country: Italy
facility: Investigational Site Number 380014
city: Torino
country: Italy
facility: Investigational Site Number 380011
city: Akashi-Shi
country: Japan
facility: Investigational Site Number 392185
city: Asahikawa-Shi
country: Japan
facility: Investigational Site Number 392128
city: Chiyoda-Ku
country: Japan
facility: Investigational Site Number 392118
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392112
city: Fukui-Shi
country: Japan
facility: Investigational Site Number 392157
city: Fukuoka-Shi
country: Japan
facility: Investigational Site Number 392137
city: Fukuyama-Shi
country: Japan
facility: Investigational Site Number 392117
city: Habikino-Shi
country: Japan
facility: Investigational Site Number 392121
city: Higashiosaka-Shi
country: Japan
facility: Investigational Site Number 392154
city: Himeji-Shi
country: Japan
facility: Investigational Site Number 392109
city: Hiroshima-Shi
country: Japan
facility: Investigational Site Number 392108
city: Hiroshima-Shi
country: Japan
facility: Investigational Site Number 392158
city: Iizuka-Shi
country: Japan
facility: Investigational Site Number 392107
city: Isesaki-Shi
country: Japan
facility: Investigational Site Number 392101
city: Itabashi-Ku
country: Japan
facility: Investigational Site Number 392147
city: Kagoshima-Shi
country: Japan
facility: Investigational Site Number 392150
city: Kagoshima-Shi
country: Japan
facility: Investigational Site Number 392178
city: Kanazawa-Shi
country: Japan
facility: Investigational Site Number 392110
city: Kanazawa-Shi
country: Japan
facility: Investigational Site Number 392136
city: Kasuga-Shi
country: Japan
facility: Investigational Site Number 392142
city: Kawaguchi-Shi
country: Japan
facility: Investigational Site Number 392166
city: Kishiwada-Shi
country: Japan
facility: Investigational Site Number 392119
city: Kobe-Shi
country: Japan
facility: Investigational Site Number 392162
city: Kodaira-Shi
country: Japan
facility: Investigational Site Number 392182
city: Kokubunji-Shi
country: Japan
facility: Investigational Site Number 392174
city: Koshi-Shi
country: Japan
facility: Investigational Site Number 392131
city: Koshigaya-Shi
country: Japan
facility: Investigational Site Number 392183
city: Kurashiki-Shi
country: Japan
facility: Investigational Site Number 392129
city: Kyoto-Shi
country: Japan
facility: Investigational Site Number 392153
city: Kyoto-Shi
country: Japan
facility: Investigational Site Number 392176
city: Kyoto-Shi
country: Japan
facility: Investigational Site Number 392184
city: Machida-Shi
country: Japan
facility: Investigational Site Number 392133
city: Matsuyama-Shi
country: Japan
facility: Investigational Site Number 392135
city: Mibu
country: Japan
facility: Investigational Site Number 392172
city: Minato-Ku
country: Japan
facility: Investigational Site Number 392114
city: Minato-Ku
country: Japan
facility: Investigational Site Number 392122
city: Minato-Ku
country: Japan
facility: Investigational Site Number 392144
city: Mizunami-Shi
country: Japan
facility: Investigational Site Number 392106
city: Muroran-Shi
country: Japan
facility: Investigational Site Number 392164
city: Nagakute-Shi
country: Japan
facility: Investigational Site Number 392161
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392163
city: Naka-Gun
country: Japan
facility: Investigational Site Number 392102
city: Nakano-Ku
country: Japan
facility: Investigational Site Number 392125
city: Naruto-Shi
country: Japan
facility: Investigational Site Number 392115
city: Obihiro-Shi
country: Japan
facility: Investigational Site Number 392187
city: Ome-Shi
country: Japan
facility: Investigational Site Number 392177
city: Osaka Sayama-Shi
country: Japan
facility: Investigational Site Number 392152
city: Osaka Sayama-Shi
country: Japan
facility: Investigational Site Number 392155
city: Osaki-Shi
country: Japan
facility: Investigational Site Number 392170
city: Ota-Ku
country: Japan
facility: Investigational Site Number 392120
city: Ota-Ku
country: Japan
facility: Investigational Site Number 392127
city: Ota-Shi
country: Japan
facility: Investigational Site Number 392138
city: Oura-Gun
country: Japan
facility: Investigational Site Number 392123
city: Sagamihara-Shi
country: Japan
facility: Investigational Site Number 392169
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392149
city: Seto-Shi
country: Japan
facility: Investigational Site Number 392179
city: Shibuya-Ku
country: Japan
facility: Investigational Site Number 392186
city: Shinagawa-Ku
country: Japan
facility: Investigational Site Number 392139
city: Shinagawa-Ku
country: Japan
facility: Investigational Site Number 392167
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392130
city: Sumida-Ku
country: Japan
facility: Investigational Site Number 392165
city: Tachikawa-Shi
country: Japan
facility: Investigational Site Number 392146
city: Tachikawa-Shi
country: Japan
facility: Investigational Site Number 392173
city: Tokyo
country: Japan
facility: Investigational Site Number 392103
city: Tomakomai-Shi
country: Japan
facility: Investigational Site Number 392113
city: Tsu-Shi
country: Japan
facility: Investigational Site Number 392151
city: Uozu-Shi
country: Japan
facility: Investigational Site Number 392168
city: Urasoe-Shi
country: Japan
facility: Investigational Site Number 392132
city: Uruma-Shi
country: Japan
facility: Investigational Site Number 392134
city: Wakayama-Shi
country: Japan
facility: Investigational Site Number 392116
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392140
city: Yonago-Shi
country: Japan
facility: Investigational Site Number 392159
city: Bucheon-Si
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Busan
country: Korea, Republic of
facility: Investigational Site Number 410015
city: Cheongju-Si
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 410013
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410008
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410006
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410004
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410012
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410005
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410007
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410009
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410010
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410011
city: Suwon
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Uijeongbu-Si
country: Korea, Republic of
facility: Investigational Site Number 410014
city: Chihuahua
country: Mexico
facility: Investigational Site Number 484013
city: Chihuahua
country: Mexico
facility: Investigational Site Number 484006
city: Cuautitlan Izcalli
country: Mexico
facility: Investigational Site Number 484014
city: Durango
country: Mexico
facility: Investigational Site Number 484008
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484001
city: Mexico City
country: Mexico
facility: Investigational Site Number 484004
city: Monterrey
country: Mexico
facility: Investigational Site Number 484003
city: Monterrey
country: Mexico
facility: Investigational Site Number 484007
city: México
country: Mexico
facility: Investigational Site Number 484010
city: San Juan Del Rio
country: Mexico
facility: Investigational Site Number 484012
city: Veracruz
country: Mexico
facility: Investigational Site Number 484011
city: Zapopan
country: Mexico
facility: Investigational Site Number 484015
city: Bialystok
country: Poland
facility: Investigational Site Number 616006
city: Gdansk
country: Poland
facility: Investigational Site Number 616003
city: Krakow
country: Poland
facility: Investigational Site Number 616007
city: Lodz
country: Poland
facility: Investigational Site Number 616001
city: Lodz
country: Poland
facility: Investigational Site Number 616005
city: Lodz
country: Poland
facility: Investigational Site Number 616009
city: Poznan
country: Poland
facility: Investigational Site Number 616002
city: Sopot
country: Poland
facility: Investigational Site Number 616004
city: Strzelce Opolskie
country: Poland
facility: Investigational Site Number 616008
city: Ekaterinburg
country: Russian Federation
facility: Investigational Site Number 643013
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643006
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643003
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643005
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643002
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643004
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643001
city: Ryazan
country: Russian Federation
facility: Investigational Site Number 643011
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643008
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643009
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643007
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643010
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 643012
city: Brandfort
country: South Africa
facility: Investigational Site Number 710009
city: Cape Town
country: South Africa
facility: Investigational Site Number 710011
city: Cape Town
country: South Africa
facility: Investigational Site Number 710004
city: Cape Town
country: South Africa
facility: Investigational Site Number 710001
city: Cape Town
country: South Africa
facility: Investigational Site Number 710002
city: Cape Town
country: South Africa
facility: Investigational Site Number 710010
city: Cape Town
country: South Africa
facility: Investigational Site Number 710003
city: Durban
country: South Africa
facility: Investigational Site Number 710005
city: Durban
country: South Africa
facility: Investigational Site Number 710006
city: Pretoria
country: South Africa
facility: Investigational Site Number 710007
city: Barcelona
country: Spain
facility: Investigational Site Number 724002
city: Barcelona
country: Spain
facility: Investigational Site Number 724001
city: Palma De Mallorca
country: Spain
facility: Investigational Site Number 724010
city: Pozuelo De Alarcón
country: Spain
facility: Investigational Site Number 724005
city: Sant Boi De Llobregat
country: Spain
facility: Investigational Site Number 724004
city: Santiago De Compostela
country: Spain
facility: Investigational Site Number 724006
city: Sevilla
country: Spain
facility: Investigational Site Number 724008
city: Valencia
country: Spain
facility: Investigational Site Number 724007
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number 158004
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number 158002
city: New Taipei City
country: Taiwan
facility: Investigational Site Number 158008
city: Taichung
country: Taiwan
facility: Investigational Site Number 158005
city: Taichung
country: Taiwan
facility: Investigational Site Number 158007
city: Taipei
country: Taiwan
facility: Investigational Site Number 158001
city: Taipei
country: Taiwan
facility: Investigational Site Number 158009
city: Taoyuan
country: Taiwan
facility: Investigational Site Number 158006
city: Ankara
country: Turkey
facility: Investigational Site Number 792004
city: Ankara
country: Turkey
facility: Investigational Site Number 792008
city: Bursa
country: Turkey
facility: Investigational Site Number 792003
city: Istanbul
country: Turkey
facility: Investigational Site Number 792001
city: Istanbul
country: Turkey
facility: Investigational Site Number 792007
city: Izmir
country: Turkey
facility: Investigational Site Number 792005
city: Izmir
country: Turkey
facility: Investigational Site Number 792010
city: Kirikkale
country: Turkey
facility: Investigational Site Number 792009
city: Kocaeli
country: Turkey
facility: Investigational Site Number 792011
city: Mersin
country: Turkey
facility: Investigational Site Number 792002
city: Rize
country: Turkey
facility: Investigational Site Number 792006
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number 804007
city: Dnipro
country: Ukraine
facility: Investigational Site Number 804023
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number 804004
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number 804009
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804005
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804021
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804001
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804003
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804008
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804011
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804013
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804017
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804016
city: Odessa
country: Ukraine
facility: Investigational Site Number 804006
city: Poltava
country: Ukraine
facility: Investigational Site Number 804002
city: Ternopil
country: Ukraine
facility: Investigational Site Number 804014
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 804012
city: Zaporizhia
country: Ukraine
facility: Investigational Site Number 804022
city: Bradford
country: United Kingdom
facility: Investigational Site Number 826001
city: London
country: United Kingdom
facility: Investigational Site Number 826002
city: Newcastle Upon Tyne
country: United Kingdom
facility: Investigational Site Number 826005
city: Portsmouth
country: United Kingdom
facility: Investigational Site Number 826007
city: South Shields
country: United Kingdom
facility: Investigational Site Number 826006
city: Sutton-In-Ashfield
country: United Kingdom
facility: Investigational Site Number 826003
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.