NCT02414854

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,902

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Apr 2015

Typical duration for phase_3 asthma

Geographic Reach
22 countries

389 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

April 27, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2017

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 23, 2018

Completed
Last Updated

October 23, 2018

Status Verified

June 1, 2018

Enrollment Period

2.3 years

First QC Date

April 8, 2015

Results QC Date

July 27, 2018

Last Update Submit

October 19, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline to Week 52

  • 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.

    Baseline, Week 12

Secondary Outcomes (37)

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

    Baseline, Week 12

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

    Baseline to Week 52

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

    Baseline, Week 12

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

    Baseline to Week 52

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

    Baseline, Week 12

  • +32 more secondary outcomes

Study Arms (4)

Placebo (for Dupilumab 200 mg) q2w

PLACEBO COMPARATOR

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.

Drug: PlaceboDrug: Inhaled corticosteroid (ICS) therapyDrug: Albuterol/SalbutamolDrug: Levalbuterol/Levosalbutamol

Dupilumab 200 mg q2w

EXPERIMENTAL

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.

Drug: DupilumabDrug: Inhaled corticosteroid (ICS) therapyDrug: Albuterol/SalbutamolDrug: Levalbuterol/Levosalbutamol

Placebo (for Dupilumab 300 mg) q2w

PLACEBO COMPARATOR

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.

Drug: PlaceboDrug: Inhaled corticosteroid (ICS) therapyDrug: Albuterol/SalbutamolDrug: Levalbuterol/Levosalbutamol

Dupilumab 300 mg q2w

EXPERIMENTAL

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.

Drug: DupilumabDrug: Inhaled corticosteroid (ICS) therapyDrug: Albuterol/SalbutamolDrug: Levalbuterol/Levosalbutamol

Interventions

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

Also known as: SAR231893, REGN668
Dupilumab 200 mg q2wDupilumab 300 mg q2w

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

Placebo (for Dupilumab 200 mg) q2wPlacebo (for Dupilumab 300 mg) q2w

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

Dupilumab 200 mg q2wDupilumab 300 mg q2wPlacebo (for Dupilumab 200 mg) q2wPlacebo (for Dupilumab 300 mg) q2w

Oral inhalation as needed

Dupilumab 200 mg q2wDupilumab 300 mg q2wPlacebo (for Dupilumab 200 mg) q2wPlacebo (for Dupilumab 300 mg) q2w

Oral inhalation as needed

Dupilumab 200 mg q2wDupilumab 300 mg q2wPlacebo (for Dupilumab 200 mg) q2wPlacebo (for Dupilumab 300 mg) q2w

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (389)

Investigational Site Number 840047

Birmingham, Alabama, 35209, United States

Location

Investigational Site Number 840056

Flagstaff, Arizona, 86001, United States

Location

Investigational Site Number 840099

Gilbert, Arizona, 85234, United States

Location

Investigational Site Number 840087

Scottsdale, Arizona, 85251, United States

Location

Investigational Site Number 840132

Little Rock, Arkansas, 72209, United States

Location

Investigational Site Number 840109

Bakersfield, California, 93301, United States

Location

Investigational Site Number 840052

Costa Mesa, California, 92626, United States

Location

Investigational Site Number 840116

Fresno, California, 93720, United States

Location

Investigational Site Number 840045

Long Beach, California, 90720, United States

Location

Investigational Site Number 840011

Los Angeles, California, 90025, United States

Location

Investigational Site Number 840061

Los Angeles, California, 90048, United States

Location

Investigational Site Number 840097

Los Angeles, California, 90064, United States

Location

Investigational Site Number 840019

Mission Viejo, California, 92691, United States

Location

Investigational Site Number 840125

Newport Beach, California, 92663, United States

Location

Investigational Site Number 840041

North Hollywood, California, 91606, United States

Location

Investigational Site Number 840036

Redwood City, California, 94063, United States

Location

Investigational Site Number 840020

Rolling Hills Estates, California, 90274, United States

Location

Investigational Site Number 840074

Roseville, California, 95661, United States

Location

Investigational Site Number 840021

San Jose, California, 95117, United States

Location

Investigational Site Number 840004

Centennial, Colorado, 80112, United States

Location

Investigational Site Number 840025

Colorado Springs, Colorado, 80907, United States

Location

Investigational Site Number 840034

Denver, Colorado, 80230, United States

Location

Investigational Site Number 840130

Denver, Colorado, 80246, United States

Location

Investigational Site Number 840102

New Haven, Connecticut, 06504, United States

Location

Investigational Site Number 840037

Aventura, Florida, 33180, United States

Location

Investigational Site Number 840018

Boynton Beach, Florida, 33472, United States

Location

Investigational Site Number 840105

Brandon, Florida, 33511, United States

Location

Investigational Site Number 840092

Clearwater, Florida, 33765, United States

Location

Investigational Site Number 840122

Hialeah, Florida, 33012, United States

Location

Investigational Site Number 840053

Loxahatchee Groves, Florida, 33470, United States

Location

Investigational Site Number 840069

Miami, Florida, 33173, United States

Location

Investigational Site Number 840123

Ocala, Florida, 34471, United States

Location

Investigational Site Number 840071

Ocala, Florida, 34474, United States

Location

Investigational Site Number 840115

Ocoee, Florida, 34761, United States

Location

Investigational Site Number 840055

Sarasota, Florida, 34239, United States

Location

Investigational Site Number 840114

South Miami, Florida, 33143, United States

Location

Investigational Site Number 840048

Tampa, Florida, 33612, United States

Location

Investigational Site Number 840084

Gainesville, Georgia, 30506, United States

Location

Investigational Site Number 840044

Savannah, Georgia, 31406, United States

Location

Investigational Site Number 840079

Twin Falls, Idaho, 83301, United States

Location

Investigational Site Number 840101

Chicago, Illinois, 60611, United States

Location

Investigational Site Number 840015

River Forest, Illinois, 60305, United States

Location

Investigational Site Number 840089

Iowa City, Iowa, 52242, United States

Location

Investigational Site Number 840032

Fort Mitchell, Kentucky, 41017, United States

Location

Investigational Site Number 840009

Owensboro, Kentucky, 42303, United States

Location

Investigational Site Number 840064

Bangor, Maine, 04401, United States

Location

Investigational Site Number 840080

Baltimore, Maryland, 21237, United States

Location

Investigational Site Number 840017

Chevy Chase, Maryland, 20815, United States

Location

Investigational Site Number 840073

Gaithersburg, Maryland, 20878, United States

Location

Investigational Site Number 840127

White Marsh, Maryland, 21162, United States

Location

Investigational Site Number 840014

North Dartmouth, Massachusetts, 02747, United States

Location

Investigational Site Number 840005

Minneapolis, Minnesota, 55402, United States

Location

Investigational Site Number 840013

Kansas City, Missouri, 64111, United States

Location

Investigational Site Number 840002

St Louis, Missouri, 63141, United States

Location

Investigational Site Number 840093

St Louis, Missouri, 63141, United States

Location

Investigational Site Number 840026

Missoula, Montana, 59808, United States

Location

Investigational Site Number 840078

Omaha, Nebraska, 68131, United States

Location

Investigational Site Number 840003

Papillion, Nebraska, 27103, United States

Location

Investigational Site Number 840111

Brick, New Jersey, 08723, United States

Location

Investigational Site Number 840068

Ocean City, New Jersey, 07712, United States

Location

Investigational Site Number 840016

Princeton, New Jersey, 08540, United States

Location

Investigational Site Number 840096

Toms River, New Jersey, 08775, United States

Location

Investigational Site Number 840106

Jamaica, New York, 11435, United States

Location

Investigational Site Number 840065

New York, New York, 10029, United States

Location

Investigational Site Number 840076

Rochester, New York, 14642, United States

Location

Investigational Site Number 840031

The Bronx, New York, 10457, United States

Location

Investigational Site Number 840126

Charlotte, North Carolina, 28226, United States

Location

Investigational Site Number 840083

Charlotte, North Carolina, 28277, United States

Location

Investigational Site Number 840108

Durham, North Carolina, 27705, United States

Location

Investigational Site Number 840107

Greensboro, North Carolina, 27403, United States

Location

Investigational Site Number 840007

High Point, North Carolina, 27262, United States

Location

Investigational Site Number 840046

Cincinnati, Ohio, 45241, United States

Location

Investigational Site Number 840049

Middleburg Heights, Ohio, 44130, United States

Location

Investigational Site Number 840042

Toledo, Ohio, 43617, United States

Location

Investigational Site Number 840112

Edmond, Oklahoma, 73034, United States

Location

Investigational Site Number 840121

Oklahoma City, Oklahoma, 73103, United States

Location

Investigational Site Number 840104

Tulsa, Oklahoma, 74136, United States

Location

Investigational Site Number 840040

Clackamas, Oregon, 97015, United States

Location

Investigational Site Number 840039

Medford, Oregon, 97504, United States

Location

Investigational Site Number 840001

Portland, Oregon, 97223, United States

Location

Investigational Site Number 840085

Hershey, Pennsylvania, 17033, United States

Location

Investigational Site Number 840081

Philadelphia, Pennsylvania, 19102, United States

Location

Investigational Site Number 840010

Philadelphia, Pennsylvania, 19107, United States

Location

Investigational Site Number 840067

Philadelphia, Pennsylvania, 19140, United States

Location

Investigational Site Number 840028

Pittsburgh, Pennsylvania, 15213, United States

Location

Investigational Site Number 840091

Pittsburgh, Pennsylvania, 15241, United States

Location

Investigational Site Number 840029

Lincoln, Rhode Island, 02286, United States

Location

Investigational Site Number 840082

Charleston, South Carolina, 29407, United States

Location

Investigational Site Number 840117

Greenville, South Carolina, 29607, United States

Location

Investigational Site Number 840100

Greer, South Carolina, 29651, United States

Location

Investigational Site Number 840054

Spartanburg, South Carolina, 29303, United States

Location

Investigational Site Number 840062

Amarillo, Texas, 79106, United States

Location

Investigational Site Number 840098

Austin, Texas, 78759, United States

Location

Investigational Site Number 840038

Boerne, Texas, 78006, United States

Location

Investigational Site Number 840124

Cypress, Texas, 77429, United States

Location

Investigational Site Number 840008

Dallas, Texas, 75231, United States

Location

Investigational Site Number 840094

Dallas, Texas, 75246, United States

Location

Investigational Site Number 840023

El Paso, Texas, 79903, United States

Location

Investigational Site Number 840022

Fort Worth, Texas, 76109, United States

Location

Investigational Site Number 840027

Fort Worth, Texas, 76244, United States

Location

Investigational Site Number 840066

Killeen, Texas, 76542, United States

Location

Investigational Site Number 840050

Live Oak, Texas, 78233, United States

Location

Investigational Site Number 840070

McKinney, Texas, 75069, United States

Location

Investigational Site Number 840128

McKinney, Texas, 75071, United States

Location

Investigational Site Number 840118

Plano, Texas, 75093, United States

Location

Investigational Site Number 840012

San Antonio, Texas, 78229, United States

Location

Investigational Site Number 840129

San Antonio, Texas, 78251, United States

Location

Investigational Site Number 840133

Sealy, Texas, 77474, United States

Location

Investigational Site Number 840119

Spring, Texas, 77380, United States

Location

Investigational Site Number 840035

Draper, Utah, 84020, United States

Location

Investigational Site Number 840077

Murray, Utah, 84107, United States

Location

Investigational Site Number 840057

South Burlington, Vermont, 05403, United States

Location

Investigational Site Number 840059

Fairfax, Virginia, 22030, United States

Location

Investigational Site Number 840113

Richmond, Virginia, 23294, United States

Location

Investigational Site Number 840051

Bellevue, Washington, 98225, United States

Location

Investigational Site Number 840043

Spokane, Washington, 99202, United States

Location

Investigational Site Number 032006

Bahía Blanca, B8000JRB, Argentina

Location

Investigational Site Number 032002

Buenos Aires, C1121ABE, Argentina

Location

Investigational Site Number 032011

Caba, 1120, Argentina

Location

Investigational Site Number 032007

Caba, C1414AIF, Argentina

Location

Investigational Site Number 032001

Caba, C1425BEN, Argentina

Location

Investigational Site Number 032003

Caba, C1425FVH, Argentina

Location

Investigational Site Number 032010

Caba, C1426ABP, Argentina

Location

Investigational Site Number 032005

Capital Federal, C1425DUC, Argentina

Location

Investigational Site Number 032008

La Plata, B1900DXM, Argentina

Location

Investigational Site Number 032004

Rosario, S2000JKR, Argentina

Location

Investigational Site Number 032012

San Miguel de Tucumán, T4000CHE, Argentina

Location

Investigational Site Number 032009

San Miguel de Tucumán, T4000IAR, Argentina

Location

Investigational Site Number 036005

Campbelltown, 2560, Australia

Location

Investigational Site Number 036001

Clayton, 3168, Australia

Location

Investigational Site Number 036002

Frankston, 3199, Australia

Location

Investigational Site Number 036006

Glen Osmond, 5064, Australia

Location

Investigational Site Number 036003

Murdoch, 6150, Australia

Location

Investigational Site Number 036004

Parkville, 3050, Australia

Location

Investigational Site Number 076009

Florianópolis, 88040-970, Brazil

Location

Investigational Site Number 076007

Porto Alegre, 90020-090, Brazil

Location

Investigational Site Number 076001

Porto Alegre, 90610-000, Brazil

Location

Investigational Site Number 076003

Salvador, 41940-455, Brazil

Location

Investigational Site Number 076013

São Bernardo do Campo, 09715-090, Brazil

Location

Investigational Site Number 076012

São Paulo, 04266-010, Brazil

Location

Investigational Site Number 076008

São Paulo, 05403-000, Brazil

Location

Investigational Site Number 076006

São Paulo, 05437-010, Brazil

Location

Investigational Site Number 076002

Sorocaba, 18040-425, Brazil

Location

Investigational Site Number 124019

Burlington, L7N 3V2, Canada

Location

Investigational Site Number 124009

Calgary, T2N 4Z6, Canada

Location

Investigational Site Number 124003

Mississauga, L5A 3V4, Canada

Location

Investigational Site Number 124001

Montreal, H2W 1T8, Canada

Location

Investigational Site Number 124012

Montreal, H4A 3J1, Canada

Location

Investigational Site Number 124010

Montreal, H4J 1C5, Canada

Location

Investigational Site Number 124013

Ottawa, K1G 6C6, Canada

Location

Investigational Site Number 124018

Québec, G1V 4G5, Canada

Location

Investigational Site Number 124014

Québec, G1V 4W2, Canada

Location

Investigational Site Number 124008

Sherbrooke, J1H 5N4, Canada

Location

Investigational Site Number 124015

Toronto, M5G 1E2, Canada

Location

Investigational Site Number 124002

Toronto, M5T 3A9, Canada

Location

Investigational Site Number 124007

Trois-Rivières, G8T 7A1, Canada

Location

Investigational Site Number 124006

Vancouver, V5Z 1M9, Canada

Location

Investigational Site Number 152015

Concepción, 41, Chile

Location

Investigational Site Number 152003

Quillota, 2260877, Chile

Location

Investigational Site Number 152014

Santiago, 7500588, Chile

Location

Investigational Site Number 152001

Santiago, 7500692, Chile

Location

Investigational Site Number 152002

Santiago, 7500698, Chile

Location

Investigational Site Number 152008

Santiago, 7500710, Chile

Location

Investigational Site Number 152017

Santiago, 7560994, Chile

Location

Investigational Site Number 152007

Santiago, 8207257, Chile

Location

Investigational Site Number 152005

Santiago, 8380456, Chile

Location

Investigational Site Number 152009

Santiago, 8910131, Chile

Location

Investigational Site Number 152004

Talca, 3460001, Chile

Location

Investigational Site Number 152013

Talcahuano, 427918, Chile

Location

Investigational Site Number 152016

Temuco, 4781156, Chile

Location

Investigational Site Number 152010

Valdivia, Chile

Location

Investigational Site Number 152011

Viña del Mar, 2520594, Chile

Location

Investigational Site Number 152012

Viña del Mar, Chile

Location

Investigational Site Number 170006

Bogotá, 110131, Colombia

Location

Investigational Site Number 170001

Bogotá, 110221, Colombia

Location

Investigational Site Number 170002

Bogotá, 110231, Colombia

Location

Investigational Site Number 170003

Bogotá, 111321, Colombia

Location

Investigational Site Number 250002

Brest, 29609, France

Location

Investigational Site Number 250013

Lille, 59000, France

Location

Investigational Site Number 250011

Lille, 59037, France

Location

Investigational Site Number 250004

Lyon, 69317, France

Location

Investigational Site Number 250010

Marseille, 13015, France

Location

Investigational Site Number 250005

Montpellier, 34295, France

Location

Investigational Site Number 250003

Nantes, 44093, France

Location

Investigational Site Number 250012

Paris, 75012, France

Location

Investigational Site Number 250001

Paris, 75018, France

Location

Investigational Site Number 250008

Strasbourg, 67091, France

Location

Investigational Site Number 250014

Vandœuvre-lès-Nancy, 54511, France

Location

Investigational Site Number 276006

Berlin, 10787, Germany

Location

Investigational Site Number 276003

Bochum, 44789, Germany

Location

Investigational Site Number 276010

Frankfurt am Main, 60596, Germany

Location

Investigational Site Number 276004

Hanover, 30625, Germany

Location

Investigational Site Number 276009

Koblenz, 56068, Germany

Location

Investigational Site Number 276007

Lübeck, 23538, Germany

Location

Investigational Site Number 276001

Mainz, 55131, Germany

Location

Investigational Site Number 276005

Rüdersdorf, 15562, Germany

Location

Investigational Site Number 348003

Gödöllö, 2100, Hungary

Location

Investigational Site Number 380004

Ancona, 60126, Italy

Location

Investigational Site Number 380005

Catania, 95123, Italy

Location

Investigational Site Number 380003

Ferrara, 44124, Italy

Location

Investigational Site Number 380006

Florence, 50134, Italy

Location

Investigational Site Number 380010

Foggia, 71122, Italy

Location

Investigational Site Number 380002

Modena, 41124, Italy

Location

Investigational Site Number 380009

Palermo, 90146, Italy

Location

Investigational Site Number 380001

Pisa, 56124, Italy

Location

Investigational Site Number 380014

Reggio Emilia, 42123, Italy

Location

Investigational Site Number 380011

Torino, 10128, Italy

Location

Investigational Site Number 392185

Akashi-Shi, Japan

Location

Investigational Site Number 392128

Asahikawa-Shi, Japan

Location

Investigational Site Number 392118

Chiyoda-Ku, Japan

Location

Investigational Site Number 392112

Chūōku, Japan

Location

Investigational Site Number 392157

Fukui-shi, Japan

Location

Investigational Site Number 392137

Fukuoka, Japan

Location

Investigational Site Number 392117

Fukuyama-Shi, Japan

Location

Investigational Site Number 392121

Habikino-Shi, Japan

Location

Investigational Site Number 392154

Higashiosaka-Shi, Japan

Location

Investigational Site Number 392109

Himeji-Shi, Japan

Location

Investigational Site Number 392108

Hiroshima, Japan

Location

Investigational Site Number 392158

Hiroshima, Japan

Location

Investigational Site Number 392107

Iizuka-Shi, Japan

Location

Investigational Site Number 392101

Isesaki-Shi, Japan

Location

Investigational Site Number 392147

Itabashi-Ku, Japan

Location

Investigational Site Number 392150

Kagoshima, Japan

Location

Investigational Site Number 392178

Kagoshima, Japan

Location

Investigational Site Number 392110

Kanazawa, Japan

Location

Investigational Site Number 392136

Kanazawa, Japan

Location

Investigational Site Number 392142

Kasuga-Shi, Japan

Location

Investigational Site Number 392166

Kawaguchi-Shi, Japan

Location

Investigational Site Number 392119

Kishiwada-Shi, Japan

Location

Investigational Site Number 392162

Kobe, Japan

Location

Investigational Site Number 392182

Kodaira-Shi, Japan

Location

Investigational Site Number 392174

Kokubunji-Shi, Japan

Location

Investigational Site Number 392131

Koshi-Shi, Japan

Location

Investigational Site Number 392183

Koshigaya-Shi, Japan

Location

Investigational Site Number 392129

Kurashiki-Shi, Japan

Location

Investigational Site Number 392153

Kyoto, Japan

Location

Investigational Site Number 392176

Kyoto, Japan

Location

Investigational Site Number 392184

Kyoto, Japan

Location

Investigational Site Number 392133

Machida-Shi, Japan

Location

Investigational Site Number 392135

Matsuyama, Japan

Location

Investigational Site Number 392172

Mibu, Japan

Location

Investigational Site Number 392114

Minatoku, Japan

Location

Investigational Site Number 392122

Minatoku, Japan

Location

Investigational Site Number 392144

Minatoku, Japan

Location

Investigational Site Number 392106

Mizunami-Shi, Japan

Location

Investigational Site Number 392164

Muroran-Shi, Japan

Location

Investigational Site Number 392161

Nagakute-Shi, Japan

Location

Investigational Site Number 392163

Nagoya, Japan

Location

Investigational Site Number 392102

Naka-Gun, Japan

Location

Investigational Site Number 392125

Nakano, Japan

Location

Investigational Site Number 392115

Naruto-Shi, Japan

Location

Investigational Site Number 392187

Obihiro-Shi, Japan

Location

Investigational Site Number 392177

Ome-Shi, Japan

Location

Investigational Site Number 392152

Osaka Sayama-Shi, Japan

Location

Investigational Site Number 392155

Osaka Sayama-Shi, Japan

Location

Investigational Site Number 392170

Osaki-Shi, Japan

Location

Investigational Site Number 392138

Ota-Shi, Japan

Location

Investigational Site Number 392123

Oura-Gun, Japan

Location

Investigational Site Number 392120

Ōta-ku, Japan

Location

Investigational Site Number 392127

Ōta-ku, Japan

Location

Investigational Site Number 392169

Sagamihara-Shi, Japan

Location

Investigational Site Number 392149

Sapporo, Japan

Location

Investigational Site Number 392179

Seto-Shi, Japan

Location

Investigational Site Number 392186

Shibuya-Ku, Japan

Location

Investigational Site Number 392139

Shinagawa-Ku, Japan

Location

Investigational Site Number 392167

Shinagawa-Ku, Japan

Location

Investigational Site Number 392130

Shinjuku-Ku, Japan

Location

Investigational Site Number 392165

Sumida-Ku, Japan

Location

Investigational Site Number 392146

Tachikawa-Shi, Japan

Location

Investigational Site Number 392173

Tachikawa-Shi, Japan

Location

Investigational Site Number 392103

Tokyo, Japan

Location

Investigational Site Number 392113

Tomakomai-Shi, Japan

Location

Investigational Site Number 392151

Tsu, Japan

Location

Investigational Site Number 392168

Uozu-Shi, Japan

Location

Investigational Site Number 392132

Urasoe-Shi, Japan

Location

Investigational Site Number 392134

Uruma, Japan

Location

Investigational Site Number 392116

Wakayama, Japan

Location

Investigational Site Number 392140

Yokohama, Japan

Location

Investigational Site Number 392159

Yonago-Shi, Japan

Location

Investigational Site Number 484013

Chihuahua City, 31020, Mexico

Location

Investigational Site Number 484006

Chihuahua City, 31200, Mexico

Location

Investigational Site Number 484014

Cuautitlán Izcalli, 54769, Mexico

Location

Investigational Site Number 484008

Durango, 34080, Mexico

Location

Investigational Site Number 484001

Guadalajara, 44100, Mexico

Location

Investigational Site Number 484004

Mexico City, 64718, Mexico

Location

Investigational Site Number 484010

México, 06700, Mexico

Location

Investigational Site Number 484003

Monterrey, 64460, Mexico

Location

Investigational Site Number 484007

Monterrey, 66465, Mexico

Location

Investigational Site Number 484012

San Juan del Río, 76800, Mexico

Location

Investigational Site Number 484011

Veracruz, 91910, Mexico

Location

Investigational Site Number 484015

Zapopan, 45100, Mexico

Location

Investigational Site Number 616006

Bialystok, 15-010, Poland

Location

Investigational Site Number 616003

Gdansk, 80-952, Poland

Location

Investigational Site Number 616007

Krakow, 31-159, Poland

Location

Investigational Site Number 616001

Lodz, 90-141, Poland

Location

Investigational Site Number 616005

Lodz, 90-153, Poland

Location

Investigational Site Number 616009

Lodz, 90-329, Poland

Location

Investigational Site Number 616002

Poznan, 60-693, Poland

Location

Investigational Site Number 616004

Sopot, 81-741, Poland

Location

Investigational Site Number 616008

Strzelce Opolskie, 47-100, Poland

Location

Investigational Site Number 643006

Moscow, 105077, Russia

Location

Investigational Site Number 643003

Moscow, 109240, Russia

Location

Investigational Site Number 643005

Moscow, 115280, Russia

Location

Investigational Site Number 643002

Moscow, 117574, Russia

Location

Investigational Site Number 643004

Moscow, 123182, Russia

Location

Investigational Site Number 643001

Moscow, 125315, Russia

Location

Investigational Site Number 643011

Ryazan, 390039, Russia

Location

Investigational Site Number 643007

Saint Petersburg, 193231, Russia

Location

Investigational Site Number 643008

Saint Petersburg, 194354, Russia

Location

Investigational Site Number 643009

Saint Petersburg, 195030, Russia

Location

Investigational Site Number 643010

Saint Petersburg, 197022, Russia

Location

Investigational Site Number 643012

Yaroslavl, 150003, Russia

Location

Investigational Site Number 643013

Yekaterinburg, 620109, Russia

Location

Investigational Site Number 710011

Cape Town, 7505, South Africa

Location

Investigational Site Number 710004

Cape Town, 7530, South Africa

Location

Investigational Site Number 710001

Cape Town, 7700, South Africa

Location

Investigational Site Number 710002

Cape Town, 7700, South Africa

Location

Investigational Site Number 710010

Cape Town, 7764, South Africa

Location

Investigational Site Number 710003

Cape Town, 8000, South Africa

Location

Investigational Site Number 710005

Durban, 4001, South Africa

Location

Investigational Site Number 710006

Durban, 4071, South Africa

Location

Investigational Site Number 710007

Pretoria, 0087, South Africa

Location

Investigational Site Number 710009

Winnie Mandela, 9400, South Africa

Location

Investigational Site Number 410002

Bucheon-si, 14584, South Korea

Location

Investigational Site Number 410015

Busan, 49201, South Korea

Location

Investigational Site Number 410003

Cheongju-si, 28644, South Korea

Location

Investigational Site Number 410013

Incheon, 21565, South Korea

Location

Investigational Site Number 410008

Seoul, 02559, South Korea

Location

Investigational Site Number 410006

Seoul, 03080, South Korea

Location

Investigational Site Number 410004

Seoul, 03722, South Korea

Location

Investigational Site Number 410012

Seoul, 04763, South Korea

Location

Investigational Site Number 410005

Seoul, 05505, South Korea

Location

Investigational Site Number 410007

Seoul, 06351, South Korea

Location

Investigational Site Number 410009

Seoul, 06591, South Korea

Location

Investigational Site Number 410010

Seoul, 06973, South Korea

Location

Investigational Site Number 410011

Seoul, 08308, South Korea

Location

Investigational Site Number 410001

Suwon, 16499, South Korea

Location

Investigational Site Number 410014

Uijeongbu-si, 11765, South Korea

Location

Investigational Site Number 724002

Barcelona, 08035, Spain

Location

Investigational Site Number 724001

Barcelona, 08036, Spain

Location

Investigational Site Number 724010

Palma de Mallorca, 07120, Spain

Location

Investigational Site Number 724005

Pozuelo de Alarcón, 28223, Spain

Location

Investigational Site Number 724004

Sant Boi de Llobregat, 08830, Spain

Location

Investigational Site Number 724006

Santiago de Compostela, 15706, Spain

Location

Investigational Site Number 724008

Seville, 41071, Spain

Location

Investigational Site Number 724007

Valencia, 46017, Spain

Location

Investigational Site Number 158004

Kaohsiung City, 807, Taiwan

Location

Investigational Site Number 158002

Kaohsiung City, 82445, Taiwan

Location

Investigational Site Number 158008

New Taipei City, 23561, Taiwan

Location

Investigational Site Number 158005

Taichung, 40201, Taiwan

Location

Investigational Site Number 158007

Taichung, 40447, Taiwan

Location

Investigational Site Number 158001

Taipei, 10043, Taiwan

Location

Investigational Site Number 158009

Taipei, 11031, Taiwan

Location

Investigational Site Number 158006

Taoyuan District, 333, Taiwan

Location

Investigational Site Number 792004

Ankara, 06100, Turkey (Türkiye)

Location

Investigational Site Number 792008

Ankara, 06100, Turkey (Türkiye)

Location

Investigational Site Number 792003

Bursa, 16059, Turkey (Türkiye)

Location

Investigational Site Number 792001

Istanbul, 34098, Turkey (Türkiye)

Location

Investigational Site Number 792007

Istanbul, 34668, Turkey (Türkiye)

Location

Investigational Site Number 792005

Izmir, 35040, Turkey (Türkiye)

Location

Investigational Site Number 792010

Izmir, 35110, Turkey (Türkiye)

Location

Investigational Site Number 792011

Kocaeli, 41100, Turkey (Türkiye)

Location

Investigational Site Number 792009

Kırıkkale, 71450, Turkey (Türkiye)

Location

Investigational Site Number 792002

Mersin, 33070, Turkey (Türkiye)

Location

Investigational Site Number 792006

Rize, 53100, Turkey (Türkiye)

Location

Investigational Site Number 804007

Chernivtsi, 58001, Ukraine

Location

Investigational Site Number 804023

Dnipro, 49101, Ukraine

Location

Investigational Site Number 804004

Ivano-Frankivsk, 76018, Ukraine

Location

Investigational Site Number 804009

Ivano-Frankivsk, 76018, Ukraine

Location

Investigational Site Number 804005

Kharkiv, 61058, Ukraine

Location

Investigational Site Number 804021

Kharkiv, 61093, Ukraine

Location

Investigational Site Number 804001

Kharkiv, 61124, Ukraine

Location

Investigational Site Number 804003

Kyiv, 03680, Ukraine

Location

Investigational Site Number 804008

Kyiv, 03680, Ukraine

Location

Investigational Site Number 804011

Kyiv, 03680, Ukraine

Location

Investigational Site Number 804013

Kyiv, 03680, Ukraine

Location

Investigational Site Number 804017

Kyiv, 03680, Ukraine

Location

Investigational Site Number 804016

Kyiv, 04050, Ukraine

Location

Investigational Site Number 804006

Odesa, 65025, Ukraine

Location

Investigational Site Number 804002

Poltava, 36038, Ukraine

Location

Investigational Site Number 804014

Ternopil, 46000, Ukraine

Location

Investigational Site Number 804012

Vinnytsia, 21001, Ukraine

Location

Investigational Site Number 804022

Zaporizhia, 69076, Ukraine

Location

Investigational Site Number 826001

Bradford, BD9 6RJ, United Kingdom

Location

Investigational Site Number 826002

London, EC1M 6BQ, United Kingdom

Location

Investigational Site Number 826005

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Investigational Site Number 826007

Portsmouth, PO6 3LY, United Kingdom

Location

Investigational Site Number 826006

South Shields, NE34 0PL, United Kingdom

Location

Investigational Site Number 826003

Sutton in Ashfield, NG17 4JL, United Kingdom

Location

Related Publications (32)

  • 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.

  • Pavord ID, Wechsler ME, Busse WW, Domingo C, Xia C, Gall R, Pandit-Abid N, Jacob-Nara JA, Radwan A, Rowe PJ, Deniz Y. Dupilumab efficacy in patients with type 2 asthma and early Feno level reductions. J Allergy Clin Immunol Glob. 2025 Apr 15;4(3):100474. doi: 10.1016/j.jacig.2025.100474. eCollection 2025 Aug.

  • Pavord ID, Casale TB, Corren J, FitzGerald MJ, Deniz Y, Altincatal A, Gall R, Pandit-Abid N, Radwan A, Jacob-Nara JA, Rowe PJ, Busse WW. Dupilumab Reduces Exacerbations Independent of Changes in Biomarkers in Moderate-to-Severe Asthma. J Allergy Clin Immunol Pract. 2024 Jul;12(7):1763-1772. doi: 10.1016/j.jaip.2024.03.031. Epub 2024 Mar 29.

  • Peters AT, Sagara H, Corren J, Domingo C, Altincatal A, Soler X, Pandit-Abid N, Crikelair N, Rowe PJ, Jacob-Nara JA, Deniz Y. Impact of dupilumab across seasons in patients with type 2, uncontrolled, moderate-to-severe asthma. Ann Allergy Asthma Immunol. 2024 Apr;132(4):477-484.e4. doi: 10.1016/j.anai.2023.11.021. Epub 2023 Nov 25.

  • Bleecker ER, Panettieri RA Jr, Lugogo NL, Corren J, Daizadeh N, Jacob-Nara JA, Deniz Y, Rowe PJ, Khodzhayev A, Soler X, Ferro TJ, Hansen CN. Dupilumab Efficacy in Patients with Type 2 Asthma with and without Elevated Blood Neutrophils. J Immunol Res. 2023 Oct 19;2023:9943584. doi: 10.1155/2023/9943584. eCollection 2023.

  • Corren J, Hanania NA, Busse WW, Sher LD, Altincatal A, Hardin M, Mannent LP, Amin N, Lederer DJ, Soler X, Jacob-Nara JA, Rowe PJ, Deniz Y. Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma with fungal sensitization. Clin Exp Allergy. 2023 Oct;53(10):1020-1030. doi: 10.1111/cea.14389. Epub 2023 Sep 26.

  • Maspero JF, Shafazand S, Cole J, Pavord ID, Busse WW, Msihid J, Gall R, Soler X, Radwan A, Khan AH, de Prado Gomez L, Jacob-Nara JA. Dupilumab efficacy in high sleep disturbance management among patients with type 2 asthma. Respir Med. 2023 Nov;218:107344. doi: 10.1016/j.rmed.2023.107344. Epub 2023 Sep 1.

  • Pavord ID, Bourdin A, Papi A, Domingo C, Corren J, Altincatal A, Radwan A, Pandit-Abid N, Jacob-Nara JA, Deniz Y, Rowe PJ, Laws E, Lederer DJ, Hardin M. Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of inhaled corticosteroids dose. Allergy. 2023 Nov;78(11):2921-2932. doi: 10.1111/all.15792. Epub 2023 Jul 11.

  • Rabe KF, Pavord ID, Busse WW, Chupp GL, Izuhara K, Altincatal A, Gall R, Pandit-Abid N, Deniz Y, Rowe PJ, Jacob-Nara JA, Radwan A. Dupilumab improves long-term outcomes in patients with uncontrolled, moderate-to-severe GINA-based type 2 asthma, irrespective of allergic status. Allergy. 2023 Aug;78(8):2148-2156. doi: 10.1111/all.15747. Epub 2023 May 21.

  • Pavord ID, Deniz Y, Corren J, Casale TB, FitzGerald JM, Izuhara K, Daizadeh N, Ortiz B, Johnson RR, Harel S, Djandji M, Goga L, Crikelair N, Rowe PJ, Busse WW. Baseline FeNO Independently Predicts the Dupilumab Response in Patients With Moderate-to-Severe Asthma. J Allergy Clin Immunol Pract. 2023 Apr;11(4):1213-1220.e2. doi: 10.1016/j.jaip.2022.11.043. Epub 2022 Dec 16.

  • Berger P, Menzies-Gow A, Peters AT, Kuna P, Rabe KF, Altincatal A, Soler X, Pandit-Abid N, Siddiqui S, Jacob-Nara JA, Deniz Y, Rowe PJ. Long-term efficacy of dupilumab in asthma with or without chronic rhinosinusitis and nasal polyps. Ann Allergy Asthma Immunol. 2023 Feb;130(2):215-224. doi: 10.1016/j.anai.2022.11.006. Epub 2022 Nov 7.

  • 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.

  • Rabe KF, FitzGerald JM, Bateman ED, Castro M, Pavord ID, Maspero JF, Busse WW, Izuhara K, Daizadeh N, Ortiz B, Pandit-Abid N, Rowe PJ, Deniz Y. Dupilumab Is Effective in Patients With Moderate-to-Severe Uncontrolled GINA-Defined Type 2 Asthma Irrespective of an Allergic Asthma Phenotype. J Allergy Clin Immunol Pract. 2022 Nov;10(11):2916-2924.e4. doi: 10.1016/j.jaip.2022.06.036. Epub 2022 Aug 23.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Asthma

Interventions

dupilumabTherapeuticsAlbuterolLevalbuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 13, 2015

Study Start

April 27, 2015

Primary Completion

July 29, 2017

Study Completion

November 23, 2017

Last Updated

October 23, 2018

Results First Posted

October 23, 2018

Record last verified: 2018-06

Locations