AzTrials
AzTrials

AsthmaPhase 3NCT02414854

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

A Phase 3 study testing Dupilumab, Inhaled corticosteroid (ICS) therapy and Albuterol/Salbutamol in people with Asthma, run by Sanofi at 389 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Dupilumab, Inhaled corticosteroid (ICS) therapy and Albuterol/Salbutamol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,902 participants
Where
389 sitesin 22 countries
Study dates
27 Apr 2015to 23 Nov 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • -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:
  • 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.
  • 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).
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

389 sites in 22 countries.

389 sites in 22 countries

United States116 sites

  • Investigational Site Number 840062

    Amarillo, Texas, 79106

  • Investigational Site Number 840098

    Austin, Texas, 78759

  • Investigational Site Number 840037

    Aventura, Florida, 33180

  • Investigational Site Number 840109

    Bakersfield, California, 93301

  • Investigational Site Number 840080

    Baltimore, Maryland, 21237

  • Investigational Site Number 840064

    Bangor, Maine, 04401

  • Investigational Site Number 840051

    Bellevue, Washington, 98225

  • Investigational Site Number 840047

    Birmingham, Alabama, 35209

  • Investigational Site Number 840038

    Boerne, Texas, 78006

  • Investigational Site Number 840018

    Boynton Beach, Florida, 33472

  • Investigational Site Number 840105

    Brandon, Florida, 33511

  • Investigational Site Number 840111

    Brick, New Jersey, 08723

  • Investigational Site Number 840004

    Centennial, Colorado, 80112

  • Investigational Site Number 840082

    Charleston, South Carolina, 29407

  • Investigational Site Number 840126

    Charlotte, North Carolina, 28226

  • Investigational Site Number 840083

    Charlotte, North Carolina, 28277

  • Investigational Site Number 840017

    Chevy Chase, Maryland, 20815

  • Investigational Site Number 840101

    Chicago, Illinois, 60611

  • Investigational Site Number 840046

    Cincinnati, Ohio, 45241

  • Investigational Site Number 840040

    Clackamas, Oregon, 97015

  • Investigational Site Number 840092

    Clearwater, Florida, 33765

  • Investigational Site Number 840025

    Colorado Springs, Colorado, 80907

  • Investigational Site Number 840052

    Costa Mesa, California, 92626

  • Investigational Site Number 840124

    Cypress, Texas, 77429

  • Investigational Site Number 840008

    Dallas, Texas, 75231

  • Investigational Site Number 840094

    Dallas, Texas, 75246

  • Investigational Site Number 840034

    Denver, Colorado, 80230

  • Investigational Site Number 840130

    Denver, Colorado, 80246

  • Investigational Site Number 840035

    Draper, Utah, 84020

  • Investigational Site Number 840108

    Durham, North Carolina, 27705

  • Investigational Site Number 840112

    Edmond, Oklahoma, 73034

  • Investigational Site Number 840023

    El Paso, Texas, 79903

  • Investigational Site Number 840059

    Fairfax, Virginia, 22030

  • Investigational Site Number 840056

    Flagstaff, Arizona, 86001

  • Investigational Site Number 840032

    Fort Mitchell, Kentucky, 41017

  • Investigational Site Number 840022

    Fort Worth, Texas, 76109

  • Investigational Site Number 840027

    Fort Worth, Texas, 76244

  • Investigational Site Number 840116

    Fresno, California, 93720

  • Investigational Site Number 840084

    Gainesville, Georgia, 30506

  • Investigational Site Number 840073

    Gaithersburg, Maryland, 20878

  • Investigational Site Number 840099

    Gilbert, Arizona, 85234

  • Investigational Site Number 840107

    Greensboro, North Carolina, 27403

  • Investigational Site Number 840117

    Greenville, South Carolina, 29607

  • Investigational Site Number 840100

    Greer, South Carolina, 29651

  • Investigational Site Number 840085

    Hershey, Pennsylvania, 17033

  • Investigational Site Number 840122

    Hialeah, Florida, 33012

  • Investigational Site Number 840007

    High Point, North Carolina, 27262

  • Investigational Site Number 840089

    Iowa City, Iowa, 52242

  • Investigational Site Number 840106

    Jamaica, New York, 11435

  • Investigational Site Number 840013

    Kansas City, Missouri, 64111

  • Investigational Site Number 840066

    Killeen, Texas, 76542

  • Investigational Site Number 840029

    Lincoln, Rhode Island, 02286

  • Investigational Site Number 840132

    Little Rock, Arkansas, 72209

  • Investigational Site Number 840050

    Live Oak, Texas, 78233

  • Investigational Site Number 840045

    Long Beach, California, 90720

  • Investigational Site Number 840011

    Los Angeles, California, 90025

  • Investigational Site Number 840061

    Los Angeles, California, 90048

  • Investigational Site Number 840097

    Los Angeles, California, 90064

  • Investigational Site Number 840053

    Loxahatchee Groves, Florida, 33470

  • Investigational Site Number 840070

    McKinney, Texas, 75069

  • Investigational Site Number 840128

    McKinney, Texas, 75071

  • Investigational Site Number 840039

    Medford, Oregon, 97504

  • Investigational Site Number 840069

    Miami, Florida, 33173

  • Investigational Site Number 840049

    Middleburg Heights, Ohio, 44130

  • Investigational Site Number 840005

    Minneapolis, Minnesota, 55402

  • Investigational Site Number 840019

    Mission Viejo, California, 92691

  • Investigational Site Number 840026

    Missoula, Montana, 59808

  • Investigational Site Number 840077

    Murray, Utah, 84107

  • Investigational Site Number 840102

    New Haven, Connecticut, 06504

  • Investigational Site Number 840065

    New York, New York, 10029

  • Investigational Site Number 840125

    Newport Beach, California, 92663

  • Investigational Site Number 840014

    North Dartmouth, Massachusetts, 02747

  • Investigational Site Number 840041

    North Hollywood, California, 91606

  • Investigational Site Number 840123

    Ocala, Florida, 34471

  • Investigational Site Number 840071

    Ocala, Florida, 34474

  • Investigational Site Number 840068

    Ocean City, New Jersey, 07712

  • Investigational Site Number 840115

    Ocoee, Florida, 34761

  • Investigational Site Number 840121

    Oklahoma City, Oklahoma, 73103

  • Investigational Site Number 840078

    Omaha, Nebraska, 68131

  • Investigational Site Number 840009

    Owensboro, Kentucky, 42303

  • Investigational Site Number 840003

    Papillion, Nebraska, 27103

  • Investigational Site Number 840081

    Philadelphia, Pennsylvania, 19102

  • Investigational Site Number 840010

    Philadelphia, Pennsylvania, 19107

  • Investigational Site Number 840067

    Philadelphia, Pennsylvania, 19140

  • Investigational Site Number 840028

    Pittsburgh, Pennsylvania, 15213

  • Investigational Site Number 840091

    Pittsburgh, Pennsylvania, 15241

  • Investigational Site Number 840118

    Plano, Texas, 75093

  • Investigational Site Number 840001

    Portland, Oregon, 97223

  • Investigational Site Number 840016

    Princeton, New Jersey, 08540

  • Investigational Site Number 840036

    Redwood City, California, 94063

  • Investigational Site Number 840113

    Richmond, Virginia, 23294

  • Investigational Site Number 840015

    River Forest, Illinois, 60305

  • Investigational Site Number 840076

    Rochester, New York, 14642

  • Investigational Site Number 840020

    Rolling Hills Estates, California, 90274

  • Investigational Site Number 840074

    Roseville, California, 95661

  • Investigational Site Number 840012

    San Antonio, Texas, 78229

  • Investigational Site Number 840129

    San Antonio, Texas, 78251

  • Investigational Site Number 840021

    San Jose, California, 95117

  • Investigational Site Number 840055

    Sarasota, Florida, 34239

  • Investigational Site Number 840044

    Savannah, Georgia, 31406

  • Investigational Site Number 840087

    Scottsdale, Arizona, 85251

  • Investigational Site Number 840133

    Sealy, Texas, 77474

  • Investigational Site Number 840057

    South Burlington, Vermont, 05403

  • Investigational Site Number 840114

    South Miami, Florida, 33143

  • Investigational Site Number 840054

    Spartanburg, South Carolina, 29303

  • Investigational Site Number 840043

    Spokane, Washington, 99202

  • Investigational Site Number 840119

    Spring, Texas, 77380

  • Investigational Site Number 840002

    St Louis, Missouri, 63141

  • Investigational Site Number 840093

    St Louis, Missouri, 63141

  • Investigational Site Number 840048

    Tampa, Florida, 33612

  • Investigational Site Number 840031

    The Bronx, New York, 10457

  • Investigational Site Number 840042

    Toledo, Ohio, 43617

  • Investigational Site Number 840096

    Toms River, New Jersey, 08775

  • Investigational Site Number 840104

    Tulsa, Oklahoma, 74136

  • Investigational Site Number 840079

    Twin Falls, Idaho, 83301

  • Investigational Site Number 840127

    White Marsh, Maryland, 21162

Other trials in United States

Japan72 sites

  • Investigational Site Number 392185

    Akashi-Shi

  • Investigational Site Number 392128

    Asahikawa-Shi

  • Investigational Site Number 392118

    Chiyoda-Ku

  • Investigational Site Number 392112

    Chūōku

  • Investigational Site Number 392157

    Fukui-shi

  • Investigational Site Number 392137

    Fukuoka

  • Investigational Site Number 392117

    Fukuyama-Shi

  • Investigational Site Number 392121

    Habikino-Shi

  • Investigational Site Number 392154

    Higashiosaka-Shi

  • Investigational Site Number 392109

    Himeji-Shi

  • Investigational Site Number 392108

    Hiroshima

  • Investigational Site Number 392158

    Hiroshima

  • Investigational Site Number 392107

    Iizuka-Shi

  • Investigational Site Number 392101

    Isesaki-Shi

  • Investigational Site Number 392150

    Kagoshima

  • Investigational Site Number 392178

    Kagoshima

  • Investigational Site Number 392110

    Kanazawa

  • Investigational Site Number 392136

    Kanazawa

  • Investigational Site Number 392142

    Kasuga-Shi

  • Investigational Site Number 392166

    Kawaguchi-Shi

  • Investigational Site Number 392119

    Kishiwada-Shi

  • Investigational Site Number 392162

    Kobe

  • Investigational Site Number 392182

    Kodaira-Shi

  • Investigational Site Number 392174

    Kokubunji-Shi

  • Investigational Site Number 392131

    Koshi-Shi

  • Investigational Site Number 392183

    Koshigaya-Shi

  • Investigational Site Number 392129

    Kurashiki-Shi

  • Investigational Site Number 392153

    Kyoto

  • Investigational Site Number 392176

    Kyoto

  • Investigational Site Number 392184

    Kyoto

  • Investigational Site Number 392133

    Machida-Shi

  • Investigational Site Number 392135

    Matsuyama

  • Investigational Site Number 392172

    Mibu

  • Investigational Site Number 392114

    Minatoku

  • Investigational Site Number 392122

    Minatoku

  • Investigational Site Number 392144

    Minatoku

  • Investigational Site Number 392106

    Mizunami-Shi

  • Investigational Site Number 392164

    Muroran-Shi

  • Investigational Site Number 392161

    Nagakute-Shi

  • Investigational Site Number 392163

    Nagoya

  • Investigational Site Number 392102

    Naka-Gun

  • Investigational Site Number 392125

    Nakano

  • Investigational Site Number 392115

    Naruto-Shi

  • Investigational Site Number 392187

    Obihiro-Shi

  • Investigational Site Number 392177

    Ome-Shi

  • Investigational Site Number 392152

    Osaka Sayama-Shi

  • Investigational Site Number 392155

    Osaka Sayama-Shi

  • Investigational Site Number 392170

    Osaki-Shi

  • Investigational Site Number 392120

    Ōta-ku

  • Investigational Site Number 392127

    Ōta-ku

  • Investigational Site Number 392138

    Ota-Shi

  • Investigational Site Number 392123

    Oura-Gun

  • Investigational Site Number 392169

    Sagamihara-Shi

  • Investigational Site Number 392149

    Sapporo

  • Investigational Site Number 392179

    Seto-Shi

  • Investigational Site Number 392186

    Shibuya-Ku

  • Investigational Site Number 392139

    Shinagawa-Ku

  • Investigational Site Number 392167

    Shinagawa-Ku

  • Investigational Site Number 392130

    Shinjuku-Ku

  • Investigational Site Number 392165

    Sumida-Ku

  • Investigational Site Number 392147

    tabashi City

  • Investigational Site Number 392146

    Tachikawa-Shi

  • Investigational Site Number 392173

    Tachikawa-Shi

  • Investigational Site Number 392103

    Tokyo

  • Investigational Site Number 392113

    Tomakomai-Shi

  • Investigational Site Number 392151

    Tsu

  • Investigational Site Number 392168

    Uozu-Shi

  • Investigational Site Number 392132

    Urasoe-Shi

  • Investigational Site Number 392134

    Uruma

  • Investigational Site Number 392116

    Wakayama

  • Investigational Site Number 392140

    Yokohama

  • Investigational Site Number 392159

    Yonago-Shi

Other trials in Japan

Ukraine18 sites

  • Investigational Site Number 804007

    Chernivtsi, 58001

  • Investigational Site Number 804023

    Dnipro, 49101

  • Investigational Site Number 804004

    Ivano-Frankivsk, 76018

  • Investigational Site Number 804009

    Ivano-Frankivsk, 76018

  • Investigational Site Number 804005

    Kharkiv, 61058

  • Investigational Site Number 804021

    Kharkiv, 61093

  • Investigational Site Number 804001

    Kharkiv, 61124

  • Investigational Site Number 804003

    Kyiv, 03680

  • Investigational Site Number 804008

    Kyiv, 03680

  • Investigational Site Number 804011

    Kyiv, 03680

  • Investigational Site Number 804013

    Kyiv, 03680

  • Investigational Site Number 804017

    Kyiv, 03680

  • Investigational Site Number 804016

    Kyiv, 04050

  • Investigational Site Number 804006

    Odesa, 65025

  • Investigational Site Number 804002

    Poltava, 36038

  • Investigational Site Number 804014

    Ternopil, 46000

  • Investigational Site Number 804012

    Vinnytsia, 21001

  • Investigational Site Number 804022

    Zaporizhia, 69076

Other trials in Ukraine

Chile16 sites

  • Investigational Site Number 152015

    Concepción, 41

  • Investigational Site Number 152003

    Quillota, 2260877

  • Investigational Site Number 152014

    Santiago, 7500588

  • Investigational Site Number 152001

    Santiago, 7500692

  • Investigational Site Number 152002

    Santiago, 7500698

  • Investigational Site Number 152008

    Santiago, 7500710

  • Investigational Site Number 152017

    Santiago, 7560994

  • Investigational Site Number 152007

    Santiago, 8207257

  • Investigational Site Number 152005

    Santiago, 8380456

  • Investigational Site Number 152009

    Santiago, 8910131

  • Investigational Site Number 152004

    Talca, 3460001

  • Investigational Site Number 152013

    Talcahuano, 427918

  • Investigational Site Number 152016

    Temuco, 4781156

  • Investigational Site Number 152010

    Valdivia

  • Investigational Site Number 152011

    Viña del Mar, 2520594

  • Investigational Site Number 152012

    Viña del Mar

Other trials in Chile

South Korea15 sites

  • Investigational Site Number 410002

    Bucheon-si, 14584

  • Investigational Site Number 410015

    Busan, 49201

  • Investigational Site Number 410003

    Cheongju-si, 28644

  • Investigational Site Number 410013

    Incheon, 21565

  • Investigational Site Number 410008

    Seoul, 02559

  • Investigational Site Number 410006

    Seoul, 03080

  • Investigational Site Number 410004

    Seoul, 03722

  • Investigational Site Number 410012

    Seoul, 04763

  • Investigational Site Number 410005

    Seoul, 05505

  • Investigational Site Number 410007

    Seoul, 06351

  • Investigational Site Number 410009

    Seoul, 06591

  • Investigational Site Number 410010

    Seoul, 06973

  • Investigational Site Number 410011

    Seoul, 08308

  • Investigational Site Number 410001

    Suwon, 16499

  • Investigational Site Number 410014

    Uijeongbu-si, 11765

Other trials in South Korea

Canada14 sites

  • Investigational Site Number 124019

    Burlington, L7N 3V2

  • Investigational Site Number 124009

    Calgary, T2N 4Z6

  • Investigational Site Number 124003

    Mississauga, L5A 3V4

  • Investigational Site Number 124001

    Montreal, H2W 1T8

  • Investigational Site Number 124012

    Montreal, H4A 3J1

  • Investigational Site Number 124010

    Montreal, H4J 1C5

  • Investigational Site Number 124013

    Ottawa, K1G 6C6

  • Investigational Site Number 124018

    Québec, G1V 4G5

  • Investigational Site Number 124014

    Québec, G1V 4W2

  • Investigational Site Number 124008

    Sherbrooke, J1H 5N4

  • Investigational Site Number 124015

    Toronto, M5G 1E2

  • Investigational Site Number 124002

    Toronto, M5T 3A9

  • Investigational Site Number 124007

    Trois-Rivières, G8T 7A1

  • Investigational Site Number 124006

    Vancouver, V5Z 1M9

Other trials in Canada

Russia13 sites

  • Investigational Site Number 643006

    Moscow, 105077

  • Investigational Site Number 643003

    Moscow, 109240

  • Investigational Site Number 643005

    Moscow, 115280

  • Investigational Site Number 643002

    Moscow, 117574

  • Investigational Site Number 643004

    Moscow, 123182

  • Investigational Site Number 643001

    Moscow, 125315

  • Investigational Site Number 643011

    Ryazan, 390039

  • Investigational Site Number 643007

    Saint Petersburg, 193231

  • Investigational Site Number 643008

    Saint Petersburg, 194354

  • Investigational Site Number 643009

    Saint Petersburg, 195030

  • Investigational Site Number 643010

    Saint Petersburg, 197022

  • Investigational Site Number 643012

    Yaroslavl, 150003

  • Investigational Site Number 643013

    Yekaterinburg, 620109

Other trials in Russia

Argentina12 sites

  • Investigational Site Number 032006

    Bahía Blanca, B8000JRB

  • Investigational Site Number 032002

    Buenos Aires, C1121ABE

  • Investigational Site Number 032011

    Caba, 1120

  • Investigational Site Number 032007

    Caba, C1414AIF

  • Investigational Site Number 032001

    Caba, C1425BEN

  • Investigational Site Number 032003

    Caba, C1425FVH

  • Investigational Site Number 032010

    Caba, C1426ABP

  • Investigational Site Number 032005

    Capital Federal, C1425DUC

  • Investigational Site Number 032008

    La Plata, B1900DXM

  • Investigational Site Number 032004

    Rosario, S2000JKR

  • Investigational Site Number 032012

    San Miguel de Tucumán, T4000CHE

  • Investigational Site Number 032009

    San Miguel de Tucumán, T4000IAR

Other trials in Argentina

Mexico12 sites

  • Investigational Site Number 484013

    Chihuahua City, 31020

  • Investigational Site Number 484006

    Chihuahua City, 31200

  • Investigational Site Number 484014

    Cuautitlán Izcalli, 54769

  • Investigational Site Number 484008

    Durango, 34080

  • Investigational Site Number 484001

    Guadalajara, 44100

  • Investigational Site Number 484010

    México, 06700

  • Investigational Site Number 484004

    Mexico City, 64718

  • Investigational Site Number 484003

    Monterrey, 64460

  • Investigational Site Number 484007

    Monterrey, 66465

  • Investigational Site Number 484012

    San Juan del Río, 76800

  • Investigational Site Number 484011

    Veracruz, 91910

  • Investigational Site Number 484015

    Zapopan, 45100

Other trials in Mexico

France11 sites

  • Investigational Site Number 250002

    Brest, 29609

  • Investigational Site Number 250013

    Lille, 59000

  • Investigational Site Number 250011

    Lille, 59037

  • Investigational Site Number 250004

    Lyon, 69317

  • Investigational Site Number 250010

    Marseille, 13015

  • Investigational Site Number 250005

    Montpellier, 34295

  • Investigational Site Number 250003

    Nantes, 44093

  • Investigational Site Number 250012

    Paris, 75012

  • Investigational Site Number 250001

    Paris, 75018

  • Investigational Site Number 250008

    Strasbourg, 67091

  • Investigational Site Number 250014

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Turkey (Türkiye)11 sites

  • Investigational Site Number 792004

    Ankara, 06100

  • Investigational Site Number 792008

    Ankara, 06100

  • Investigational Site Number 792003

    Bursa, 16059

  • Investigational Site Number 792001

    Istanbul, 34098

  • Investigational Site Number 792007

    Istanbul, 34668

  • Investigational Site Number 792005

    Izmir, 35040

  • Investigational Site Number 792010

    Izmir, 35110

  • Investigational Site Number 792009

    Kirikkale, 71450

  • Investigational Site Number 792011

    Kocaeli, 41100

  • Investigational Site Number 792002

    Mersin, 33070

  • Investigational Site Number 792006

    Rize, 53100

Other trials in Turkey (Türkiye)

Italy10 sites

  • Investigational Site Number 380004

    Ancona, 60126

  • Investigational Site Number 380005

    Catania, 95123

  • Investigational Site Number 380003

    Ferrara, 44124

  • Investigational Site Number 380006

    Florence, 50134

  • Investigational Site Number 380010

    Foggia, 71122

  • Investigational Site Number 380002

    Modena, 41124

  • Investigational Site Number 380009

    Palermo, 90146

  • Investigational Site Number 380001

    Pisa, 56124

  • Investigational Site Number 380014

    Reggio Emilia, 42123

  • Investigational Site Number 380011

    Torino, 10128

Other trials in Italy

South Africa10 sites

  • Investigational Site Number 710011

    Cape Town, 7505

  • Investigational Site Number 710004

    Cape Town, 7530

  • Investigational Site Number 710001

    Cape Town, 7700

  • Investigational Site Number 710002

    Cape Town, 7700

  • Investigational Site Number 710010

    Cape Town, 7764

  • Investigational Site Number 710003

    Cape Town, 8000

  • Investigational Site Number 710005

    Durban, 4001

  • Investigational Site Number 710006

    Durban, 4071

  • Investigational Site Number 710007

    Pretoria, 0087

  • Investigational Site Number 710009

    Winnie Mandela, 9400

Other trials in South Africa

Brazil9 sites

  • Investigational Site Number 076009

    Florianópolis, 88040-970

  • Investigational Site Number 076007

    Porto Alegre, 90020-090

  • Investigational Site Number 076001

    Porto Alegre, 90610-000

  • Investigational Site Number 076003

    Salvador, 41940-455

  • Investigational Site Number 076013

    São Bernardo do Campo, 09715-090

  • Investigational Site Number 076012

    São Paulo, 04266-010

  • Investigational Site Number 076008

    São Paulo, 05403-000

  • Investigational Site Number 076006

    São Paulo, 05437-010

  • Investigational Site Number 076002

    Sorocaba, 18040-425

Other trials in Brazil

Poland9 sites

  • Investigational Site Number 616006

    Bialystok, 15-010

  • Investigational Site Number 616003

    Gdansk, 80-952

  • Investigational Site Number 616007

    Krakow, 31-159

  • Investigational Site Number 616001

    Lodz, 90-141

  • Investigational Site Number 616005

    Lodz, 90-153

  • Investigational Site Number 616009

    Lodz, 90-329

  • Investigational Site Number 616002

    Poznan, 60-693

  • Investigational Site Number 616004

    Sopot, 81-741

  • Investigational Site Number 616008

    Strzelce Opolskie, 47-100

Other trials in Poland

Germany8 sites

  • Investigational Site Number 276006

    Berlin, 10787

  • Investigational Site Number 276003

    Bochum, 44789

  • Investigational Site Number 276010

    Frankfurt am Main, 60596

  • Investigational Site Number 276004

    Hanover, 30625

  • Investigational Site Number 276009

    Koblenz, 56068

  • Investigational Site Number 276007

    Lübeck, 23538

  • Investigational Site Number 276001

    Mainz, 55131

  • Investigational Site Number 276005

    Rüdersdorf, 15562

Other trials in Germany

Spain8 sites

  • Investigational Site Number 724002

    Barcelona, 08035

  • Investigational Site Number 724001

    Barcelona, 08036

  • Investigational Site Number 724010

    Palma de Mallorca, 07120

  • Investigational Site Number 724005

    Pozuelo de Alarcón, 28223

  • Investigational Site Number 724004

    Sant Boi de Llobregat, 08830

  • Investigational Site Number 724006

    Santiago de Compostela, 15706

  • Investigational Site Number 724008

    Seville, 41071

  • Investigational Site Number 724007

    Valencia, 46017

Other trials in Spain

Taiwan8 sites

  • Investigational Site Number 158004

    Kaohsiung City, 807

  • Investigational Site Number 158002

    Kaohsiung City, 82445

  • Investigational Site Number 158008

    New Taipei City, 23561

  • Investigational Site Number 158005

    Taichung, 40201

  • Investigational Site Number 158007

    Taichung, 40447

  • Investigational Site Number 158001

    Taipei, 10043

  • Investigational Site Number 158009

    Taipei, 11031

  • Investigational Site Number 158006

    Taoyuan, 333

Other trials in Taiwan

Australia6 sites

  • Investigational Site Number 036005

    Campbelltown, 2560

  • Investigational Site Number 036001

    Clayton, 3168

  • Investigational Site Number 036002

    Frankston, 3199

  • Investigational Site Number 036006

    Glen Osmond, 5064

  • Investigational Site Number 036003

    Murdoch, 6150

  • Investigational Site Number 036004

    Parkville, 3050

Other trials in Australia

United Kingdom6 sites

  • Investigational Site Number 826001

    Bradford, BD9 6RJ

  • Investigational Site Number 826002

    London, EC1M 6BQ

  • Investigational Site Number 826005

    Newcastle upon Tyne, NE7 7DN

  • Investigational Site Number 826007

    Portsmouth, PO6 3LY

  • Investigational Site Number 826006

    South Shields, NE34 0PL

  • Investigational Site Number 826003

    Sutton in Ashfield, NG17 4JL

Other trials in United Kingdom

Colombia4 sites

  • Investigational Site Number 170006

    Bogotá, 110131

  • Investigational Site Number 170001

    Bogotá, 110221

  • Investigational Site Number 170002

    Bogotá, 110231

  • Investigational Site Number 170003

    Bogotá, 111321

Other trials in Colombia

Hungary1 site

  • Investigational Site Number 348003

    Gödöllö, 2100

Other trials in Hungary

About this study

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

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.
Read the 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.

Conditions
Asthma
Being tested
Dupilumab, Placebo, Inhaled corticosteroid (ICS) therapy, Albuterol/Salbutamol, Levalbuterol/Levosalbutamol
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called SAR231893, REGN668

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

  • PlaceboDrug

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

  • Inhaled corticosteroid (ICS) therapyDrug

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

  • Albuterol/SalbutamolDrug

    Oral inhalation as needed

  • Levalbuterol/LevosalbutamolDrug

    Oral inhalation as needed

Study groups in NCT02414854
Study groupRoleWhat they receive
Placebo (for Dupilumab 200 mg) q2wPlacebo comparator2 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.
Receives: Drug: Placebo; Drug: Inhaled corticosteroid (ICS) therapy; Drug: Albuterol/Salbutamol; Drug: Levalbuterol/Levosalbutamol
Dupilumab 200 mg q2wExperimental2 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.
Receives: Drug: Dupilumab; Drug: Inhaled corticosteroid (ICS) therapy; Drug: Albuterol/Salbutamol; Drug: Levalbuterol/Levosalbutamol
Placebo (for Dupilumab 300 mg) q2wPlacebo comparator2 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.
Receives: Drug: Placebo; Drug: Inhaled corticosteroid (ICS) therapy; Drug: Albuterol/Salbutamol; Drug: Levalbuterol/Levosalbutamol
Dupilumab 300 mg q2wExperimental2 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.
Receives: Drug: Dupilumab; Drug: Inhaled corticosteroid (ICS) therapy; Drug: Albuterol/Salbutamol; Drug: Levalbuterol/Levosalbutamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 52

  2. 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.

    Measured: Baseline, Week 12

Secondary outcomes (37)

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

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

    Measured: Baseline, Week 12

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

    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.

    Measured: Baseline to Week 52

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

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

    Measured: Baseline, Week 12

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

    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.

    Measured: Baseline to Week 52

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

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

    Measured: Baseline, Week 12

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

    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.

    Measured: Baseline to Week 52

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

    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.

    Measured: Baseline to Week 52

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

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

    Measured: Baseline, Week 12

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

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

    Measured: Baseline, Week 24

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

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

    Measured: Baseline, Week 24

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

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

    Measured: Baseline, Week 24

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

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

    Measured: Baseline to Week 52

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

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

    Measured: Baseline, Week 12

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

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

    Measured: Baseline, Week 12

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

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

    Measured: Baseline, Week 12

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

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

    Measured: Baseline, Week 12

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Measured: Baseline to Week 52

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

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

    Measured: Baseline up to Week 52

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

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

    Measured: Baseline up to Week 52

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Measured: Baseline, Weeks 12, 36, and 52

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

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

    Measured: Baseline, Weeks 12, 24, 36, and 52

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

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

    Measured: Baseline, Weeks 12, 24, 36, and 52

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

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

    Measured: Baseline, Weeks 12, 24, 36, and 52

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

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

    Measured: Baseline, Weeks 12, 24, 36, and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2015 (estimated)
  2. Study start27 Apr 2015
  3. Primary completion29 Jul 2017
  4. Study completion23 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,902 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02414854
Sponsor's protocol ID
EFC13579
Other IDs
2014-004940-36, U1111-1163-1293, 2014
Status last verified
Jun 2018
First submitted
8 Apr 2015
Last updated
23 Oct 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29782217

  • Busse WW, Castro M, Lugogo NL, O'Byrne PM, Bacharier LB, Xia C, Ledanois O, Soliman M. Improved asthma outcomes with dupilumab plus medium-dose inhaled corticosteroids vs placebo plus high-dose inhaled corticosteroids. Ann Allergy Asthma Immunol. 2026 May 23:S1081-1206(26)00223-1. doi: 10.1016/j.anai.2026.05.019. Online ahead of print.

    PubMed 42178021

  • Busse WW, Kraft M, Domingo C, de Mir-Messa I, Maselli DJ, Soler X, Xia C, Pandit-Abid N, Jacob-Nara JA, Sacks HJ, Rowe PJ, Deniz Y. Impact of asthma age of onset or duration on efficacy of dupilumab in moderate-to-severe type 2 asthma. J Asthma. 2025 Oct;62(10):1678-1689. doi: 10.1080/02770903.2025.2494233. Epub 2025 Aug 6.

    PubMed 40767333

  • 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.

    PubMed 40458676

  • Pavord ID, Rabe KF, Israel E, Szefler SJ, Brusselle G, Pandit-Abid N, Altincatal A, Chen Z, Amin N, Khan AH, Lederer DJ, Zhang Y, Rowe PJ, Deniz Y, Radwan A, Jacob-Nara JA, Busse WW. Dupilumab Induces Long-Term On-Treatment Clinical Remission in Patients With Type 2 Asthma. J Allergy Clin Immunol Pract. 2025 Jan;13(1):132-142. doi: 10.1016/j.jaip.2024.10.009. Epub 2024 Oct 16.

    PubMed 39424189

  • 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.

    PubMed 38555079

  • 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.

    PubMed 38013139

  • 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.

    PubMed 37901346

  • 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.

    PubMed 37752621

  • 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.

    PubMed 37659435

  • 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.

    PubMed 37431558

  • 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.

    PubMed 37073882

  • 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.

    PubMed 36535524

  • 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.

    PubMed 36356712

  • 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.

    PubMed 36087550

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab, Inhaled corticosteroid (ICS) therapy and Albuterol/Salbutamol in people with Asthma, run by Sanofi at 389 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 389 sites in United States, Japan, Ukraine, Chile, South Korea and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (time frame: Baseline to Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02414854, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.

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