AzTrials
AzTrials

AsthmaPhase 2NCT01854047

An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

A Phase 2 study testing Dupilumab, ICS/LABA therapy and Salbutamol/albuterol in people with Asthma, run by Sanofi at 201 sites in 16 countries.

Completed

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

Official record
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Trial summary

Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma. Secondary Objective: To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to: Safety and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Dupilumab, ICS/LABA therapy and Salbutamol/albuterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
776 participants
Where
201 sitesin 16 countries
Study dates
Jun 2013to Apr 2015
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with a physician diagnosis of moderate to severe, uncontrolled asthma for >=12 months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:
  • Existing treatment with moderate or high-dose inhaled corticosteroid / long-acting beta-2 agonist
  • Forced expiratory volume (FEV1) 40 to 80% of predicted normal
  • Asthma Control Questionnaire, 5-question version (ACQ-5) score >=1.5
  • Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)
  • Had experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma

Who cannot join

  • Participants <18 years
  • Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impaired pulmonary function tests
  • Chest X-ray within 12 months of screening visit or at screening visit with clinically significant findings of lung disease(s) other than asthma
  • Current smoker or cessation of smoking within 6 months prior to Visit 1
  • Previous smoker with a smoking history >10 pack-years
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

201 sites in 16 countries.

201 sites in 16 countries

United States50 sites

  • Investigational Site Number 840048

    Albany, Georgia, 31707

  • Investigational Site Number 840028

    Baltimore, Maryland, 21287

  • Investigational Site Number 840025

    Cincinnati, Ohio, 45231

  • Investigational Site Number 840015

    Cincinnati, Ohio, 45236

  • Investigational Site Number 840020

    Cincinnati, Ohio, 45241

  • Investigational Site Number 840032

    Colorado Springs, Colorado, 80907

  • Investigational Site Number 840040

    Colorado Springs, Colorado, 80907

  • Investigational Site Number 840023

    Dallas, Texas, 75231

  • Investigational Site Number 840027

    Daytona Beach, Florida, 32117

  • Investigational Site Number 840043

    Denver, Colorado, 80206

  • Investigational Site Number 840006

    Denver, Colorado, 80230

  • Investigational Site Number 840024

    Denver, Colorado, 80230

  • Investigational Site Number 840005

    El Paso, Texas, 79902

  • Investigational Site Number 840053

    Evansville, Indiana, 47713

  • Investigational Site Number 840054

    Everett, Washington, 98203

  • Investigational Site Number 840050

    Fullerton, California, 92835

  • Investigational Site Number 840041

    Huntington Beach, California, 92647

  • Investigational Site Number 840031

    Lake Oswego, Oregon, 97035

  • Investigational Site Number 840019

    Los Angeles, California, 90025

  • Investigational Site Number 840029

    Los Angeles, California, 90025

  • Investigational Site Number 840022

    Los Angeles, California, 90048

  • Investigational Site Number 840017

    Louisville, Kentucky, 40223-5440

  • Investigational Site Number 840034

    Medford, Oregon, 97504

  • Investigational Site Number 840039

    Miami, Florida, 33135

  • Investigational Site Number 840018

    Minneapolis, Minnesota, 55402

  • Investigational Site Number 840013

    Mission Viejo, California, 92691

  • Investigational Site Number 840037

    Missoula, Montana, 59804

  • Investigational Site Number 840044

    Newport Beach, California, 92663

  • Investigational Site Number 840045

    North Dartmouth, Massachusetts, 02747

  • Investigational Site Number 840046

    Novi, Michigan, 48375

  • Investigational Site Number 840051

    Novi, Michigan, 48375

  • Investigational Site Number 840001

    Oklahoma City, Oklahoma, 73120

  • Investigational Site Number 840030

    Owensboro, Kentucky, 42303

  • Investigational Site Number 840004

    Papillion, Nebraska, 27103

  • Investigational Site Number 840042

    Philadelphia, Pennsylvania, 19107

  • Investigational Site Number 840010

    Pittsburgh, Pennsylvania, 15213

  • Investigational Site Number 840011

    Princeton, New Jersey, 08540

  • Investigational Site Number 840035

    Richmond, Virginia, 23225

  • Investigational Site Number 840026

    River Forest, Illinois, 60305

  • Investigational Site Number 840007

    Riverside, California, 92506

  • Investigational Site Number 840016

    Rochester, New York, 14618

  • Investigational Site Number 840014

    Rolling Hills Estates, California, 90274

  • Investigational Site Number 840008

    San Antonio, Texas, 78229

  • Investigational Site Number 840036

    San Jose, California, 95117

  • Investigational Site Number 840021

    Spartanburg, South Carolina, 29303

  • Investigational Site Number 840002

    St Louis, Missouri, 63110

  • Investigational Site Number 840003

    St Louis, Missouri, 63141

  • Investigational Site Number 840033

    Tacoma, Washington, 98405

  • Investigational Site Number 840009

    Upland, Pennsylvania, 19013

  • Investigational Site Number 840052

    Wheaton, Maryland, 20902

Other trials in United States

Japan40 sites

  • Investigational Site Number 392009

    Asahi-Shi

  • Investigational Site Number 392037

    Chiyoda-Ku

  • Investigational Site Number 392007

    Chuoh-Ku

  • Investigational Site Number 392002

    Chūōku

  • Investigational Site Number 392012

    Edogawa-Ku

  • Investigational Site Number 392017

    Fukuoka

  • Investigational Site Number 392021

    Fukuyama-Shi

  • Investigational Site Number 392030

    Habikino-Shi

  • Investigational Site Number 392004

    Himeji-Shi

  • Investigational Site Number 392032

    Hirakata-Shi

  • Investigational Site Number 392013

    Iizuka-Shi

  • Investigational Site Number 392042

    Isesaki-Shi

  • Investigational Site Number 392023

    Kanazawa

  • Investigational Site Number 392001

    Kitakyushu-Shi

  • Investigational Site Number 392022

    Kiyose-Shi

  • Investigational Site Number 392025

    Kobe

  • Investigational Site Number 392040

    Kodaira-Shi

  • Investigational Site Number 392044

    Kokubunji-Shi

  • Investigational Site Number 392010

    Kurashiki-Shi

  • Investigational Site Number 392036

    Kyoto

  • Investigational Site Number 392041

    Nagaoka-Shi

  • Investigational Site Number 392020

    Naka-Gun

  • Investigational Site Number 392015

    Nakano

  • Investigational Site Number 392005

    Naruto-Shi

  • Investigational Site Number 392043

    Ohta-Shi

  • Investigational Site Number 392019

    Sagamihara-Shi

  • Investigational Site Number 392011

    Sakaide-Shi

  • Investigational Site Number 392024

    Sakaishi

  • Investigational Site Number 392008

    Sapporo

  • Investigational Site Number 392034

    Sapporo

  • Investigational Site Number 392038

    Setagaya-Ku

  • Investigational Site Number 392028

    Sumida-Ku

  • Investigational Site Number 392026

    tabashi City

  • Investigational Site Number 392006

    Tomakomai-Shi

  • Investigational Site Number 392003

    Toride-Shi

  • Investigational Site Number 392029

    Tsu

  • Investigational Site Number 392018

    Tsukubo-Gun

  • Investigational Site Number 392045

    Uruma

  • Investigational Site Number 392014

    Yokohama

  • Investigational Site Number 392035

    Yokohama

Other trials in Japan

Ukraine12 sites

  • Investigational Site Number 804016

    Donetsk, 83099

  • Investigational Site Number 804001

    Kharkiv, 61124

  • Investigational Site Number 804004

    Kyiv, 03049

  • Investigational Site Number 804003

    Kyiv, 03680

  • Investigational Site Number 804008

    Kyiv, 03680

  • Investigational Site Number 804018

    Kyiv, 03680

  • Investigational Site Number 804020

    Kyiv, 03680

  • Investigational Site Number 804006

    Odesa, 65025

  • Investigational Site Number 804002

    Poltava, 36038

  • Investigational Site Number 804019

    Vinnytsia, 21001

  • Investigational Site Number 804015

    Yalta, 98603

  • Investigational Site Number 804012

    Zaporizhzhya, 69118

Other trials in Ukraine

Argentina11 sites

  • Investigational Site Number 032004

    Buenos Aires, B6500BWQ

  • Investigational Site Number 032003

    Buenos Aires, C1121ABE

  • Investigational Site Number 032008

    Caba, 1424

  • Investigational Site Number 032010

    Caba, 1425

  • Investigational Site Number 032001

    Caba

  • Investigational Site Number 032002

    La Plata, 1900

  • Investigational Site Number 032005

    Rosario, 2000

  • Investigational Site Number 032006

    Rosario, 2000

  • Investigational Site Number 032007

    Rosario, 2000

  • Investigational Site Number 032009

    San Miguel de Tucumán, 4000

  • Investigational Site Number 032012

    Santa Fe, 3000

Other trials in Argentina

Chile11 sites

  • Investigational Site Number 152007

    Quillota, 226000

  • Investigational Site Number 152011

    Santiago, 00000

  • Investigational Site Number 152001

    Santiago, 7500710

  • Investigational Site Number 152002

    Santiago, 8380456

  • Investigational Site Number 152014

    Santiago, 8910131

  • Investigational Site Number 152003

    Santiago

  • Investigational Site Number 152005

    Santiago

  • Investigational Site Number 152012

    Santiago

  • Investigational Site Number 152013

    Santiago

  • Investigational Site Number 152008

    Talca

  • Investigational Site Number 152006

    Viña del Mar

Other trials in Chile

France11 sites

  • Investigational Site Number 250009

    Brest, 29610

  • Investigational Site Number 250004

    Grenoble, 38043

  • Investigational Site Number 250010

    Lille, 59037

  • Investigational Site Number 250006

    Lyon, 69317

  • Investigational Site Number 250001

    Marseille, 13915

  • Investigational Site Number 250002

    Montpellier, 34295

  • Investigational Site Number 250005

    Nantes, 44093

  • Investigational Site Number 250007

    Nîmes, 30029

  • Investigational Site Number 250003

    Pessac, 33604

  • Investigational Site Number 250008

    Strasbourg, 67091

  • Investigational Site Number 250011

    Vernon, 27200

Other trials in France

Italy10 sites

  • Investigational Site Number 380010

    Ancona, 60126

  • Investigational Site Number 380009

    Catania, 95123

  • Investigational Site Number 380004

    Ferrara, 44121

  • Investigational Site Number 380002

    Florence, 50134

  • Investigational Site Number 380008

    Foggia, 71100

  • Investigational Site Number 380003

    Modena, 41124

  • Investigational Site Number 380007

    Padova, 35128

  • Investigational Site Number 380001

    Pisa, 56100

  • Investigational Site Number 380005

    Torino, 10126

  • Investigational Site Number 380006

    Verona, 37126

Other trials in Italy

Russia10 sites

  • Investigational Site Number 643003

    Moscow, 105229

  • Investigational Site Number 643002

    Moscow, 109240

  • Investigational Site Number 643007

    Moscow, 115446

  • Investigational Site Number 643012

    Moscow, 123182

  • Investigational Site Number 643001

    Moscow, 125367

  • Investigational Site Number 643006

    Novosibirsk, 630091

  • Investigational Site Number 643010

    Saint Petersburg, 194354

  • Investigational Site Number 643011

    Saint Petersburg, 196356

  • Investigational Site Number 643009

    Saint Petersburg, 197022

  • Investigational Site Number 643008

    Yaroslavl, 150003

Other trials in Russia

Turkey (Türkiye)10 sites

  • Investigational Site Number 792011

    Amasya, 53100

  • Investigational Site Number 792002

    Ankara, 06100

  • Investigational Site Number 792008

    Bursa, 16059

  • Investigational Site Number 792007

    Istanbul, 34020

  • Investigational Site Number 792001

    Istanbul, 34098

  • Investigational Site Number 792004

    Istanbul, 34098

  • Investigational Site Number 792003

    Istanbul, 34844

  • Investigational Site Number 792005

    Izmir, 35040

  • Investigational Site Number 792013

    Kirikkale, 71450

  • Investigational Site Number 792006

    Mersin, 33070

Other trials in Turkey (Türkiye)

Australia8 sites

  • Investigational Site Number 036004

    Adelaide, 5000

  • Investigational Site Number 036002

    Brisbane, 4101

  • Investigational Site Number 036005

    Campbelltown, 2560

  • Investigational Site Number 036001

    Clayton, 3168

  • Investigational Site Number 036008

    Frankston, 3199

  • Investigational Site Number 036003

    Nedlands, 6009

  • Investigational Site Number 036009

    Prahran, 3004

  • Investigational Site Number 036006

    Woolloongabba, 4102

Other trials in Australia

Poland7 sites

  • Investigational Site Number 616006

    Bialystok, 15-025

  • Investigational Site Number 616004

    Gdansk, 80-405

  • Investigational Site Number 616003

    Gdansk, 80-952

  • Investigational Site Number 616007

    Krakow, 31-159

  • Investigational Site Number 616001

    Lodz, 90-153

  • Investigational Site Number 616005

    Lodz, 90-153

  • Investigational Site Number 616008

    Warsaw, 00-013

Other trials in Poland

Spain7 sites

  • Investigational Site Number 724005

    Barcelona, 08025

  • Investigational Site Number 724002

    Barcelona, 08035

  • Investigational Site Number 724001

    Barcelona, 08036

  • Investigational Site Number 724004

    Cáceres, 10003

  • Investigational Site Number 724006

    Pozuelo de Alarcón, 28223

  • Investigational Site Number 724003

    Sabadell, 08208

  • Investigational Site Number 724007

    Sant Boi de Llobregat, 08830

Other trials in Spain

Mexico5 sites

  • Investigational Site Number 484006

    Chihuahua City, 31000

  • Investigational Site Number 484005

    Distrito Federal, 07760

  • Investigational Site Number 484001

    Guadalajara, 44100

  • Investigational Site Number 484004

    Mexico City, 64718

  • Investigational Site Number 484003

    Monterrey, 64460

Other trials in Mexico

South Korea5 sites

  • Investigational Site Number 410002

    Bucheon-si, 420-767

  • Investigational Site Number 410003

    Cheongju-si, 361-711

  • Investigational Site Number 410004

    Seoul, 120-752

  • Investigational Site Number 410005

    Seoul, 138-736

  • Investigational Site Number 410001

    Suwon, 443-721

Other trials in South Korea

New Zealand2 sites

  • Investigational Site Number 554001

    Dunedin, 9012

  • Investigational Site Number 554002

    Wellington, 6021

Other trials in New Zealand

South Africa2 sites

  • Investigational Site Number 710001

    Cape Town, 7531

  • Investigational Site Number 710002

    Cape Town, 7764

Other trials in South Africa

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.

Secondary Objective:

To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:

  • Safety and tolerability
  • Dupilumab systemic exposure and anti-drug antibodies
Read the detailed description

Total duration per participant of approximately 43 weeks including a screening period (14-21 days), a randomized treatment period (24 weeks), and a post-treatment period (16 weeks).

Conditions
Asthma
Being tested
Dupilumab, placebo, ICS/LABA therapy, Salbutamol/albuterol, Levosalbutamol/levalbuterol
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

  • placeboDrug

    Solution for injection, Subcutaneous injection

  • ICS/LABA therapyDrug

    Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose

  • Salbutamol/albuterolDrug

    Oral inhalation as needed

  • Levosalbutamol/levalbuterolDrug

    Oral inhalation as needed

Study groups in NCT01854047
Study groupRoleWhat they receive
Dupilumab 300 mg q2wExperimental2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Receives: Drug: Dupilumab; Drug: ICS/LABA therapy; Drug: Salbutamol/albuterol; Drug: Levosalbutamol/levalbuterol
Dupilumab 200 mg q2wExperimental2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Receives: Drug: Dupilumab; Drug: ICS/LABA therapy; Drug: Salbutamol/albuterol; Drug: Levosalbutamol/levalbuterol
Dupilumab 300 mg q4wExperimental2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Receives: Drug: Dupilumab; Drug: placebo; Drug: ICS/LABA therapy; Drug: Salbutamol/albuterol; Drug: Levosalbutamol/levalbuterol
Dupilumab 200 mg q4wExperimental2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Receives: Drug: Dupilumab; Drug: placebo; Drug: ICS/LABA therapy; Drug: Salbutamol/albuterol; Drug: Levosalbutamol/levalbuterol
Placebo q2wPlacebo comparator2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Receives: Drug: placebo; Drug: ICS/LABA therapy; Drug: Salbutamol/albuterol; Drug: Levosalbutamol/levalbuterol

What is being measured

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

  1. Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-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. Absolute Change From Baseline in 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 (20)

  1. Percent Change From Baseline in FEV1 at Week 12: HEos-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. Percent Change From Baseline in 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

  3. Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-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 24

  4. Annualized Event Rate of Severe Exacerbation During The 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 that occurred during the treatment period divided by the total number of participant-years treated.

    Measured: Baseline to Week 24

  5. Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population

    The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.

    Measured: Baseline up to Week 24

  6. Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population

    The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.

    Measured: Baseline up to Week 24

  7. Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-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 inhaled corticosteroid (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 24

  8. Annualized Event Rate of LOAC During The 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 24

  9. Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population

    The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.

    Measured: Baseline up to Week 24

  10. Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population

    The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.

    Measured: Baseline up to Week 24

  11. Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-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, Week 12

  12. Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population

    Morning asthma symptom score was determined using AM 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, Week 12

  13. Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-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, Week 12

  14. Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population

    Evening asthma symptom score was determined using PM 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, Week 12

  15. Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-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 12

  16. Change From Baseline in ACQ-5 Score at Week 12: 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 12

  17. Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-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 12

  18. Change From Baseline in AQLQ Global Score at Week 12: 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 12

  19. Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-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 by the participants in their electronic diary.

    Measured: Baseline, Week 12

  20. Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: 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 by the participants in their electronic diary.

    Measured: Baseline, Week 12

Timeline

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

  1. First posted15 May 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionNov 2014
  4. Study completionApr 2015

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
776 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01854047
Sponsor's protocol ID
DRI12544
Other IDs
2013-000856-16, U1111-1138-3962
Status last verified
Jun 2017
First submitted
10 May 2013
Last updated
26 Jun 2017
Data monitoring committee
Yes

Publications

  • Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, Pirozzi G, Sutherland ER, Evans RR, Joish VN, Eckert L, Graham NM, Stahl N, Yancopoulos GD, Louis-Tisserand M, Teper A. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting beta2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016 Jul 2;388(10039):31-44. doi: 10.1016/S0140-6736(16)30307-5. Epub 2016 Apr 27.

    PubMed 27130691

  • 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

  • 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.

    PubMed 35636689

  • 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.

    PubMed 33010038

  • 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.

    PubMed 31351189

  • Corren J, Castro M, Ford LB, Bernstein JA, Jayawardena S, Maroni J, Rowe P, Amin N, Pirozzi G, Graham NMH, Khan A, Eckert L, Teper A. Dupilumab improves asthma outcomes irrespective of frequency of previous asthma exacerbation history. Ann Allergy Asthma Immunol. 2019 Aug;123(2):222-224.e1. doi: 10.1016/j.anai.2019.04.028. Epub 2019 May 8. No abstract available.

    PubMed 31075309

  • 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.

    PubMed 30138668

  • 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.

    PubMed 29355679

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dupilumab, ICS/LABA therapy and Salbutamol/albuterol in people with Asthma, run by Sanofi at 201 sites in 16 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 6 inclusion and 6 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 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in United States, Japan, Ukraine, Argentina, Chile and 11 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 2 Jun 2017). 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?

Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population (time frame: Baseline, Week 12). 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 NCT01854047, which also lists 8 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 26 Jun 2017.

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