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

June 7, 2017 updated by: Sanofi

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

776

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B6500BWQ
        • Investigational Site Number 032004
      • Buenos Aires, Argentina, C1121ABE
        • Investigational Site Number 032003
      • Caba, Argentina, 1424
        • Investigational Site Number 032008
      • Caba, Argentina, 1425
        • Investigational Site Number 032010
      • Caba, Argentina
        • Investigational Site Number 032001
      • La Plata, Argentina, 1900
        • Investigational Site Number 032002
      • Rosario, Argentina, 2000
        • Investigational Site Number 032005
      • Rosario, Argentina, 2000
        • Investigational Site Number 032006
      • Rosario, Argentina, 2000
        • Investigational Site Number 032007
      • Santa Fe, Argentina, 3000
        • Investigational Site Number 032012
      • Tucumán, Argentina, 4000
        • Investigational Site Number 032009
  • Australia
      • Adelaide, Australia, 5000
        • Investigational Site Number 036004
      • Brisbane, Australia, 4101
        • Investigational Site Number 036002
      • Campbelltown, Australia, 2560
        • Investigational Site Number 036005
      • Clayton, Australia, 3168
        • Investigational Site Number 036001
      • Frankston, Australia, 3199
        • Investigational Site Number 036008
      • Nedlands, Australia, 6009
        • Investigational Site Number 036003
      • Prahran, Australia, 3004
        • Investigational Site Number 036009
      • Woolloongabba, Australia, 4102
        • Investigational Site Number 036006
  • Chile
      • Quillota, Chile, 226000
        • Investigational Site Number 152007
      • Santiago, Chile
        • Investigational Site Number 152005
      • Santiago, Chile, 8380456
        • Investigational Site Number 152002
      • Santiago, Chile
        • Investigational Site Number 152012
      • Santiago, Chile
        • Investigational Site Number 152013
      • Santiago, Chile, 7500710
        • Investigational Site Number 152001
      • Santiago, Chile, 00000
        • Investigational Site Number 152011
      • Santiago, Chile, 8910131
        • Investigational Site Number 152014
      • Santiago, Chile
        • Investigational Site Number 152003
      • Talca, Chile
        • Investigational Site Number 152008
      • Viña Del Mar, Chile
        • Investigational Site Number 152006
  • France
      • Brest Cedex, France, 29610
        • Investigational Site Number 250009
      • Grenoble Cedex 09, France, 38043
        • Investigational Site Number 250004
      • Lille, France, 59037
        • Investigational Site Number 250010
      • Lyon, France, 69317
        • Investigational Site Number 250006
      • Marseille, France, 13915
        • Investigational Site Number 250001
      • Montpellier, France, 34295
        • Investigational Site Number 250002
      • Nantes, France, 44093
        • Investigational Site Number 250005
      • Nimes, France, 30029
        • Investigational Site Number 250007
      • Pessac, France, 33604
        • Investigational Site Number 250003
      • Strasbourg, France, 67091
        • Investigational Site Number 250008
      • Vernon, France, 27200
        • Investigational Site Number 250011
  • Italy
      • Ancona, Italy, 60126
        • Investigational Site Number 380010
      • Catania, Italy, 95123
        • Investigational Site Number 380009
      • Ferrara, Italy, 44121
        • Investigational Site Number 380004
      • Firenze, Italy, 50134
        • Investigational Site Number 380002
      • Foggia, Italy, 71100
        • Investigational Site Number 380008
      • Modena, Italy, 41124
        • Investigational Site Number 380003
      • Padova, Italy, 35128
        • Investigational Site Number 380007
      • Pisa, Italy, 56100
        • Investigational Site Number 380001
      • Torino, Italy, 10126
        • Investigational Site Number 380005
      • Verona, Italy, 37126
        • Investigational Site Number 380006
  • Japan
      • Asahi-Shi, Japan
        • Investigational Site Number 392009
      • Chiyoda-Ku, Japan
        • Investigational Site Number 392037
      • Chuo-Ku, Japan
        • Investigational Site Number 392002
      • Chuoh-Ku, Japan
        • Investigational Site Number 392007
      • Edogawa-Ku, Japan
        • Investigational Site Number 392012
      • Fukuoka-Shi, Japan
        • Investigational Site Number 392017
      • Fukuyama-Shi, Japan
        • Investigational Site Number 392021
      • Habikino-Shi, Japan
        • Investigational Site Number 392030
      • Himeji-Shi, Japan
        • Investigational Site Number 392004
      • Hirakata-Shi, Japan
        • Investigational Site Number 392032
      • Iizuka-Shi, Japan
        • Investigational Site Number 392013
      • Isesaki-Shi, Japan
        • Investigational Site Number 392042
      • Itabashi-Ku, Japan
        • Investigational Site Number 392026
      • Kanazawa-Shi, Japan
        • Investigational Site Number 392023
      • Kitakyushu-Shi, Japan
        • Investigational Site Number 392001
      • Kiyose-Shi, Japan
        • Investigational Site Number 392022
      • Kobe-Shi, Japan
        • Investigational Site Number 392025
      • Kodaira-Shi, Japan
        • Investigational Site Number 392040
      • Kokubunji-Shi, Japan
        • Investigational Site Number 392044
      • Kurashiki-Shi, Japan
        • Investigational Site Number 392010
      • Kyoto-Shi, Japan
        • Investigational Site Number 392036
      • Nagaoka-Shi, Japan
        • Investigational Site Number 392041
      • Naka-Gun, Japan
        • Investigational Site Number 392020
      • Nakano-Ku, Japan
        • Investigational Site Number 392015
      • Naruto-Shi, Japan
        • Investigational Site Number 392005
      • Ohta-Shi, Japan
        • Investigational Site Number 392043
      • Sagamihara-Shi, Japan
        • Investigational Site Number 392019
      • Sakai-Shi, Japan
        • Investigational Site Number 392024
      • Sakaide-Shi, Japan
        • Investigational Site Number 392011
      • Sapporo-Shi, Japan
        • Investigational Site Number 392008
      • Sapporo-Shi, Japan
        • Investigational Site Number 392034
      • Setagaya-Ku, Japan
        • Investigational Site Number 392038
      • Sumida-Ku, Japan
        • Investigational Site Number 392028
      • Tomakomai-Shi, Japan
        • Investigational Site Number 392006
      • Toride-Shi, Japan
        • Investigational Site Number 392003
      • Tsu-Shi, Japan
        • Investigational Site Number 392029
      • Tsukubo-Gun, Japan
        • Investigational Site Number 392018
      • Uruma-Shi, Japan
        • Investigational Site Number 392045
      • Yokohama-Shi, Japan
        • Investigational Site Number 392014
      • Yokohama-Shi, Japan
        • Investigational Site Number 392035
  • Korea, Republic of
      • Bucheon, Korea, Republic of, 420-767
        • Investigational Site Number 410002
      • Cheongju, Korea, Republic of, 361-711
        • Investigational Site Number 410003
      • Seoul, Korea, Republic of, 120-752
        • Investigational Site Number 410004
      • Seoul, Korea, Republic of, 138-736
        • Investigational Site Number 410005
      • Suwon, Korea, Republic of, 443-721
        • Investigational Site Number 410001
  • Mexico
      • Chihuahua, Mexico, 31000
        • Investigational Site Number 484006
      • Distrito Federal, Mexico, 07760
        • Investigational Site Number 484005
      • Guadalajara, Mexico, 44100
        • Investigational Site Number 484001
      • Mexico City, Mexico, 64718
        • Investigational Site Number 484004
      • Monterrey, Mexico, 64460
        • Investigational Site Number 484003
  • New Zealand
      • Dunedin, New Zealand, 9012
        • Investigational Site Number 554001
      • Wellington, New Zealand, 6021
        • Investigational Site Number 554002
  • Poland
      • Bialystok, Poland, 15-025
        • Investigational Site Number 616006
      • Gdansk, Poland, 80-405
        • Investigational Site Number 616004
      • Gdansk, Poland, 80-952
        • Investigational Site Number 616003
      • Krakow, Poland, 31-159
        • Investigational Site Number 616007
      • Lodz, Poland, 90-153
        • Investigational Site Number 616005
      • Lodz, Poland, 90-153
        • Investigational Site Number 616001
      • Warszawa, Poland, 00-013
        • Investigational Site Number 616008
  • Russian Federation
      • Moscow, Russian Federation, 109240
        • Investigational Site Number 643002
      • Moscow, Russian Federation, 123182
        • Investigational Site Number 643012
      • Moscow, Russian Federation, 105229
        • Investigational Site Number 643003
      • Moscow, Russian Federation, 115446
        • Investigational Site Number 643007
      • Moscow, Russian Federation, 125367
        • Investigational Site Number 643001
      • Novosibirsk, Russian Federation, 630091
        • Investigational Site Number 643006
      • Saint-Petersburg, Russian Federation, 194354
        • Investigational Site Number 643010
      • Saint-Petersburg, Russian Federation, 196356
        • Investigational Site Number 643011
      • St-Petersburg, Russian Federation, 197022
        • Investigational Site Number 643009
      • Yaroslavl, Russian Federation, 150003
        • Investigational Site Number 643008
  • South Africa
      • Cape Town, South Africa, 7764
        • Investigational Site Number 710002
      • Cape Town, South Africa, 7531
        • Investigational Site Number 710001
  • Spain
      • Barcelona, Spain, 08036
        • Investigational Site Number 724001
      • Barcelona, Spain, 08035
        • Investigational Site Number 724002
      • Barcelona, Spain, 08025
        • Investigational Site Number 724005
      • Cáceres, Spain, 10003
        • Investigational Site Number 724004
      • Pozuelo De Alarcón, Spain, 28223
        • Investigational Site Number 724006
      • Sabadell, Spain, 08208
        • Investigational Site Number 724003
      • Sant Boi De Llobregat, Spain, 08830
        • Investigational Site Number 724007
  • Turkey
      • Amasya, Turkey, 53100
        • Investigational Site Number 792011
      • Ankara, Turkey, 06100
        • Investigational Site Number 792002
      • Bursa, Turkey, 16059
        • Investigational Site Number 792008
      • Istanbul, Turkey, 34020
        • Investigational Site Number 792007
      • Istanbul, Turkey, 34098
        • Investigational Site Number 792001
      • Istanbul, Turkey, 34098
        • Investigational Site Number 792004
      • Istanbul, Turkey, 34844
        • Investigational Site Number 792003
      • Izmir, Turkey, 35040
        • Investigational Site Number 792005
      • Kirikkale, Turkey, 71450
        • Investigational Site Number 792013
      • Mersin, Turkey, 33070
        • Investigational Site Number 792006
  • Ukraine
      • Donetsk, Ukraine, 83099
        • Investigational Site Number 804016
      • Kharkiv, Ukraine, 61124
        • Investigational Site Number 804001
      • Kyiv, Ukraine, 03049
        • Investigational Site Number 804004
      • Kyiv, Ukraine, 03680
        • Investigational Site Number 804003
      • Kyiv, Ukraine, 03680
        • Investigational Site Number 804008
      • Kyiv, Ukraine, 03680
        • Investigational Site Number 804018
      • Kyiv, Ukraine, 03680
        • Investigational Site Number 804020
      • Odessa, Ukraine, 65025
        • Investigational Site Number 804006
      • Poltava, Ukraine, 36038
        • Investigational Site Number 804002
      • Vinnytsya, Ukraine, 21001
        • Investigational Site Number 804019
      • Yalta, Ukraine, 98603
        • Investigational Site Number 804015
      • Zaporozhye, Ukraine, 69118
        • Investigational Site Number 804012
  • United States
    • California
      • Fullerton, California, United States, 92835
        • Investigational Site Number 840050
      • Huntington Beach, California, United States, 92647
        • Investigational Site Number 840041
      • Los Angeles, California, United States, 90025
        • Investigational Site Number 840019
      • Los Angeles, California, United States, 90025
        • Investigational Site Number 840029
      • Los Angeles, California, United States, 90048
        • Investigational Site Number 840022
      • Mission Viejo, California, United States, 92691
        • Investigational Site Number 840013
      • Newport Beach, California, United States, 92663
        • Investigational Site Number 840044
      • Riverside, California, United States, 92506
        • Investigational Site Number 840007
      • Rolling Hills Estates, California, United States, 90274
        • Investigational Site Number 840014
      • San Jose, California, United States, 95117
        • Investigational Site Number 840036
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Investigational Site Number 840040
      • Colorado Springs, Colorado, United States, 80907
        • Investigational Site Number 840032
      • Denver, Colorado, United States, 80230
        • Investigational Site Number 840006
      • Denver, Colorado, United States, 80230
        • Investigational Site Number 840024
      • Denver, Colorado, United States, 80206
        • Investigational Site Number 840043
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Investigational Site Number 840027
      • Miami, Florida, United States, 33135
        • Investigational Site Number 840039
    • Georgia
      • Albany, Georgia, United States, 31707
        • Investigational Site Number 840048
    • Illinois
      • River Forest, Illinois, United States, 60305
        • Investigational Site Number 840026
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Investigational Site Number 840053
    • Kentucky
      • Louisville, Kentucky, United States, 40223-5440
        • Investigational Site Number 840017
      • Owensboro, Kentucky, United States, 42303
        • Investigational Site Number 840030
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Investigational Site Number 840028
      • Wheaton, Maryland, United States, 20902
        • Investigational Site Number 840052
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Investigational Site Number 840045
    • Michigan
      • Novi, Michigan, United States, 48375
        • Investigational Site Number 840046
      • Novi, Michigan, United States, 48375
        • Investigational Site Number 840051
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Investigational Site Number 840018
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Investigational Site Number 840002
      • Saint Louis, Missouri, United States, 63141
        • Investigational Site Number 840003
    • Montana
      • Missoula, Montana, United States, 59804
        • Investigational Site Number 840037
    • Nebraska
      • Papillion, Nebraska, United States, 27103
        • Investigational Site Number 840004
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Investigational Site Number 840011
    • New York
      • Rochester, New York, United States, 14618
        • Investigational Site Number 840016
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Investigational Site Number 840015
      • Cincinnati, Ohio, United States, 45231
        • Investigational Site Number 840025
      • Cincinnati, Ohio, United States, 45241
        • Investigational Site Number 840020
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Investigational Site Number 840001
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Investigational Site Number 840031
      • Medford, Oregon, United States, 97504
        • Investigational Site Number 840034
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Investigational Site Number 840042
      • Pittsburgh, Pennsylvania, United States, 15213
        • Investigational Site Number 840010
      • Upland, Pennsylvania, United States, 19013
        • Investigational Site Number 840009
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Investigational Site Number 840021
    • Texas
      • Dallas, Texas, United States, 75231
        • Investigational Site Number 840023
      • El Paso, Texas, United States, 79902
        • Investigational Site Number 840005
      • San Antonio, Texas, United States, 78229
        • Investigational Site Number 840008
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Investigational Site Number 840035
    • Washington
      • Everett, Washington, United States, 98203
        • Investigational Site Number 840054
      • Tacoma, Washington, United States, 98405
        • Investigational Site Number 840033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dupilumab 300 mg q2w
2 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.
Drug: Dupilumab
Solution for injection, Subcutaneous injection
Other Names:
  • REGN668
  • SAR231893
Drug: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose
Drug: Salbutamol/albuterol
Oral inhalation as needed
Drug: Levosalbutamol/levalbuterol
Oral inhalation as needed
EXPERIMENTAL: Dupilumab 200 mg q2w
2 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.
Drug: Dupilumab
Solution for injection, Subcutaneous injection
Other Names:
  • REGN668
  • SAR231893
Drug: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose
Drug: Salbutamol/albuterol
Oral inhalation as needed
Drug: Levosalbutamol/levalbuterol
Oral inhalation as needed
EXPERIMENTAL: Dupilumab 300 mg q4w
2 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.
Drug: Dupilumab
Solution for injection, Subcutaneous injection
Other Names:
  • REGN668
  • SAR231893
Drug: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose
Drug: Salbutamol/albuterol
Oral inhalation as needed
Drug: Levosalbutamol/levalbuterol
Oral inhalation as needed
Drug: placebo
Solution for injection, Subcutaneous injection
EXPERIMENTAL: Dupilumab 200 mg q4w
2 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.
Drug: Dupilumab
Solution for injection, Subcutaneous injection
Other Names:
  • REGN668
  • SAR231893
Drug: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose
Drug: Salbutamol/albuterol
Oral inhalation as needed
Drug: Levosalbutamol/levalbuterol
Oral inhalation as needed
Drug: placebo
Solution for injection, Subcutaneous injection
PLACEBO_COMPARATOR: Placebo q2w
2 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.
Drug: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose
Drug: Salbutamol/albuterol
Oral inhalation as needed
Drug: Levosalbutamol/levalbuterol
Oral inhalation as needed
Drug: placebo
Solution for injection, Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Absolute Change From Baseline in FEV1 at Week 12: ITT Population
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Percent Change From Baseline in FEV1 at Week 12: ITT Population
Time Frame: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Baseline, Week 12
Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population
Time Frame: Baseline to Week 24
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Baseline to Week 24
Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population
Time Frame: Baseline to Week 24
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Baseline to Week 24
Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population
Time Frame: Baseline up to Week 24
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.
Baseline up to Week 24
Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population
Time Frame: Baseline up to Week 24
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.
Baseline up to Week 24
Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population
Time Frame: Baseline to Week 24
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.
Baseline to Week 24
Annualized Event Rate of LOAC During The Treatment Period: ITT Population
Time Frame: Baseline to Week 24
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.
Baseline to Week 24
Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population
Time Frame: Baseline up to Week 24
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.
Baseline up to Week 24
Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population
Time Frame: Baseline up to Week 24
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.
Baseline up to Week 24
Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in ACQ-5 Score at Week 12: ITT Population
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in AQLQ Global Score at Week 12: ITT Population
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population
Time Frame: Baseline, Week 12
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.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (ESTIMATE)

May 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI12544
  • 2013-000856-16 (EUDRACT_NUMBER)
  • U1111-1138-3962 (OTHER: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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