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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01854047




Registration number
NCT01854047
Ethics application status
Date submitted
10/05/2013
Date registered
15/05/2013
Date last updated
26/06/2017

Titles & IDs
Public title
An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Secondary ID [1] 0 0
2013-000856-16
Secondary ID [2] 0 0
DRI12544
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab
Treatment: Drugs - placebo
Treatment: Drugs - ICS/LABA therapy
Treatment: Drugs - Salbutamol/albuterol
Treatment: Drugs - Levosalbutamol/levalbuterol

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.

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.

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.

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.

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.


Treatment: Drugs: Dupilumab
Solution for injection, Subcutaneous injection

Treatment: Drugs: placebo
Solution for injection, Subcutaneous injection

Treatment: Drugs: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose

Treatment: Drugs: Salbutamol/albuterol
Oral inhalation as needed

Treatment: Drugs: Levosalbutamol/levalbuterol
Oral inhalation as needed
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Absolute Change From Baseline in FEV1 at Week 12: ITT Population
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Percent Change From Baseline in FEV1 at Week 12: ITT Population
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population
Timepoint [3] 0 0
Baseline to Week 24
Secondary outcome [4] 0 0
Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [5] 0 0
Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population
Timepoint [5] 0 0
Baseline up to Week 24
Secondary outcome [6] 0 0
Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population
Timepoint [6] 0 0
Baseline up to Week 24
Secondary outcome [7] 0 0
Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population
Timepoint [7] 0 0
Baseline to Week 24
Secondary outcome [8] 0 0
Annualized Event Rate of LOAC During The Treatment Period: ITT Population
Timepoint [8] 0 0
Baseline to Week 24
Secondary outcome [9] 0 0
Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population
Timepoint [9] 0 0
Baseline up to Week 24
Secondary outcome [10] 0 0
Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population
Timepoint [10] 0 0
Baseline up to Week 24
Secondary outcome [11] 0 0
Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population
Timepoint [11] 0 0
Baseline, Week 12
Secondary outcome [12] 0 0
Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population
Timepoint [12] 0 0
Baseline, Week 12
Secondary outcome [13] 0 0
Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population
Timepoint [13] 0 0
Baseline, Week 12
Secondary outcome [14] 0 0
Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population
Timepoint [14] 0 0
Baseline, Week 12
Secondary outcome [15] 0 0
Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population
Timepoint [15] 0 0
Baseline, Week 12
Secondary outcome [16] 0 0
Change From Baseline in ACQ-5 Score at Week 12: ITT Population
Timepoint [16] 0 0
Baseline, Week 12
Secondary outcome [17] 0 0
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population
Timepoint [17] 0 0
Baseline, Week 12
Secondary outcome [18] 0 0
Change From Baseline in AQLQ Global Score at Week 12: ITT Population
Timepoint [18] 0 0
Baseline, Week 12
Secondary outcome [19] 0 0
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population
Timepoint [19] 0 0
Baseline, Week 12
Secondary outcome [20] 0 0
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population
Timepoint [20] 0 0
Baseline, Week 12

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
776
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036004 - Adelaide
Recruitment hospital [2] 0 0
Investigational Site Number 036002 - Brisbane
Recruitment hospital [3] 0 0
Investigational Site Number 036005 - Campbelltown
Recruitment hospital [4] 0 0
Investigational Site Number 036001 - Clayton
Recruitment hospital [5] 0 0
Investigational Site Number 036008 - Frankston
Recruitment hospital [6] 0 0
Investigational Site Number 036003 - Nedlands
Recruitment hospital [7] 0 0
Investigational Site Number 036009 - Prahran
Recruitment hospital [8] 0 0
Investigational Site Number 036006 - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
2560 - Campbelltown
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
3004 - Prahran
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
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Missouri
Country [13] 0 0
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Montana
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
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Oklahoma
Country [19] 0 0
United States of America
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Oregon
Country [20] 0 0
United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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La Plata
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Argentina
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Rosario
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Argentina
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Santa Fe
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Argentina
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Tucumán
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Chile
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Quillota
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Chile
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Santiago
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Chile
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Talca
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Chile
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Viña Del Mar
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France
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Brest Cedex
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France
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Grenoble Cedex 09
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Lille
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Marseille
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France
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Nantes
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France
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Nimes
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France
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France
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Strasbourg
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Vernon
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Ancona
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Italy
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Catania
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Ferrara
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Firenze
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Foggia
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Modena
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Padova
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Italy
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Pisa
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Italy
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Torino
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Italy
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Verona
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Japan
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Asahi-Shi
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Chuo-Ku
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Chuoh-Ku
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Japan
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Edogawa-Ku
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Fukuoka-Shi
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Fukuyama-Shi
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Habikino-Shi
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Himeji-Shi
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Japan
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Hirakata-Shi
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Iizuka-Shi
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Japan
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Isesaki-Shi
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Japan
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Itabashi-Ku
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Japan
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Kanazawa-Shi
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Japan
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Kitakyushu-Shi
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Japan
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Kiyose-Shi
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Japan
State/province [72] 0 0
Kobe-Shi
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Japan
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Kodaira-Shi
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Japan
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Kokubunji-Shi
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Japan
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Kurashiki-Shi
Country [76] 0 0
Japan
State/province [76] 0 0
Kyoto-Shi
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Japan
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Nagaoka-Shi
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Japan
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Naka-Gun
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Japan
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Nakano-Ku
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Japan
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Naruto-Shi
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Japan
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Ohta-Shi
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Japan
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Sagamihara-Shi
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Japan
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Sakai-Shi
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Japan
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Sakaide-Shi
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Japan
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Sapporo-Shi
Country [86] 0 0
Japan
State/province [86] 0 0
Setagaya-Ku
Country [87] 0 0
Japan
State/province [87] 0 0
Sumida-Ku
Country [88] 0 0
Japan
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Tomakomai-Shi
Country [89] 0 0
Japan
State/province [89] 0 0
Toride-Shi
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Japan
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Tsu-Shi
Country [91] 0 0
Japan
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Tsukubo-Gun
Country [92] 0 0
Japan
State/province [92] 0 0
Uruma-Shi
Country [93] 0 0
Japan
State/province [93] 0 0
Yokohama-Shi
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Bucheon
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Korea, Republic of
State/province [95] 0 0
Cheongju
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Korea, Republic of
State/province [96] 0 0
Seoul
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Korea, Republic of
State/province [97] 0 0
Suwon
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Mexico
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Chihuahua
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Mexico
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Distrito Federal
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Mexico
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Guadalajara
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Mexico
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Mexico City
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Mexico
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Monterrey
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New Zealand
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Dunedin
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New Zealand
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Wellington
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Poland
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Bialystok
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Gdansk
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Warszawa
Country [110] 0 0
Russian Federation
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Moscow
Country [111] 0 0
Russian Federation
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Novosibirsk
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Russian Federation
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Saint-Petersburg
Country [113] 0 0
Russian Federation
State/province [113] 0 0
St-Petersburg
Country [114] 0 0
Russian Federation
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Yaroslavl
Country [115] 0 0
South Africa
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Cape Town
Country [116] 0 0
Spain
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Barcelona
Country [117] 0 0
Spain
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Cáceres
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Spain
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Pozuelo De Alarcón
Country [119] 0 0
Spain
State/province [119] 0 0
Sabadell
Country [120] 0 0
Spain
State/province [120] 0 0
Sant Boi De Llobregat
Country [121] 0 0
Turkey
State/province [121] 0 0
Amasya
Country [122] 0 0
Turkey
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Ankara
Country [123] 0 0
Turkey
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Bursa
Country [124] 0 0
Turkey
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Istanbul
Country [125] 0 0
Turkey
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Izmir
Country [126] 0 0
Turkey
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Kirikkale
Country [127] 0 0
Turkey
State/province [127] 0 0
Mersin
Country [128] 0 0
Ukraine
State/province [128] 0 0
Donetsk
Country [129] 0 0
Ukraine
State/province [129] 0 0
Kharkiv
Country [130] 0 0
Ukraine
State/province [130] 0 0
Kyiv
Country [131] 0 0
Ukraine
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Odessa
Country [132] 0 0
Ukraine
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Poltava
Country [133] 0 0
Ukraine
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Vinnytsya
Country [134] 0 0
Ukraine
State/province [134] 0 0
Yalta
Country [135] 0 0
Ukraine
State/province [135] 0 0
Zaporozhye

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Wenzel S, Castro M, Corren J, Maspero J, Wang L, Z... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01854047