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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02414854




Registration number
NCT02414854
Ethics application status
Date submitted
8/04/2015
Date registered
13/04/2015
Date last updated
23/10/2018

Titles & IDs
Public title
Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)
Scientific title
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Secondary ID [1] 0 0
2014-004940-36
Secondary ID [2] 0 0
EFC13579
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 - Inhaled corticosteroid (ICS) therapy
Treatment: Drugs - Albuterol/Salbutamol
Treatment: Drugs - Levalbuterol/Levosalbutamol

Placebo comparator: Placebo (for Dupilumab 200 mg) q2w - 2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.

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 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.

Placebo comparator: Placebo (for Dupilumab 300 mg) q2w - 2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.

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 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines . Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.


Treatment: Drugs: Dupilumab
Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

Treatment: Drugs: Placebo
Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

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

Treatment: Drugs: Albuterol/Salbutamol
Oral inhalation as needed

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

Outcomes
Primary outcome [1] 0 0
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population
Timepoint [1] 0 0
Baseline to Week 52
Primary outcome [2] 0 0
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L
Timepoint [6] 0 0
Baseline to Week 52
Secondary outcome [7] 0 0
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline
Timepoint [7] 0 0
Baseline to Week 52
Secondary outcome [8] 0 0
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline
Timepoint [8] 0 0
Baseline, Week 12
Secondary outcome [9] 0 0
Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population
Timepoint [9] 0 0
Baseline, Week 24
Secondary outcome [10] 0 0
Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Timepoint [10] 0 0
Baseline, Week 24
Secondary outcome [11] 0 0
Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population
Timepoint [11] 0 0
Baseline, Week 24
Secondary outcome [12] 0 0
Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population
Timepoint [12] 0 0
Baseline to Week 52
Secondary outcome [13] 0 0
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L
Timepoint [13] 0 0
Baseline, Week 12
Secondary outcome [14] 0 0
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Timepoint [14] 0 0
Baseline, Week 12
Secondary outcome [15] 0 0
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline
Timepoint [15] 0 0
Baseline, Week 12
Secondary outcome [16] 0 0
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
Timepoint [16] 0 0
Baseline, Week 12
Secondary outcome [17] 0 0
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population
Timepoint [17] 0 0
Baseline, Weeks 2, 4, 8, 24, 36, and 52
Secondary outcome [18] 0 0
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population
Timepoint [18] 0 0
Baseline, Weeks 2, 4, 8, 24, 36, and 52
Secondary outcome [19] 0 0
Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Timepoint [19] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Secondary outcome [20] 0 0
Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Timepoint [20] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Secondary outcome [21] 0 0
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Timepoint [21] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Secondary outcome [22] 0 0
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Timepoint [22] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Secondary outcome [23] 0 0
Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Timepoint [23] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Secondary outcome [24] 0 0
Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population
Timepoint [24] 0 0
Baseline to Week 52
Secondary outcome [25] 0 0
Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population
Timepoint [25] 0 0
Baseline up to Week 52
Secondary outcome [26] 0 0
Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population
Timepoint [26] 0 0
Baseline up to Week 52
Secondary outcome [27] 0 0
Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population
Timepoint [27] 0 0
Baseline, Weeks 2, 4, 8, 12, 36, and 52
Secondary outcome [28] 0 0
Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Timepoint [28] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Secondary outcome [29] 0 0
Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Timepoint [29] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Secondary outcome [30] 0 0
Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Timepoint [30] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Secondary outcome [31] 0 0
Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Timepoint [31] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Secondary outcome [32] 0 0
Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Timepoint [32] 0 0
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Secondary outcome [33] 0 0
Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population
Timepoint [33] 0 0
Baseline, Weeks 12, 36, and 52
Secondary outcome [34] 0 0
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population
Timepoint [34] 0 0
Baseline, Weeks 12, 24, 36, and 52
Secondary outcome [35] 0 0
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population
Timepoint [35] 0 0
Baseline, Weeks 12, 24, 36, and 52
Secondary outcome [36] 0 0
Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis
Timepoint [36] 0 0
Baseline, Weeks 12, 24, 36, and 52
Secondary outcome [37] 0 0
Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis
Timepoint [37] 0 0
Baseline, Weeks 12, 24, 36, and 52

Eligibility
Key inclusion criteria
Inclusion criteria:

-Adults and adolescent participants with a physician diagnosis of asthma for =12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:

a) Existing treatment with medium to high dose ICS (=250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose =1 month prior to Visit 1.

i) Note for Japan: for participants aged 18 years and older, ICS must be on =200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be =100 mcg of fluticasone propionate twice daily or equivalent).

ii) Participants requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose =1 month prior to Visit 1.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Participants <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who are =18 years of age).
* Weight is less than 30 kilograms.
* Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
* A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
* Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care.
* Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) available within 3 months prior to screening to exclude participants with suspected active or untreated latent tuberculosis.
* Current smoker or cessation of smoking within 6 months prior to Visit 1.
* Previous smoker with a smoking history >10 pack-years.
* Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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 3
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
27/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/11/2017
Sample size
Target
Accrual to date
Final
1902
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036005 - Campbelltown
Recruitment hospital [2] 0 0
Investigational Site Number 036001 - Clayton
Recruitment hospital [3] 0 0
Investigational Site Number 036002 - Frankston
Recruitment hospital [4] 0 0
Investigational Site Number 036006 - Glen Osmond
Recruitment hospital [5] 0 0
Investigational Site Number 036003 - Murdoch
Recruitment hospital [6] 0 0
Investigational Site Number 036004 - Parkville
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
5064 - Glen Osmond
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Vermont
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
Argentina
State/province [34] 0 0
Bahia Blanca
Country [35] 0 0
Argentina
State/province [35] 0 0
Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
Caba
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Argentina
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Capital Federal
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Argentina
State/province [38] 0 0
La Plata
Country [39] 0 0
Argentina
State/province [39] 0 0
Rosario
Country [40] 0 0
Argentina
State/province [40] 0 0
San Miguel De Tucuman
Country [41] 0 0
Argentina
State/province [41] 0 0
San Miguel De Tucumán
Country [42] 0 0
Brazil
State/province [42] 0 0
Florianópolis
Country [43] 0 0
Brazil
State/province [43] 0 0
Porto Alegre
Country [44] 0 0
Brazil
State/province [44] 0 0
Salvador
Country [45] 0 0
Brazil
State/province [45] 0 0
Sao Paulo
Country [46] 0 0
Brazil
State/province [46] 0 0
Sorocaba
Country [47] 0 0
Brazil
State/province [47] 0 0
São Bernardo Do Campo
Country [48] 0 0
Canada
State/province [48] 0 0
Burlington
Country [49] 0 0
Canada
State/province [49] 0 0
Calgary
Country [50] 0 0
Canada
State/province [50] 0 0
Mississauga
Country [51] 0 0
Canada
State/province [51] 0 0
Montreal
Country [52] 0 0
Canada
State/province [52] 0 0
Ottawa
Country [53] 0 0
Canada
State/province [53] 0 0
Quebec
Country [54] 0 0
Canada
State/province [54] 0 0
Sherbrooke
Country [55] 0 0
Canada
State/province [55] 0 0
Toronto
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Canada
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Trois-Rivieres
Country [57] 0 0
Canada
State/province [57] 0 0
Vancouver
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Chile
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Concepción
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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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Talcahuano
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Chile
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Talca
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Chile
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Temuco
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Chile
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Valdivia
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Chile
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Viña Del Mar
Country [66] 0 0
Colombia
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Bogota
Country [67] 0 0
Colombia
State/province [67] 0 0
Bogotá
Country [68] 0 0
France
State/province [68] 0 0
Brest
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France
State/province [69] 0 0
Lille Cedex
Country [70] 0 0
France
State/province [70] 0 0
Lille
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France
State/province [71] 0 0
Lyon
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France
State/province [72] 0 0
Marseille
Country [73] 0 0
France
State/province [73] 0 0
Montpellier
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France
State/province [74] 0 0
Nantes Cedex 1
Country [75] 0 0
France
State/province [75] 0 0
Paris
Country [76] 0 0
France
State/province [76] 0 0
Strasbourg
Country [77] 0 0
France
State/province [77] 0 0
Vandoeuvre-Les-Nancy
Country [78] 0 0
Germany
State/province [78] 0 0
Berlin
Country [79] 0 0
Germany
State/province [79] 0 0
Bochum
Country [80] 0 0
Germany
State/province [80] 0 0
Frankfurt Am Main
Country [81] 0 0
Germany
State/province [81] 0 0
Hannover
Country [82] 0 0
Germany
State/province [82] 0 0
Koblenz
Country [83] 0 0
Germany
State/province [83] 0 0
Lübeck
Country [84] 0 0
Germany
State/province [84] 0 0
Mainz
Country [85] 0 0
Germany
State/province [85] 0 0
Rüdersdorf
Country [86] 0 0
Hungary
State/province [86] 0 0
Gödöllö
Country [87] 0 0
Italy
State/province [87] 0 0
Ancona
Country [88] 0 0
Italy
State/province [88] 0 0
Catania
Country [89] 0 0
Italy
State/province [89] 0 0
Ferrara
Country [90] 0 0
Italy
State/province [90] 0 0
Firenze
Country [91] 0 0
Italy
State/province [91] 0 0
Foggia
Country [92] 0 0
Italy
State/province [92] 0 0
Modena
Country [93] 0 0
Italy
State/province [93] 0 0
Palermo
Country [94] 0 0
Italy
State/province [94] 0 0
Pisa
Country [95] 0 0
Italy
State/province [95] 0 0
Reggio Emilia
Country [96] 0 0
Italy
State/province [96] 0 0
Torino
Country [97] 0 0
Japan
State/province [97] 0 0
Akashi-Shi
Country [98] 0 0
Japan
State/province [98] 0 0
Asahikawa-Shi
Country [99] 0 0
Japan
State/province [99] 0 0
Chiyoda-Ku
Country [100] 0 0
Japan
State/province [100] 0 0
Chuo-Ku
Country [101] 0 0
Japan
State/province [101] 0 0
Fukui-Shi
Country [102] 0 0
Japan
State/province [102] 0 0
Fukuoka-Shi
Country [103] 0 0
Japan
State/province [103] 0 0
Fukuyama-Shi
Country [104] 0 0
Japan
State/province [104] 0 0
Habikino-Shi
Country [105] 0 0
Japan
State/province [105] 0 0
Higashiosaka-Shi
Country [106] 0 0
Japan
State/province [106] 0 0
Himeji-Shi
Country [107] 0 0
Japan
State/province [107] 0 0
Hiroshima-Shi
Country [108] 0 0
Japan
State/province [108] 0 0
Iizuka-Shi
Country [109] 0 0
Japan
State/province [109] 0 0
Isesaki-Shi
Country [110] 0 0
Japan
State/province [110] 0 0
Itabashi-Ku
Country [111] 0 0
Japan
State/province [111] 0 0
Kagoshima-Shi
Country [112] 0 0
Japan
State/province [112] 0 0
Kanazawa-Shi
Country [113] 0 0
Japan
State/province [113] 0 0
Kasuga-Shi
Country [114] 0 0
Japan
State/province [114] 0 0
Kawaguchi-Shi
Country [115] 0 0
Japan
State/province [115] 0 0
Kishiwada-Shi
Country [116] 0 0
Japan
State/province [116] 0 0
Kobe-Shi
Country [117] 0 0
Japan
State/province [117] 0 0
Kodaira-Shi
Country [118] 0 0
Japan
State/province [118] 0 0
Kokubunji-Shi
Country [119] 0 0
Japan
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Sutton-In-Ashfield

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
Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma.

Secondary Objectives:

* To evaluate the safety and tolerability of dupilumab.
* To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life.
* To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.
Trial website
https://clinicaltrials.gov/study/NCT02414854
Trial related presentations / publications
Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, Busse WW, Ford L, Sher L, FitzGerald JM, Katelaris C, Tohda Y, Zhang B, Staudinger H, Pirozzi G, Amin N, Ruddy M, Akinlade B, Khan A, Chao J, Martincova R, Graham NMH, Hamilton JD, Swanson BN, Stahl N, Yancopoulos GD, Teper A. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018 Jun 28;378(26):2486-2496. doi: 10.1056/NEJMoa1804092. Epub 2018 May 21.
Bourdin A, Virchow JC, Papi A, Lugogo NL, Bardin P, Antila M, Halpin DMG, Daizadeh N, Djandji M, Ortiz B, Jacob-Nara JA, Gall R, Deniz Y, Rowe PJ. Dupilumab efficacy in subgroups of type 2 asthma with high-dose inhaled corticosteroids at baseline. Respir Med. 2022 Oct;202:106938. doi: 10.1016/j.rmed.2022.106938. Epub 2022 Aug 11.
Papi A, Corren J, Castro M, Domingo C, Rogers L, Chapman KR, Jackson DJ, Daizadeh N, Pandit-Abid N, Gall R, Jacob-Nara JA, Rowe PJ, Deniz Y, Ortiz B. Dupilumab reduced impact of severe exacerbations on lung function in patients with moderate-to-severe type 2 asthma. Allergy. 2023 Jan;78(1):233-243. doi: 10.1111/all.15456. Epub 2022 Aug 9.
Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.
Rabe KF, Pavord ID, Castro M, Wechsler ME, Daizadeh N, Kapoor U, Ortiz B, Radwan A, Johnson RR, Rowe PJ, Deniz Y, Jacob-Nara JA. Dupilumab efficacy and safety in patients with asthma and blood eosinophils >/=500 cells.microL-1. Eur Respir J. 2022 Jun 23;59(6):2102577. doi: 10.1183/13993003.02577-2021. Print 2022 Jun.
Rhee CK, Park JW, Park HW, Cho YS. Effect of Dupilumab in Korean Patients With Uncontrolled Moderate-to-Severe Asthma: A LIBERTY ASTHMA QUEST Sub-analysis. Allergy Asthma Immunol Res. 2022 Mar;14(2):182-195. doi: 10.4168/aair.2022.14.2.182.
Geng B, Bachert C, Busse WW, Gevaert P, Lee SE, Niederman MS, Chen Z, Lu X, Khokhar FA, Kapoor U, Pandit-Abid N, Jacob-Nara JA, Rowe PJ, Deniz Y, Ortiz B. Respiratory Infections and Anti-Infective Medication Use From Phase 3 Dupilumab Respiratory Studies. J Allergy Clin Immunol Pract. 2022 Mar;10(3):732-741. doi: 10.1016/j.jaip.2021.12.006. Epub 2021 Dec 22.
Tohda Y, Matsumoto H, Miyata M, Taguchi Y, Ueyama M, Joulain F, Arakawa I. Cost-effectiveness analysis of dupilumab among patients with oral corticosteroid-dependent uncontrolled severe asthma in Japan. J Asthma. 2022 Nov;59(11):2162-2173. doi: 10.1080/02770903.2021.1996596. Epub 2021 Dec 8.
Busse WW, Paggiaro P, Munoz X, Casale TB, Castro M, Canonica GW, Douglass JA, Tohda Y, Daizadeh N, Ortiz B, Pandit-Abid N. Impact of baseline patient characteristics on dupilumab efficacy in type 2 asthma. Eur Respir J. 2021 Oct 7;58(4):2004605. doi: 10.1183/13993003.04605-2020. Print 2021 Oct.
Corren J, Katelaris CH, Castro M, Maspero JF, Ford LB, Halpin DMG, Rice MS, Radwan A, Deniz Y, Rowe PJ, Teper A, Djandji M. Effect of exacerbation history on clinical response to dupilumab in moderate-to-severe uncontrolled asthma. Eur Respir J. 2021 Oct 28;58(4):2004498. doi: 10.1183/13993003.04498-2020. Print 2021 Oct.
Busse WW, Wenzel SE, Casale TB, FitzGerald JM, Rice MS, Daizadeh N, Deniz Y, Patel N, Harel S, Rowe PJ, Graham NMH, O'Riordan T, Pavord ID. Baseline FeNO as a prognostic biomarker for subsequent severe asthma exacerbations in patients with uncontrolled, moderate-to-severe asthma receiving placebo in the LIBERTY ASTHMA QUEST study: a post-hoc analysis. Lancet Respir Med. 2021 Oct;9(10):1165-1173. doi: 10.1016/S2213-2600(21)00124-7. Epub 2021 Jun 25.
Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26.
Maspero JF, FitzGerald JM, Pavord ID, Rice MS, Maroni J, Rowe PJ, Pirozzi G, Amin N, Ruddy M, Graham NMH, Teper A, Hardin M. Dupilumab efficacy in adolescents with uncontrolled, moderate-to-severe asthma: LIBERTY ASTHMA QUEST. Allergy. 2021 Aug;76(8):2621-2624. doi: 10.1111/all.14872. Epub 2021 May 10. No abstract available.
Bansal A, Simpson EL, Paller AS, Siegfried EC, Blauvelt A, de Bruin-Weller M, Corren J, Sher L, Guttman-Yassky E, Chen Z, Daizadeh N, Kamal MA, Shumel B, Mina-Osorio P, Mannent L, Patel N, Graham NMH, Khokhar FA, Ardeleanu M. Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma. Am J Clin Dermatol. 2021 Jan;22(1):101-115. doi: 10.1007/s40257-020-00577-1.
Bourdin A, Papi AA, Corren J, Virchow JC, Rice MS, Deniz Y, Djandji M, Rowe P, Pavord ID. Dupilumab is effective in type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline. Allergy. 2021 Jan;76(1):269-280. doi: 10.1111/all.14611. Epub 2020 Oct 21.
Tohda Y, Nakamura Y, Fujisawa T, Ebisawa M, Arima K, Miyata M, Takahashi Y, Rice MS, Deniz Y, Rowe P, Patel N, Graham NMH, Teper A. Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study. Allergol Int. 2020 Oct;69(4):578-587. doi: 10.1016/j.alit.2020.04.002. Epub 2020 May 20.
Corren J, Castro M, O'Riordan T, Hanania NA, Pavord ID, Quirce S, Chipps BE, Wenzel SE, Thangavelu K, Rice MS, Harel S, Jagerschmidt A, Khan AH, Kamat S, Maroni J, Rowe P, Lu Y, Amin N, Pirozzi G, Ruddy M, Graham NMH, Teper A. Dupilumab Efficacy in Patients with Uncontrolled, Moderate-to-Severe Allergic Asthma. J Allergy Clin Immunol Pract. 2020 Feb;8(2):516-526. doi: 10.1016/j.jaip.2019.08.050. Epub 2019 Sep 12.
Maspero JF, Katelaris CH, Busse WW, Castro M, Corren J, Chipps BE, Peters AT, Pavord ID, Ford LB, Sher L, Rabe KF, Rice MS, Rowe P, Lu Y, Harel S, Jagerschmidt A, Khan AH, Kamat S, Pirozzi G, Amin N, Ruddy M, Graham NMH, Mannent LP, Teper A. Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2020 Feb;8(2):527-539.e9. doi: 10.1016/j.jaip.2019.07.016. Epub 2019 Jul 24.
Corren J, Castro M, Chanez P, Fabbri L, Joish VN, Amin N, Graham NMH, Mastey V, Abbe A, Taniou C, Mahajan P, Teper A, Pirozzi G, Eckert L. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019 Jan;122(1):41-49.e2. doi: 10.1016/j.anai.2018.08.005. Epub 2018 Aug 21.
Busse WW, Maspero JF, Rabe KF, Papi A, Wenzel SE, Ford LB, Pavord ID, Zhang B, Staudinger H, Pirozzi G, Amin N, Akinlade B, Eckert L, Chao J, Graham NMH, Teper A. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018 May;35(5):737-748. doi: 10.1007/s12325-018-0702-4. Epub 2018 May 3.
Weinstein SF, Katial R, Jayawardena S, Pirozzi G, Staudinger H, Eckert L, Joish VN, Amin N, Maroni J, Rowe P, Graham NMH, Teper A. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol. 2018 Jul;142(1):171-177.e1. doi: 10.1016/j.jaci.2017.11.051. Epub 2018 Jan 31.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02414854