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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000856-16 | EudraCT Number | ||
| U1111-1138-3962 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab 300 mg q2w | Experimental | 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. |
|
| Dupilumab 200 mg q2w | Experimental | 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. |
|
| Dupilumab 300 mg q4w | Experimental | 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. |
|
| Dupilumab 200 mg q4w | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Solution for injection, Subcutaneous injection |
|
| 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 | 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 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Baseline, Week 12 |
| Percent Change From Baseline in FEV1 at Week 12: ITT Population |
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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:
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840050 | Fullerton | California | 92835 | United States | ||
| Investigational Site Number 840041 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27130691 | Result | Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, Pirozzi G, Sutherland ER, Evans RR, Joish VN, Eckert L, Graham NM, Stahl N, Yancopoulos GD, Louis-Tisserand M, Teper A. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting beta2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016 Jul 2;388(10039):31-44. doi: 10.1016/S0140-6736(16)30307-5. Epub 2016 Apr 27. | |
| 37431558 |
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Randomization was stratified using blood eosinophils count (eosinophils >=0.3 Giga/L [G/L]; eosinophils 0.2 to 0.299 G/L; eosinophils<0.2 G/L) and country. Assignment was done by Interactive Voice/Web Response System (1:1:1:1:1) for Placebo and Dupilumab (300 mg every 2 weeks [q2w]; 200 mg q2w; 300 mg every 4 week [q4w] and 200 mg q4w).
The study was conducted at 201 sites in 16 countries. A total of 1532 participants were screened between June 2013 and June 2014, of which, 776 participants were randomized at 174 sites in 15 countries. 756 participants were screen failures mainly due to exclusion criteria met and inclusion criteria not met.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. |
| FG001 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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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 q2w | Placebo Comparator | 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. |
|
|
| placebo | Drug | Solution for injection, Subcutaneous injection |
|
| ICS/LABA therapy | Drug | Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose |
|
| Salbutamol/albuterol | Drug | Oral inhalation as needed |
|
| Levosalbutamol/levalbuterol | Drug | Oral inhalation as needed |
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Huntington Beach |
| California |
| 92647 |
| United States |
| Investigational Site Number 840019 | Los Angeles | California | 90025 | United States |
| Investigational Site Number 840029 | Los Angeles | California | 90025 | United States |
| Investigational Site Number 840022 | Los Angeles | California | 90048 | United States |
| Investigational Site Number 840013 | Mission Viejo | California | 92691 | United States |
| Investigational Site Number 840044 | Newport Beach | California | 92663 | United States |
| Investigational Site Number 840007 | Riverside | California | 92506 | United States |
| Investigational Site Number 840014 | Rolling Hills Estates | California | 90274 | United States |
| Investigational Site Number 840036 | San Jose | California | 95117 | United States |
| Investigational Site Number 840032 | Colorado Springs | Colorado | 80907 | United States |
| Investigational Site Number 840040 | Colorado Springs | Colorado | 80907 | United States |
| Investigational Site Number 840043 | Denver | Colorado | 80206 | United States |
| Investigational Site Number 840006 | Denver | Colorado | 80230 | United States |
| Investigational Site Number 840024 | Denver | Colorado | 80230 | United States |
| Investigational Site Number 840027 | Daytona Beach | Florida | 32117 | United States |
| Investigational Site Number 840039 | Miami | Florida | 33135 | United States |
| Investigational Site Number 840048 | Albany | Georgia | 31707 | United States |
| Investigational Site Number 840026 | River Forest | Illinois | 60305 | United States |
| Investigational Site Number 840053 | Evansville | Indiana | 47713 | United States |
| Investigational Site Number 840017 | Louisville | Kentucky | 40223-5440 | United States |
| Investigational Site Number 840030 | Owensboro | Kentucky | 42303 | United States |
| Investigational Site Number 840028 | Baltimore | Maryland | 21287 | United States |
| Investigational Site Number 840052 | Wheaton | Maryland | 20902 | United States |
| Investigational Site Number 840045 | North Dartmouth | Massachusetts | 02747 | United States |
| Investigational Site Number 840046 | Novi | Michigan | 48375 | United States |
| Investigational Site Number 840051 | Novi | Michigan | 48375 | United States |
| Investigational Site Number 840018 | Minneapolis | Minnesota | 55402 | United States |
| Investigational Site Number 840002 | St Louis | Missouri | 63110 | United States |
| Investigational Site Number 840003 | St Louis | Missouri | 63141 | United States |
| Investigational Site Number 840037 | Missoula | Montana | 59804 | United States |
| Investigational Site Number 840004 | Papillion | Nebraska | 27103 | United States |
| Investigational Site Number 840011 | Princeton | New Jersey | 08540 | United States |
| Investigational Site Number 840016 | Rochester | New York | 14618 | United States |
| Investigational Site Number 840025 | Cincinnati | Ohio | 45231 | United States |
| Investigational Site Number 840015 | Cincinnati | Ohio | 45236 | United States |
| Investigational Site Number 840020 | Cincinnati | Ohio | 45241 | United States |
| Investigational Site Number 840001 | Oklahoma City | Oklahoma | 73120 | United States |
| Investigational Site Number 840031 | Lake Oswego | Oregon | 97035 | United States |
| Investigational Site Number 840034 | Medford | Oregon | 97504 | United States |
| Investigational Site Number 840042 | Philadelphia | Pennsylvania | 19107 | United States |
| Investigational Site Number 840010 | Pittsburgh | Pennsylvania | 15213 | United States |
| Investigational Site Number 840009 | Upland | Pennsylvania | 19013 | United States |
| Investigational Site Number 840021 | Spartanburg | South Carolina | 29303 | United States |
| Investigational Site Number 840023 | Dallas | Texas | 75231 | United States |
| Investigational Site Number 840005 | El Paso | Texas | 79902 | United States |
| Investigational Site Number 840008 | San Antonio | Texas | 78229 | United States |
| Investigational Site Number 840035 | Richmond | Virginia | 23225 | United States |
| Investigational Site Number 840054 | Everett | Washington | 98203 | United States |
| Investigational Site Number 840033 | Tacoma | Washington | 98405 | United States |
| Investigational Site Number 032004 | Buenos Aires | B6500BWQ | Argentina |
| Investigational Site Number 032003 | Buenos Aires | C1121ABE | Argentina |
| Investigational Site Number 032008 | Caba | 1424 | Argentina |
| Investigational Site Number 032010 | Caba | 1425 | Argentina |
| Investigational Site Number 032001 | Caba | Argentina |
| Investigational Site Number 032002 | La Plata | 1900 | Argentina |
| Investigational Site Number 032005 | Rosario | 2000 | Argentina |
| Investigational Site Number 032006 | Rosario | 2000 | Argentina |
| Investigational Site Number 032007 | Rosario | 2000 | Argentina |
| Investigational Site Number 032009 | San Miguel de Tucumán | 4000 | Argentina |
| Investigational Site Number 032012 | Santa Fe | 3000 | Argentina |
| Investigational Site Number 036004 | Adelaide | 5000 | Australia |
| Investigational Site Number 036002 | Brisbane | 4101 | Australia |
| Investigational Site Number 036005 | Campbelltown | 2560 | Australia |
| Investigational Site Number 036001 | Clayton | 3168 | Australia |
| Investigational Site Number 036008 | Frankston | 3199 | Australia |
| Investigational Site Number 036003 | Nedlands | 6009 | Australia |
| Investigational Site Number 036009 | Prahran | 3004 | Australia |
| Investigational Site Number 036006 | Woolloongabba | 4102 | Australia |
| Investigational Site Number 152007 | Quillota | 226000 | Chile |
| Investigational Site Number 152011 | Santiago | 00000 | Chile |
| Investigational Site Number 152001 | Santiago | 7500710 | Chile |
| Investigational Site Number 152002 | Santiago | 8380456 | Chile |
| Investigational Site Number 152014 | Santiago | 8910131 | Chile |
| Investigational Site Number 152003 | Santiago | Chile |
| Investigational Site Number 152005 | Santiago | Chile |
| Investigational Site Number 152012 | Santiago | Chile |
| Investigational Site Number 152013 | Santiago | Chile |
| Investigational Site Number 152008 | Talca | Chile |
| Investigational Site Number 152006 | Viña del Mar | Chile |
| Investigational Site Number 250009 | Brest | 29610 | France |
| Investigational Site Number 250004 | Grenoble | 38043 | France |
| Investigational Site Number 250010 | Lille | 59037 | France |
| Investigational Site Number 250006 | Lyon | 69317 | France |
| Investigational Site Number 250001 | Marseille | 13915 | France |
| Investigational Site Number 250002 | Montpellier | 34295 | France |
| Investigational Site Number 250005 | Nantes | 44093 | France |
| Investigational Site Number 250007 | Nîmes | 30029 | France |
| Investigational Site Number 250003 | Pessac | 33604 | France |
| Investigational Site Number 250008 | Strasbourg | 67091 | France |
| Investigational Site Number 250011 | Vernon | 27200 | France |
| Investigational Site Number 380010 | Ancona | 60126 | Italy |
| Investigational Site Number 380009 | Catania | 95123 | Italy |
| Investigational Site Number 380004 | Ferrara | 44121 | Italy |
| Investigational Site Number 380002 | Florence | 50134 | Italy |
| Investigational Site Number 380008 | Foggia | 71100 | Italy |
| Investigational Site Number 380003 | Modena | 41124 | Italy |
| Investigational Site Number 380007 | Padova | 35128 | Italy |
| Investigational Site Number 380001 | Pisa | 56100 | Italy |
| Investigational Site Number 380005 | Torino | 10126 | Italy |
| Investigational Site Number 380006 | Verona | 37126 | Italy |
| Investigational Site Number 392009 | Asahi-Shi | Japan |
| Investigational Site Number 392037 | Chiyoda-Ku | Japan |
| Investigational Site Number 392007 | Chuoh-Ku | Japan |
| Investigational Site Number 392002 | Chūōku | Japan |
| Investigational Site Number 392012 | Edogawa-Ku | Japan |
| Investigational Site Number 392017 | Fukuoka | Japan |
| Investigational Site Number 392021 | Fukuyama-Shi | Japan |
| Investigational Site Number 392030 | Habikino-Shi | Japan |
| Investigational Site Number 392004 | Himeji-Shi | Japan |
| Investigational Site Number 392032 | Hirakata-Shi | Japan |
| Investigational Site Number 392013 | Iizuka-Shi | Japan |
| Investigational Site Number 392042 | Isesaki-Shi | Japan |
| Investigational Site Number 392026 | Itabashi-Ku | Japan |
| Investigational Site Number 392023 | Kanazawa | Japan |
| Investigational Site Number 392001 | Kitakyushu-Shi | Japan |
| Investigational Site Number 392022 | Kiyose-Shi | Japan |
| Investigational Site Number 392025 | Kobe | Japan |
| Investigational Site Number 392040 | Kodaira-Shi | Japan |
| Investigational Site Number 392044 | Kokubunji-Shi | Japan |
| Investigational Site Number 392010 | Kurashiki-Shi | Japan |
| Investigational Site Number 392036 | Kyoto | Japan |
| Investigational Site Number 392041 | Nagaoka-Shi | Japan |
| Investigational Site Number 392020 | Naka-Gun | Japan |
| Investigational Site Number 392015 | Nakano | Japan |
| Investigational Site Number 392005 | Naruto-Shi | Japan |
| Investigational Site Number 392043 | Ohta-Shi | Japan |
| Investigational Site Number 392019 | Sagamihara-Shi | Japan |
| Investigational Site Number 392011 | Sakaide-Shi | Japan |
| Investigational Site Number 392024 | Sakaishi | Japan |
| Investigational Site Number 392008 | Sapporo | Japan |
| Investigational Site Number 392034 | Sapporo | Japan |
| Investigational Site Number 392038 | Setagaya-Ku | Japan |
| Investigational Site Number 392028 | Sumida-Ku | Japan |
| Investigational Site Number 392006 | Tomakomai-Shi | Japan |
| Investigational Site Number 392003 | Toride-Shi | Japan |
| Investigational Site Number 392029 | Tsu | Japan |
| Investigational Site Number 392018 | Tsukubo-Gun | Japan |
| Investigational Site Number 392045 | Uruma | Japan |
| Investigational Site Number 392014 | Yokohama | Japan |
| Investigational Site Number 392035 | Yokohama | Japan |
| Investigational Site Number 484006 | Chihuahua City | 31000 | Mexico |
| Investigational Site Number 484005 | Distrito Federal | 07760 | Mexico |
| Investigational Site Number 484001 | Guadalajara | 44100 | Mexico |
| Investigational Site Number 484004 | Mexico City | 64718 | Mexico |
| Investigational Site Number 484003 | Monterrey | 64460 | Mexico |
| Investigational Site Number 554001 | Dunedin | 9012 | New Zealand |
| Investigational Site Number 554002 | Wellington | 6021 | New Zealand |
| Investigational Site Number 616006 | Bialystok | 15-025 | Poland |
| Investigational Site Number 616004 | Gdansk | 80-405 | Poland |
| Investigational Site Number 616003 | Gdansk | 80-952 | Poland |
| Investigational Site Number 616007 | Krakow | 31-159 | Poland |
| Investigational Site Number 616001 | Lodz | 90-153 | Poland |
| Investigational Site Number 616005 | Lodz | 90-153 | Poland |
| Investigational Site Number 616008 | Warsaw | 00-013 | Poland |
| Investigational Site Number 643003 | Moscow | 105229 | Russia |
| Investigational Site Number 643002 | Moscow | 109240 | Russia |
| Investigational Site Number 643007 | Moscow | 115446 | Russia |
| Investigational Site Number 643012 | Moscow | 123182 | Russia |
| Investigational Site Number 643001 | Moscow | 125367 | Russia |
| Investigational Site Number 643006 | Novosibirsk | 630091 | Russia |
| Investigational Site Number 643010 | Saint Petersburg | 194354 | Russia |
| Investigational Site Number 643011 | Saint Petersburg | 196356 | Russia |
| Investigational Site Number 643009 | Saint Petersburg | 197022 | Russia |
| Investigational Site Number 643008 | Yaroslavl | 150003 | Russia |
| Investigational Site Number 710001 | Cape Town | 7531 | South Africa |
| Investigational Site Number 710002 | Cape Town | 7764 | South Africa |
| Investigational Site Number 410002 | Bucheon-si | 420-767 | South Korea |
| Investigational Site Number 410003 | Cheongju-si | 361-711 | South Korea |
| Investigational Site Number 410004 | Seoul | 120-752 | South Korea |
| Investigational Site Number 410005 | Seoul | 138-736 | South Korea |
| Investigational Site Number 410001 | Suwon | 443-721 | South Korea |
| Investigational Site Number 724005 | Barcelona | 08025 | Spain |
| Investigational Site Number 724002 | Barcelona | 08035 | Spain |
| Investigational Site Number 724001 | Barcelona | 08036 | Spain |
| Investigational Site Number 724004 | Cáceres | 10003 | Spain |
| Investigational Site Number 724006 | Pozuelo de Alarcón | 28223 | Spain |
| Investigational Site Number 724003 | Sabadell | 08208 | Spain |
| Investigational Site Number 724007 | Sant Boi de Llobregat | 08830 | Spain |
| Investigational Site Number 792011 | Amasya | 53100 | Turkey (Türkiye) |
| Investigational Site Number 792002 | Ankara | 06100 | Turkey (Türkiye) |
| Investigational Site Number 792008 | Bursa | 16059 | Turkey (Türkiye) |
| Investigational Site Number 792007 | Istanbul | 34020 | Turkey (Türkiye) |
| Investigational Site Number 792001 | Istanbul | 34098 | Turkey (Türkiye) |
| Investigational Site Number 792004 | Istanbul | 34098 | Turkey (Türkiye) |
| Investigational Site Number 792003 | Istanbul | 34844 | Turkey (Türkiye) |
| Investigational Site Number 792005 | Izmir | 35040 | Turkey (Türkiye) |
| Investigational Site Number 792013 | Kirikkale | 71450 | Turkey (Türkiye) |
| Investigational Site Number 792006 | Mersin | 33070 | Turkey (Türkiye) |
| Investigational Site Number 804016 | Donetsk | 83099 | Ukraine |
| Investigational Site Number 804001 | Kharkiv | 61124 | Ukraine |
| Investigational Site Number 804004 | Kyiv | 03049 | Ukraine |
| Investigational Site Number 804003 | Kyiv | 03680 | Ukraine |
| Investigational Site Number 804008 | Kyiv | 03680 | Ukraine |
| Investigational Site Number 804018 | Kyiv | 03680 | Ukraine |
| Investigational Site Number 804020 | Kyiv | 03680 | Ukraine |
| Investigational Site Number 804006 | Odesa | 65025 | Ukraine |
| Investigational Site Number 804002 | Poltava | 36038 | Ukraine |
| Investigational Site Number 804019 | Vinnytsia | 21001 | Ukraine |
| Investigational Site Number 804015 | Yalta | 98603 | Ukraine |
| Investigational Site Number 804012 | Zaporizhzhya | 69118 | Ukraine |
| Derived |
| Pavord ID, Bourdin A, Papi A, Domingo C, Corren J, Altincatal A, Radwan A, Pandit-Abid N, Jacob-Nara JA, Deniz Y, Rowe PJ, Laws E, Lederer DJ, Hardin M. Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of inhaled corticosteroids dose. Allergy. 2023 Nov;78(11):2921-2932. doi: 10.1111/all.15792. Epub 2023 Jul 11. |
| 35636689 | Derived | 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. |
| 33010038 | Derived | 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. |
| 31351189 | Derived | 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. |
| 31075309 | Derived | Corren J, Castro M, Ford LB, Bernstein JA, Jayawardena S, Maroni J, Rowe P, Amin N, Pirozzi G, Graham NMH, Khan A, Eckert L, Teper A. Dupilumab improves asthma outcomes irrespective of frequency of previous asthma exacerbation history. Ann Allergy Asthma Immunol. 2019 Aug;123(2):222-224.e1. doi: 10.1016/j.anai.2019.04.028. Epub 2019 May 8. No abstract available. |
| 30138668 | Derived | 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. |
| 29355679 | Derived | 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. |
| 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 ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
|
| Treated |
|
| Completed 12-week Study Treatment |
|
| COMPLETED | Completed = Completed study treatment period. |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants According to Blood Eosinophil Count | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | HEos-ITT population: subset of intent to treat (ITT) population (defined as randomized population analyzed according to the treatment group allocated by randomization, regardless of whether the treatment was actually received) which included participants with baseline blood eosinophils >=0.3 G/L. | Posted | Mean | Standard Deviation | liter | Baseline, Week 12 |
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| Primary | Absolute Change From Baseline in FEV1 at Week 12: ITT Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | ITT population. | Posted | Mean | Standard Deviation | liter | Baseline, Week 12 |
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| Secondary | Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | HEos-ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 12 |
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| Secondary | Percent Change From Baseline in FEV1 at Week 12: ITT Population | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 12 |
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| Secondary | Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. | HEos-ITT population. Here 'overall number of participants analyzed' signifies participants of the HEos-ITT population who were treated. | Posted | Number | 95% Confidence Interval | exacerbation per participant-year | Baseline to Week 24 |
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| Secondary | Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. | ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated. | Posted | Number | 95% Confidence Interval | exacerbation per participant-year | Baseline to Week 24 |
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| Secondary | Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population | The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics. | HEos-ITT population. Here 'overall number of participants analyzed' signifies participants of the HEos-ITT population who were treated. | Posted | Number | 95% Confidence Interval | probability of Severe Exacerbation | Baseline up to Week 24 |
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| Secondary | Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population | The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics. | ITT population. Here 'overall number of participants analyzed' signifies participants of ITT population who were treated. | Posted | Number | 95% Confidence Interval | probability of Severe Exacerbation | Baseline up to Week 24 |
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| Secondary | Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population | LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in inhaled corticosteroid (ICS) >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated. | HEos-ITT population. Here 'overall number of participants analyzed' signifies participants of the HEos-ITT population who were treated. | Posted | Number | 95% Confidence Interval | LOAC per participant-year | Baseline to Week 24 |
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| Secondary | Annualized Event Rate of LOAC During The Treatment Period: ITT Population | LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated. | ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated. | Posted | Number | 95% Confidence Interval | LOAC per participant-year | Baseline to Week 24 |
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| Secondary | Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population | The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics. | HEos-ITT population. Here 'overall number of participants analyzed' signifies participants of the HEos-ITT population who were treated. | Posted | Number | 95% Confidence Interval | probability of LOAC | Baseline up to Week 24 |
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| Secondary | Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population | The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics. | ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated. | Posted | Number | 95% Confidence Interval | probability of LOAC | Baseline up to Week 24 |
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| Secondary | Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population | Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma. | HEos-ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population | Morning asthma symptom score was determined using AM symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population | Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual. | HEos ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population | Evening asthma symptom score was determined using PM symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population | The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. | HEos-ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in ACQ-5 Score at Week 12: ITT Population | The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population | The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life. | HEos-ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in AQLQ Global Score at Week 12: ITT Population | The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population | Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary. | HEos-ITT Population. | Posted | Mean | Standard Deviation | inhalations per day | Baseline, Week 12 |
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| Secondary | Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population | Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary. | ITT population. | Posted | Mean | Standard Deviation | inhalations per day | Baseline, Week 12 |
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| Post-Hoc | Change From Baseline in FEV1 at Week 12: Subset of ITT Population With Baseline Blood Eosinophil <0.3 G/L | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. | Analysis was performed on subset of ITT population which included participants with baseline blood eosinophil count <0.3 G/L. | Posted | Mean | Standard Deviation | liter | Baseline, Week 12 |
|
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants exposed to Placebo (for Dupilumab) added to stable ICS/LABA therapy (mean exposure of 23 weeks). | 0 | 158 | 9 | 158 | 88 | 158 |
| EG001 | Dupilumab 300 mg q2w | Participants exposed to Dupilumab 300 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks). | 0 | 156 | 13 | 156 | 95 | 156 |
| EG002 | Dupilumab 200 mg q2w | Participants exposed to Dupilumab 200 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks). | 0 | 148 | 10 | 148 | 81 | 148 |
| EG003 | Dupilumab 300 mg q4w | Participants exposed to Dupilumab 300 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks). | 2 | 157 | 16 | 157 | 96 | 157 |
| EG004 | Dupilumab 200 mg q4w | Participants exposed to Dupilumab 200 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks). | 0 | 150 | 6 | 150 | 74 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Epiglottitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Hypergammaglobulinaemia benign monoclonal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cor pulmonale acute | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Bone fissure | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 18.0 | Systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
| D000420 | Albuterol |
| D064412 | Levalbuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic Or Latino |
|
| >=0.3 G/L |
|
|
| Week 12 |
|
|
| Change from baseline at Week 12 |
|
|
| Mixed Models Analysis | 0.0008 | Threshold for significance at 0.05. | LS Mean Difference | 0.26 | 2-Sided | 95 | 0.11 | 0.40 | Dupilumab 200 mg q2w vs. Placebo q2w | Superiority |
| Mixed Models Analysis | 0.0212 | Threshold for significance at 0.05. | LS Mean Difference | 0.17 | 2-Sided | 95 | 0.03 | 0.32 | Dupilumab 300 mg q4w vs. Placebo q2w | Superiority |
| Mixed Models Analysis | 0.2774 | Threshold for significance at 0.05. | LS Mean Difference | 0.08 | 2-Sided | 95 | -0.07 | 0.23 | Dupilumab 200 mg q4w vs. Placebo q2w | Superiority |
| OG003 | 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. |
| OG004 | 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. |
|
|
|
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG003 | 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. |
| OG004 | 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. |
|
|
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 |
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 |
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG003 | 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. |
| OG004 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
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