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

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ClinicalTrials.gov Identifier: NCT01854047
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : June 2, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Dupilumab
Drug: placebo
Drug: ICS/LABA therapy
Drug: Salbutamol/albuterol
Drug: Levosalbutamol/levalbuterol
Enrollment 776
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description 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. 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. 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. 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. 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.
Period Title: Overall Study
Started [1] 158 157 150 157 154
Treated 158 156 148 157 150
Completed 12-week Study Treatment 153 149 141 146 143
Completed [2] 146 149 137 142 135
Not Completed 12 8 13 15 19
Reason Not Completed
Lack of Efficacy             1             0             0             0             0
Poor compliance to protocol             3             0             2             0             0
Adverse Event             5             4             6             10             7
Randomized but not treated             0             1             2             0             4
Other than specified above             3             3             3             5             8
[1]
Started = Randomized
[2]
Completed = Completed study treatment period.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w Total
Hide Arm/Group Description 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. 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 158 157 150 157 154 776
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 158 participants 157 participants 150 participants 157 participants 154 participants 776 participants
49  (12.7) 47.5  (12.4) 51  (13.4) 47.9  (13.1) 47.9  (13.1) 48.6  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 157 participants 150 participants 157 participants 154 participants 776 participants
Female
104
  65.8%
103
  65.6%
96
  64.0%
100
  63.7%
87
  56.5%
490
  63.1%
Male
54
  34.2%
54
  34.4%
54
  36.0%
57
  36.3%
67
  43.5%
286
  36.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 157 participants 150 participants 157 participants 154 participants 776 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
1
   0.1%
Asian
25
  15.8%
22
  14.0%
25
  16.7%
23
  14.6%
20
  13.0%
115
  14.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
0
   0.0%
1
   0.1%
Black or African American
9
   5.7%
5
   3.2%
9
   6.0%
12
   7.6%
7
   4.5%
42
   5.4%
White
119
  75.3%
129
  82.2%
114
  76.0%
120
  76.4%
125
  81.2%
607
  78.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   3.2%
1
   0.6%
1
   0.7%
1
   0.6%
2
   1.3%
10
   1.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 157 participants 150 participants 157 participants 154 participants 776 participants
Hispanic Or Latino
31
  19.6%
29
  18.5%
29
  19.3%
33
  21.0%
26
  16.9%
148
  19.1%
Not Hispanic Or Latino
127
  80.4%
128
  81.5%
121
  80.7%
124
  79.0%
128
  83.1%
628
  80.9%
Number of Participants According to Blood Eosinophil Count  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 157 participants 150 participants 157 participants 154 participants 776 participants
<0.3 G/L
90
  57.0%
93
  59.2%
85
  56.7%
91
  58.0%
92
  59.7%
451
  58.1%
>=0.3 G/L
68
  43.0%
64
  40.8%
65
  43.3%
66
  42.0%
62
  40.3%
325
  41.9%
1.Primary Outcome
Title Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population
Hide Description FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 64 65 66 62
Mean (Standard Deviation)
Unit of Measure: liter
Baseline Number Analyzed 68 participants 64 participants 65 participants 66 participants 62 participants
1.86  (0.68) 1.77  (0.5) 1.8  (0.52) 1.87  (0.6) 1.8  (0.49)
Week 12 Number Analyzed 58 participants 59 participants 57 participants 55 participants 53 participants
2.13  (0.78) 2.12  (0.54) 2.26  (0.68) 2.26  (0.70) 2.09  (0.54)
Change from baseline at Week 12 Number Analyzed 58 participants 59 participants 57 participants 55 participants 53 participants
0.18  (0.38) 0.36  (0.46) 0.45  (0.40) 0.35  (0.43) 0.26  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Dupilumab 300 mg q2w
Comments Analysis was performed using mixed effect model with repeated measures (MMRM) approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w, and 200 mg q4w.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments Threshold for significance at 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
0.06 to 0.36
Estimation Comments Dupilumab 300 mg q2w vs. Placebo q2w
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Dupilumab 200 mg q2w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Threshold for significance at 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
0.11 to 0.40
Estimation Comments Dupilumab 200 mg q2w vs. Placebo q2w
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Dupilumab 300 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0212
Comments Threshold for significance at 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
0.03 to 0.32
Estimation Comments Dupilumab 300 mg q4w vs. Placebo q2w
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Dupilumab 200 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2774
Comments Threshold for significance at 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.07 to 0.23
Estimation Comments Dupilumab 200 mg q4w vs. Placebo q2w
2.Primary Outcome
Title Absolute Change From Baseline in FEV1 at Week 12: ITT Population
Hide Description FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 157 150 157 154
Mean (Standard Deviation)
Unit of Measure: liter
Baseline Number Analyzed 158 participants 157 participants 150 participants 157 participants 154 participants
1.82  (0.55) 1.85  (0.53) 1.79  (0.52) 1.86  (0.57) 1.88  (0.54)
Week 12 Number Analyzed 129 participants 146 participants 136 participants 134 participants 134 participants
2.01  (0.69) 2.12  (0.59) 2.12  (0.68) 2.14  (0.69) 2.07  (0.63)
Change from baseline at Week 12 Number Analyzed 129 participants 146 participants 136 participants 134 participants 134 participants
0.13  (0.37) 0.26  (0.39) 0.32  (0.38) 0.24  (0.4) 0.20  (0.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Dupilumab 300 mg q2w
Comments Analysis was performed using MMRM approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w and 200 mg q4w.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Threshold for significance at 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
0.08 to 0.25
Estimation Comments Dupilumab 300 mg q2w vs. Placebo q2w
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Dupilumab 200 mg q2w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.011 to 0.28
Estimation Comments Dupilumab 200 mg q2w vs. Placebo q2w
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Dupilumab 300 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments Threshold for significance at 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.04 to 0.21
Estimation Comments Dupilumab 300 mg q4w vs. Placebo q2w
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Dupilumab 200 mg q4w
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0304
Comments Threshold for significance at 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.01 to 0.18
Estimation Comments Dupilumab 200 mg q4w vs. Placebo q2w
3.Secondary Outcome
Title Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population
Hide Description FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
HEos-ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 58 59 57 55 53
Mean (Standard Deviation)
Unit of Measure: percent change
10.07  (19.65) 25.29  (36.15) 27.42  (25.68) 20.68  (24.86) 18.07  (29.18)
4.Secondary Outcome
Title Percent Change From Baseline in FEV1 at Week 12: ITT Population
Hide Description FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 129 146 136 134 134
Mean (Standard Deviation)
Unit of Measure: percent change
7.04  (19.26) 16.64  (27.78) 19.15  (23.53) 13.55  (23.01) 13.04  (24.21)
5.Secondary Outcome
Title Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population
Hide Description 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.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 64 64 66 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: exacerbation per participant-year
1.044
(0.572 to 1.904)
0.201
(0.078 to 0.517)
0.30
(0.133 to 0.678)
0.678
(0.356 to 1.29)
0.358
(0.158 to 0.809)
6.Secondary Outcome
Title Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population
Hide Description 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.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 156 148 157 150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: exacerbation per participant-year
0.897
(0.619 to 1.30)
0.265
(0.157 to 0.445)
0.269
(0.157 to 0.461)
0.599
(0.369 to 0.907)
0.415
(0.26 to 0.664)
7.Secondary Outcome
Title Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population
Hide Description 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.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 64 64 66 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of Severe Exacerbation
Probability at Week 12
0.21
(0.122 to 0.314)
0.082
(0.03 to 0.167)
0.082
(0.03 to 0.167)
0.094
(0.038 to 0.181)
0.052
(0.014 to 0.13)
Probability at Week 24
0.287
(0.184 to 0.398)
0.116
(0.051 to 0.21)
0.082
(0.03 to 0.167)
0.175
(0.093 to 0.278)
0.125
(0.055 to 0.226)
8.Secondary Outcome
Title Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population
Hide Description 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.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here 'overall number of participants analyzed' signifies participants of ITT population who were treated.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 156 148 157 150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of Severe Exacerbation
Probability at Week 12
0.207
(0.147 to 0.274)
0.092
(0.053 to 0.145)
0.07
(0.036 to 0.119)
0.112
(0.068 to 0.168)
0.075
(0.04 to 0.125)
Probability at Week 24
0.266
(0.199 to 0.338)
0.112
(0.068 to 0.169)
0.091
(0.051 to 0.145)
0.195
(0.136 to 0.262)
0.16
(0.106 to 0.225)
9.Secondary Outcome
Title Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population
Hide Description 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.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 64 64 66 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: LOAC per participant-year
1.312
(0.804 to 2.142)
0.322
(0.153 to 0.677)
0.446
(0.231 to 0.864)
0.788
(0.458 to 1.355)
0.424
(0.212 to 0.851)
10.Secondary Outcome
Title Annualized Event Rate of LOAC During The Treatment Period: ITT Population
Hide Description 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.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 156 148 157 150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: LOAC per participant-year
1.107
(0.801 to 1.53)
0.326
(0.206 to 0.515)
0.347
(0.217 to 0.555)
0.73
(0.508 to 1.048)
0.563
(0.378 to 0.839)
11.Secondary Outcome
Title Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population
Hide Description 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.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 64 64 66 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of LOAC
Probability at Week 12
0.30
(0.195 to 0.411)
0.115
(0.05 to 0.208)
0.113
(0.05 to 0.206)
0.126
(0.059 to 0.22)
0.052
(0.014 to 0.13)
Probability at Week 24
0.392
(0.275 to 0.507)
0.166
(0.085 to 0.269)
0.113
(0.05 to 0.206)
0.207
(0.117 to 0.314)
0.162
(0.079 to 0.269)
12.Secondary Outcome
Title Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population
Hide Description 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.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 156 148 157 150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of LOAC
Probability at Week 12
0.258
(0.192 to 0.329)
0.112
(0.068 to 0.168)
0.09
(0.051 to 0.144)
0.145
(0.095 to 0.206)
0.096
(0.055 to 0.15)
Probability at Week 24
0.338
(0.265 to 0.413)
0.146
(0.095 to 0.207)
0.112
(0.067 to 0.169)
0.242
(0.177 to 0.314)
0.209
(0.147 to 0.279)
13.Secondary Outcome
Title Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
HEos-ITT population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 64 65 66 62
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 68 participants 64 participants 65 participants 66 participants 62 participants
1.15  (0.82) 1.45  (0.81) 1.22  (0.81) 1.31  (0.72) 1.18  (0.82)
Week 12 Number Analyzed 62 participants 59 participants 58 participants 61 participants 56 participants
0.83  (0.66) 0.78  (0.88) 0.70  (0.69) 0.70  (0.78) 0.63  (0.62)
Change from baseline at Week 12 Number Analyzed 62 participants 59 participants 58 participants 61 participants 56 participants
-0.29  (0.70) -0.66  (0.67) -0.55  (0.75) -0.57  (0.63) -0.57  (0.60)
14.Secondary Outcome
Title Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 157 150 157 154
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 158 participants 157 participants 150 participants 157 participants 154 participants
1.17  (0.79) 1.25  (0.78) 1.24  (0.81) 1.33  (0.78) 1.29  (0.82)
Week 12 Number Analyzed 143 participants 148 participants 138 participants 148 participants 140 participants
0.90  (0.67) 0.82  (0.79) 0.79  (0.77) 0.80  (0.73) 0.72  (0.68)
Change from baseline at Week 12 Number Analyzed 143 participants 148 participants 138 participants 148 participants 140 participants
-0.23  (0.70) -0.43  (0.70) -0.46  (0.75) -0.52  (0.65) -0.54  (0.64)
15.Secondary Outcome
Title Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
HEos ITT population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 64 65 66 62
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 68 participants 64 participants 65 participants 66 participants 62 participants
1.33  (0.83) 1.72  (0.89) 1.46  (0.73) 1.52  (0.72) 1.39  (0.87)
Week 12 Number Analyzed 62 participants 59 participants 58 participants 61 participants 56 participants
0.95  (0.71) 0.88  (0.91) 0.89  (0.79) 0.76  (0.84) 0.69  (0.68)
Change from baseline at Week 12 Number Analyzed 62 participants 59 participants 58 participants 61 participants 56 participants
-0.35  (0.71) -0.84  (0.87) -0.62  (0.70) -0.73  (0.77) -0.69  (0.70)
16.Secondary Outcome
Title Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 157 150 157 154
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 158 participants 157 participants 150 participants 157 participants 154 participants
1.32  (0.81) 1.47  (0.85) 1.42  (0.79) 1.50  (0.74) 1.47  (0.84)
Week 12 Number Analyzed 143 participants 148 participants 136 participants 148 participants 140 participants
1.02  (0.73) 0.95  (0.88) 0.95  (0.81) 0.89  (0.79) 0.89  (0.81)
Change from baseline at Week 12 Number Analyzed 143 participants 148 participants 136 participants 148 participants 140 participants
-0.27  (0.76) -0.52  (0.79) -0.52  (0.80) -0.59  (0.79) -0.54  (0.71)
17.Secondary Outcome
Title Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
HEos-ITT population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 64 65 66 62
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 68 participants 64 participants 65 participants 66 participants 61 participants
2.55  (0.84) 2.98  (0.90) 2.65  (0.74) 2.69  (0.81) 2.76  (0.91)
Week 12 Number Analyzed 58 participants 59 participants 56 participants 55 participants 53 participants
1.52  (1.09) 1.20  (0.96) 1.20  (0.88) 1.27  (0.91) 1.39  (0.94)
Change from baseline at Week 12 Number Analyzed 58 participants 59 participants 56 participants 55 participants 53 participants
-1.03  (0.93) -1.72  (1.14) -1.40  (1.03) -1.39  (1.02) -1.38  (0.90)
18.Secondary Outcome
Title Change From Baseline in ACQ-5 Score at Week 12: ITT Population
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 157 150 157 154
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 158 participants 157 participants 150 participants 157 participants 153 participants
2.69  (0.80) 2.80  (0.83) 2.73  (0.82) 2.70  (0.79) 2.78  (0.84)
Week 12 Number Analyzed 129 participants 145 participants 134 participants 134 participants 135 participants
1.55  (1.00) 1.41  (1.02) 1.38  (0.96) 1.38  (0.86) 1.49  (0.98)
Change from baseline at Week 12 Number Analyzed 129 participants 145 participants 134 participants 134 participants 135 participants
-1.11  (0.93) -1.38  (1.10) -1.35  (1.05) -1.32  (1.02) -1.24  (0.95)
19.Secondary Outcome
Title Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
HEos-ITT population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 64 65 66 62
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 68 participants 63 participants 64 participants 66 participants 60 participants
4.16  (1.27) 3.82  (1.13) 4.02  (1.15) 3.99  (1.06) 3.89  (1.88)
Week 12 Number Analyzed 60 participants 60 participants 58 participants 58 participants 53 participants
5.05  (1.22) 5.35  (1.21) 5.41  (1.06) 5.06  (1.19) 5.05  (1.29)
Change from baseline at Week 12 Number Analyzed 60 participants 59 participants 57 participants 58 participants 52 participants
0.80  (1.02) 1.54  (1.18) 1.42  (0.97) 1.08  (0.97) 1.16  (1.01)
20.Secondary Outcome
Title Change From Baseline in AQLQ Global Score at Week 12: ITT Population
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 157 150 157 154
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 156 participants 153 participants 148 participants 157 participants 152 participants
4.12  (1.10) 3.91  (1.13) 4.03  (1.15) 4.02  (1.01) 4.00  (1.09)
Week 12 Number Analyzed 135 participants 145 participants 136 participants 139 participants 136 participants
5.00  (1.10) 5.13  (1.22) 5.22  (1.11) 5.04  (1.13) 5.03  (1.12)
Change from baseline at Week 12 Number Analyzed 133 participants 142 participants 134 participants 139 participants 135 participants
0.86  (0.99) 1.25  (1.10) 1.19  (1.05) 1.03  (1.02) 0.98  (1.02)
21.Secondary Outcome
Title Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
HEos-ITT Population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 64 65 66 62
Mean (Standard Deviation)
Unit of Measure: inhalations per day
Baseline Number Analyzed 68 participants 64 participants 65 participants 66 participants 62 participants
2.53  (2.77) 3.61  (3.56) 3.02  (2.85) 3.15  (2.70) 2.42  (2.75)
Week 12 Number Analyzed 62 participants 59 participants 58 participants 61 participants 56 participants
1.88  (2.53) 2.14  (3.22) 2.15  (2.67) 1.85  (2.75) 1.36  (1.76)
Change from baseline at Week 12 Number Analyzed 62 participants 59 participants 58 participants 61 participants 56 participants
-0.51  (1.74) -1.47  (2.31) -0.93  (2.31) -1.49  (2.37) -1.01  (2.00)
22.Secondary Outcome
Title Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 157 150 157 154
Mean (Standard Deviation)
Unit of Measure: inhalations per day
Baseline Number Analyzed 158 participants 157 participants 150 participants 157 participants 154 participants
2.72  (2.73) 3.25  (3.15) 2.98  (2.74) 3.36  (3.43) 3.01  (2.87)
Week 12 Number Analyzed 142 participants 148 participants 136 participants 148 participants 140 participants
2.20  (2.57) 2.30  (3.02) 2.03  (2.46) 2.09  (2.73) 1.99  (2.42)
Change from baseline at Week 12 Number Analyzed 142 participants 148 participants 136 participants 148 participants 140 participants
-0.44  (1.75) -0.95  (2.05) -0.99  (2.27) -1.35  (2.84) -0.92  (2.16)
23.Post-Hoc Outcome
Title Change From Baseline in FEV1 at Week 12: Subset of ITT Population With Baseline Blood Eosinophil <0.3 G/L
Hide Description FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subset of ITT population which included participants with baseline blood eosinophil count <0.3 G/L.
Arm/Group Title Placebo q2w Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 90 93 85 91 92
Mean (Standard Deviation)
Unit of Measure: liter
Baseline Number Analyzed 90 participants 93 participants 85 participants 91 participants 92 participants
1.79  (0.42) 1.9  (0.55) 1.79  (0.53) 1.85  (0.56) 1.94  (0.56)
Week 12 Number Analyzed 71 participants 87 participants 79 participants 79 participants 81 participants
1.92  (0.61) 2.12  (0.63) 2.02  (0.67) 2.05  (0.68) 2.06  (0.68)
Change from baseline at Week 12 Number Analyzed 71 participants 87 participants 79 participants 79 participants 81 participants
0.09  (0.36) 0.19  (0.31) 0.23  (0.33) 0.16  (0.36) 0.17  (0.36)
Time Frame 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.
Adverse Event Reporting Description 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).
 
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Hide Arm/Group Description Participants exposed to Placebo (for Dupilumab) added to stable ICS/LABA therapy (mean exposure of 23 weeks). Participants exposed to Dupilumab 300 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks). Participants exposed to Dupilumab 200 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks). Participants exposed to Dupilumab 300 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks). Participants exposed to Dupilumab 200 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
All-Cause Mortality
Placebo Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/158 (0.00%)   0/156 (0.00%)   0/148 (0.00%)   2/157 (1.27%)   0/150 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/158 (5.70%)   13/156 (8.33%)   10/148 (6.76%)   16/157 (10.19%)   6/150 (4.00%) 
Blood and lymphatic system disorders           
Eosinophilia  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Cardiac disorders           
Atrioventricular block complete  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  0/157 (0.00%)  1/150 (0.67%) 
Cardiac failure acute  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Cor pulmonale acute  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Gastrointestinal disorders           
Colitis  1  0/158 (0.00%)  0/156 (0.00%)  1/148 (0.68%)  0/157 (0.00%)  0/150 (0.00%) 
Large intestine polyp  1  1/158 (0.63%)  0/156 (0.00%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Subileus  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Hepatobiliary disorders           
Cholecystitis  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Hepatitis cholestatic  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Immune system disorders           
Anaphylactic reaction  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Drug hypersensitivity  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Infections and infestations           
Appendicitis  1  1/158 (0.63%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Diverticulitis  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Epiglottitis  1  0/158 (0.00%)  0/156 (0.00%)  1/148 (0.68%)  0/157 (0.00%)  0/150 (0.00%) 
Erysipelas  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Gastroenteritis  1  0/158 (0.00%)  2/156 (1.28%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Herpes zoster  1  1/158 (0.63%)  0/156 (0.00%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Pneumonia  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Pneumonia bacterial  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Sinusitis  1  0/158 (0.00%)  0/156 (0.00%)  1/148 (0.68%)  0/157 (0.00%)  0/150 (0.00%) 
Injury, poisoning and procedural complications           
Bone fissure  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Comminuted fracture  1  1/158 (0.63%)  0/156 (0.00%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Joint dislocation  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  0/157 (0.00%)  1/150 (0.67%) 
Procedural intestinal perforation  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Procedural pain  1  0/158 (0.00%)  0/156 (0.00%)  1/148 (0.68%)  0/157 (0.00%)  0/150 (0.00%) 
Soft tissue injury  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Upper limb fracture  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  0/157 (0.00%)  1/150 (0.67%) 
Investigations           
Blood pressure increased  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Benign neoplasm of thyroid gland  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  0/157 (0.00%)  1/150 (0.67%) 
Bowen's disease  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Breast cancer metastatic  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Colon cancer  1  1/158 (0.63%)  0/156 (0.00%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Hypergammaglobulinaemia benign monoclonal  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Metastatic gastric cancer  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Nervous system disorders           
Syncope  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous  1  0/158 (0.00%)  0/156 (0.00%)  2/148 (1.35%)  1/157 (0.64%)  0/150 (0.00%) 
Pregnancy  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Psychiatric disorders           
Suicide attempt  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Reproductive system and breast disorders           
Uterine prolapse  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma  1  4/158 (2.53%)  1/156 (0.64%)  5/148 (3.38%)  2/157 (1.27%)  2/150 (1.33%) 
Organising pneumonia  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Pulmonary embolism  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  1/157 (0.64%)  0/150 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermal cyst  1  0/158 (0.00%)  0/156 (0.00%)  0/148 (0.00%)  0/157 (0.00%)  1/150 (0.67%) 
Eczema  1  0/158 (0.00%)  1/156 (0.64%)  0/148 (0.00%)  0/157 (0.00%)  0/150 (0.00%) 
Vascular disorders           
Hypertension  1  0/158 (0.00%)  0/156 (0.00%)  1/148 (0.68%)  0/157 (0.00%)  0/150 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 200 mg q4w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   88/158 (55.70%)   95/156 (60.90%)   81/148 (54.73%)   96/157 (61.15%)   74/150 (49.33%) 
General disorders           
Injection site erythema  1  12/158 (7.59%)  34/156 (21.79%)  21/148 (14.19%)  12/157 (7.64%)  13/150 (8.67%) 
Injection site oedema  1  1/158 (0.63%)  8/156 (5.13%)  4/148 (2.70%)  0/157 (0.00%)  2/150 (1.33%) 
Injection site pain  1  7/158 (4.43%)  14/156 (8.97%)  7/148 (4.73%)  6/157 (3.82%)  5/150 (3.33%) 
Injection site pruritus  1  5/158 (3.16%)  12/156 (7.69%)  10/148 (6.76%)  0/157 (0.00%)  3/150 (2.00%) 
Infections and infestations           
Bronchitis  1  16/158 (10.13%)  19/156 (12.18%)  11/148 (7.43%)  11/157 (7.01%)  10/150 (6.67%) 
Influenza  1  5/158 (3.16%)  9/156 (5.77%)  6/148 (4.05%)  13/157 (8.28%)  10/150 (6.67%) 
Nasopharyngitis  1  15/158 (9.49%)  16/156 (10.26%)  15/148 (10.14%)  19/157 (12.10%)  9/150 (6.00%) 
Pharyngitis  1  8/158 (5.06%)  5/156 (3.21%)  3/148 (2.03%)  7/157 (4.46%)  3/150 (2.00%) 
Sinusitis  1  11/158 (6.96%)  6/156 (3.85%)  5/148 (3.38%)  13/157 (8.28%)  12/150 (8.00%) 
Upper respiratory tract infection  1  28/158 (17.72%)  20/156 (12.82%)  22/148 (14.86%)  19/157 (12.10%)  22/150 (14.67%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  9/158 (5.70%)  3/156 (1.92%)  3/148 (2.03%)  7/157 (4.46%)  7/150 (4.67%) 
Back pain  1  6/158 (3.80%)  12/156 (7.69%)  8/148 (5.41%)  4/157 (2.55%)  7/150 (4.67%) 
Nervous system disorders           
Headache  1  20/158 (12.66%)  17/156 (10.90%)  17/148 (11.49%)  19/157 (12.10%)  9/150 (6.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  5/158 (3.16%)  11/156 (7.05%)  4/148 (2.70%)  7/157 (4.46%)  3/150 (2.00%) 
Oropharyngeal pain  1  3/158 (1.90%)  6/156 (3.85%)  1/148 (0.68%)  9/157 (5.73%)  3/150 (2.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01854047     History of Changes
Other Study ID Numbers: DRI12544
2013-000856-16 ( EudraCT Number )
U1111-1138-3962 ( Other Identifier: UTN )
First Submitted: May 10, 2013
First Posted: May 15, 2013
Results First Submitted: April 27, 2017
Results First Posted: June 2, 2017
Last Update Posted: June 26, 2017