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Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

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ClinicalTrials.gov Identifier: NCT01312961
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : June 8, 2017
Last Update Posted : June 8, 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 (for Dupilumab)
Drug: Fluticasone/Salmeterol combination therapy
Drug: Fluticasone monotherapy
Drug: Albuterol
Drug: Levalbuterol
Enrollment 104
Recruitment Details The study was conducted at 50 sites in the United States. A total of 491 participants were screened between March 2011 and June 2012, of whom 104 were randomized at 28 sites. A total of 387 participants were screen failures mainly due to inclusion criteria for eosinophilic asthma not met.
Pre-assignment Details Randomization was stratified according to prior inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) combination therapy dose. Assignment to arms was done centrally using Interactive Voice Response System in 1:1 ratio to receive either Dupilumab 300 mg or Placebo.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol were given as rescue medication. Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Period Title: Overall Study
Started 52 52
Treated 52 52
Completed 35 45
Not Completed 17 7
Reason Not Completed
Adverse Event             3             3
Lack of Efficacy             11             1
Poor compliance to protocol             1             0
Other than specified above             2             3
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw Total
Hide Arm/Group Description Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol were given as rescue medication. Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. Total of all reporting groups
Overall Number of Baseline Participants 52 52 104
Hide Baseline Analysis Population Description
Baseline participants included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 52 participants 104 participants
41.6  (13.1) 37.8  (13.2) 39.7  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
Female
26
  50.0%
26
  50.0%
52
  50.0%
Male
26
  50.0%
26
  50.0%
52
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
Hispanic or Latino
4
   7.7%
12
  23.1%
16
  15.4%
Not Hispanic or Latino
48
  92.3%
40
  76.9%
88
  84.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
Caucasian/White
38
  73.1%
45
  86.5%
83
  79.8%
Black
9
  17.3%
5
   9.6%
14
  13.5%
Asian/Oriental
3
   5.8%
1
   1.9%
4
   3.8%
Other than specified above
2
   3.8%
1
   1.9%
3
   2.9%
Prior ICS/LABA Combination Therapy Dose   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
High Dose
41
  78.8%
42
  80.8%
83
  79.8%
Medium Dose
11
  21.2%
10
  19.2%
21
  20.2%
[1]
Measure Description: High-Dose combination therapy was defined as Fluticasone (≥500 µg) and Salmeterol (50 µg) twice daily or the equivalent. Medium-dose combination therapy was defined as Fluticasone (250-499 µg) and Salmeterol (50 µg) twice daily or the equivalent.
Morning Peak Expiratory Flow (PEF)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  L/min
Number Analyzed 52 participants 51 participants 103 participants
406.87  (110.74) 393.04  (101.13) 400.02  (105.80)
[1]
Measure Description: PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Testing for PEF was performed at home while sitting or standing prior to using any medication for asthma.
[2]
Measure Analysis Population Description: Number of participants analyzed = participants with available data for this baseline measure.
Number of Inhalations of Albuterol or Levalbuterol in a 24-hour Period   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Number of inhalations
Number Analyzed 52 participants 50 participants 102 participants
2.04  (1.78) 2.16  (2.40) 2.10  (2.10)
[1]
Measure Description: Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary.
[2]
Measure Analysis Population Description: Number of participants analyzed = participants with available data for this baseline measure.
1.Primary Outcome
Title Percentage of Participants With Asthma Exacerbation
Hide Description An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population that included all randomized participants who received at least one dose of study drug. Participants were analysed in the treatment group to which they were randomized.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 52 52
Measure Type: Number
Unit of Measure: percentage of participants
Asthma exacerbation 44.2 5.8
≥30% reduction from baseline in morning PEF 19.2 1.9
≥6additional albuterol/levalbuterol puffs 19.2 1.9
Systemic steroid treatment 9.6 1.9
Increase in ICS ≥4 times baseline dose of ICS 5.8 0.0
Hospitalization 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (for Dupilumab), Dupilumab 300 mg qw
Comments Analysis was performed using a logistic regression model with treatment groups and stratification factor (prior ICS/LABA combination therapy dose) as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.077
Confidence Interval (2-Sided) 95%
0.021 to 0.280
Estimation Comments Dupilumab 300 mg vs. Placebo
2.Secondary Outcome
Title Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12
Hide Description The time-to-asthma exacerbation was defined as the time from the date of randomization to the date of the first asthma exacerbation event; for participants without asthma exacerbation, it was censored at the end of treatment visit date. The median time to first asthma exacerbation was not estimated because the number of asthma exacerbations was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of asthma exacerbation at Week 4, 8 and 12, are presented as the descriptive measure statistics.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 52 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of asthma exacerbation
Probability at Week 4
0.058
(0.000 to 0.122)
0.038
(0.000 to 0.091)
Probability at Week 8
0.245
(0.124 to 0.366)
0.058
(0.000 to 0.121)
Probability at Week 12
0.460
(0.318 to 0.602)
0.058
(0.000 to 0.121)
3.Secondary Outcome
Title Percentage of Participants With Composite Asthma Events
Hide Description Composite asthma event was defined as a 30% or greater reduction from baseline in morning PEF on 2 consecutive days together with 6 or more additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 52 52
Measure Type: Number
Unit of Measure: percentage of participants
1.9 0
4.Secondary Outcome
Title Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12
Hide Description FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.
Arm/Group Title Placebo Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 36 45
Mean (Standard Deviation)
Unit of Measure: Liters
-0.12  (0.35) 0.06  (0.32)
5.Secondary Outcome
Title Change From Baseline in Peak Expiratory Flow (PEF) to Week 12
Hide Description The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number analyzed = participants with at least one post-baseline assessment for each category.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: liters/minute
Change in morning PEF Number Analyzed 36 participants 44 participants
-11.2  (66.1) 10.6  (48.5)
Change in evening PEF Number Analyzed 35 participants 45 participants
-15.6  (70.7) -3.4  (49.3)
6.Secondary Outcome
Title Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12
Hide Description ACQ-5 questionnaire is a validated questionnaire comprising of 5 questions for 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 rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score is the mean of the 5 questions and range between 0 (disease totally controlled) and 6 (disease severely uncontrolled), a higher score indicated lower asthma control.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.50  (1.12) -1.07  (0.94)
7.Secondary Outcome
Title Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12
Hide Description The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 51 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.27  (15.85) -9.17  (15.40)
8.Secondary Outcome
Title Change From Baseline in Morning Asthma Symptom Scores to Week 12
Hide Description AM (ante meridiem) symptom scoring system rates were participant’s overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning. No nighttime 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
mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 36 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.3  (0.7) -0.4  (0.7)
9.Secondary Outcome
Title Change From Baseline in Evening Asthma Symptom Scores to Week 12
Hide Description PM (post meridiem) symptom scoring system rates were participant’s overall asthma symptoms experienced during the day. It ranges 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
mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 36 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1  (0.9) -0.5  (0.6)
10.Secondary Outcome
Title Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12
Hide Description Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 36 45
Mean (Standard Deviation)
Unit of Measure: number of awakenings/day
0.1  (0.7) -0.3  (0.7)
11.Secondary Outcome
Title Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12
Hide Description Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary as Albuterol or Levalbuterol was to be used only as needed for symptoms, not on a regular basis or prophylactically.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description:
Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: number of inhalations/day
0.4  (2.4) -1.3  (1.7)
Time Frame All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) 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 the ‘on treatment period’ (time from first dose of investigatory medicinal product (IMP) up to the end of the follow-up period [i.e. up to 7 weeks after the last dose of IMP]).
 
Arm/Group Title Placebo (for Dupilumab) Dupilumab 300 mg qw
Hide Arm/Group Description Participants exposed to Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks). Participants exposed to Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks).
All-Cause Mortality
Placebo (for Dupilumab) Dupilumab 300 mg qw
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/52 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (for Dupilumab) Dupilumab 300 mg qw
Affected / at Risk (%) Affected / at Risk (%)
Total   3/52 (5.77%)   1/52 (1.92%) 
Infections and infestations     
Pneumonia  1  1/52 (1.92%)  0/52 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/52 (1.92%)  0/52 (0.00%) 
Gun shot wound  1  1/52 (1.92%)  0/52 (0.00%) 
Psychiatric disorders     
Bipolar disorder  1  0/52 (0.00%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/52 (1.92%)  0/52 (0.00%) 
Pneumothorax  1  1/52 (1.92%)  0/52 (0.00%) 
1
Term from vocabulary, MedDRA 15.1
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 (for Dupilumab) Dupilumab 300 mg qw
Affected / at Risk (%) Affected / at Risk (%)
Total   24/52 (46.15%)   33/52 (63.46%) 
Gastrointestinal disorders     
Nausea  1  1/52 (1.92%)  4/52 (7.69%) 
General disorders     
Injection site erythema  1  0/52 (0.00%)  3/52 (5.77%) 
Injection site pain  1  3/52 (5.77%)  5/52 (9.62%) 
Injection site rash  1  0/52 (0.00%)  3/52 (5.77%) 
Injection site reaction  1  0/52 (0.00%)  5/52 (9.62%) 
Infections and infestations     
Gastroenteritis viral  1  3/52 (5.77%)  0/52 (0.00%) 
Nasopharyngitis  1  2/52 (3.85%)  7/52 (13.46%) 
Sinusitis  1  5/52 (9.62%)  1/52 (1.92%) 
Upper respiratory tract infection  1  9/52 (17.31%)  7/52 (13.46%) 
Viral upper respiratory tract infection  1  0/52 (0.00%)  3/52 (5.77%) 
Injury, poisoning and procedural complications     
Arthropod bite  1  0/52 (0.00%)  3/52 (5.77%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  0/52 (0.00%)  3/52 (5.77%) 
Nervous system disorders     
Headache  1  3/52 (5.77%)  6/52 (11.54%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1  1/52 (1.92%)  3/52 (5.77%) 
Rhinitis seasonal  1  3/52 (5.77%)  0/52 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/52 (1.92%)  3/52 (5.77%) 
Urticaria  1  0/52 (0.00%)  3/52 (5.77%) 
1
Term from vocabulary, MedDRA 15.1
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: NCT01312961     History of Changes
Other Study ID Numbers: ACT11457
U1111-1117-7826 ( Other Identifier: UTN )
First Submitted: March 9, 2011
First Posted: March 11, 2011
Results First Submitted: April 27, 2017
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017