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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01312961
First received: March 9, 2011
Last updated: June 7, 2017
Last verified: June 2017
Results First Received: April 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo (for Dupilumab) 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 qw 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.

Participant Flow:   Overall Study
    Placebo (for Dupilumab)   Dupilumab 300 mg qw
STARTED   52   52 
Treated   52   52 
COMPLETED   35   45 
NOT COMPLETED   17   7 
Adverse Event                3                3 
Lack of Efficacy                11                1 
Poor compliance to protocol                1                0 
Other than specified above                2                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline participants included all randomized participants.

Reporting Groups
  Description
Placebo (for Dupilumab) 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 qw 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 Total of all reporting groups

Baseline Measures
   Placebo (for Dupilumab)   Dupilumab 300 mg qw   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   52   104 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 52   52   104 
   41.6  (13.1)   37.8  (13.2)   39.7  (13.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 52   52   104 
Female      26  50.0%      26  50.0%      52  50.0% 
Male      26  50.0%      26  50.0%      52  50.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 52   52   104 
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 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 52   52   104 
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] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 52   52   104 
High Dose      41  78.8%      42  80.8%      83  79.8% 
Medium Dose      11  21.2%      10  19.2%      21  20.2% 
[1] 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] 
[Units: L/min]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 52   51   103 
   406.87  (110.74)   393.04  (101.13)   400.02  (105.80) 
[1] 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] 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] 
[Units: Number of inhalations]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 52   50   102 
   2.04  (1.78)   2.16  (2.40)   2.10  (2.10) 
[1] Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary.
[2] Number of participants analyzed = participants with available data for this baseline measure.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Asthma Exacerbation   [ Time Frame: Baseline up to Week 12 ]

2.  Secondary:   Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12   [ Time Frame: Baseline up to Week 12 ]

3.  Secondary:   Percentage of Participants With Composite Asthma Events   [ Time Frame: Baseline up to Week 12 ]

4.  Secondary:   Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Change From Baseline in Peak Expiratory Flow (PEF) to Week 12   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   Change From Baseline in Morning Asthma Symptom Scores to Week 12   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   Change From Baseline in Evening Asthma Symptom Scores to Week 12   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12   [ Time Frame: Baseline, Week 12 ]

11.  Secondary:   Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12   [ Time Frame: Baseline, Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-US@sanofi.com


Publications of Results:

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01312961     History of Changes
Other Study ID Numbers: ACT11457
U1111-1117-7826 ( Other Identifier: UTN )
Study First Received: March 9, 2011
Results First Received: April 27, 2017
Last Updated: June 7, 2017