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Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01859988
First received: May 20, 2013
Last updated: July 26, 2017
Last verified: July 2017
Results First Received: July 26, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: Dupilumab
Drug: Placebo

  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 95 study sites in 7 countries. A total of 452 participants were screened between 15 May 2013 and 10 January 2014. 380 participants were randomized and 379 were treated. 72 participants were screen failures mainly due to exclusion criteria met and inclusion criteria not met.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was stratified by disease severity (moderate Investigator's global assessment [IGA] = 3 versus severe IGA = 4 atopic dermatitis) and region (Japan versus rest of world). Assignment to arms was done centrally in 1:1:1:1:1:1 ratio for Dupilumab (300 mg qw; 300 mg q2w; 200 mg q2w; 300 mg q4w and 100 mg q4w) and Placebo.

Reporting Groups
  Description
Dupilumab 300 mg qw Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection every week (qw) from Week 1 to Week 15.
Dupilumab 300 mg q2w Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.
Dupilumab 200 mg q2w Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
Dupilumab 300 mg q4w Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab every 4 weeks (q4w) and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
Dupilumab 100 mg q4w Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
Placebo Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.

Participant Flow:   Overall Study
    Dupilumab 300 mg qw   Dupilumab 300 mg q2w   Dupilumab 200 mg q2w   Dupilumab 300 mg q4w   Dupilumab 100 mg q4w   Placebo
STARTED   63   64   62   65   65   61 
Treated   63   64   61   65   65   61 
COMPLETED   52   52   34   55   42   42 
NOT COMPLETED   11   12   28   10   23   19 
Withdrawal by Subject                6                3                4                3                2                2 
Lack of Efficacy                1                1                5                0                7                9 
Physician Decision                1                3                1                3                4                1 
Adverse Event                2                1                3                1                2                2 
Lost to Follow-up                1                2                3                0                3                2 
Protocol Violation                0                0                1                0                0                0 
Other than specified above                0                2                11                3                5                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 population included safety analysis set (SAF) that included all randomized participants who received any investigational product and analyzed as treated. One participant randomized into Dupilumab 200 mg q2w arm was not treated and hence, excluded from the baseline population.

Reporting Groups
  Description
Dupilumab 300 mg qw Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
Dupilumab 300 mg q2w Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.
Dupilumab 200 mg q2w Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
Dupilumab 300 mg q4w Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
Dupilumab 100 mg q4w Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.
Placebo Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Total Total of all reporting groups

Baseline Measures
   Dupilumab 300 mg qw   Dupilumab 300 mg q2w   Dupilumab 200 mg q2w   Dupilumab 300 mg q4w   Dupilumab 100 mg q4w   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   64   61   65   65   61   379 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.2  (10.74)   39.4  (12.06)   35.8  (14.90)   36.8  (10.77)   36.6  (11.55)   37.2  (13.10)   37.0  (12.06) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      20  31.7%      23  35.9%      25  41.0%      25  38.5%      31  47.7%      21  34.4%      145  38.3% 
Male      43  68.3%      41  64.1%      36  59.0%      40  61.5%      34  52.3%      40  65.6%      234  61.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

2.  Secondary:   Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16   [ Time Frame: Week 16 ]

3.  Secondary:   Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16   [ Time Frame: Week 16 ]

4.  Secondary:   Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

5.  Secondary:   Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

6.  Secondary:   Absolute Change in EASI Score From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

7.  Secondary:   Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

8.  Secondary:   Absolute Change in SCORAD Scores From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

9.  Secondary:   Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16   [ Time Frame: Week 16 ]

10.  Secondary:   Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16   [ Time Frame: Week 16 ]

11.  Secondary:   Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

12.  Secondary:   Absolute Change in POEM Scores From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

13.  Secondary:   Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

14.  Secondary:   Changes in GISS Cumulative Score From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]


  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: Clinical Trial Management
Organization: Regeneron Pharmaceuticals, Inc
e-mail: clinicaltrials@regeneron.com


Publications of Results:

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01859988     History of Changes
Other Study ID Numbers: R668-AD-1021
Study First Received: May 20, 2013
Results First Received: July 26, 2017
Last Updated: July 26, 2017