We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01639040
First Posted: July 12, 2012
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
Results First Submitted: May 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: Dupilumab
Drug: Placebo (for Dupilumab)
Other: Topical Corticosteroid (TCS)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 38 participants were screened in the study between 30 July 2012 and 20 December 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 38 participants, 31 were randomized and treated in the study. Participants were randomized in 2:1 ratio to receive Dupilumab 300 mg or Placebo.

Reporting Groups
  Description
Placebo QW Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days.
Dupilumab 300 mg QW Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days

Participant Flow:   Overall Study
    Placebo QW   Dupilumab 300 mg QW
STARTED   10   21 
COMPLETED   9   21 
NOT COMPLETED   1   0 
Adverse Event                1                0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Placebo Placebo (for REGN668) once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days.
REGN668 300 mg REGN668 300 mg once weekly for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
Total Total of all reporting groups

Baseline Measures
   Placebo   REGN668 300 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   21   31 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.8  (16.73)   36.0  (11.26)   36.6  (13.01) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  50.0%      13  61.9%      18  58.1% 
Male      5  50.0%      8  38.1%      13  41.9% 
Eczema Area and Severity Index (EASI) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 24.1  (12.70)   23.1  (12.35)   23.4  (12.26) 
[1] The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Investigator's Global Assessment (IGA) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.4  (0.47)   3.4  (0.60)   3.4  (0.55) 
[1] IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 6-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe; and 5 = very severe disease) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear).
Pruritus Numerical Rating Scale (NRS) score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.0  (1.39)   6.4  (2.00)   6.0  (1.93) 
[1] Pruritus NRS was an assessment tool that was used to report intensity of subject’s pruritus (itch), both maximum and average intensity during a 24-hour recall period. Participants were asked following question: how would a subject rate his itch at worst moment during previous 24 hours (for maximum itch intensity on a scale of 0–10 [0 = no itch; 10 = worst itch imaginable]).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: Baseline up to the end of study (up to Day 78) ]

2.  Other Pre-specified:   Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score: Reduction of ≥50 at Day 29 - Censored Last Observation Carried Forward (LOCF)   [ Time Frame: Day 29 ]

3.  Other Pre-specified:   Percent Change in Pruritus Numerical Rating Scale (NRS) From Day 1 (Baseline) to Day 29 (Week 4)   [ Time Frame: Baseline up to Day 29 ]

4.  Other Pre-specified:   Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of "0" or "1" at Day 29   [ Time Frame: Day 29 ]

5.  Other Pre-specified:   Percent Change in Investigator's Global Assessment (IGA) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF   [ Time Frame: Baseline up to Day 29 ]

6.  Other Pre-specified:   Percent Change in Eczema Area and Severity Index (EASI) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF   [ Time Frame: Baseline up to Day 29 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
This was a small safety study that was not adequately powered to assess efficacy.


  More Information
  Hide More Information

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: NCT01639040     History of Changes
Other Study ID Numbers: R668-AD-1121
First Submitted: July 9, 2012
First Posted: July 12, 2012
Results First Submitted: May 22, 2017
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017