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Trial record 1 of 1 for:    Dupilumab, 1307
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Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

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.
 
ClinicalTrials.gov Identifier: NCT01979016
Recruitment Status : Completed
First Posted : November 8, 2013
Results First Posted : March 18, 2020
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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 (AD)
Interventions Drug: Dupilumab
Drug: Placebo
Other: Background treatment
Enrollment 54
Recruitment Details The study was conducted at 5 sites in USA and Canada between 05 December 2013 and 30 January 2015. A total of 66 participants were screened in the study.
Pre-assignment Details Out of 66 participants, 54 participants were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive Dupilumab 200 mg once weekly (qw) or placebo qw.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description 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. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Period Title: Overall Study
Started 27 27
Completed 25 26
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             0
Adverse Event             0             1
Arm/Group Title Placebo qw Dupilumab 200 mg qw Total
Hide Arm/Group Description 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. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15. Total of all reporting groups
Overall Number of Baseline Participants 27 27 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 54 participants
44.1  (15.73) 38.5  (13.55) 41.3  (14.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Female
13
  48.1%
11
  40.7%
24
  44.4%
Male
14
  51.9%
16
  59.3%
30
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Hispanic or Latino
1
   3.7%
1
   3.7%
2
   3.7%
Not Hispanic or Latino
25
  92.6%
26
  96.3%
51
  94.4%
Unknown or Not Reported
1
   3.7%
0
   0.0%
1
   1.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
White 20 19 39
Black or African American 3 3 6
Asian 3 5 8
Other 1 0 1
Eczema Area and Severity Index (EASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 27 participants 54 participants
34.2  (14.59) 33.4  (15.41) 33.8  (14.87)
[1]
Measure Description: 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 ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Investigator Global Assessment (IGA) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 27 participants 54 participants
3.5  (0.51) 3.5  (0.51) 3.5  (0.50)
[1]
Measure Description: IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear).
Weekly Peak Pruritus Numeric Rating Scale (NRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 27 participants 54 participants
7.4  (2.04) 7.1  (2.42) 7.3  (2.22)
[1]
Measure Description: Pruritus NRS was an assessment tool that was used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant 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]).
Global Individual Signs Score (GISS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 27 participants 54 participants
8.9  (1.69) 8.4  (1.82) 8.6  (1.76)
[1]
Measure Description: Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Patient Oriented Eczema Measure (POEM) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 27 participants 54 participants
21.4  (5.60) 21.7  (5.55) 21.6  (5.52)
[1]
Measure Description: The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).
Body Surface Area (BSA) Involvement with Atopic Dermatitis   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of BSA
Number Analyzed 27 participants 27 participants 54 participants
54.5  (26.91) 53.8  (29.72) 54.2  (28.08)
[1]
Measure Description: Body surface area affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.
SCORing Atopic Dermatitis (SCORAD) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 27 participants 54 participants
65.1  (13.36) 64.2  (17.67) 64.6  (15.52)
[1]
Measure Description: SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Dermatology Life Quality Index (DLQI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 27 participants 54 participants
14.9  (7.05) 17.0  (7.67) 16.0  (7.38)
[1]
Measure Description: DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.
Total Hospital Anxiety Depression Scale (HADS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 27 participants 54 participants
12.7  (6.70) 13.3  (7.66) 13.0  (7.13)
[1]
Measure Description: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
1.Primary Outcome
Title Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16
Hide Description The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values imputed by last observation carried forward (LOCF).
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population that included all participants who were randomized into this study and received at least 1 dose of study drug.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-5.8  (8.16) -75.2  (8.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Analysis was performed by a mixed model repeated measures (MMRM) model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -69.4
Confidence Interval (2-Sided) 95%
-92.5 to -46.2
Estimation Comments Dupilumab 200 mg qw vs Placebo qw
2.Secondary Outcome
Title Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16
Hide Description IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were considered as non-responders.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Measure Type: Number
Unit of Measure: percentage of participants
0 37
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 37.0
Confidence Interval (2-Sided) 95%
18.82 to 55.25
Estimation Comments Dupilumab 200 mg qw vs Placebo qw
3.Secondary Outcome
Title Percentage of Participants Who Achieved IGA Score Reduction From Baseline of ≥2 Points at Week 16
Hide Description IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Participants with reduction in IGA score from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as non-responders.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Measure Type: Number
Unit of Measure: percentage of participants
3.7 51.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 48.1
Confidence Interval (2-Sided) 95%
28.00 to 68.30
Estimation Comments Dupilumab 200 mg qw vs Placebo qw
4.Secondary Outcome
Title Absolute Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16
Hide Description Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 26
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.98  (0.398) -3.64  (0.405)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.66
Confidence Interval (2-Sided) 95%
-3.80 to -1.52
Estimation Comments Dupilumab 200 mg qw vs Placebo qw
5.Secondary Outcome
Title Percent Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16
Hide Description Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 26
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-8.36  (8.098) -56.44  (8.248)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -48.08
Confidence Interval (2-Sided) 95%
-71.31 to -24.85
Estimation Comments Dupilumab 200 mg qw vs Placebo qw
6.Secondary Outcome
Title Absolute Change From Baseline in EASI Score to Week 16
Hide Description The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.7  (2.65) -25.2  (2.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -21.5
Confidence Interval (2-Sided) 95%
-29.0 to -14.0
Estimation Comments Dupilumab 200 mg qw vs Placebo qw
7.Secondary Outcome
Title Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16
Hide Description SCORAD was a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.1  (3.60) -36.4  (3.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -31.3
Confidence Interval (2-Sided) 95%
-41.5 to -21.1
Estimation Comments Dupilumab 200 mg qw vs Placebo qw
8.Secondary Outcome
Title Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16
Hide Description SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-8.2  (5.41) -54.8  (5.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Analysis was performed by MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -46.6
Confidence Interval (2-Sided) 95%
-62.0 to -31.3
Estimation Comments Dupilumab 200 mg qw vs Placebo qw
9.Secondary Outcome
Title 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
Hide Description EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% respectively, overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Measure Type: Number
Unit of Measure: percentage of participants
Participants with EASI-50 22.2 77.8
Participants with EASI-75 14.8 66.7
Participants with EASI-90 0 33.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Statistical comparison for percentage of participants who achieved 50% reduction from baseline in EASI score (EASI-50). Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 55.6
Confidence Interval (2-Sided) 95%
33.38 to 77.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Statistical comparison for percentage of participants who achieved 75% reduction from baseline in EASI score (EASI-75). Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 51.9
Confidence Interval (2-Sided) 95%
29.59 to 74.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Statistical comparison for percentage of participants who achieved 90% reduction from baseline in EASI score (EASI-90). Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0011
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 33.3
Confidence Interval (2-Sided) 95%
15.55 to 51.11
Estimation Comments [Not Specified]
10.Secondary Outcome
Title 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
Hide Description SCORAD was a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% respectively, overall improvement in SCORAD score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing SCORAD score at Week 16 were counted as non-responders.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Measure Type: Number
Unit of Measure: percentage of participants
Participants with SCORAD-50 7.4 55.6
Participants with SCORAD-75 0 11.1
Participants with SCORAD-90 0 7.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Statistical comparison for percentage of participants who achieved 50% reduction from baseline in SCORAD Score (SCORAD-50). Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 48.1
Confidence Interval (2-Sided) 95%
27.0 to 69.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Statistical comparison for percentage of participants who achieved 75% reduction from baseline in SCORAD Score (SCORAD-75). Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0792
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 11.1
Confidence Interval (2-Sided) 95%
-0.7 to 23.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Statistical comparison for percentage of participants who achieved 90% reduction from baseline in SCORAD Score (SCORAD-90). Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.1573
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 7.4
Confidence Interval (2-Sided) 95%
-2.5 to 17.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Absolute Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16
Hide Description POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.6  (1.34) -13.1  (1.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.4
Confidence Interval (2-Sided) 95%
-14.3 to -6.6
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percent Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16
Hide Description POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-12.1  (6.18) -58.3  (6.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments Analysis was performed by a MMRM model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -46.2
Confidence Interval (2-Sided) 95%
-63.9 to -28.5
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) to Week 16
Hide Description Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change in Erythema GISS 0.0  (0.14) -0.7  (0.14)
Change in Infiltration/Papulation GISS -0.1  (0.13) -1.0  (0.13)
Change in Excoriation GISS -0.3  (0.14) -1.3  (0.14)
Change in Lichenification GISS -0.1  (0.14) -1.2  (0.14)
14.Secondary Outcome
Title Changes From Baseline in GISS Cumulative Score to Week 16
Hide Description Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used.
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description:
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.
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 27 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.5  (0.46) -4.2  (0.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-5.02 to -2.39
Estimation Comments [Not Specified]
Time Frame All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events: AEs that developed/worsened during the on treatment period (time period from the administration of first dose of study drug to the final visit [Week 32]).
 
Arm/Group Title Placebo qw Dupilumab 200 mg qw
Hide Arm/Group Description Participants exposed to Placebo (for Dupilumab) (mean exposure of 10 weeks). Participants exposed to Dupilumab 200 mg qw (mean exposure of 14 weeks).
All-Cause Mortality
Placebo qw Dupilumab 200 mg qw
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/27 (0.00%) 
Hide Serious Adverse Events
Placebo qw Dupilumab 200 mg qw
Affected / at Risk (%) Affected / at Risk (%)
Total   3/27 (11.11%)   0/27 (0.00%) 
Cardiac disorders     
Coronary artery stenosis  1  1/27 (3.70%)  0/27 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/27 (3.70%)  0/27 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain  1  1/27 (3.70%)  0/27 (0.00%) 
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo qw Dupilumab 200 mg qw
Affected / at Risk (%) Affected / at Risk (%)
Total   17/27 (62.96%)   20/27 (74.07%) 
Eye disorders     
Conjunctivitis allergic  1  0/27 (0.00%)  2/27 (7.41%) 
General disorders     
Fatigue  1  1/27 (3.70%)  2/27 (7.41%) 
Injection site erythema  1  1/27 (3.70%)  2/27 (7.41%) 
Injection site reaction  1  0/27 (0.00%)  2/27 (7.41%) 
Infections and infestations     
Folliculitis  1  0/27 (0.00%)  2/27 (7.41%) 
Gastroenteritis  1  0/27 (0.00%)  2/27 (7.41%) 
Nasopharyngitis  1  5/27 (18.52%)  3/27 (11.11%) 
Post procedural infection  1  0/27 (0.00%)  2/27 (7.41%) 
Upper respiratory tract infection  1  4/27 (14.81%)  4/27 (14.81%) 
Viral upper respiratory tract infection  1  2/27 (7.41%)  3/27 (11.11%) 
Dermatitis Infected  1  2/27 (7.41%)  0/27 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  0/27 (0.00%)  2/27 (7.41%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/27 (7.41%)  1/27 (3.70%) 
Nervous system disorders     
Headache  1  1/27 (3.70%)  2/27 (7.41%) 
Presyncope  1  0/27 (0.00%)  2/27 (7.41%) 
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  4/27 (14.81%)  4/27 (14.81%) 
1
Term from vocabulary, MedDRA (16.0)
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.
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Management
Organization: Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
EMail: clinicaltrials@regeneron.com
Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01979016    
Other Study ID Numbers: R668-AD-1307
First Submitted: November 1, 2013
First Posted: November 8, 2013
Results First Submitted: March 5, 2020
Results First Posted: March 18, 2020
Last Update Posted: March 18, 2020