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

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ClinicalTrials.gov Identifier: NCT01859988
Recruitment Status : Completed
First Posted : May 22, 2013
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
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
Interventions Drug: Dupilumab
Drug: Placebo
Enrollment 380

Recruitment Details 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 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.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 63 64 61 65 65 61 379
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 64 participants 61 participants 65 participants 65 participants 61 participants 379 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 64 participants 61 participants 65 participants 65 participants 61 participants 379 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%
1.Primary Outcome
Title Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16
Hide 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 range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants with EASI score assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by last observation carried forward (LOCF).
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 61 63 60 65 64 61
Least Squares Mean (Standard Deviation)
Unit of Measure: Percent change
-75.5  (26.86) -70.5  (35.09) -67.4  (31.97) -64.9  (37.21) -46.7  (41.96) -20.2  (46.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dupilumab 300 mg qw, Placebo
Comments LS mean and standard error were obtained using analysis of covariance (ANCOVA) model with treatment and randomization strata (moderate vs severe;Japan vs rest of world) and relevant baseline values as covariates. Multiplicity was controlled using hierarchical testing procedure:highest dose vs. placebo was tested first. Comparison order was 300 mg qw,300 mg q2w,200 mg q2w,300 mg q4w & 100 mg q4w, vs placebo respectively. Testing continues only if previous comparison was statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value -55.7
Confidence Interval (2-Sided) 95%
-68.9 to -42.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.74
Estimation Comments Dupilumab 300 mg qw vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dupilumab 300 mg q2w, Placebo
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -50.1
Confidence Interval (2-Sided) 95%
-63.3 to -37.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.67
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dupilumab 200 mg q2w, Placebo
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -47.4
Confidence Interval (2-Sided) 95%
-60.6 to -34.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.76
Estimation Comments Dupilumab 200 mg q2w vs Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dupilumab 300 mg q4w, Placebo
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -45.4
Confidence Interval (2-Sided) 95%
-58.5 to -32.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.66
Estimation Comments Dupilumab 300 mg q4w vs Placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dupilumab 100 mg q4w, Placebo
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -26.8
Confidence Interval (2-Sided) 95%
-39.8 to -13.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.65
Estimation Comments Dupilumab 100 mg q4w vs Placebo
2.Secondary Outcome
Title Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16
Hide Description IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is 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 treated as a non-responders.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 63 64 61 65 65 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
33.3
(21.95 to 46.34)
29.7
(18.91 to 42.42)
27.9
(17.15 to 40.83)
21.5
(12.31 to 33.49)
12.3
(5.47 to 22.82)
1.6
(0.04 to 8.80)
3.Secondary Outcome
Title Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16
Hide Description IGA is 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 success is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score reduction 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 a non-responders.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 63 64 61 65 65 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
50.8
(37.89 to 63.62)
46.9
(34.28 to 59.77)
42.6
(30.04 to 55.94)
35.4
(23.92 to 48.23)
20.0
(11.10 to 31.77)
9.8
(3.70 to 20.19)
4.Secondary Outcome
Title Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16
Hide Description Pruritus NRS is an assessment tool that is 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 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]).
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, number of participants analyzed = participants with pruritus NRS assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 62 63 58 63 64 58
Mean (Standard Deviation)
Unit of Measure: Percent change
-52.85  (31.368) -46.22  (31.964) -40.6  (33.073) -38.69  (38.366) -21.47  (32.952) -0.43  (38.423)
5.Secondary Outcome
Title Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16
Hide Description Pruritus NRS is an assessment tool that is 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 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]).
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, number of participants analyzed =participants with pruritus NRS assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 63 64 61 65 65 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 62 participants 63 participants 59 participants 63 participants 64 participants 58 participants
6.54  (1.54) 6.74  (2.072) 6.98  (2.315) 6.84  (1.853) 6.71  (1.882) 6.34  (1.832)
Week 16 Number Analyzed 63 participants 64 participants 61 participants 64 participants 65 participants 61 participants
3.07  (2.148) 3.64  (2.388) 4.21  (2.763) 3.99  (2.449) 5.26  (2.465) 6.05  (2.312)
Change at Week 16 Number Analyzed 62 participants 63 participants 59 participants 63 participants 64 participants 58 participants
-3.48  (2.32) -3.16  (2.467) -2.77  (2.595) -2.79  (2.609) -1.46  (2.038) -0.27  (2.28)
6.Secondary Outcome
Title Absolute Change in EASI Score From Baseline to Week 16
Hide 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 range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, number of participants analyzed = participants with EASI score assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 63 64 61 65 65 61
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Baseline Number Analyzed 63 participants 64 participants 61 participants 65 participants 65 participants 61 participants
30.1  (11.23) 33.8  (14.52) 32.9  (15.5) 29.4  (11.48) 32.2  (13.49) 32.9  (13.77)
Week 16 Number Analyzed 61 participants 63 participants 60 participants 65 participants 64 participants 61 participants
7.2  (8.83) 10.7  (12.89) 10.9  (12.41) 9.8  (11.16) 17.4  (15.28) 25.6  (18.32)
Change at Week 16 Number Analyzed 61 participants 63 participants 60 participants 65 participants 64 participants 61 participants
-23.1  (1.70) -21.1  (1.68) -20.7  (1.71) -20.4  (1.62) -13.8  (1.64) -5.8  (1.71)
7.Secondary Outcome
Title Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16
Hide Description SCORAD is a clinical tool for assessing the severity of AD 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).
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 61 63 60 65 64 60
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
-56.9  (4.12) -51.2  (4.05) -46.0  (4.12) -48.8  (3.95) -26.6  (3.98) -13.8  (4.14)
8.Secondary Outcome
Title Absolute Change in SCORAD Scores From Baseline to Week 16
Hide Description SCORAD is a clinical tool for assessing the severity of AD 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).
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 61 63 60 65 64 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-38.2  (2.76) -34.4  (2.71) -30.9  (2.76) -33.1  (2.64) -18.0  (2.66) -10.5  (2.77)
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 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. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in EASI score respectively from baseline to Week 16.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Participants with a missing EASI score at Week 16 were treated as non-responders.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 63 64 61 65 65 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Reduction of 50%
82.5
(70.90 to 90.95)
78.1
(66.03 to 87.49)
62.3
(48.96 to 74.39)
70.8
(58.17 to 81.40)
44.6
(32.27 to 57.47)
29.5
(18.52 to 42.57)
Reduction of 75%
60.3
(47.20 to 72.43)
53.1
(40.23 to 65.72)
55.7
(42.45 to 68.45)
49.2
(36.60 to 61.93)
29.2
(18.60 to 41.83)
11.5
(4.74 to 22.22)
Reduction of 90%
36.5
(24.73 to 49.60)
29.7
(18.91 to 42.42)
31.1
(19.90 to 44.29)
29.2
(18.60 to 41.83)
15.4
(7.63 to 26.48)
3.3
(0.40 to 11.35)
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 is a clinical tool for assessing the severity of AD 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). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in SCORAD score respectively from baseline to Week 16.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Participants with a missing SCORAD score at Week 16 were treated as non-responders.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 63 64 61 65 65 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Reduction of 50%
68.3
(55.3 to 79.4)
59.4
(46.4 to 71.5)
52.5
(39.3 to 65.4)
55.4
(42.5 to 67.7)
26.2
(16.0 to 38.5)
19.7
(10.6 to 31.8)
Reduction of 75%
23.8
(14.0 to 36.2)
25.0
(15.0 to 37.4)
16.4
(8.2 to 28.1)
21.5
(12.3 to 33.5)
7.7
(2.5 to 17.0)
3.3
(0.4 to 11.3)
Reduction of 90%
6.3
(1.8 to 15.5)
6.3
(1.7 to 15.2)
4.9
(1.0 to 13.7)
3.1
(0.4 to 10.7)
3.1
(0.4 to 10.7)
0.0
(0.0 to 5.9)
11.Secondary Outcome
Title Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16
Hide Description POEM is 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]).
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 61 63 59 65 64 59
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
-57.3  (4.52) -44.0  (4.44) -49.2  (5.54) -46.6  (4.33) -14.2  (4.35) 0.2  (4.61)
12.Secondary Outcome
Title Absolute Change in POEM Scores From Baseline to Week 16
Hide Description POEM is 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]).
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 61 63 59 65 64 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-12.1  (0.88) -9.8  (0.87) -10.4  (0.89) -9.9  (0.85) -3.3  (0.85) -1.1  (0.90)
13.Secondary Outcome
Title Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline 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).
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 61 63 60 65 64 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Erythema -0.9  (0.10) -0.9  (0.10) -0.8  (0.10) -0.8  (0.10) -0.4  (0.10) -0.2  (0.10)
Infiltration/Papulation -1.2  (0.11) -1.1  (0.11) -1.0  (0.11) -1.1  (0.10) -0.6  (0.11) -0.3  (0.11)
Excoriations -1.4  (0.11) -1.4  (0.11) -1.1  (0.11) -1.3  (0.11) -0.6  (0.11) -0.4  (0.11)
Lichenification -1.1  (0.12) -1.1  (0.11) -1.0  (0.12) -1.1  (0.11) -0.7  (0.11) -0.3  (0.12)
14.Secondary Outcome
Title Changes in GISS Cumulative Score From Baseline 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).
Time Frame Baseline to Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 61 63 60 65 64 61
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.6  (0.38) -4.5  (0.37) -3.9  (0.38) -4.3  (0.37) -2.3  (0.37) -1.2  (0.38)
Time Frame Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product
Adverse Event Reporting Description TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit [Week 32]).
 
Arm/Group Title Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Hide Arm/Group Description Participants who received 2 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. Participants who received 2 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. Participants who received 2 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. Participants who received 2 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. Participants who received 2 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. Participants who received 2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15.
All-Cause Mortality
Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/63 (1.59%)      2/64 (3.13%)      1/61 (1.64%)      3/65 (4.62%)      5/65 (7.69%)      4/61 (6.56%)    
Cardiac disorders             
Tachycardia  1  0/63 (0.00%)  0 0/64 (0.00%)  0 1/61 (1.64%)  1 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0
Congenital, familial and genetic disorders             
Hip dysplasia  1  0/63 (0.00%)  0 0/64 (0.00%)  0 0/61 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 1/61 (1.64%)  1
Immune system disorders             
Anaphylactic shock  1  0/63 (0.00%)  0 0/64 (0.00%)  0 1/61 (1.64%)  1 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0
Infections and infestations             
Cellulitis  1  0/63 (0.00%)  0 0/64 (0.00%)  0 0/61 (0.00%)  0 0/65 (0.00%)  0 1/65 (1.54%)  1 0/61 (0.00%)  0
Peritonsillar abscess  1  0/63 (0.00%)  0 0/64 (0.00%)  0 0/61 (0.00%)  0 1/65 (1.54%)  1 0/65 (0.00%)  0 0/61 (0.00%)  0
Viral infection  1  1/63 (1.59%)  1 0/64 (0.00%)  0 0/61 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Osteonecrosis  1  0/63 (0.00%)  0 0/64 (0.00%)  0 0/61 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 1/61 (1.64%)  1
Nervous system disorders             
Syncope  1  0/63 (0.00%)  0 1/64 (1.56%)  1 0/61 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0
Psychiatric disorders             
Suicidal ideation  1  0/63 (0.00%)  0 0/64 (0.00%)  0 0/61 (0.00%)  0 1/65 (1.54%)  1 0/65 (0.00%)  0 0/61 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Asthma  1  0/63 (0.00%)  0 0/64 (0.00%)  0 0/61 (0.00%)  0 0/65 (0.00%)  0 1/65 (1.54%)  1 0/61 (0.00%)  0
Respiratory failure  1  0/63 (0.00%)  0 0/64 (0.00%)  0 1/61 (1.64%)  1 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0
Skin and subcutaneous tissue disorders             
Dermatitis atopic  1  0/63 (0.00%)  0 1/64 (1.56%)  1 0/61 (0.00%)  0 0/65 (0.00%)  0 4/65 (6.15%)  5 1/61 (1.64%)  1
Dermatitis exfoliative  1  0/63 (0.00%)  0 0/64 (0.00%)  0 0/61 (0.00%)  0 1/65 (1.54%)  1 0/65 (0.00%)  0 0/61 (0.00%)  0
Surgical and medical procedures             
Abortion induced  1  0/63 (0.00%)  0 0/64 (0.00%)  0 0/61 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 1/61 (1.64%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, meddra (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/63 (55.56%)      34/64 (53.13%)      34/61 (55.74%)      39/65 (60.00%)      38/65 (58.46%)      38/61 (62.30%)    
Eye disorders             
Conjunctivitis  1  4/63 (6.35%)  5 1/64 (1.56%)  1 0/61 (0.00%)  0 1/65 (1.54%)  1 0/65 (0.00%)  0 0/61 (0.00%)  0
Conjunctivitis allergic  1  3/63 (4.76%)  5 2/64 (3.13%)  4 6/61 (9.84%)  9 3/65 (4.62%)  3 1/65 (1.54%)  1 2/61 (3.28%)  2
Gastrointestinal disorders             
Abdominal pain upper  1  1/63 (1.59%)  1 2/64 (3.13%)  2 0/61 (0.00%)  0 0/65 (0.00%)  0 4/65 (6.15%)  4 1/61 (1.64%)  1
Vomiting  1  1/63 (1.59%)  1 0/64 (0.00%)  0 4/61 (6.56%)  7 0/65 (0.00%)  0 0/65 (0.00%)  0 3/61 (4.92%)  3
General disorders             
Fatigue  1  2/63 (3.17%)  2 1/64 (1.56%)  1 1/61 (1.64%)  1 4/65 (6.15%)  4 0/65 (0.00%)  0 3/61 (4.92%)  3
Infections and infestations             
Herpes simplex  1  1/63 (1.59%)  1 2/64 (3.13%)  2 3/61 (4.92%)  4 1/65 (1.54%)  1 5/65 (7.69%)  7 0/61 (0.00%)  0
Nasopharyngitis  1  16/63 (25.40%)  23 16/64 (25.00%)  18 16/61 (26.23%)  25 21/65 (32.31%)  29 20/65 (30.77%)  29 16/61 (26.23%)  23
Oral herpes  1  0/63 (0.00%)  0 3/64 (4.69%)  5 2/61 (3.28%)  4 3/65 (4.62%)  4 5/65 (7.69%)  8 0/61 (0.00%)  0
Upper respiratory tract infection  1  5/63 (7.94%)  7 6/64 (9.38%)  8 2/61 (3.28%)  2 5/65 (7.69%)  6 5/65 (7.69%)  7 11/61 (18.03%)  11
Urinary tract infection  1  0/63 (0.00%)  0 3/64 (4.69%)  5 6/61 (9.84%)  7 3/65 (4.62%)  3 2/65 (3.08%)  2 2/61 (3.28%)  2
Investigations             
Blood triglycerides increased  1  0/63 (0.00%)  0 1/64 (1.56%)  1 0/61 (0.00%)  0 4/65 (6.15%)  5 0/65 (0.00%)  0 0/61 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  1/63 (1.59%)  1 4/64 (6.25%)  4 4/61 (6.56%)  5 1/65 (1.54%)  1 1/65 (1.54%)  1 0/61 (0.00%)  0
Back pain  1  2/63 (3.17%)  16 2/64 (3.13%)  3 0/61 (0.00%)  0 2/65 (3.08%)  5 3/65 (4.62%)  3 5/61 (8.20%)  5
Nervous system disorders             
Headache  1  8/63 (12.70%)  40 5/64 (7.81%)  13 9/61 (14.75%)  24 5/65 (7.69%)  6 7/65 (10.77%)  18 2/61 (3.28%)  2
Respiratory, thoracic and mediastinal disorders             
Cough  1  4/63 (6.35%)  4 4/64 (6.25%)  4 2/61 (3.28%)  2 1/65 (1.54%)  1 0/65 (0.00%)  0 1/61 (1.64%)  1
Skin and subcutaneous tissue disorders             
Dermatitis atopic  1  8/63 (12.70%)  9 13/64 (20.31%)  19 8/61 (13.11%)  10 10/65 (15.38%)  12 11/65 (16.92%)  13 10/61 (16.39%)  12
Urticaria  1  1/63 (1.59%)  1 0/64 (0.00%)  0 1/61 (1.64%)  1 0/65 (0.00%)  0 4/65 (6.15%)  5 0/61 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, meddra (16.0)
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.
Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor’s request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.
Results Point of Contact
Name/Title: Clinical Trial Management
Organization: Regeneron Pharmaceuticals, Inc
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01859988     History of Changes
Other Study ID Numbers: R668-AD-1021
First Submitted: May 20, 2013
First Posted: May 22, 2013
Results First Submitted: July 26, 2017
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017