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Trial record 70 of 737 for:    "Dermatitis, Atopic"

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 2)

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: NCT02277769
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : October 16, 2017
Last Update Posted : October 16, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dermatitis, Atopic
Interventions Drug: Dupilumab
Drug: Placebo (for Dupilumab)
Enrollment 708
Recruitment Details The study was conducted in 11 countries between 03 December 2014 and 21 January 2016. A total of 962 participants were screened in the study.
Pre-assignment Details Out of 962 participants, 708 were randomized and 707 were treated in the study. Participants were randomized in 1:1:1 ratio to receive Dupilumab 300 mg once weekly (qw), Dupilumab 300 mg every 2 weeks (q2w) or Placebo qw.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Period Title: Overall Study
Started 236 233 239
Treated 235 233 239
Safety Population 234 [1] 236 [2] 237 [3]
Completed 190 220 221
Not Completed 46 13 18
Reason Not Completed
Protocol Violation             3             3             5
Lack of Efficacy             17             0             4
Adverse Event             14             2             4
Other than specified above             12             8             5
[1]
1 participant received at least 1 injection of Dupilumab 300mg(analyzed in Dupilumab 300 mg q2w arm)
[2]
3 participants (1 [placebo] + 2 [Dupilumab 300 mg qw arm]) analyzed in Dupilumab 300 mg q2w arm
[3]
2 participants received fewer injections of Dupilumab 300 mg (analyzed in Dupilumab 300 mg q2w arm)
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15. Total of all reporting groups
Overall Number of Baseline Participants 236 233 239 708
Hide Baseline Analysis Population Description
Baseline population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 236 participants 233 participants 239 participants 708 participants
37.4  (14.09) 36.9  (13.96) 37.1  (14.51) 37.1  (14.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 236 participants 233 participants 239 participants 708 participants
Female
104
  44.1%
96
  41.2%
100
  41.8%
300
  42.4%
Male
132
  55.9%
137
  58.8%
139
  58.2%
408
  57.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 236 participants 233 participants 239 participants 708 participants
Hispanic or Latino
8
   3.4%
7
   3.0%
12
   5.0%
27
   3.8%
Not Hispanic or Latino
219
  92.8%
218
  93.6%
220
  92.1%
657
  92.8%
Unknown or Not Reported
9
   3.8%
8
   3.4%
7
   2.9%
24
   3.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 236 participants 233 participants 239 participants 708 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
50
  21.2%
44
  18.9%
45
  18.8%
139
  19.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
   8.5%
13
   5.6%
15
   6.3%
48
   6.8%
White
156
  66.1%
165
  70.8%
168
  70.3%
489
  69.1%
More than one race
3
   1.3%
5
   2.1%
7
   2.9%
15
   2.1%
Unknown or Not Reported
7
   3.0%
6
   2.6%
4
   1.7%
17
   2.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 236 participants 233 participants 239 participants 708 participants
North and South America
116
  49.2%
114
  48.9%
116
  48.5%
346
  48.9%
Western Europe
54
  22.9%
54
  23.2%
55
  23.0%
163
  23.0%
Eastern Europe
38
  16.1%
37
  15.9%
39
  16.3%
114
  16.1%
Asia Pacific
28
  11.9%
28
  12.0%
29
  12.1%
85
  12.0%
Eczema Area and Severity Index (EASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 236 participants 233 participants 239 participants 708 participants
33.6  (14.31) 31.8  (13.08) 31.9  (12.70) 32.4  (13.39)
[1]
Measure Description: The EASI score was used to measure the severity and extent of atopic dermatitis (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 range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Investigator’s Global Assessment (IGA) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 236 participants 233 participants 239 participants 708 participants
3.5  (0.50) 3.5  (0.50) 3.5  (0.50) 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 Average of Peak Daily Pruritus Numerical Rating Scale (NRS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 235 participants 232 participants 238 participants 705 participants
7.5  (1.85) 7.6  (1.60) 7.5  (1.81) 7.5  (1.76)
[1]
Measure Description: Pruritus NRS scale 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]).
[2]
Measure Analysis Population Description: Number of participants analyzed = participants with available data for the baseline parameter.
Body Surface Area (BSA) Involvement with AD   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of body surface area
Number Analyzed 236 participants 233 participants 239 participants 708 participants
54.3  (23.06) 52.7  (21.23) 52.2  (21.51) 53.1  (21.94)
[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] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 233 participants 230 participants 236 participants 699 participants
69.2  (14.91) 67.2  (13.48) 67.5  (13.10) 68.0  (13.86)
[1]
Measure Description: SCORAD was 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.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
[2]
Measure Analysis Population Description: Number of participants analyzed = participants with available data for the baseline parameter.
Dermatology Life Quality Index (DLQI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 236 participants 233 participants 239 participants 708 participants
15.4  (7.69) 15.4  (7.07) 16.0  (7.33) 15.6  (7.37)
[1]
Measure Description: The 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 indicative of a poor QOL.
Patient Oriented Eczema Measure (POEM)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 236 participants 233 participants 239 participants 708 participants
21.0  (5.94) 20.8  (5.49) 20.9  (5.59) 20.9  (5.67)
[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]).
Global Individual Signs Score (GISS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 236 participants 233 participants 239 participants 708 participants
9.2  (1.78) 9.0  (1.80) 9.0  (1.75) 9.1  (1.77)
[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).
Total Hospital Anxiety Depression Scale (HADS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 231 participants 227 participants 233 participants 691 participants
13.7  (8.32) 13.7  (7.52) 14.6  (8.24) 14.0  (8.04)
[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.
[2]
Measure Analysis Population Description: Number of participants analyzed = participants with available data for the baseline parameter.
1.Primary Outcome
Title Percentage of Participants With Investigator’s Global Assessment (IGA) Score of “0” or “1” and Reduction From Baseline of ≥2 Points 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 response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of “0” or “1” and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 236 233 239
Measure Type: Number
Unit of Measure: percentage of participants
8.5 36.1 36.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 27.6
Confidence Interval (2-Sided) 95%
20.46 to 34.69
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 27.9
Confidence Interval (2-Sided) 95%
20.87 to 34.99
Estimation Comments Dupilumab 300 mg qw vs Placebo
2.Secondary Outcome
Title Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at 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. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 236 233 239
Measure Type: Number
Unit of Measure: percentage of participants
11.9 44.2 48.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 32.3
Confidence Interval (2-Sided) 95%
24.75 to 39.94
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 36.3
Confidence Interval (2-Sided) 95%
28.69 to 43.81
Estimation Comments Dupilumab 300 mg qw vs Placebo
3.Secondary Outcome
Title Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to 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]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 221 225 228
Measure Type: Number
Unit of Measure: percentage of participants
9.5 36.0 39.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 26.5
Confidence Interval (2-Sided) 95%
19.13 to 33.87
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 29.5
Confidence Interval (2-Sided) 95%
22.11 to 36.95
Estimation Comments Dupilumab 300 mg qw vs Placebo
4.Secondary Outcome
Title Percentage of Participants With Improvement (Reduction ≥3 Points) in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to 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]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 226 231 234
Measure Type: Number
Unit of Measure: percentage of participants
12.8 50.6 49.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 37.8
Confidence Interval (2-Sided) 95%
30.03 to 45.60
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 36.3
Confidence Interval (2-Sided) 95%
28.56 to 44.06
Estimation Comments Dupilumab 300 mg qw vs Placebo
5.Secondary Outcome
Title Percent Change From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (NRS) Score to 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]).
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 105 195 182
Mean (Standard Deviation)
Unit of Measure: percent change
-18.1  (27.66) -47.2  (28.50) -50.9  (30.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -28.9
Confidence Interval (2-Sided) 95%
-36.04 to -21.83
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value -32.8
Confidence Interval (2-Sided) 95%
-40.20 to -25.49
Estimation Comments Dupilumab 300 mg qw vs Placebo
6.Secondary Outcome
Title Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4
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]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 221 225 228
Measure Type: Number
Unit of Measure: percentage of participants
6.3 22.7 27.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 16.3
Confidence Interval (2-Sided) 95%
9.99 to 22.68
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 21.3
Confidence Interval (2-Sided) 95%
14.66 to 27.93
Estimation Comments Dupilumab 300 mg qw vs Placebo
7.Secondary Outcome
Title Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2
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]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 221 225 228
Measure Type: Number
Unit of Measure: percentage of participants
0.9 10.7 12.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 9.8
Confidence Interval (2-Sided) 95%
5.54 to 13.98
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 11.8
Confidence Interval (2-Sided) 95%
7.31 to 16.32
Estimation Comments Dupilumab 300 mg qw vs Placebo
8.Secondary Outcome
Title Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to 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]).
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 105 195 182
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.41  (1.973) -3.56  (2.258) -3.87  (2.426)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.10
Confidence Interval (2-Sided) 95%
-2.605 to -1.587
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.47
Confidence Interval (2-Sided) 95%
-2.982 to -1.957
Estimation Comments Dupilumab 300 mg qw vs Placebo
9.Secondary Outcome
Title Percent Change From Baseline in Eczema Area and Severity Index (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.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 105 197 181
Mean (Standard Deviation)
Unit of Measure: percent change
-33.7  (33.45) -69.6  (27.84) -71.6  (27.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
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 -36.2
Confidence Interval (2-Sided) 95%
-43.46 to -28.86
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -38.2
Confidence Interval (2-Sided) 95%
-45.55 to -30.88
Estimation Comments Dupilumab 300 mg qw vs Placebo
10.Secondary Outcome
Title Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at 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. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 236 233 239
Measure Type: Number
Unit of Measure: percentage of participants
22.0 65.2 61.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 43.2
Confidence Interval (2-Sided) 95%
35.12 to 51.29
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 39.1
Confidence Interval (2-Sided) 95%
30.92 to 47.19
Estimation Comments Dupilumab 300 mg qw vs Placebo
11.Secondary Outcome
Title Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at 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. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 236 233 239
Measure Type: Number
Unit of Measure: percentage of particpants
7.2 30 30.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 22.8
Confidence Interval (2-Sided) 95%
16.09 to 29.59
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 23.3
Confidence Interval (2-Sided) 95%
16.63 to 30.05
Estimation Comments Dupilumab 300 mg qw vs Placebo
12.Secondary Outcome
Title Change From Baseline in Percent Body Surface Area (BSA) to Week 16
Hide Description BSA 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.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 105 197 181
Mean (Standard Deviation)
Unit of Measure: percentage of body surface area
-14.48  (17.810) -31.69  (19.614) -32.97  (20.400)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -17.99
Confidence Interval (2-Sided) 95%
-22.062 to -13.927
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -19.51
Confidence Interval (2-Sided) 95%
-23.491 to -15.529
Estimation Comments Dupilumab 300 mg qw vs Placebo
13.Secondary Outcome
Title Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 105 193 178
Mean (Standard Deviation)
Unit of Measure: percent change
-22.7  (25.48) -53.5  (25.23) -56.0  (25.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -31.4
Confidence Interval (2-Sided) 95%
-37.36 to -25.40
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -33.8
Confidence Interval (2-Sided) 95%
-39.75 to -27.80
Estimation Comments Dupilumab 300 mg qw vs Placebo
14.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16
Hide Description The 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.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 105 197 181
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.0  (5.75) -9.7  (6.20) -10.3  (6.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.7
Confidence Interval (2-Sided) 95%
-6.86 to -4.47
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.9
Confidence Interval (2-Sided) 95%
-7.10 to -4.72
Estimation Comments Dupilumab 300 mg qw vs Placebo
15.Secondary Outcome
Title Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16
Hide Description The 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 104 196 181
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.8  (6.07) -10.7  (6.89) -11.7  (7.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -7.0
Confidence Interval (2-Sided) 95%
-8.36 to -5.57
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -8.0
Confidence Interval (2-Sided) 95%
-9.36 to -6.64
Estimation Comments Dupilumab 300 mg qw vs Placebo
16.Secondary Outcome
Title Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16
Hide Description HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) 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.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 103 191 175
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (4.44) -5.2  (5.42) -6.2  (6.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-5.34 to -3.09
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.9
Confidence Interval (2-Sided) 95%
-6.04 to -3.81
Estimation Comments Dupilumab 300 mg qw vs Placebo
17.Secondary Outcome
Title Percent Change From Baseline in Global Individual Signs Score (GISS) 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 105 197 181
Mean (Standard Deviation)
Unit of Measure: percent change
-20.3  (25.03) -47.5  (27.0) -48.4  (27.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -27.7
Confidence Interval (2-Sided) 95%
-33.73 to -21.70
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -28.9
Confidence Interval (2-Sided) 95%
-35.03 to -22.74
Estimation Comments Dupilumab 300 mg qw vs Placebo
18.Secondary Outcome
Title Percent Change From Baseline in Weekly Average of Peak Daily Pruritus NRS Score to Week 2
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]).
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 223 224 229
Mean (Standard Deviation)
Unit of Measure: percent change
-6.3  (21.91) -24.1  (21.22) -21.2  (24.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -17.7
Confidence Interval (2-Sided) 95%
-21.96 to -13.53
Estimation Comments Dupilumab 300 mg q2w vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dupilumab 300 mg qw
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.025 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -15.0
Confidence Interval (2-Sided) 95%
-19.16 to -10.78
Estimation Comments Dupilumab 300 mg qw vs Placebo
19.Secondary Outcome
Title Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment
Hide Description Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.
Time Frame Baseline up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 234 236 237
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0
20.Secondary Outcome
Title Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16
Hide Description Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Time Frame Baseline up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set which included all randomized participants who received any study drug, and was analyzed based on the treatment received.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 234 236 237
Measure Type: Number
Unit of Measure: percentage of participants
5.6 1.7 3.4
21.Secondary Outcome
Title Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16
Hide Description Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Time Frame Baseline up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 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 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab 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 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 234 236 237
Measure Type: Number
Unit of Measure: percentage of participants
2.1 0.8 1.3
Time Frame All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs are treatment-emergent adverse events that developed/worsened during the ‘on-treatment period’ (time form the first dose of study drug up to the end of study [Week 28]). Analysis was performed on safety population.
 
Arm/Group Title Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw
Hide Arm/Group Description Participants exposed to Placebo (for Dupilumab) for 16 weeks (mean exposure of 14 weeks) Participants exposed to Dupilumab 300 mg alternating with placebo qw for 16 weeks (mean exposure of 15 weeks). Participants exposed to Dupilumab 300 mg qw for 16 weeks (mean exposure of 15 weeks).
All-Cause Mortality
Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/234 (0.00%)      3/236 (1.27%)      1/237 (0.42%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/234 (6.84%)      6/236 (2.54%)      9/237 (3.80%)    
Blood and lymphatic system disorders       
Thrombocytopenia  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Cardiac disorders       
Acute myocardial infarction  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Cardiac failure congestive  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Eye disorders       
Angle closure glaucoma  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Colonic pseudo-obstruction  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Infections and infestations       
Cellulitis  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Endocarditis bacterial  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Erysipelas  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Pyelonephritis  1  0/234 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0
Sepsis  1  2/234 (0.85%)  2 0/236 (0.00%)  0 0/237 (0.00%)  0
Septic embolus  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Skin infection  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Injury, poisoning and procedural complications       
Concussion  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Fall  1  0/234 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0
Ligament sprain  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Radius fracture  1  0/234 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0
Metabolism and nutrition disorders       
Failure to thrive  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Tetany  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Bursitis  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hodgkin's disease  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Malignant melanoma in situ  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Headache  1  0/234 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0
Hypoxic-Ischaemic encephalopathy  1  0/234 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0
Subarachnoid haemorrhage  1  0/234 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Psychiatric disorders       
Completed suicide  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Confusional state  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Delirium  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Mental status changes  1  0/234 (0.00%)  0 0/236 (0.00%)  0 1/237 (0.42%)  1
Psychotic disorder  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Schizophrenia, paranoid type  1  1/234 (0.43%)  1 0/236 (0.00%)  0 0/237 (0.00%)  0
Suicidal ideation  1  1/234 (0.43%)  2 0/236 (0.00%)  0 0/237 (0.00%)  0
Suicide attempt  1  1/234 (0.43%)  2 0/236 (0.00%)  0 0/237 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  1  2/234 (0.85%)  2 0/236 (0.00%)  0 0/237 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/234 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0
Respiratory failure  1  0/234 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis atopic  1  6/234 (2.56%)  8 0/236 (0.00%)  0 1/237 (0.42%)  1
Dermatitis exfoliative  1  0/234 (0.00%)  0 1/236 (0.42%)  1 0/237 (0.00%)  0
1
Term from vocabulary, meddra (18.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   109/234 (46.58%)      84/236 (35.59%)      90/237 (37.97%)    
General disorders       
Injection site reaction  1  15/234 (6.41%)  17 32/236 (13.56%)  58 31/237 (13.08%)  84
Infections and infestations       
Nasopharyngitis  1  25/234 (10.68%)  26 23/236 (9.75%)  25 22/237 (9.28%)  26
Nervous system disorders       
Headache  1  12/234 (5.13%)  20 18/236 (7.63%)  29 23/237 (9.70%)  50
Skin and subcutaneous tissue disorders       
Dermatitis atopic  1  82/234 (35.04%)  136 34/236 (14.41%)  39 39/237 (16.46%)  49
1
Term from vocabulary, meddra (18.0)
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.
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: NCT02277769     History of Changes
Other Study ID Numbers: R668-AD-1416
First Submitted: October 27, 2014
First Posted: October 29, 2014
Results First Submitted: August 16, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017