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Trial record 1 of 1 for:    Dupilumab, 1314
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Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02210780
Recruitment Status : Completed
First Posted : August 7, 2014
Results First Posted : May 7, 2020
Last Update Posted : May 7, 2020
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 Atopic Dermatitis
Interventions Drug: Dupilumab
Drug: Placebo
Enrollment 194
Recruitment Details The study was conducted at approximately 50 study sites in United States (US) between 05 August 2014 and 15 September 2015. A total of 243 participants were screened in the study.
Pre-assignment Details Out of 243 participants, 194 were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive 600 mg subcutaneous (SC) dupilumab loading dose on day 1 and then dupilumab 300 mg once weekly (qw) or placebo qw.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Period Title: Overall Study
Started 97 97
Completed 92 89
Not Completed 5 8
Reason Not Completed
Adverse Event             0             5
Lost to Follow-up             2             1
Withdrawal by Subject             1             1
Physician Decision             1             0
Protocol Violation             1             0
Other than specified above             0             1
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15. Total of all reporting groups
Overall Number of Baseline Participants 97 97 194
Hide Baseline Analysis Population Description
The safety analysis set (SAF) included all randomized participants who received any study drug, and was analyzed as treated. Any participant given at least 1 dupilumab injection was assigned to the dupilumab group. The safety analysis was based on the SAF.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 97 participants 194 participants
39.9  (14.04) 39.2  (13.55) 39.6  (13.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 97 participants 194 participants
Female
51
  52.6%
48
  49.5%
99
  51.0%
Male
46
  47.4%
49
  50.5%
95
  49.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 97 participants 194 participants
Hispanic or Latino
13
  13.4%
15
  15.5%
28
  14.4%
Not Hispanic or Latino
84
  86.6%
81
  83.5%
165
  85.1%
Unknown or Not Reported
0
   0.0%
1
   1.0%
1
   0.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 97 participants 97 participants 194 participants
67
  69.1%
60
  61.9%
127
  65.5%
Black or African American Number Analyzed 97 participants 97 participants 194 participants
17
  17.5%
23
  23.7%
40
  20.6%
Asian Number Analyzed 97 participants 97 participants 194 participants
11
  11.3%
12
  12.4%
23
  11.9%
American Indian or Alaska Native Number Analyzed 97 participants 97 participants 194 participants
0
   0.0%
1
   1.0%
1
   0.5%
Other Number Analyzed 97 participants 97 participants 194 participants
2
   2.1%
1
   1.0%
3
   1.5%
Anti-tetanus Immunoglobulin G (IgG) Titer   [1] 
Mean (Standard Deviation)
Unit of measure:  IU/mL
Number Analyzed 97 participants 97 participants 194 participants
1.74  (1.908) 1.51  (1.328) 1.62  (1.644)
[1]
Measure Description: Immune responses to vaccines included anti-tetanus IgG (Adacel [Tdap] vaccine) titre: A ≥ 2-fold or ≥ 4-fold increase from pre-vaccination at baseline in IgG titer for participants with a pre-vaccination tetanus antibody titers ≥ 0.1 IU/ml or a titer of ≥ 0.2 IU/ml for participants with pre-vaccination titers of <0.1 IU/ml.
Eczema Area and Severity Index (EASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 97 participants 97 participants 194 participants
31.23  (13.771) 29.04  (13.085) 30.14  (13.442)
[1]
Measure Description: The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Investigator Global Assessment (IGA) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 97 participants 97 participants 194 participants
3.4  (0.49) 3.4  (0.49) 3.4  (0.49)
[1]
Measure Description: IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear).
Weekly Peak Pruritus Numeric Rating Scale (NRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a Scale
Number Analyzed 90 participants 94 participants 184 participants
7.3  (2.19) 7.4  (2.20) 7.3  (2.19)
[1]
Measure Analysis Population Description: Pruritus NRS was a tool used to report intensity of participant's pruritus (itch)--max & average intensity. Participants were asked: how would you rate the itch at worst moment during previous 24 hrs (max itch intensity, scale of 0-10 [0=no itch;10=worst itch imaginable]). Participants were excluded if baseline values were missed.
Global Individual Signs Score (GISS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 97 participants 97 participants 194 participants
8.8  (1.80) 8.8  (1.76) 8.8  (1.78)
[1]
Measure Description: Individual components of the AD lesions (erythema,infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Patient Oriented Eczema Measure (POEM) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 97 participants 97 participants 194 participants
20.6  (5.59) 21.5  (6.04) 21.1  (5.82)
[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]).
1.Primary Outcome
Title Percentage of Participants With a Positive Response (≥4-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16
Hide Description A positive response was defined as a ≥ 4-fold increase from pre-vaccination at baseline in anti-tetanus immunoglobulin G (IgG) titer for participants with a pre-vaccination tetanus antibody titers ≥ 0.1 IU/ml or a titer of ≥ 0.2 IU/ml for participants with pre-vaccination titers of <0.1 IU/ml. There was no planned statistical hypothesis testing regarding the difference in immune response between the 2 treatment groups for this study, therefore no formal statistical hypothesis between groups was performed.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The immune response analysis set (IRS) included all randomized participants who received any study drug, vaccine injection at Week 12, and had 1 measurement for responses to tetanus toxoid vaccine at Week 16.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 92 90
Measure Type: Number
Unit of Measure: Percentage of participants
83.7 83.3
2.Secondary Outcome
Title Percentage of Participants With a Positive Response (≥2-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16
Hide Description Participants with positive response defined as a ≥2-fold increase from pre-vaccination baseline in anti-tetanus IgG titer for participants with pre-vaccination tetanus antibody titers ≥0.1 IU/ml or a titer of ≥0.2 IU/ml for participants with pre-vaccination titers of <0.1 IU/ml.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The immune response analysis set (IRS) included all randomized participants who received any study drug, vaccine injection at Week 12, and had 1 measurement for responses to tetanus toxoid vaccine at Week 16.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 92 90
Measure Type: Number
Unit of Measure: Percentage of participants
94.6 95.6
3.Secondary Outcome
Title Percentage of Participants With a Positive Response (SBA Antibody Titer of ≥8 for Serogroup C) to Menomune Vaccine at Week 16
Hide Description A positive response to the Menomune vaccine was a serum bactericidal antibody (SBA) titer of ≥8 for serogroup C.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The immune response analysis set (IRS) included all randomized participants who received any study drug, vaccine injection at Week 12, and had 1 measurement for responses to tetanus toxoid vaccine at Week 16.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 92 90
Measure Type: Number
Unit of Measure: Percentage of participants
87.0 86.7
4.Secondary Outcome
Title Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16
Hide Description IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were counted as non-responders.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 97 97
Measure Type: Number
Unit of Measure: Percentage of participants
10.3 44.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 300 mg qw
Comments Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate [IGA=3] vs. severe [IGA=4] AD).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 34.0
Confidence Interval (2-Sided) 90%
24.29 to 43.75
Estimation Comments Dupilumab 300 mg qw vs. Placebo qw
5.Secondary Outcome
Title Percentage of Participants Achieving an 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 atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. 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 score at Week 16 were counted as non-responders.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 97 97
Measure Type: Number
Unit of Measure: Percentage of participants
32.0 72.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 300 mg qw
Comments Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate [IGA=3] vs. severe [IGA=4] AD).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 40.2
Confidence Interval (2-Sided) 90%
29.40 to 51.01
Estimation Comments Dupilumab 300 mg qw vs. Placebo qw
6.Secondary Outcome
Title Percentage of Participants Achieving an 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 atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. 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 (FAS) that included all randomized participants.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 97 97
Measure Type: Number
Unit of Measure: Percentage of participants
19.6 53.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 300 mg qw
Comments Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate [IGA=3] vs. severe [IGA=4] AD).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 34.0
Confidence Interval (2-Sided) 90%
23.38 to 44.66
Estimation Comments Dupilumab 300 mg qw vs. Placebo qw
7.Secondary Outcome
Title Change From Baseline in Peak Weekly Averaged Pruritis Numerical Rating Scale (NRS) Scores at Week 16
Hide Description Pruritus NRS was an assessment tool that was used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at 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]). Weekly average obtained in the 7-day period prior to the baseline visit. Values after first rescue medication use were set to missing and missing values were imputed by Last observation carried forward (LOCF).
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants. Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 90 94
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.11  (0.259) -4.24  (0.250)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 300 mg qw
Comments Analysis was performed using ANCOVA model which includes treatment, randomization strata, and baseline value as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.13
Confidence Interval (2-Sided) 90%
-2.72 to -1.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.354
Estimation Comments Dupilumab 300 mg qw vs. Placebo qw
8.Secondary Outcome
Title Change From Baseline in Body Surface Area (BSA) Affected by AD at 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. Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants. Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 97 97
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of BSA
-11.0  (2.11) -28.7  (2.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 300 mg qw
Comments Analysis was performed using ANCOVA model that includes treatment, randomization strata and baseline value as covariates.
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 -17.8
Confidence Interval (2-Sided) 90%
-22.5 to -13.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.84
Estimation Comments Dupilumab 300 mg qw vs. Placebo qw
9.Secondary Outcome
Title Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations and Lichenification) at Week 16
Hide Description Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease). Values after first rescue treatment were set to missing. Analysis was completed using MMRM model which includes treatment, randomization strata, visit, baseline value, treatment-by-visit interaction, and baseline-by-visit interaction as covariates. These results are observed results without imputation.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants. Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 97 97
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Erythema Number Analyzed 79 participants 87 participants
-0.4  (0.08) -0.9  (0.08)
Infiltration/Papulation Number Analyzed 79 participants 87 participants
-0.4  (0.08) -1.1  (0.08)
Excoriations Number Analyzed 79 participants 87 participants
-0.5  (0.09) -1.2  (0.08)
Lichenification Number Analyzed 79 participants 87 participants
-0.4  (0.09) -1.0  (0.09)
10.Secondary Outcome
Title Changes From Baseline in GISS Cumulative Score to Week 16
Hide Description Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants. Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 97 97
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.7  (0.28) -4.1  (0.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 300 mg qw
Comments Analysis was performed using the ANCOVA model which includes treatment, randomization strata, and baseline values as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.4
Confidence Interval (2-Sided) 90%
-3.0 to -1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments Dupilumab 300 mg qw vs. Placebo qw
11.Secondary Outcome
Title Change in Patient Oriented Eczema Measure (POEM) Score From Baseline to Week 16
Hide Description The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants. Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
Overall Number of Participants Analyzed 97 97
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-4.8  (0.72) -13.1  (0.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 300 mg qw
Comments Analysis was performed using the ANCOVA model which included treatment, randomization strata, and baseline value as covariates.
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 -8.3
Confidence Interval (2-Sided) 90%
-9.9 to -6.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.99
Estimation Comments Dupilumab 300 mg qw vs. Placebo qw
Time Frame Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Adverse Event Reporting Description Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit [Week 32]).
 
Arm/Group Title Placebo qw 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 single 300 mg injection qw from Week 1 to Week 15.
All-Cause Mortality
Placebo qw Dupilumab 300 mg qw
Affected / at Risk (%) Affected / at Risk (%)
Total   0/97 (0.00%)   0/97 (0.00%) 
Hide Serious Adverse Events
Placebo qw Dupilumab 300 mg qw
Affected / at Risk (%) Affected / at Risk (%)
Total   0/97 (0.00%)   3/97 (3.09%) 
Immune system disorders     
Serum sickness-like reaction  1  0/97 (0.00%)  1/97 (1.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Mycosis fungoides stage iv  1  0/97 (0.00%)  1/97 (1.03%) 
Squamous cell carcinoma  1  0/97 (0.00%)  1/97 (1.03%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo qw Dupilumab 300 mg qw
Affected / at Risk (%) Affected / at Risk (%)
Total   29/97 (29.90%)   30/97 (30.93%) 
General disorders     
Injection site reaction  1  0/97 (0.00%)  5/97 (5.15%) 
Infections and infestations     
Conjunctivitis  1  0/97 (0.00%)  8/97 (8.25%) 
Nasopharyngitis  1  5/97 (5.15%)  4/97 (4.12%) 
Upper respiratory tract infection  1  14/97 (14.43%)  11/97 (11.34%) 
Nervous system disorders     
Headache  1  3/97 (3.09%)  5/97 (5.15%) 
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  11/97 (11.34%)  1/97 (1.03%) 
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.
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Management
Organization: Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
EMail: clinicaltrials@regeneron.com
Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02210780    
Other Study ID Numbers: R668-AD-1314
First Submitted: August 5, 2014
First Posted: August 7, 2014
Results First Submitted: March 20, 2020
Results First Posted: May 7, 2020
Last Update Posted: May 7, 2020