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Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01979016
Collaborator
Sanofi (Industry)
54
Enrollment
4
Locations
2
Arms
13
Actual Duration (Months)
13.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy, Safety, Serum Concentration and Biomarker Profile of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date :
Dec 31, 2013
Actual Primary Completion Date :
Dec 31, 2014
Actual Study Completion Date :
Jan 31, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Placebo qw

Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15.

Drug: Placebo
Matching placebo

Other: Background treatment
Participants were required to apply stable doses of a topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit and at least 7 days after the baseline visit (day -7 to day 8).
Other Names:
  • Topical emollient

    		•
    Experimental: Dupilumab 200 mg qw

    Two subcutaneous injections of Dupilumab 200 milligram (mg) (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.

    Drug: Dupilumab
    Other Names:
  • REGN668
  • SAR231893
  • Dupixent

    • Other: Background treatment
    Participants were required to apply stable doses of a topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit and at least 7 days after the baseline visit (day -7 to day 8).
    Other Names:
  • Topical emollient

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16 [Baseline to Week 16]

      The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values imputed by last observation carried forward (LOCF).

    Secondary Outcome Measures

    1. Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16 [Week 16]

      IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were considered as non-responders.

    2. Percentage of Participants Who Achieved IGA Score Reduction From Baseline of ≥2 Points at Week 16 [Baseline to Week 16]

      IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Participants with reduction in IGA score from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as non-responders.

    3. Absolute Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16 [Baseline to Week 16]

      Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment were set to missing and missing values were imputed by LOCF.

    4. Percent Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16 [Baseline to Week 16]

      Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment were set to missing and missing values were imputed by LOCF.

    5. Absolute Change From Baseline in EASI Score to Week 16 [Baseline to Week 16]

      The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values were imputed by LOCF.

    6. Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16 [Baseline to Week 16]

      SCORAD was a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.

    7. Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16 [Baseline to Week 16]

      SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.

    8. Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score ( EASI-50, EASI-75, and EASI-90 Respectively) at Week 16 [Baseline to Week 16]

      EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% respectively, overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.

    9. Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16 [Baseline to Week 16]

      SCORAD was a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% respectively, overall improvement in SCORAD score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing SCORAD score at Week 16 were counted as non-responders.

    10. Absolute Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16 [Baseline to Week 16]

      POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.

    11. Percent Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16 [Baseline to Week 16]

      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.

    12. Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) to Week 16 [Baseline to Week 16]

      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.

    13. Changes From Baseline in GISS Cumulative Score to Week 16 [Baseline to Week 16]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female, 18 years or older;

    2. Chronic AD that had been present for at least 3 years before the screening visit;

    3. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable;

    4. Willing and able to comply with all clinic visits and study-related procedures.

    Exclusion Criteria:

    1. Prior participation in a Dupilumab clinical trial;

    2. Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;

    3. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:

    • Systemic corticosteroids;

    • Immunosuppressive/immunomodulating drugs;

    • Phototherapy for AD;

    1. Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;

    2. Treatment with certain biologics;

    3. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;

    4. Planned major surgical procedure during the participant's participation in this study;

    5. Participant was a member of the investigational team or his/her immediate family;

    6. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit

    7. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;

    Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/exclusion criteria are listed.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chicago Illinois United States
    2 New York New York United States
    3 Dallas Texas United States
    4 Montreal Quebec Canada

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals
    • Sanofi

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01979016
    Other Study ID Numbers:
    • R668-AD-1307
    First Posted:
    Nov 8, 2013
    Last Update Posted:
    Mar 18, 2020
    Last Verified:
    Mar 1, 2020
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema
    Emollients

    Study Results

    Participant Flow

    Recruitment Details The study was conducted at 5 sites in USA and Canada between 05 December 2013 and 30 January 2015. A total of 66 participants were screened in the study.
    Pre-assignment Detail Out of 66 participants, 54 participants were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive Dupilumab 200 mg once weekly (qw) or placebo qw.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Period Title: Overall Study
    STARTED 27 27
    COMPLETED 25 26
    NOT COMPLETED 2 1

    Baseline Characteristics

    Arm/Group Title Placebo qw Dupilumab 200 mg qw Total
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15. Total of all reporting groups
    Overall Participants 27 27 54
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    44.1
    (15.73)
    38.5
    (13.55)
    41.3
    (14.81)
    Sex: Female, Male (Count of Participants)
    Female
    13
    48.1%
    11
    40.7%
    24
    44.4%
    Male
    14
    51.9%
    16
    59.3%
    30
    55.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    3.7%
    1
    3.7%
    2
    3.7%
    Not Hispanic or Latino
    25
    92.6%
    26
    96.3%
    51
    94.4%
    Unknown or Not Reported
    1
    3.7%
    0
    0%
    1
    1.9%
    Race/Ethnicity, Customized (Number) [Number]
    White
    20
    74.1%
    19
    70.4%
    39
    72.2%
    Black or African American
    3
    11.1%
    3
    11.1%
    6
    11.1%
    Asian
    3
    11.1%
    5
    18.5%
    8
    14.8%
    Other
    1
    3.7%
    0
    0%
    1
    1.9%
    Eczema Area and Severity Index (EASI) Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    34.2
    (14.59)
    33.4
    (15.41)
    33.8
    (14.87)
    Investigator Global Assessment (IGA) Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    3.5
    (0.51)
    3.5
    (0.51)
    3.5
    (0.50)
    Weekly Peak Pruritus Numeric Rating Scale (NRS) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    7.4
    (2.04)
    7.1
    (2.42)
    7.3
    (2.22)
    Global Individual Signs Score (GISS) Total Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    8.9
    (1.69)
    8.4
    (1.82)
    8.6
    (1.76)
    Patient Oriented Eczema Measure (POEM) Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    21.4
    (5.60)
    21.7
    (5.55)
    21.6
    (5.52)
    Body Surface Area (BSA) Involvement with Atopic Dermatitis (Percentage of BSA) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of BSA]
    54.5
    (26.91)
    53.8
    (29.72)
    54.2
    (28.08)
    SCORing Atopic Dermatitis (SCORAD) Score (Units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Units on a scale]
    65.1
    (13.36)
    64.2
    (17.67)
    64.6
    (15.52)
    Dermatology Life Quality Index (DLQI) Score (Units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Units on a scale]
    14.9
    (7.05)
    17.0
    (7.67)
    16.0
    (7.38)
    Total Hospital Anxiety Depression Scale (HADS) (Units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Units on a scale]
    12.7
    (6.70)
    13.3
    (7.66)
    13.0
    (7.13)

    Outcome Measures

    1. Primary Outcome
    Title Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16
    Description The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values imputed by last observation carried forward (LOCF).
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    Full analysis set (FAS) population that included all participants who were randomized into this study and received at least 1 dose of study drug.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Least Squares Mean (Standard Error) [percent change]
    -5.8
    (8.16)
    -75.2
    (8.15)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Analysis was performed by a mixed model repeated measures (MMRM) model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
    Estimated Value -69.4
    Confidence Interval (2-Sided) 95%
    -92.5 to -46.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Dupilumab 200 mg qw vs Placebo qw
    2. Secondary Outcome
    Title Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16
    Description IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were considered as non-responders.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    FAS population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Number [percentage of participants]
    0
    0%
    37.0
    137%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value = 0.0006
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Percentage difference
    Estimated Value 37.0
    Confidence Interval (2-Sided) 95%
    18.82 to 55.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments Dupilumab 200 mg qw vs Placebo qw
    3. Secondary Outcome
    Title Percentage of Participants Who Achieved IGA Score Reduction From Baseline of ≥2 Points at Week 16
    Description IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Participants with reduction in IGA score from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as non-responders.
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    FAS population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Number [percentage of participants]
    3.7
    13.7%
    51.9
    192.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Percentage difference
    Estimated Value 48.1
    Confidence Interval (2-Sided) 95%
    28.00 to 68.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments Dupilumab 200 mg qw vs Placebo qw
    4. Secondary Outcome
    Title Absolute Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16
    Description Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment were set to missing and missing values were imputed by LOCF.
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on FAS. Here, number of participants analyzed = participants with available data for this endpoint.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 26
    Least Squares Mean (Standard Error) [units on a scale]
    -0.98
    (0.398)
    -3.64
    (0.405)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -2.66
    Confidence Interval (2-Sided) 95%
    -3.80 to -1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments Dupilumab 200 mg qw vs Placebo qw
    5. Secondary Outcome
    Title Percent Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16
    Description Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment were set to missing and missing values were imputed by LOCF.
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    FAS population. Here, number of participants analyzed = participants with available data for this endpoint.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 26
    Least Squares Mean (Standard Error) [percent change]
    -8.36
    (8.098)
    -56.44
    (8.248)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value = 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -48.08
    Confidence Interval (2-Sided) 95%
    -71.31 to -24.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments Dupilumab 200 mg qw vs Placebo qw
    6. Secondary Outcome
    Title Absolute Change From Baseline in EASI Score to Week 16
    Description The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    FAS population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Least Squares Mean (Standard Error) [units on a scale]
    -3.7
    (2.65)
    -25.2
    (2.65)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -21.5
    Confidence Interval (2-Sided) 95%
    -29.0 to -14.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments Dupilumab 200 mg qw vs Placebo qw
    7. Secondary Outcome
    Title Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16
    Description SCORAD was a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    FAS population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Least Squares Mean (Standard Error) [units on a scale]
    -5.1
    (3.60)
    -36.4
    (3.60)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -31.3
    Confidence Interval (2-Sided) 95%
    -41.5 to -21.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments Dupilumab 200 mg qw vs Placebo qw
    8. Secondary Outcome
    Title Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16
    Description SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    FAS Population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Least Squares Mean (Standard Error) [percent change]
    -8.2
    (5.41)
    -54.8
    (5.40)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Analysis was performed by MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -46.6
    Confidence Interval (2-Sided) 95%
    -62.0 to -31.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments Dupilumab 200 mg qw vs Placebo qw
    9. Secondary Outcome
    Title Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score ( EASI-50, EASI-75, and EASI-90 Respectively) at Week 16
    Description EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% respectively, overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    FAS population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Participants with EASI-50
    22.2
    82.2%
    77.8
    288.1%
    Participants with EASI-75
    14.8
    54.8%
    66.7
    247%
    Participants with EASI-90
    0
    0%
    33.3
    123.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Statistical comparison for percentage of participants who achieved 50% reduction from baseline in EASI score (EASI-50). Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Percentage difference
    Estimated Value 55.6
    Confidence Interval (2-Sided) 95%
    33.38 to 77.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Statistical comparison for percentage of participants who achieved 75% reduction from baseline in EASI score (EASI-75). Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value = 0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Percentage difference
    Estimated Value 51.9
    Confidence Interval (2-Sided) 95%
    29.59 to 74.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Statistical comparison for percentage of participants who achieved 90% reduction from baseline in EASI score (EASI-90). Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value = 0.0011
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Percentage difference
    Estimated Value 33.3
    Confidence Interval (2-Sided) 95%
    15.55 to 51.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16
    Description SCORAD was a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% respectively, overall improvement in SCORAD score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing SCORAD score at Week 16 were counted as non-responders.
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    FAS population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Participants with SCORAD-50
    7.4
    27.4%
    55.6
    205.9%
    Participants with SCORAD-75
    0
    0%
    11.1
    41.1%
    Participants with SCORAD-90
    0
    0%
    7.4
    27.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Statistical comparison for percentage of participants who achieved 50% reduction from baseline in SCORAD Score (SCORAD-50). Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value = 0.0002
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Percentage difference
    Estimated Value 48.1
    Confidence Interval (2-Sided) 95%
    27.0 to 69.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Statistical comparison for percentage of participants who achieved 75% reduction from baseline in SCORAD Score (SCORAD-75). Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value = 0.0792
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Percentage difference
    Estimated Value 11.1
    Confidence Interval (2-Sided) 95%
    -0.7 to 23.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Statistical comparison for percentage of participants who achieved 90% reduction from baseline in SCORAD Score (SCORAD-90). Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value = 0.1573
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Percentage difference
    Estimated Value 7.4
    Confidence Interval (2-Sided) 95%
    -2.5 to 17.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Absolute Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16
    Description POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    FAS population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Least Squares Mean (Standard Error) [units on a scale]
    -2.6
    (1.34)
    -13.1
    (1.37)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -10.4
    Confidence Interval (2-Sided) 95%
    -14.3 to -6.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Percent Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16
    Description POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
    Time Frame Baseline to Week 16

    Outcome Measure Data

    Analysis Population Description
    FAS population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Least Squares Mean (Standard Error) [percent change]
    -12.1
    (6.18)
    -58.3
    (6.31)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments Analysis was performed by a MMRM model.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -46.2
    Confidence Interval (2-Sided) 95%
    -63.9 to -28.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) to Week 16
    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

    Outcome Measure Data

    Analysis Population Description
    FAS population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Change in Erythema GISS
    0.0
    (0.14)
    -0.7
    (0.14)
    Change in Infiltration/Papulation GISS
    -0.1
    (0.13)
    -1.0
    (0.13)
    Change in Excoriation GISS
    -0.3
    (0.14)
    -1.3
    (0.14)
    Change in Lichenification GISS
    -0.1
    (0.14)
    -1.2
    (0.14)
    14. Secondary Outcome
    Title Changes From Baseline in GISS Cumulative Score to Week 16
    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

    Outcome Measure Data

    Analysis Population Description
    FAS population was used.
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
    Measure Participants 27 27
    Least Squares Mean (Standard Error) [units on a scale]
    -0.5
    (0.46)
    -4.2
    (0.46)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo qw, Dupilumab 200 mg qw
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.7
    Confidence Interval (2-Sided) 95%
    -5.02 to -2.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product.
    Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events: AEs that developed/worsened during the on treatment period (time period from the administration of first dose of study drug to the final visit [Week 32]).
    Arm/Group Title Placebo qw Dupilumab 200 mg qw
    Arm/Group Description Participants exposed to Placebo (for Dupilumab) (mean exposure of 10 weeks). Participants exposed to Dupilumab 200 mg qw (mean exposure of 14 weeks).
    All Cause Mortality
    Placebo qw Dupilumab 200 mg qw
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/27 (0%) 0/27 (0%)
    Serious Adverse Events
    Placebo qw Dupilumab 200 mg qw
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/27 (11.1%) 0/27 (0%)
    Cardiac disorders
    Coronary artery stenosis 1/27 (3.7%) 0/27 (0%)
    Hepatobiliary disorders
    Cholecystitis 1/27 (3.7%) 0/27 (0%)
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain 1/27 (3.7%) 0/27 (0%)
    Other (Not Including Serious) Adverse Events
    Placebo qw Dupilumab 200 mg qw
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/27 (63%) 20/27 (74.1%)
    Eye disorders
    Conjunctivitis allergic 0/27 (0%) 2/27 (7.4%)
    General disorders
    Fatigue 1/27 (3.7%) 2/27 (7.4%)
    Injection site erythema 1/27 (3.7%) 2/27 (7.4%)
    Injection site reaction 0/27 (0%) 2/27 (7.4%)
    Infections and infestations
    Folliculitis 0/27 (0%) 2/27 (7.4%)
    Gastroenteritis 0/27 (0%) 2/27 (7.4%)
    Nasopharyngitis 5/27 (18.5%) 3/27 (11.1%)
    Post procedural infection 0/27 (0%) 2/27 (7.4%)
    Upper respiratory tract infection 4/27 (14.8%) 4/27 (14.8%)
    Viral upper respiratory tract infection 2/27 (7.4%) 3/27 (11.1%)
    Dermatitis Infected 2/27 (7.4%) 0/27 (0%)
    Injury, poisoning and procedural complications
    Contusion 0/27 (0%) 2/27 (7.4%)
    Musculoskeletal and connective tissue disorders
    Back pain 2/27 (7.4%) 1/27 (3.7%)
    Nervous system disorders
    Headache 1/27 (3.7%) 2/27 (7.4%)
    Presyncope 0/27 (0%) 2/27 (7.4%)
    Skin and subcutaneous tissue disorders
    Dermatitis atopic 4/27 (14.8%) 4/27 (14.8%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Name/Title Clinical Trial Management
    Organization Regeneron Pharmaceuticals, Inc.
    Phone 844-734-6643
    Email clinicaltrials@regeneron.com
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01979016
    Other Study ID Numbers:
    • R668-AD-1307
    First Posted:
    Nov 8, 2013
    Last Update Posted:
    Mar 18, 2020
    Last Verified:
    Mar 1, 2020