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CompletedNCT02277743SOLO 1Updated Nov 21, 2017Results posted

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

A Phase 3 interventional study of Dupilumab and Placebo (for Dupilumab) in Dermatitis, Atopic, sponsored by Regeneron Pharmaceuticals. Completed at 101 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-21.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
671
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

02

Conditions studied

  • Dermatitis, Atopic
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 671 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, 18 years or older
  2. Chronic AD (according to American Academy of Dermatology Consensus Criteria Eichenfield 2014) that has been present for at least 3 years before the screening visit;
  3. Eczema Area and Severity Index (EASI) Score ≥16 at the screening and baseline visits;
  4. Investigator's Global Assessment (IGA) Score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits;
  5. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits;
  6. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g, because of important side effects or safety risks).

Exclusion criteria

Exclusion Criteria:

  1. Participation in a prior Dupilumab clinical study;
  2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever was longer, before the baseline visit;

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

    • Immunosuppressive/ immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.);
    • Phototherapy for AD
  4. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit;

  5. Treatment with biologics as follows:

    • Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever was longer
    • Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever was longer
  6. Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit;
  7. Planned or anticipated use of any prohibited medications and procedures during study treatment;
  8. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
  9. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: Participants might be rescreened after infection resolves;
  10. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment;
  11. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
  12. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;
  13. Participant was a member of the investigational team or his/her immediate family;
  14. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;
  15. Women unwilling to use adequate birth control, if of reproductive potential and sexually active.

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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
671 participants (actual)

Study arms

  • Experimental
    Placebo

    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 (for Dupilumab)

  • Experimental
    Dupilumab 300 mg once weekly (qw)

    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.

    Drug: Dupilumab

  • Experimental
    Dupilumab 300 mg every 2 weeks (q2w)

    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.

    Drug: Dupilumab · Drug: Placebo (for Dupilumab)

Interventions

  • DrugDupilumab

    Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

    Also known as: REGN668, SAR231893, DUPIXENT®

  • DrugPlacebo (for Dupilumab)

    Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16

    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

Secondary outcomes

  1. Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at 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. 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

  2. Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From 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 \[0 = no itch; 10 = worst itch imaginable\]). 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

  3. Percentage of Participants With Improvement (Reduction ≥3 Points) of Pruritus Numerical Rating Scale (NRS) Score From 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 \[0 = no itch; 10 = worst itch imaginable\]). 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

  4. Percent Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score 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 \[0 = no itch; 10 = worst itch imaginable\]).

    Time frame: Baseline to Week 16

  5. Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4

    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 subjects with missing peak NRS at Week 4 were considered as non-responders.

    Time frame: Baseline to Week 4

  6. Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2

    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

  7. Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score 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 \[0 = no itch; 10 = worst itch imaginable\]).

    Time frame: Baseline to Week 16

  8. Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score 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.

    Time frame: Baseline to Week 16

  9. Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at 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. 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

  10. Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at 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. 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

  11. Change From Baseline in Percent Body Surface Area (BSA) to Week 16

    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

  12. Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16

    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

  13. Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16

    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

  14. Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16

    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

  15. Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16

    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

  16. Percent Change From Baseline in Global Individual Signs Score (GISS) 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).

    Time frame: Baseline to Week 16

  17. Percent Change From Baseline in Peak Daily Pruritus NRS Score to Week 2

    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

  18. Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic 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. 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

  19. Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16

    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

  20. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16

    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

07

Results

Posted Nov 21, 2017

Participant flow

The study was conducted in 10 countries between 28 Oct 2014 and 12 Feb 2016. A total of 917 participants were screened in the study.

Participant flow — Overall Study
MilestonePlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Started224224223
Treated223223223
Safety population222229218
Completed184208197
Not completed401626
Withdrew: Protocol violation111
Withdrew: Adverse event1066
Withdrew: Lack of efficacy1143
Withdrew: Other than specified above18516

Outcome measures

PrimaryPercentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16

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
Reported as:
Number · percentage of participants
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 1610.337.937.2
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 27.7 · 95% CI 20.18 to 35.17Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 27.0 · 95% CI 19.47 to 34.44Dupilumab 300 mg qw vs Placebo
SecondaryPercentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at 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. 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
Reported as:
Number · percentage of participants
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 1614.751.352.5
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 36.6 · 95% CI 28.58 to 44.63Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 37.7 · 95% CI 29.70 to 45.77Dupilumab 300 mg qw vs Placebo
SecondaryPercentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From 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 \[0 = no itch; 10 = worst itch imaginable\]). 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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 1612.340.840.3
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 28.6 · 95% CI 20.64 to 36.52Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 28.0 · 95% CI 19.94 to 36.13Dupilumab 300 mg qw vs Placebo
SecondaryPercentage of Participants With Improvement (Reduction ≥3 Points) of Pruritus Numerical Rating Scale (NRS) Score From 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 \[0 = no itch; 10 = worst itch imaginable\]). 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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement (Reduction ≥3 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Improvement (Reduction ≥3 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 1617.246.851.7
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 29.6 · 95% CI 21.36 to 37.88Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 34.5 · 95% CI 26.08 to 42.84Dupilumab 300 mg qw vs Placebo
SecondaryPercent Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score 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 \[0 = no itch; 10 = worst itch imaginable\]).

Time frame:
Baseline to Week 16
Reported as:
Mean · percent change
Percent Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
percent changePlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percent Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16-26.8 ± 28.38-51.1 ± 28.81-49.0 ± 33.45
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Least square (ls) mean difference: -24.9 · 95% CI -32.26 to -17.52Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -22.8 · 95% CI -30.33 to -15.33Dupilumab 300 mg qw vs Placebo
SecondaryPercentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4

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 subjects with missing peak NRS at Week 4 were considered as non-responders.

Time frame:
Baseline to Week 4
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 46.116.023.4
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · Cochran-Mantel-Haenszel · p = 0.0012 (Threshold for significance at 0.025 level.) · Difference in percentages: 9.8 · 95% CI 3.95 to 15.71Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 17.3 · 95% CI 10.57 to 23.93Dupilumab 300 mg qw vs Placebo
SecondaryPercentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2

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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 23.39.49.5
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · Cochran-Mantel-Haenszel · p = 0.0097 (Threshold for significance at 0.025 level.) · Difference in percentages: 6.1 · 95% CI 1.49 to 10.68Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · Cochran-Mantel-Haenszel · p = 0.0094 (Threshold for significance at 0.025 level.) · Difference in percentages: 6.2 · 95% CI 1.45 to 10.86Dupilumab 300 mg qw vs Placebo
SecondaryChange From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score 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 \[0 = no itch; 10 = worst itch imaginable\]).

Time frame:
Baseline to Week 16
Reported as:
Mean · units on a scale
Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
units on a scalePlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16-2.13 ± 2.044-3.78 ± 2.325-3.72 ± 2.186
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -1.75 · 95% CI -2.236 to -1.260Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -1.69 · 95% CI -2.189 to -1.186Dupilumab 300 mg qw vs Placebo
SecondaryPercent Change From Baseline in Eczema Area and Severity Index (EASI) Score 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.

Time frame:
Baseline to Week 16
Reported as:
Mean · percent change
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16
percent changePlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16-39.5 ± 33.66-73.9 ± 26.28-73.8 ± 26.41
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -34.6 · 95% CI -42.35 to -26.88Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -34.4 · 95% CI -42.17 to -26.56Dupilumab 300 mg qw vs Placebo
SecondaryPercentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at 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. 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
Reported as:
Number · percentage of participants
Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 1624.668.861.0
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 44.2 · 95% CI 35.91 to 52.48Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 36.4 · 95% CI 27.90 to 44.96Dupilumab 300 mg qw vs Placebo
SecondaryPercentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at 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. 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
Reported as:
Number · percentage of participants
Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 167.635.733.2
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 28.1 · 95% CI 20.96 to 35.29Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · Cochran-Mantel-Haenszel · p = < 0.0001 (Threshold for significance at 0.025 level.) · Difference in percentages: 25.6 · 95% CI 18.51 to 32.68Dupilumab 300 mg qw vs Placebo
SecondaryChange From Baseline in Percent Body Surface Area (BSA) to Week 16

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
Reported as:
Mean · percentage of body surface area
Change From Baseline in Percent Body Surface Area (BSA) to Week 16
percentage of body surface areaPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Change From Baseline in Percent Body Surface Area (BSA) to Week 16-17.2 ± 17.381-33.72 ± 19.619-35.42 ± 19.926
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -17.92 · 95% CI -22.487 to -13.353Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -18.89 · 95% CI -23.125 to -14.650Dupilumab 300 mg qw vs Placebo
SecondaryPercent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16

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
Reported as:
Mean · percent change
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16
percent changePlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16-28.9 ± 24.25-57.2 ± 24.03-56.7 ± 24.27
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -28.7 · 95% CI -35.79 to -21.54Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -28.0 · 95% CI -35.09 to -20.87Dupilumab 300 mg qw vs Placebo
SecondaryChange From Baseline in Dermatology Life Quality Index (DLQI) to Week 16

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
Reported as:
Mean · units on a scale
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16
units on a scalePlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16-5.6 ± 5.86-9.0 ± 6.61-8.8 ± 6.79
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -4.0 · 95% CI -5.16 to -2.80Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -3.7 · 95% CI -4.87 to -2.49Dupilumab 300 mg qw vs Placebo
SecondaryChange From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16

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
Reported as:
Mean · units on a scale
Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16
units on a scalePlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16-5.3 ± 6.24-11.5 ± 7.07-11.3 ± 6.36
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -6.5 · 95% CI -8.02 to -5.01Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -5.9 · 95% CI -7.44 to -4.32Dupilumab 300 mg qw vs Placebo
SecondaryChange From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16

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
Reported as:
Mean · units on a scale
Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16
units on a scalePlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16-2.7 ± 4.40-4.8 ± 5.50-4.9 ± 5.36
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = 0.0006 (Threshold for significance at 0.025 level.) · Ls mean difference: -2.2 · 95% CI -3.44 to -0.95Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · ANCOVA · p = 0.0003 (Threshold for significance at 0.025 level.) · Ls mean difference: -2.2 · 95% CI -3.46 to -1.03Dupilumab 300 mg qw vs Placebo
SecondaryPercent Change From Baseline in Global Individual Signs Score (GISS) 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).

Time frame:
Baseline to Week 16
Reported as:
Mean · percent change
Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16
percent changePlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16-26.2 ± 25.70-52.5 ± 27.33-51.1 ± 26.58
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -27.0 · 95% CI -35.04 to -18.91Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -25.6 · 95% CI -33.06 to -18.12Dupilumab 300 mg qw vs Placebo
SecondaryPercent Change From Baseline in Peak Daily Pruritus NRS Score to Week 2

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
Reported as:
Mean · percent change
Percent Change From Baseline in Peak Daily Pruritus NRS Score to Week 2
percent changePlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percent Change From Baseline in Peak Daily Pruritus NRS Score to Week 2-4.2 ± 22.77-20.4 ± 21.40-18.9 ± 28.40
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -16.5 · 95% CI -21.08 to -11.90Dupilumab 300 mg q2w vs Placebo
  • Placebo vs Dupilumab 300 mg qw · ANCOVA · p = < 0.0001 (Threshold for significance at 0.025 level.) · Ls mean difference: -15.1 · 95% CI -19.62 to -10.50Dupilumab 300 mg qw vs Placebo
SecondaryPercentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic 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. 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
Reported as:
Number · percentage of participants
Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment000
SecondaryPercentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16

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
Reported as:
Number · percentage of participants
Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 165.03.10.9
SecondaryPercentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16

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
Reported as:
Number · percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16
percentage of participantsPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 160.91.71.8

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/222 (0%)12/222 (5.4%)97/222 (43.7%)
Dupilumab 300 mg q2w0/229 (0%)7/229 (3.1%)92/229 (40.2%)
Dupilumab 300 mg qw0/218 (0%)2/218 (0.9%)90/218 (41.3%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Dermatitis atopicSkin and subcutaneous tissue disorders3/2222/2290/218
Suicidal ideationPsychiatric disorders2/2220/2290/218
Myocardial infarctionCardiac disorders0/2220/2291/218
Kidney infectionInfections and infestations0/2220/2291/218
NephrolithiasisRenal and urinary disorders0/2220/2291/218
AnaemiaBlood and lymphatic system disorders1/2220/2290/218
Coronary artery diseaseCardiac disorders1/2220/2290/218
Device related infectionInfections and infestations1/2220/2290/218
MastitisInfections and infestations1/2220/2290/218
SepsisInfections and infestations1/2220/2290/218
Most frequent other events
Most frequent other events
EventPlaceboDupilumab 300 mg q2wDupilumab 300 mg qw
Dermatitis atopicSkin and subcutaneous tissue disorders66/22235/22921/218
Injection site reactionGeneral disorders13/22219/22941/218
NasopharyngitisInfections and infestations22/22227/22926/218
HeadacheNervous system disorders13/22221/22911/218
Upper respiratory tract infectionInfections and infestations7/2227/22912/218
Conjunctivitis allergicEye disorders3/22212/2298/218

Baseline characteristics

Baseline population included all randomized participants.

Age, Continuous
Age, Continuous(years)PlaceboDupilumab 300 mg q2wDupilumab 300 mg qwTotal
Mean39.5 ± 13.9139.8 ± 14.6839.3 ± 14.3939.5 ± 14.31
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboDupilumab 300 mg q2wDupilumab 300 mg qwTotal
Female1069481281
Male118130142390
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboDupilumab 300 mg q2wDupilumab 300 mg qwTotal
Hispanic or Latino116825
Not Hispanic or Latino212215212639
Unknown or Not Reported1337
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboDupilumab 300 mg q2wDupilumab 300 mg qwTotal
American Indian or Alaska Native0000
Asian565451161
Native Hawaiian or Other Pacific Islander0000
Black or African American16102046
White146155149450
More than one race0000
Unknown or Not Reported65314
Region of Enrollment
Region of Enrollment(Participants)PlaceboDupilumab 300 mg q2wDupilumab 300 mg qwTotal
North and South America959596286
Asia Pacific404238120
Eastern Europe23222469
Western Europe666565196
Eczema Area and Severity Index (EASI) Score
Eczema Area and Severity Index (EASI) Score(units on scale)PlaceboDupilumab 300 mg q2wDupilumab 300 mg qwTotal
Mean34.5 ± 14.4733 ± 13.5733.2 ± 13.9833.6 ± 14.00
Investigator's Global Assessment (IGA) Score
Investigator's Global Assessment (IGA) Score(units on a scale)PlaceboDupilumab 300 mg q2wDupilumab 300 mg qwTotal
Mean3.5 ± 0.53.5 ± 0.53.5 ± 0.53.5 ± 0.5
Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS)
Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS)(units on a scale)PlaceboDupilumab 300 mg q2wDupilumab 300 mg qwTotal
Mean7.4 ± 1.777.2 ± 1.897.2 ± 2.067.3 ± 1.91

6 further baseline measures are reported on the registry.

08

Study locations

101 sites
  • Birmingham, Alabama, United States
  • Fort Smith, Arkansas, United States
  • Rogers, Arkansas, United States
  • Clovis, California, United States
  • Lomita, California, United States
  • Los Angeles, California, United States
  • Oceanside, California, United States
  • Palmdale, California, United States
  • Rolling Hills Estates, California, United States
  • San Diego, California, United States
  • Santa Monica, California, United States
  • Stockton, California, United States
  • Boca Raton, Florida, United States
  • Clearwater, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Miami Lakes, Florida, United States
  • Miami, Florida, United States
  • Pensacola, Florida, United States
  • Tampa, Florida, United States
  • Newnan, Georgia, United States
  • Chicago, Illinois, United States
  • Normal, Illinois, United States
  • Evansville, Indiana, United States
  • Indianapolis, Indiana, United States
  • Louisville, Kentucky, United States
  • Boston, Massachusetts, United States
  • Troy, Michigan, United States
  • Saint Louis, Missouri, United States
  • Newington, New Hampshire, United States
  • East Windsor, New Jersey, United States
  • Buffalo, New York, United States
  • Corning, New York, United States
  • New Hyde Park, New York, United States
  • Rochester, New York, United States
  • High Point, North Carolina, United States
  • Bethlehem, Pennsylvania, United States
  • Upland, Pennsylvania, United States
  • Chattanooga, Tennessee, United States
  • Knoxville, Tennessee, United States
  • San Antonio, Texas, United States
  • Waco, Texas, United States
  • Ogden, Utah, United States
  • Newport News, Virginia, United States
  • Norfolk, Virginia, United States
  • Spokane, Washington, United States
  • Dupnitsa, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Winnepeg, Manitoba, Canada
  • Bathurst, New Brunswick, Canada
  • Hamilton, Ontario, Canada
  • Mississauga, Ontario, Canada
  • Newmarket, Ontario, Canada
  • Ottawa, Ontario, Canada
  • Richmond Hill, Ontario, Canada
  • Toronto, Ontario, Canada
  • Copenhagen, Denmark
  • Hellerup, Denmark
  • Tallinn, Estonia
  • Tartu, Estonia
  • Helsinki, Finland
  • Tampere, Finland
  • Turku, Finland
  • Berlin, Germany
  • Bielefed, Germany
  • Blaubeuren, Germany
  • Erlangen, Germany
  • Halle, Germany
  • Hamburg, Germany
  • Hannover, Germany
  • Muenster, Germany
  • Munchen, Germany
  • Osnabruck, Germany
  • Schwerin, Germany
  • Stuttgart, Germany
  • Kurume, Fukuoka, Japan
  • Fukuyama, Hiroshima, Japan
  • Inashiki, Ibaraki, Japan
  • Yokohama, Kanagawa, Japan
  • Habikino, Osaka, Japan
  • Neyagawa, Osaka, Japan
  • Sakai, Osaka, Japan
  • Takatsuki, Osaka, Japan
  • Hamamatsu, Shizuoka, Japan
  • Bunkyo-ku, Tokyo, Japan
  • Chuo-ku, Tokyo, Japan
  • Nerima-ku, Tokyo, Japan
  • Shinagawa, Tokyo, Japan
  • Shinjuku, Tokyo, Japan
  • Kofu, Yamanashi, Japan
  • Gifu, Japan
  • Hiroshima, Japan
  • Kyoto, Japan
  • Osaka, Japan
  • Singapore, Singapore
  • Alcaniz, Spain
  • Alicante, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Sevilla, Spain

Showing the first 100 of 101 sites across 10 countries.

09

References and documents

Publications

  • Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, Kingo K, Worm M, Poulin Y, Wollenberg A, Soo Y, Graham NM, Pirozzi G, Akinlade B, Staudinger H, Mastey V, Eckert L, Gadkari A, Stahl N, Yancopoulos GD, Ardeleanu M; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348. doi: 10.1056/NEJMoa1610020. Epub 2016 Sep 30. PubMed 27690741 ↗
  • Silverberg JI, Boguniewicz M, Hanifin J, Papp KA, Zhang H, Rossi AB, Levit NA. Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis is Efficacious Regardless of Age of Disease Onset: a Post Hoc Analysis of Two Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2731-2746. doi: 10.1007/s13555-022-00822-x. Epub 2022 Oct 21. PubMed 36269503 ↗
  • Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28. PubMed 35636689 ↗
  • Armstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13. PubMed 34897582 ↗
  • Paller AS, Tan JKL, Bagel J, Rossi AB, Shumel B, Zhang H, Abramova A. IGAxBSA composite for assessing disease severity and response in patients with atopic dermatitis. Br J Dermatol. 2022 Mar;186(3):496-507. doi: 10.1111/bjd.20872. Epub 2022 Feb 25. PubMed 34726270 ↗
  • Griffiths C, de Bruin-Weller M, Deleuran M, Fargnoli MC, Staumont-Salle D, Hong CH, Sanchez-Carazo J, Foley P, Seo SJ, Msihid J, Chen Z, Cyr SL, Rossi AB. Dupilumab in Adults with Moderate-to-Severe Atopic Dermatitis and Prior Use of Systemic Non-Steroidal Immunosuppressants: Analysis of Four Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Aug;11(4):1357-1372. doi: 10.1007/s13555-021-00558-0. Epub 2021 Jun 18. PubMed 34142350 ↗
  • Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26. PubMed 34037993 ↗
  • Boguniewicz M, Beck LA, Sher L, Guttman-Yassky E, Thaci D, Blauvelt A, Worm M, Corren J, Soong W, Lio P, Rossi AB, Lu Y, Chao J, Eckert L, Gadkari A, Hultsch T, Ruddy M, Mannent LP, Graham NMH, Pirozzi G, Chen Z, Ardeleanu M. Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223.e6. doi: 10.1016/j.jaip.2020.12.059. Epub 2021 Jan 13. PubMed 33453450 ↗
  • Silverberg JI, Simpson EL, Guttman-Yassky E, Cork MJ, de Bruin-Weller M, Yosipovitch G, Eckert L, Chen Z, Ardeleanu M, Shumel B, Hultsch T, Rossi AB, Hamilton JD, Orengo JM, Ruddy M, Graham NMH, Pirozzi G, Gadkari A. Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis: A Post Hoc Analysis of 5 Randomized Clinical Trials. Dermatitis. 2021 Oct 1;32(1S):S81-S91. doi: 10.1097/DER.0000000000000698. PubMed 33165005 ↗
  • Alexis AF, Rendon M, Silverberg JI, Pariser DM, Lockshin B, Griffiths CE, Weisman J, Wollenberg A, Chen Z, Davis JD, Li M, Eckert L, Gadkari A, Shumel B, Rossi AB, Graham NM, Ardeleanu M. Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials. J Drugs Dermatol. 2019 Aug 1;18(8):804-813. PubMed 31424712 ↗
  • Wollenberg A, Beck LA, Blauvelt A, Simpson EL, Chen Z, Chen Q, Shumel B, Khokhar FA, Hultsch T, Rizova E, Rossi AB, Graham NMH, Pirozzi G, Lu Y, Ardeleanu M. Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS). Br J Dermatol. 2020 May;182(5):1120-1135. doi: 10.1111/bjd.18434. Epub 2019 Dec 1. PubMed 31407311 ↗
  • Silverberg JI, Simpson EL, Ardeleanu M, Thaci D, Barbarot S, Bagel J, Chen Z, Eckert L, Chao J, Korotzer A, Rizova E, Rossi AB, Lu Y, Graham NMH, Hultsch T, Pirozzi G, Akinlade B. Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the Investigator's Global Assessment: a pooled analysis of data from two phase III trials. Br J Dermatol. 2019 Jul;181(1):80-87. doi: 10.1111/bjd.17791. Epub 2019 Apr 11. PubMed 30791102 ↗
  • Simpson EL. Dupilumab Improves General Health-Related Quality-of-Life in Patients with Moderate-to-Severe Atopic Dermatitis: Pooled Results from Two Randomized, Controlled Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2017 Jun;7(2):243-248. doi: 10.1007/s13555-017-0181-6. Epub 2017 May 13. PubMed 28503712 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02277743
Lead sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Oct 29, 2014
Start date
Oct 2014
Primary completion
Nov 2015
Completion
Feb 2016
Results posted
Nov 21, 2017
Last update
Nov 21, 2017

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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