- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03054428
Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
July 16, 2019 updated by: Regeneron Pharmaceuticals
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe atopic dermatitis (AD).
The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe AD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
251
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2G 1B1
- Regeneron Investigational Site
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British Columbia
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Surrey, British Columbia, Canada, V3R 6A7
- Regeneron Investigational Site
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Surrey, British Columbia, Canada, V3V 0C6
- Regeneron Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
- Regeneron Investigational Site
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Ontario
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Markham, Ontario, Canada, L3P 1X2
- Regeneron Investigational Site
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Ottawa, Ontario, Canada, K2G 6E2
- Regeneron Investigational Site
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Peterborough, Ontario, Canada, K9J 5K2
- Regeneron Investigational Site
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Richmond Hill, Ontario, Canada, L4C9M7
- Regeneron Research Site
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Windsor, Ontario, Canada, N8W 1E6
- Regeneron Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35209
- Regeneron Investigational Site
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Arizona
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Gilbert, Arizona, United States, 85234
- Regeneron Investigational Site
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California
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Bakersfield, California, United States, 93309
- Regeneron Investigational Site
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Long Beach, California, United States, 90808
- Regeneron Investigational Site
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Rolling Hills Estates, California, United States, 90274
- Regeneron Investigational Site
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San Diego, California, United States, 92123
- Regeneron Investigational Site
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Santa Rosa, California, United States, 95403
- Regeneron Investigational Site
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Colorado
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Centennial, Colorado, United States, 80112
- Regeneron Investigational Site
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Denver, Colorado, United States, 80206
- Regeneron Investigational Site
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District of Columbia
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Washington, District of Columbia, United States, 20016
- Regeneron Investigational Site
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Florida
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Tampa, Florida, United States, 33624
- Regeneron Investigational Site
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Georgia
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Macon, Georgia, United States, 31217
- Regeneron Investigational Site
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Sandy Springs, Georgia, United States, 30328
- Regeneron Investigational Site
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Illinois
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Chicago, Illinois, United States, 60611
- Regeneron Investigational Site
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Indiana
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Evansville, Indiana, United States, 47713
- Regeneron Investigational Site
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Indianapolis, Indiana, United States, 46256
- Regeneron Investigational Site
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Plainfield, Indiana, United States, 46168
- Regeneron Investigational Site
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Maryland
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Rockville, Maryland, United States, 20850
- Regeneron Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Regeneron Investigational Site
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Boston, Massachusetts, United States, 02111
- Regeneron Investigational Site
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Minnesota
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Plymouth, Minnesota, United States, 55441
- Regeneron Investigational Site
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Missouri
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Saint Louis, Missouri, United States, 63110
- Regeneron Investigational Site
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New York
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Forest Hills, New York, United States, 11375
- Regeneron Investigational Site
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New York, New York, United States, 10029
- Regeneron Investigational Site
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Rochester, New York, United States, 14642
- Regeneron Investigational Site
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North Carolina
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Chapel Hill, North Carolina, United States, 27516
- Regeneron Investigational Site
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Ohio
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Bexley, Ohio, United States, 43209
- Regeneron Investigational Site
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Regeneron Investigational Site
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Oregon
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Portland, Oregon, United States, 97223
- Regeneron Investigational Site
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Portland, Oregon, United States, 97239
- Regeneron Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Regeneron Investigational Site
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South Carolina
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Charleston, South Carolina, United States, 29407
- Regeneron Investigational Site
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Texas
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Bellaire, Texas, United States, 77401
- Regeneron Investigational Site
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San Antonio, Texas, United States, 78218
- Regeneron Investigational Site
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Virginia
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Norfolk, Virginia, United States, 23502
- Regeneron Investigational Site
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Washington
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Seattle, Washington, United States, 98105
- Regeneron Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female ≥12 to <18 years of age at time of screening visit
- Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit
- IGA ≥3 at screening and baseline visit
- EASI ≥16 at the screening and baseline visit
- Baseline Pruritus NRS average score for maximum itch intensity ≥4
- ≥10% BSA of AD involvement at the screening and baseline visits
- With documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable
Exclusion Criteria:
- Participation in a prior dupilumab clinical study
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
- Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
- Body weight <30 kg at baseline
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit
- Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening
- History of malignancy before the baseline visit
- Diagnosed active endoparasitic infections or at high risk of these infections
- Patient is female who is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- Patient is female of childbearing potential and sexually active, who is unwilling to use adequate methods of contraception throughout the duration of the study and for 120 days after the last dose of study drug
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Placebo
Participants received placebo matching dupilumab once every 2 weeks (Q2W) (including doubling the amount of placebo on day 1 to match the loading dose).
In order to maintain blinding for the study, participants in the <60 kilogram (kg) weight stratum received, in a 1:1 ratio, either placebo matching 200 milligram (mg) dupilumab (including doubling the amount of placebo on day 1 to match the loading dose) or placebo matching 300 milligram (mg) dupilumab (including doubling the amount of placebo on day 1 to match the loading dose).
In the ≥60 kg weight stratum, the participants randomized to the placebo group received placebo matching 300 mg dupilumab (including doubling the amount of placebo on day 1 to match the loading dose).
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Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
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EXPERIMENTAL: Dupilumab 300 mg Q4W
Participants received once every 4 weeks (Q4W) subcutaneous (SC) injections of 300 milligrams (mg) dupilumab following a loading dose of 600 mg on day 1.
In order to maintain blinding, all participants received an injection once every 2 weeks (Q2W) from day 1 to week 14.
Participants received placebo 2 milliliter (mL) injection at the weeks dupilumab was not given.
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Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
Other Names:
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EXPERIMENTAL: Dupilumab 200 mg or 300 mg Q2W
Participants with baseline weight <60 kg received once every 2 weeks (Q2W) subcutaneous (SC) injections of 200 milligrams (mg) dupilumab following a loading dose of 400 mg on day 1.
Participants with baseline weight ≥60 kg received Q2W SC injections of 300 mg dupilumab following a loading dose of 600 mg on day 1.
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Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 (and Reduction From Baseline of ≥2 Points) at Week 16
Time Frame: Baseline and Week 16
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IGA is an assessment scale used to determine severity of atopic dermatitis (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).
Participants with IGA "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported.
[Values after first rescue treatment used were set to missing.
Participants with missing score at week 16 were considered as a non-responder.
Participant considered non-responder after rescue treatment use.
Efficacy analyses were based on the treatment allocated at randomization (as randomized).]
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Baseline and Week 16
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Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Improvement From Baseline) at Week 16
Time Frame: Baseline and Week 16
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The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities.
The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
EASI--75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. [Values after first rescue treatment used were set to missing.
Participants with missing score at week 16 were considered as a non-responder.
Participant considered nonresponder after rescue treatment use.
Efficacy analyses were based on the treatment allocated at randomization (as randomized).]
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Baseline and Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent Change From Baseline in EASI Score at Week 16
Time Frame: Baseline and Week 16
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The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities.
The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. [Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.]
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Baseline and Week 16
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Percent Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score at Week 16
Time Frame: Baseline and Week 16
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Peak Pruritus NRS is an assessment tool used by subjects to report intensity of pruritus (itch) during a 24-hour recall period.
Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"
For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week.
For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3) /3.
[Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.]
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Baseline and Week 16
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Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16
Time Frame: Baseline to Week 16
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Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period.
Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"
[For this endpoint, 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 counted as non-responders.]
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Baseline to Week 16
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Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16
Time Frame: Baseline to Week 16
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Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period.
Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"
[For this endpoint, 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 counted as non-responders.]
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Baseline to Week 16
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Percentage of Participants With EASI-50 (≥50% Improvement From Baseline) at Week 16
Time Frame: Baseline and Week 16
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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 at Week 16. [Values after first rescue treatment used were set to missing.
Participants with missing value at Week 16 were considered as a non-responder].
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Baseline and Week 16
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Percentage of Participants With EASI-90 (≥90% Improvement From Baseline) at Week 16
Time Frame: Baeline and Week 16
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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 at Week 16. [Values after first rescue treatment used were set to missing.
Participants with missing value at week 16 were considered as a non-responder.]
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Baeline and Week 16
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Time to Onset of Effect on Pruritus as Measured by Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline
Time Frame: Baseline up to week 16
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Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period.
Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"
[For this endpoint, 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 counted as non-responders.]
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Baseline up to week 16
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Time to Onset of Effect on Pruritus as Measured by Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline
Time Frame: Baseline up to Week 16
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Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period.
Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"
[For this endpoint, subjects 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 counted as non-responders.]
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Baseline up to Week 16
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Change From Baseline in Percent Body Surface Area (BSA) at Week 16
Time Frame: Baseline and Week 16
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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.
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Baseline and Week 16
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Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
Time Frame: Baseline and Week 16
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The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis.
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).
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Baseline and Week 16
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Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Week 16
Time Frame: Baseline and Week 16
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The CDLQI is a 10-item questionnaire used to measure how much a participant's skin problem had affected the participant's quality of life (QOL) over a recall period of the past week.
The questionnaire consists of 10 items.
For each item the scale is rated as follows: 0 = Not at all = Not relevant; 1 = Only a little; 2 = Quite a lot; 3 = Very much = Yes = Prevents school.
The CDLQI total score is the sum of the score of each question with a maximum of 30 and a minimum of 0. The higher the score, the greater the impact is on the QOL.
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Baseline and Week 16
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Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16
Time Frame: Baseline and Week 16
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The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults with atopic eczema.
The format is subject response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (ie, 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day').
The total score is the sum of the 7 items which is ranged from 0 to 28; a high score is indicative of a poor quality of life (QOL).
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Baseline and Week 16
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Change From Baseline in Weekly Average of Daily Peak Pruritus NRS at Week 16
Time Frame: Baseline and Week 16
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Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period.
Particpants were asked the following question for maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"
For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week.
For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3.
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Baseline and Week 16
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Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS at Week 4
Time Frame: Baseline and Week 4
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Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period.
Participants were asked the following question for maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"
For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week.
For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3.
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Baseline and Week 4
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Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) at Week 16
Time Frame: Baseline and Week 16
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The HADS is 14-item questionnaire with two subscales: anxiety & depression.
Each item is rated on a 4-point scale (0-3).
A person could score between 0 & 21 for each subscale (anxiety & depression).
A high score is indicative of a poor state.
Scores of 11 or more on either subscale are considered a 'definite case' of psychological morbidity, while scores of 8 to 10 represents 'probable case' & 0 to 7 'not a case'.
The total score was the sum of the 2 sub-scores; therefore, the full range of possible values for the reported data is 0-42.
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Baseline and Week 16
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Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline at Week 4
Time Frame: Baseline and Week 4
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Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period.
Participants were asked the following question for maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?"
For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week.
For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3.
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Baseline and Week 4
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Percentage of Participants With Skin-infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Through Week 16
Time Frame: Baseline through Week 16
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Any untoward medical occurrence in a subject 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 16)).
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.
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Baseline through Week 16
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Percentage of Participants With Serious TEAEs Through Week 16
Time Frame: Baseline through Week 16
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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.
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Baseline through Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Simpson EL, Paller AS, Siegfried EC, Thaci D, Wollenberg A, Cork MJ, Marcoux D, Huang R, Chen Z, Rossi AB, Shumel B, Sierka D, Bansal A. Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older. Dermatol Ther (Heidelb). 2021 Oct;11(5):1643-1656. doi: 10.1007/s13555-021-00568-y. Epub 2021 Aug 24.
- Kamal MA, Kovalenko P, Kosloski MP, Srinivasan K, Zhang Y, Rajadhyaksha M, Lai CH, Kanamaluru V, Xu C, Sun X, Simpson EL, Paller AS, Siegfried EC, Shumel B, Bansal A, Al-Huniti N, Davis JD. The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis. Clin Pharmacol Ther. 2021 Nov;110(5):1318-1328. doi: 10.1002/cpt.2366. Epub 2021 Aug 24.
- Blauvelt A, Guttman-Yassky E, Paller AS, Simpson EL, Cork MJ, Weisman J, Browning J, Soong W, Sun X, Chen Z, Kosloski MP, Kamal MA, Delevry D, Chuang CC, O'Malley JT, Bansal A. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022 May;23(3):365-383. doi: 10.1007/s40257-022-00683-2. Epub 2022 May 14.
- Siegfried EC, Bieber T, Simpson EL, Paller AS, Beck LA, Boguniewicz M, Schneider LC, Khokhar FA, Chen Z, Prescilla R, Mina-Osorio P, Bansal A. Effect of Dupilumab on Laboratory Parameters in Adolescents with Atopic Dermatitis: Results from a Randomized, Placebo-Controlled, Phase 3 Clinical Trial. Am J Clin Dermatol. 2021 Mar;22(2):243-255. doi: 10.1007/s40257-020-00583-3. Epub 2021 Mar 3.
- Bansal A, Simpson EL, Paller AS, Siegfried EC, Blauvelt A, de Bruin-Weller M, Corren J, Sher L, Guttman-Yassky E, Chen Z, Daizadeh N, Kamal MA, Shumel B, Mina-Osorio P, Mannent L, Patel N, Graham NMH, Khokhar FA, Ardeleanu M. Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma. Am J Clin Dermatol. 2021 Jan;22(1):101-115. doi: 10.1007/s40257-020-00577-1.
- Silverberg JI, Yosipovitch G, Simpson EL, Kim BS, Wu JJ, Eckert L, Guillemin I, Chen Z, Ardeleanu M, Bansal A, Kaur M, Rossi AB, Graham NMH, Patel N, Gadkari A. Dupilumab treatment results in early and sustained improvements in itch in adolescents and adults with moderate to severe atopic dermatitis: Analysis of the randomized phase 3 studies SOLO 1 and SOLO 2, AD ADOL, and CHRONOS. J Am Acad Dermatol. 2020 Jun;82(6):1328-1336. doi: 10.1016/j.jaad.2020.02.060. Epub 2020 Mar 3.
- Paller AS, Bansal A, Simpson EL, Boguniewicz M, Blauvelt A, Siegfried EC, Guttman-Yassky E, Hultsch T, Chen Z, Mina-Osorio P, Lu Y, Rossi AB, He X, Kamal M, Graham NMH, Pirozzi G, Ruddy M, Eckert L, Gadkari A. Clinically Meaningful Responses to Dupilumab in Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis: Post-hoc Analyses from a Randomized Clinical Trial. Am J Clin Dermatol. 2020 Feb;21(1):119-131. doi: 10.1007/s40257-019-00478-y.
- Simpson EL, Paller AS, Siegfried EC, Boguniewicz M, Sher L, Gooderham MJ, Beck LA, Guttman-Yassky E, Pariser D, Blauvelt A, Weisman J, Lockshin B, Hultsch T, Zhang Q, Kamal MA, Davis JD, Akinlade B, Staudinger H, Hamilton JD, Graham NMH, Pirozzi G, Gadkari A, Eckert L, Stahl N, Yancopoulos GD, Ruddy M, Bansal A. Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jan 1;156(1):44-56. doi: 10.1001/jamadermatol.2019.3336.
- Simpson EL, de Bruin-Weller M, Eckert L, Whalley D, Guillemin I, Reaney M, Chen Z, Nelson L, Qin S, Bansal A, Gadkari A. Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children's Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis. Dermatol Ther (Heidelb). 2019 Dec;9(4):799-805. doi: 10.1007/s13555-019-00333-2. Epub 2019 Oct 22.
- Cork MJ, Thaci D, Eichenfield LF, Arkwright PD, Hultsch T, Davis JD, Zhang Y, Zhu X, Chen Z, Li M, Ardeleanu M, Teper A, Akinlade B, Gadkari A, Eckert L, Kamal MA, Ruddy M, Graham NMH, Pirozzi G, Stahl N, DiCioccio AT, Bansal A. Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension. Br J Dermatol. 2020 Jan;182(1):85-96. doi: 10.1111/bjd.18476. Epub 2019 Oct 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 21, 2017
Primary Completion (ACTUAL)
April 4, 2018
Study Completion (ACTUAL)
June 5, 2018
Study Registration Dates
First Submitted
February 13, 2017
First Submitted That Met QC Criteria
February 13, 2017
First Posted (ACTUAL)
February 15, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 16, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R668-AD-1526
- 2015-004458-16 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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