- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01859988
Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
July 26, 2017 updated by: Regeneron Pharmaceuticals
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of Dupilumab (REGN668) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
380
Phase
- Phase 2
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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Quebec, Canada
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British Columbia
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Vancouver (2 locations), British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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Ontario
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Markham, Ontario, Canada
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Oakville, Ontario, Canada
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Peterborough, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Quebec
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St. Hyacinthe, Quebec, Canada
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Kutná Hora, Czechia
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Nachod, Czechia
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Praha, Czechia
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Svitavy, Czechia
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Usti nad Labem, Czechia
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Augsburg, Germany
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Baden, Germany
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Berlin, Germany
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Bonn, Germany
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Dresden, Germany
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Dülmen, Germany
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Frankfurt/ Main, Germany
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Frankfurt/Main, Hessen, Germany
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Gera, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Kiel, Germany
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Mahlow, Germany
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Muenster, Germany
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Munich, Germany
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Osnabruck, Germany
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Tübingen, Germany
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Borsod-Abauj-Zemplen, Hungary
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Budapest, Hungary
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Kaposvár, Hungary
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Szeged, Hungary
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Szolnok, Hungary
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Tolna, Hungary
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Fukuoka, Japan
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Hokkaido, Japan
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Saitama, Japan
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Tokyo, Bunkyo-ku, Japan
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Tokyo, Chiyoda-ku, Japan
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Tokyo, Nakano-ku, Japan
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Tokyo, Nerima-ku, Japan
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Tokyo, Shibuya-ku, Japan
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Tokyo, Shinagawa-ku, Japan
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Tokyo, Shinjuku-ku (2 locations), Japan
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Tokyo, Suginami-ku (2 locations), Japan
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Yokohama, Japan
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Gdansk (2 locations), Poland
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Katowice, Poland
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Lodz, Poland
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Lublin, Poland
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Poznan, Poland
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Warsaw (2 locations), Poland
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Wroclaw, Poland
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Alabama
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Arizona
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Tucson, Arizona, United States
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California
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Bakersfield, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Florida
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Jacksonville, Florida, United States
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Ormond Beach, Florida, United States
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Illinois
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Skokie, Illinois, United States
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Louisiana
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New Orleans, Louisiana, United States
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Massachusetts
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Andover, Massachusetts, United States
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Boston, Massachusetts, United States
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Michigan
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Troy, Michigan, United States
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Missouri
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Saint Louis, Missouri, United States
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New York
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New York, New York, United States
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Rochester, New York, United States
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North Carolina
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Winston-Salem, North Carolina, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
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Rhode Island
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Johnston, Rhode Island, United States
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South Carolina
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Greer, South Carolina, United States
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Tennessee
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Nashville, Tennessee, United States
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Texas
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Houston, Texas, United States
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San Antonio, Texas, United States
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Washington
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Seattle, Washington, United States
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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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
The inclusion criteria included, but were not limited to, the following:
- Chronic Atopic Dermatitis that had been present for at least 3 years
- History of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable (e.g, because of important side effects or safety risks)
- Willing and able to comply with all clinic visits and study-related procedures
The exclusion criteria included, but were not limited to, the following:
- Prior treatment with dupilumab (REGN668/SAR231893)
- Presence of certain laboratory abnormalities at the screening visit
- Treatment with an investigational drug within 8 weeks of baseline visit
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
- Known history of human immunodeficiency virus (HIV) infection
- History of malignancy within 5 years before the baseline visit (with certain exceptions)
- Planned surgical procedure during the length of the study
- High risk of parasite infection
- Any other medical or psychological condition that in the opinion of the investigator or the sponsor's medical monitor, would place the participants at risk, interfere with participation in the study or interfere with interpretation of study results
- Pregnant or breast-feeding women
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 qw
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15.
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EXPERIMENTAL: Dupilumab 300 mg 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 qw from Week 1 to Week 15.
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Other Names:
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EXPERIMENTAL: Dupilumab 300 mg q2w
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.
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Other Names:
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EXPERIMENTAL: Dupilumab 200 mg q2w
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
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Other Names:
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EXPERIMENTAL: Dupilumab 300 mg q4w
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 every 4 weeks (q4w) and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
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Other Names:
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EXPERIMENTAL: Dupilumab 100 mg q4w
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16
Time Frame: Baseline to Week 16
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The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities.
The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
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Baseline to Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16
Time Frame: Week 16
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IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a static 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).
Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.
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Week 16
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Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16
Time Frame: Week 16
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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 success is an IGA score of 0 (clear) or 1 (almost clear).
Participants with IGA score reduction from baseline of ≥2 points at Week 16 were reported.
Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.
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Week 16
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Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16
Time Frame: Baseline to Week 16
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Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period.
Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
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Baseline to Week 16
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Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16
Time Frame: Baseline to Week 16
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Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period.
Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
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Baseline to Week 16
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Absolute Change in EASI Score From Baseline to Week 16
Time Frame: Baseline to Week 16
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The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities.
The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
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Baseline to Week 16
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Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16
Time Frame: Baseline to Week 16
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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).
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Baseline to Week 16
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Absolute Change in SCORAD Scores From Baseline to Week 16
Time Frame: Baseline to Week 16
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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).
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Baseline to Week 16
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Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16
Time Frame: Week 16
|
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities.
The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in EASI score respectively from baseline to Week 16.
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Week 16
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Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16
Time Frame: 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).
SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in SCORAD score respectively from baseline to Week 16.
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Week 16
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Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16
Time Frame: Baseline to Week 16
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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]).
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Baseline to Week 16
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Absolute Change in POEM Scores From Baseline to Week 16
Time Frame: Baseline to Week 16
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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]).
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Baseline to Week 16
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Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16
Time Frame: Baseline to Week 16
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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).
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Baseline to Week 16
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Changes in GISS Cumulative Score From Baseline to Week 16
Time Frame: Baseline to Week 16
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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).
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Baseline to 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
- Thaci D, Simpson EL, Beck LA, Bieber T, Blauvelt A, Papp K, Soong W, Worm M, Szepietowski JC, Sofen H, Kawashima M, Wu R, Weinstein SP, Graham NM, Pirozzi G, Teper A, Sutherland ER, Mastey V, Stahl N, Yancopoulos GD, Ardeleanu M. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016 Jan 2;387(10013):40-52. doi: 10.1016/S0140-6736(15)00388-8. Epub 2015 Oct 8.
- Simpson EL, Bieber T, Eckert L, Wu R, Ardeleanu M, Graham NM, Pirozzi G, Mastey V. Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults. J Am Acad Dermatol. 2016 Mar;74(3):491-8. doi: 10.1016/j.jaad.2015.10.043. Epub 2016 Jan 14.
- Simpson EL, Gadkari A, Worm M, Soong W, Blauvelt A, Eckert L, Wu R, Ardeleanu M, Graham NMH, Pirozzi G, Sutherland ER, Mastey V. Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD). J Am Acad Dermatol. 2016 Sep;75(3):506-515. doi: 10.1016/j.jaad.2016.04.054. Epub 2016 Jun 4.
- 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.
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
May 1, 2013
Primary Completion (ACTUAL)
May 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
May 20, 2013
First Submitted That Met QC Criteria
May 21, 2013
First Posted (ESTIMATE)
May 22, 2013
Study Record Updates
Last Update Posted (ACTUAL)
August 28, 2017
Last Update Submitted That Met QC Criteria
July 26, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R668-AD-1021
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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