Back to resultsStudy of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dupilumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo qw
Dupilumab 300 mg qw
Dupilumab 300 mg q2w
Dupilumab 200 mg q2w
Dupilumab 300 mg q4w
Dupilumab 100 mg q4w
Arm Description
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to 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.
Secondary Outcome Measures
Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16
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.
Percentage of Participants Who Achieved IGA Score Reduction of ≥2 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 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.
Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16
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]).
Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16
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]).
Absolute Change in EASI Score From Baseline to 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.
Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline 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).
Absolute Change in SCORAD Scores From Baseline 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).
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
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.
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
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.
Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16
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]).
Absolute Change in POEM Scores From Baseline to Week 16
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]).
Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16
Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Changes in GISS Cumulative Score From Baseline to Week 16
Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none,1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Full Information
NCT ID
NCT01859988
First Posted
May 20, 2013
Last Updated
July 26, 2017
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT01859988
Brief Title
Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo qw
Arm Type
Experimental
Arm Description
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.
Arm Title
Dupilumab 300 mg qw
Arm Type
Experimental
Arm Description
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.
Arm Title
Dupilumab 300 mg q2w
Arm Type
Experimental
Arm Description
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.
Arm Title
Dupilumab 200 mg q2w
Arm Type
Experimental
Arm Description
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.
Arm Title
Dupilumab 300 mg q4w
Arm Type
Experimental
Arm Description
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.
Arm Title
Dupilumab 100 mg q4w
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Other Intervention Name(s)
REGN668, SAR231893, Dupixent
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16
Description
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16
Description
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.
Time Frame
Week 16
Title
Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16
Description
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]).
Time Frame
Baseline to Week 16
Title
Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16
Description
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]).
Time Frame
Baseline to Week 16
Title
Absolute Change in EASI Score From Baseline to Week 16
Description
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time Frame
Baseline to Week 16
Title
Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16
Description
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
Title
Absolute Change in SCORAD Scores From Baseline to Week 16
Description
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
Title
Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16
Description
SCORAD 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.
Time Frame
Week 16
Title
Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16
Description
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
Title
Absolute Change in POEM Scores From Baseline to Week 16
Description
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
Title
Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16
Description
Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Time Frame
Baseline to Week 16
Title
Changes in GISS Cumulative Score From Baseline to Week 16
Description
Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none,1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Time Frame
Baseline to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Mobile
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Bakersfield
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Santa Monica
State/Province
California
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Ormond Beach
State/Province
Florida
Country
United States
City
Skokie
State/Province
Illinois
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Andover
State/Province
Massachusetts
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Johnston
State/Province
Rhode Island
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Vancouver (2 locations)
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Barrie
State/Province
Ontario
Country
Canada
City
Hamilton
State/Province
Ontario
Country
Canada
City
Markham
State/Province
Ontario
Country
Canada
City
Oakville
State/Province
Ontario
Country
Canada
City
Peterborough
State/Province
Ontario
Country
Canada
City
Richmond Hill
State/Province
Ontario
Country
Canada
City
Waterloo
State/Province
Ontario
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
City
St. Hyacinthe
State/Province
Quebec
Country
Canada
City
Quebec
Country
Canada
City
Kutná Hora
Country
Czechia
City
Nachod
Country
Czechia
City
Praha
Country
Czechia
City
Svitavy
Country
Czechia
City
Usti nad Labem
Country
Czechia
City
Augsburg
Country
Germany
City
Baden
Country
Germany
City
Berlin
Country
Germany
City
Bonn
Country
Germany
City
Dresden
Country
Germany
City
Dülmen
Country
Germany
City
Frankfurt/ Main
Country
Germany
City
Frankfurt/Main, Hessen
Country
Germany
City
Gera
Country
Germany
City
Hamburg
Country
Germany
City
Heidelberg
Country
Germany
City
Kiel
Country
Germany
City
Mahlow
Country
Germany
City
Muenster
Country
Germany
City
Munich
Country
Germany
City
Osnabruck
Country
Germany
City
Tübingen
Country
Germany
City
Borsod-Abauj-Zemplen
Country
Hungary
City
Budapest
Country
Hungary
City
Kaposvár
Country
Hungary
City
Szeged
Country
Hungary
City
Szolnok
Country
Hungary
City
Tolna
Country
Hungary
City
Fukuoka
Country
Japan
City
Hokkaido
Country
Japan
City
Saitama
Country
Japan
City
Tokyo, Bunkyo-ku
Country
Japan
City
Tokyo, Chiyoda-ku
Country
Japan
City
Tokyo, Nakano-ku
Country
Japan
City
Tokyo, Nerima-ku
Country
Japan
City
Tokyo, Shibuya-ku
Country
Japan
City
Tokyo, Shinagawa-ku
Country
Japan
City
Tokyo, Shinjuku-ku (2 locations)
Country
Japan
City
Tokyo, Suginami-ku (2 locations)
Country
Japan
City
Yokohama
Country
Japan
City
Gdansk (2 locations)
Country
Poland
City
Katowice
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Warsaw (2 locations)
Country
Poland
City
Wroclaw
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
26454361
Citation
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.
Results Reference
result
PubMed Identifier
26777100
Citation
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.
Results Reference
result
PubMed Identifier
27268421
Citation
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.
Results Reference
result
PubMed Identifier
33165005
Citation
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.
Results Reference
derived
Learn more about this trial
Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
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