Atopic DermatitisPhase 2NCT01859988
Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study testing Dupilumab in people with Atopic Dermatitis, run by Regeneron Pharmaceuticals at 84 sites in 7 countries.
Trial summary
To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 84 sitesin 7 countries
- Study dates
- May 2013to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
84 sites in 7 countries.
84 sites in 7 countries
United States25 sites
Study site
Andover, Massachusetts
Study site
Bakersfield, California
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Greer, South Carolina
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Johnston, Rhode Island
Study site
Mobile, Alabama
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Ormond Beach, Florida
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Rochester, New York
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Santa Monica, California
Study site
Seattle, Washington
Study site
Skokie, Illinois
Study site
St Louis, Missouri
Study site
Troy, Michigan
Study site
Tucson, Arizona
Study site
Winston-Salem, North Carolina
Germany17 sites
Study site
Augsburg
Study site
Baden
Study site
Berlin
Study site
Bonn
Study site
Dresden
Study site
Dülmen
Study site
Frankfurt am Main
Study site
Frankfurt/Main, Hessen
Study site
Gera
Study site
Hamburg
Study site
Heidelberg
Study site
Kiel
Study site
Mahlow
Study site
Munich
Study site
Münster
Study site
Osnabrück
Study site
Tübingen
Canada12 sites
Study site
Barrie, Ontario
Study site
Hamilton, Ontario
Study site
Markham, Ontario
Study site
Oakville, Ontario
Study site
Peterborough, Ontario
Study site
Québec
Study site
Richmond Hill, Ontario
Study site
Saint-Hyacinthe, Quebec
Study site
Vancouver (2 Locations), British Columbia
Study site
Waterloo, Ontario
Study site
Windsor, Ontario
Study site
Winnipeg, Manitoba
Japan12 sites
Study site
Fukuoka
Study site
Hokkaido
Study site
Saitama
Study site
Tokyo, Bunkyo-ku
Study site
Tokyo, Chiyoda-ku
Study site
Tokyo, Nakano-ku
Study site
Tokyo, Nerima-ku
Study site
Tokyo, Shibuya-ku
Study site
Tokyo, Shinagawa-ku
Study site
Tokyo, Shinjuku-ku (2 Locations)
Study site
Tokyo, Suginami-ku (2 Locations)
Study site
Yokohama
Poland7 sites
Study site
Gdansk (2 Locations)
Study site
Katowice
Study site
Lodz
Study site
Lublin
Study site
Poznan
Study site
Warsaw (2 Locations)
Study site
Wroclaw
Hungary6 sites
Study site
Borsod-Abauj-Zemplen
Study site
Budapest
Study site
Kaposvár
Study site
Szeged
Study site
Szolnok
Study site
Tolna
Czechia5 sites
Study site
Kutná Hora
Study site
Náchod
Study site
Prague
Study site
Svitavy
Study site
Ústí nad Labem
About this study
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
To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).
- Conditions
- Atopic Dermatitis
- Being tested
- Dupilumab, Placebo
- Keywords
- Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called REGN668, SAR231893, Dupixent
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo qw | Experimental | 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. Receives: Drug: Placebo |
| Dupilumab 300 mg qw | Experimental | 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. Receives: Drug: Dupilumab |
| Dupilumab 300 mg q2w | Experimental | 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. Receives: Drug: Dupilumab; Drug: Placebo |
| Dupilumab 200 mg q2w | Experimental | 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. Receives: Drug: Dupilumab; Drug: Placebo |
| Dupilumab 300 mg q4w | Experimental | 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. Receives: Drug: Dupilumab; Drug: Placebo |
| Dupilumab 100 mg q4w | Experimental | 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. Receives: Drug: Dupilumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 16
Secondary outcomes (13)
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.
Measured: Week 16
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.
Measured: Week 16
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]).
Measured: Baseline to Week 16
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]).
Measured: Baseline to Week 16
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.
Measured: Baseline to Week 16
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).
Measured: Baseline to Week 16
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).
Measured: Baseline to Week 16
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.
Measured: 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.
Measured: 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]).
Measured: Baseline to Week 16
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]).
Measured: Baseline to Week 16
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).
Measured: Baseline to Week 16
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).
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859988
- Sponsor's protocol ID
- R668-AD-1021
- Status last verified
- Jul 2017
- First submitted
- 20 May 2013
- Last updated
- 28 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 26454361Simpson 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.
PubMed 26777100Simpson 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.
PubMed 27268421Paller AS, Silverberg JI, Cork MJ, Guttman-Yassky E, Lockshin B, Irvine AD, Kim MB, Kabashima K, Chen Z, Lu Y, Bansal A, Rossi AB, Shabbir A. Efficacy and Safety of Dupilumab in Patients With Erythrodermic Atopic Dermatitis: A Post Hoc Analysis of 6 Randomized Clinical Trials. JAMA Dermatol. 2023 Mar 1;159(3):255-266. doi: 10.1001/jamadermatol.2022.6192.
PubMed 36723913Kamal MA, Davis JD, Kovalenko P, Srinivasan K, Simpson EL, Nakahara T, Sugaya M, Igarashi A, Ardeleanu M, Xu C, Arima K. Pharmacokinetics, pharmacodynamics, and exposure-efficacy of dupilumab in adults with atopic dermatitis. Clin Transl Sci. 2022 Oct;15(10):2342-2354. doi: 10.1111/cts.13363. Epub 2022 Aug 20.
PubMed 35986664Silverberg JI, Simpson EL, Guttman-Yassky E, Cork MJ, de Bruin-Weller M, Yosipovitch G, Eckert L, Chen Z, Ardeleanu M, Shumel B, Hultsch T, Rossi AB, Hamilton JD, Orengo JM, Ruddy M, Graham NMH, Pirozzi G, Gadkari A. Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis: A Post Hoc Analysis of 5 Randomized Clinical Trials. Dermatitis. 2021 Oct 1;32(1S):S81-S91. doi: 10.1097/DER.0000000000000698.
PubMed 33165005
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01859988
- Acronym / sponsor ID
- R668-AD-1021
- Conditions
- Atopic Dermatitis
- Keywords
- Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Posted 28 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo qw | Experimental | Drug: PlaceboTwo 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. |
| Dupilumab 300 mg qw | Experimental | Drug: DupilumabTwo 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. |
| Dupilumab 300 mg q2w | Experimental | Drug: Dupilumab, Drug: PlaceboTwo 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. |
| Dupilumab 200 mg q2w | Experimental | Drug: Dupilumab, Drug: PlaceboTwo 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. |
| Dupilumab 300 mg q4w | Experimental | Drug: Dupilumab, Drug: PlaceboTwo 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. |
| Dupilumab 100 mg q4w | Experimental | Drug: Dupilumab, Drug: PlaceboTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: REGN668, SAR231893, Dupixent | Drug | Dupilumab 100 mg q4w, Dupilumab 200 mg q2w, Dupilumab 300 mg q2w, Dupilumab 300 mg q4w, Dupilumab 300 mg qw |
| Placebo | Drug | Dupilumab 100 mg q4w, Dupilumab 200 mg q2w, Dupilumab 300 mg q2w, Dupilumab 300 mg q4w, Placebo qw |
Primary outcome
Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16
Time frame: 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.
13 secondary outcomes
Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16
Time frame: Week 16
Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16
Time frame: Week 16
Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16
Time frame: Baseline to Week 16
Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16
Time frame: Baseline to Week 16
Absolute Change in EASI Score From Baseline to Week 16
Time frame: Baseline to Week 16
Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16
Time frame: Baseline to Week 16
Absolute Change in SCORAD Scores From Baseline to Week 16
Time frame: Baseline to Week 16
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
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
Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16
Time frame: Baseline to Week 16
Absolute Change in POEM Scores From Baseline to Week 16
Time frame: Baseline to Week 16
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
Changes in GISS Cumulative Score From Baseline to Week 16
Time frame: Baseline to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26454361Thaci 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 publication: PubMed 26777100Simpson 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 publication: PubMed 27268421Simpson 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.
- Derived from this study: PubMed 36723913Paller AS, Silverberg JI, Cork MJ, Guttman-Yassky E, Lockshin B, Irvine AD, Kim MB, Kabashima K, Chen Z, Lu Y, Bansal A, Rossi AB, Shabbir A. Efficacy and Safety of Dupilumab in Patients With Erythrodermic Atopic Dermatitis: A Post Hoc Analysis of 6 Randomized Clinical Trials. JAMA Dermatol. 2023 Mar 1;159(3):255-266. doi: 10.1001/jamadermatol.2022.6192.
- Derived from this study: PubMed 35986664Kamal MA, Davis JD, Kovalenko P, Srinivasan K, Simpson EL, Nakahara T, Sugaya M, Igarashi A, Ardeleanu M, Xu C, Arima K. Pharmacokinetics, pharmacodynamics, and exposure-efficacy of dupilumab in adults with atopic dermatitis. Clin Transl Sci. 2022 Oct;15(10):2342-2354. doi: 10.1111/cts.13363. Epub 2022 Aug 20.
- Derived from this study: PubMed 33165005Silverberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
84 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Atopic Dermatitis, run by Regeneron Pharmaceuticals at 84 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Germany, Canada, Japan, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859988, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.