Clinical trial NCT01859988: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Eczema
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2013-05-22
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).


Eligibility criteria: The inclusion criteria included, but were not limited to, the following:

1. Chronic Atopic Dermatitis that had been present for at least 3 years
2. 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)
3. Willing and able to comply with all clinic visits and study-related procedures

The exclusion criteria included, but were not limited to, the following:

1. Prior treatment with dupilumab (REGN668/SAR231893)
2. Presence of certain laboratory abnormalities at the screening visit
3. Treatment with an investigational drug within 8 weeks of baseline visit
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
5. Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
6. Known history of human immunodeficiency virus (HIV) infection
7. History of malignancy within 5 years before the baseline visit (with certain exceptions)
8. Planned surgical procedure during the length of the study
9. High risk of parasite infection
10. 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
11. Pregnant or breast-feeding women

Primary outcomes:
measure: Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16
timeFrame: Week 16
measure: Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Absolute Change in EASI Score From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Absolute Change in SCORAD Scores From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: 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
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Absolute Change in POEM Scores From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Changes in GISS Cumulative Score From Baseline to Week 16
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Bakersfield
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Skokie
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Andover
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Troy
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Johnston
country: United States
state: Rhode Island
city: Greer
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Vancouver (2 locations)
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Barrie
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: St. Hyacinthe
country: Canada
state: Quebec
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
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.