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Study of Dupilumab (REGN668/SAR231893) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

This study has been completed.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals Identifier:
First received: May 20, 2013
Last updated: August 10, 2015
Last verified: August 2015
To assess the efficacy of multiple dupilumab (REGN668/SAR231893) dose-regimens, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).

Condition Intervention Phase
Atopic Dermatitis Drug: Dupilumab (REGN668/SAR231893) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Percent change in Eczema Area and Severity Index score [ Time Frame: Baseline to week 16 ]
    Percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16.

Secondary Outcome Measures:
  • Investigator's Global Assessment score [ Time Frame: At week 16 ]
    Proportion of participants achieving Investigator's Global Assessment (IGA) score 0 (clear) or 1 (almost clear) at week 16

  • Absolute change in EASI score [ Time Frame: Baseline to week 16 ]
    Absolute change in EASI scores from baseline to week 16

Enrollment: 380
Study Start Date: May 2013
Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
dose regimen 1
Drug: Dupilumab (REGN668/SAR231893)
Experimental: Group 2
dose regimen 2
Drug: Dupilumab (REGN668/SAR231893)
Experimental: Group 3
dose regimen 3
Drug: Dupilumab (REGN668/SAR231893)
Experimental: Group 4
dose regimen 4
Drug: Dupilumab (REGN668/SAR231893)
Experimental: Group 5
dose regimen 5
Drug: Dupilumab (REGN668/SAR231893)
Placebo Comparator: Group 6
dose regimen 6
Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

The inclusion criteria include, but are not limited to, the following:

  1. Chronic Atopic Dermatitis that has been present for at least 3 years
  2. History of inadequate response to outpatient treatment with topical medications, or for whom topical treatments are otherwise inadvisable (eg, 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 include, but are 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 timeframe 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 patient at risk, interfere with participation in the study or interfere with interpretation of study results.
  11. Pregnant or breast-feeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01859988

  Hide Study Locations
United States, Alabama
Birmingham (2 locations), Alabama, United States
Mobile, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Bakersfield, California, United States
San Diego (2 locations), California, United States
Santa Monica, California, United States
United States, Florida
Jacksonville (2 locations), Florida, United States
Ormond Beach, Florida, United States
United States, Illinois
Skokie, Illinois, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Andover, Massachusetts, United States
Boston (2 locations), Massachusetts, United States
United States, Michigan
Troy, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
New York, New York, United States
Rochester (2 locations), New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Oregon
Portland (2 locations), Oregon, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Johnston, Rhode Island, United States
United States, South Carolina
Greer, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
San Antonio (2 locations), Texas, United States
United States, Washington
Seattle, Washington, United States
Canada, British Columbia
Vancouver (2 locations), British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
Barrie, Ontario, Canada
Hamilton, Ontario, Canada
Markham, Ontario, Canada
Oakville, Ontario, Canada
Peterborough, Ontario, Canada
Richmond Hill, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Canada, Quebec
St. Hyacinthe, Quebec, Canada
Quebec, Canada
Czech Republic
Kutná Hora, Czech Republic
Nachod, Czech Republic
Praha, Czech Republic
Svitavy, Czech Republic
Usti nad Labem, Czech Republic
Augsburg, Germany
Baden, Germany
Berlin, Germany
Bonn, Germany
Dresden, Germany
Dülmen, Germany
Frankfurt/ Main, Germany
Frankfurt/Main, Hessen, Germany
Gera, Germany
Hamburg, Germany
Heidelberg, Germany
Kiel, Germany
Mahlow, Germany
Muenster, Germany
Munich, Germany
Osnabruck, Germany
Tübingen, Germany
Borsod-Abauj-Zemplen, Hungary
Budapest, Hungary
Kaposvár, Hungary
Szeged, Hungary
Szolnok, Hungary
Tolna, Hungary
Fukuoka, Japan
Hokkaido, Japan
Saitama, Japan
Tokyo, Bunkyo-ku, Japan
Tokyo, Chiyoda-ku, Japan
Tokyo, Nakano-ku, Japan
Tokyo, Nerima-ku, Japan
Tokyo, Shibuya-ku, Japan
Tokyo, Shinagawa-ku, Japan
Tokyo, Shinjuku-ku (2 locations), Japan
Tokyo, Suginami-ku (2 locations), Japan
Yokohama, Japan
Gdansk (2 locations), Poland
Katowice, Poland
Lodz, Poland
Lublin, Poland
Poznan, Poland
Warsaw (2 locations), Poland
Wroclaw, Poland
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals Identifier: NCT01859988     History of Changes
Other Study ID Numbers: R668-AD-1021
Study First Received: May 20, 2013
Last Updated: August 10, 2015

Keywords provided by Regeneron Pharmaceuticals:

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases processed this record on August 18, 2017