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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT01859988

  Show 84 Study Locations
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
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Canada: Health Canada
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Regeneron Pharmaceuticals:

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic processed this record on May 26, 2016