Recruitment

Recruitment Status
Completed
Estimated Enrollment
50

Inclusion Criterias

Willing and able to comply with all clinic visits and study-related procedures.
Male or female, 18 years or older;
Chronic AD that had been present for at least 3 years before the screening visit;
...
Willing and able to comply with all clinic visits and study-related procedures.
Male or female, 18 years or older;
Chronic AD that had been present for at least 3 years before the screening visit;
Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable;

Exclusion Criterias

Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
Phototherapy for AD;
Systemic corticosteroids;
...
Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
Phototherapy for AD;
Systemic corticosteroids;
Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;
Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;
Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;
Treatment with certain biologics;
Participant was a member of the investigational team or his/her immediate family;
Immunosuppressive/immunomodulating drugs;
Prior participation in a Dupilumab clinical trial;
Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
Planned major surgical procedure during the participant's participation in this study;

Summary

Conditions
Atopic Dermatitis (AD)
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Willing and able to comply with all clinic visits and study-related procedures.
Male or female, 18 years or older;
Chronic AD that had been present for at least 3 years before the screening visit;
...
Willing and able to comply with all clinic visits and study-related procedures.
Male or female, 18 years or older;
Chronic AD that had been present for at least 3 years before the screening visit;
Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable;

Exclusion Criterias

Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
Phototherapy for AD;
Systemic corticosteroids;
...
Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
Phototherapy for AD;
Systemic corticosteroids;
Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;
Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;
Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;
Treatment with certain biologics;
Participant was a member of the investigational team or his/her immediate family;
Immunosuppressive/immunomodulating drugs;
Prior participation in a Dupilumab clinical trial;
Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
Planned major surgical procedure during the participant's participation in this study;

Locations

Chicago, Illinois
Dallas, Texas
New York, New York
Montreal, Quebec
...
Chicago, Illinois
Dallas, Texas
New York, New York
Montreal, Quebec

Tracking Information

NCT #
NCT01979016
Collaborators
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals