Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis (AD)

In brief

The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).

Key facts

Study ID

NCT01979016

Run by

Regeneron Pharmaceuticals

People needed

54

Starts

2013-12-31

Expected to finish

2015-01-31

Last updated by the study team

2020-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Willing and able to comply with all clinic visits and study-related procedures.

You may not qualify if…

• Prior participation in a Dupilumab clinical trial;
• Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;
• The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:
• Systemic corticosteroids;
• Immunosuppressive/immunomodulating drugs;
• Phototherapy for AD;
• Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
• Treatment with certain biologics;
• Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;
• Planned major surgical procedure during the participant's participation in this study;
• Participant was a member of the investigational team or his/her immediate family;
• Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
• Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;
• Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/exclusion criteria are listed.

Where it is running

• Study site — Chicago, Illinois, United States
• Study site — New York, New York, United States
• Study site — Dallas, Texas, United States
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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