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

• Status: Completed
• Trial end date: 2015-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Emollients

Criteria

Inclusion Criteria:

1. Male or female, 18 years or older;

2. Chronic AD that had been present for at least 3 years before the screening visit;

3. 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;

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

Exclusion Criteria:

1. Prior participation in a Dupilumab clinical trial;

2. Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;

3. 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;

4. Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;

5. Treatment with certain biologics;

6. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;

7. Planned major surgical procedure during the participant's participation in this study;

8. Participant was a member of the investigational team or his/her immediate family;

9. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit

10. 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.