Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)
Condition: Atopic Dermatitis (AD)
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab; Placebo; Background treatment
Intervention description: Matching placebo; Participants were required to apply stable doses of a topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit and at least 7 days after the baseline visit (day -7 to day 8).
Intervention MeSH terms: Emollients
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility 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.