Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: Dupilumab; Placebo (for Dupilumab)
Intervention description: Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms.; Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 708.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the
      efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic
      dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chronic AD that has been present for at least 3 years before the screening visit;

          2. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits;

          3. Documented recent history (within 6 months before the screening visit) of inadequate
             response to treatment with topical medications or for whom topical treatments are
             otherwise medically inadvisable (eg, because of important side effects or safety
             risks).

        Exclusion Criteria:

          1. Participation in a prior Dupilumab clinical study.

          2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if
             known), whichever is longer, before the baseline visit;

          3. Having used any of the following treatments within 4 weeks before the baseline visit,
             or any condition that, in the opinion of the investigator, is likely to require such
             treatment(s) during the first 4 weeks of study treatment:

               -  Immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids,
                  cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors,
                  azathioprine, methotrexate, etc.)

               -  Phototherapy for AD

          4. Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of
             the screening visit;

          5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;

          6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
             screening;

          7. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the
             screening visit;

          8. Active chronic or acute infection requiring systemic treatment within 2 weeks before
             the baseline visit;

          9. Known or suspected history of immunosuppression;

         10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during the study;

         11. Women unwilling to use adequate birth control, if of reproductive potential and
             sexually active.

        Note: The information listed above is not intended to contain all considerations relevant
        to a participant's potential participation in this clinical trial therefore not all
        inclusion/ exclusion criteria are listed.