Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab; Placebo (for Dupilumab); Topical Corticosteroid (TCS)
Intervention description: Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs; Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs; All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
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: 740.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to demonstrate the efficacy of Dupilumab administered
      concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with
      moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with
      TCS.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Chronic AD that had been present for at least 3 years before the screening visit;

          2. Documented recent history (within 6 months before the screening visit) of inadequate
             response to a sufficient course of out-patient treatment with topical AD
             medication(s).

        Key Exclusion Criteria:

          1. Participation in a prior Dupilumab clinical trial;

          2. Important side effects of topical medication (e.g. intolerance to treatment,
             hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed
             by the investigator or treating physician;

          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, was likely to require such
             treatment(s) during the first 2 weeks of study treatment:

               1. Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine,
                  mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma [IFN-γ],
                  azathioprine, methotrexate, etc.);

               2. Phototherapy for AD;

          4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;

          5. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
             screening;

          6. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or
             hepatitis C antibody at the screening visit;

          7. Active or acute infection requiring systemic treatment within 2 weeks before baseline
             visit;

          8. Known or suspected history of immunosuppression;

          9. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during
             the participant's participation in this study.

        Note: The eligibility criteria 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.