Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: Dupilumab; Matching Placebo; Background Treatment: Topical Corticosteroids; Background Treatment: Moisturizers
Intervention description: Pharmaceutical form: Solution for injection in pre-filled syringe;
Route of administration: Subcutaneous (SC); Pharmaceutical form: Solution for injection;
Route of administration: Subcutaneous (SC); All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.; All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 367.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Eczema

Summary:

      The main objective of the trial is to demonstrate the efficacy of dupilumab administered
      concomitantly with topical corticosteroids (TCS) in participants ≥6 years to <12 years of age
      with severe atopic dermatitis (AD).

      The secondary objective is to assess the safety of dupilumab administered concomitantly with
      TCS in patients ≥6 years to <12 years of age with severe AD.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Diagnosis of AD according to the American Academy of Dermatology consensus criteria
             (Eichenfield 2003) at screening visit

          2. Chronic AD diagnosed at least 1 year prior to the screening visit

          3. IGA = 4 at screening and baseline visits

          4. EASI ≥21 at the screening and baseline visits

          5. BSA ≥15% at screening and baseline visits

          6. Documented recent history (within 6 months before the baseline visit) of inadequate
             response to topical AD medication(s)

          7. At least 11 (of a total of 14) applications of a stable dose of topical emollient
             (moisturizer) twice daily during the 7 consecutive days immediately before the
             baseline visit

        Key Exclusion Criteria:

          1. Participation in a prior dupilumab clinical study

          2. Treatment with a systemic investigational drug before the baseline visit

          3. Treatment with a topical investigational drug within 2 weeks prior to the baseline
             visit

          4. Treatment with crisabarole within 2 weeks prior to the baseline visit

          5. History of important side effects of medium potency topical corticosteroids (e.g,
             intolerance to treatment, hypersensitivity reactions, significant skin atrophy,
             systemic effects), as assessed by the investigator or patient's treating physician

          6. Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the
             baseline visit

          7. 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:

               1. Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids,
                  cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors,
                  azathioprine, methotrexate, etc.)

               2. Phototherapy for AD

          8. Treatment with biologics, as follows:

               1. Any cell-depleting agents including but not limited to rituximab:

                  within 6 months before the baseline visit, or until lymphocyte and CD 19+
                  lymphocyte count returns to normal, whichever is longer

               2. Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline
                  visit, whichever is longer

          9. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit

         10. Body weight <15 kg at baseline

        Note: Other Inclusion/ Exclusion criteria apply