Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
Condition: Moderate-to-Severe Atopic Dermatitis; Dermatitis, Dermatitis Atopic; Eczema, Skin Diseases, Skin; Diseases Genetic, Genetic; Diseases Inborn, Skin; Disease, Eczematous Skin; Hypersensitivity, Immediate; Hypersensitivity, Immune System Diseases; Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Eczematous; Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate
Intervention: Dupilumab; Placebo
Intervention description: Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.; Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 251.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to demonstrate the efficacy of dupilumab as a
      monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe atopic
      dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab
      as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥12 to <18 years of age at time of screening visit

          -  Diagnosis of AD according to the American Academy of Dermatology consensus criteria at
             screening visit

          -  IGA ≥3 at screening and baseline visit

          -  EASI ≥16 at the screening and baseline visit

          -  Baseline Pruritus NRS average score for maximum itch intensity ≥4

          -  ≥10% BSA of AD involvement at the screening and baseline visits

          -  With documented recent history (within 6 months before the screening visit) of
             inadequate response to topical AD medication(s) or for whom topical treatments is
             medically inadvisable

        Exclusion Criteria:

          -  Participation in a prior dupilumab clinical study

          -  Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)
             within 2 weeks before the baseline visit

          -  Having used immunosuppressive/immunomodulating drugs within 4 weeks before the
             baseline visit

          -  Body weight <30 kg at baseline

          -  Active chronic or acute infection requiring treatment with systemic antibiotics,
             antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit

          -  Known or suspected immunodeficiency, known history of human immunodeficiency virus
             (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of
             HBV infection or HBV seropositivity at screening, established diagnosis of HCV
             infection or HCV seropositivity at screening

          -  History of malignancy before the baseline visit

          -  Diagnosed active endoparasitic infections or at high risk of these infections

          -  Patient is female who is pregnant, breastfeeding, or planning to become pregnant or
             breastfeed during the study

          -  Patient is female of childbearing potential and sexually active, who is unwilling to
             use adequate methods of contraception throughout the duration of the study and for 120
             days after the last dose of study drug

        Other protocol-defined inclusion/exclusion criteria may apply