A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; Upadacitinib; Topical corticosteroids (TCS)
Intervention description: Tablets taken orally once a day; Tablets taken orally once a day; Topical corticosteroids will be applied in a stepdown regimen, starting with medium potency once daily to areas with active lesions until lesions are clear or almost clear, or for 3 consecutive weeks, whichever is shorter; then low potency topical corticosteroids once daily. If lesions return or persist, this step-down approach will be repeated until lesion resolution or evidence of local or systemic topical corticosteroids toxicity.
Recommended TCS include triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment as medium potency topical corticosteroids and hydrocortisone 1% cream as low potency topical corticosteroid.
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 968.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Upadacitinib

Summary:

      The objective of this study is to assess the efficacy and safety of upadacitinib combined
      with topical corticosteroids (TCS) for the treatment of adolescent and adult participants
      with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age

          -  Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
             Baseline Visit and subject meets Hanifin and Rajka criteria.

          -  Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index
             (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body
             surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus
             numerical rating scale (NRS) ≥ 4.

          -  Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days
             before the Baseline Visit.

          -  Documented history of inadequate response to topical corticosteroids or topical
             calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to
             Baseline Visit

        Exclusion Criteria:

          -  Prior exposure to any Janus kinase (JAK) inhibitor

          -  Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to
             the study

          -  Requirement of prohibited medications during the study

          -  Other active skin diseases or skin infections requiring systemic treatment or would
             interfere with appropriate assessment of atopic dermatitis lesions

          -  Female subject who is pregnant, breastfeeding, or considering pregnancy during the
             study