Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Lebrikizumab; Placebo
Intervention description: Subcutaneous injection; Subcutaneous Injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, parallel group, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 424.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Eczema; Dermatitis; Dermatitis, Atopic; Skin Diseases

Summary:

      This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52
      weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab
      as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week
      induction treatment period and a 36-week long-term maintenance treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults and adolescents (≥12 years and ≥40 kg)

          -  Chronic atopic dermatitis (according to American Academy of Dermatology Consensus
             Criteria) that has been present for ≥1 year before the screening visit

          -  Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit

          -  Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit

          -  ≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit

          -  History of inadequate response to treatment with topical medications; or determination
             that topical treatments are otherwise medically inadvisable

        Exclusion Criteria:

          -  Prior treatment with dupilumab or tralokinumab

          -  Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4
             inhibitors such as crisaborole within 1 week prior to the baseline visit

          -  Treatment with any of the following agents within 4 weeks prior to the baseline visit:

               -  Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,
                  cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors,
                  azathioprine, methotrexate, etc.)

               -  Phototherapy and photochemotherapy (PUVA) for AD

          -  Treatment with the following prior to the baseline visit:

               -  An investigational drug within 8 weeks or within 5 half-lives (if known) of
                  baseline, whichever is longer

               -  Cell-depleting biologics, including to rituximab, within 6 months of baseline

               -  Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever
                  is longer

          -  Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or
             planned during the study

          -  Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g.,
             co-morbid severe uncontrolled asthma

          -  Evidence of active acute or chronic hepatitis

          -  History of human immunodeficiency virus (HIV) infection or positive HIV serology

          -  History of malignancy, including mycosis fungoides, within 5 years before the
             screening visit, except completely treated in situ carcinoma of the cervix, completely
             treated and resolved non-metastatic squamous or basal cell carcinoma of the skin

          -  Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during the study