Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Lebrikizumab; Placebo; Topical Corticosteroid
Intervention description: Subcutaneous injection; Subcutaneous injection; Topical Corticosteroid
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)
Enrollment: 228.0
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 16
      weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab
      when used in combination with topical corticosteroid (TCS) treatment compared with placebo in
      combination with TCS treatment for moderate-to-severe atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adult and adolescents (≥12 years to <18 years, and weighing ≥40 kg).

          2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has
             been present for ≥1 year before the screening visit.

          3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.

          4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit

          5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.

          6. History of inadequate response to treatment with topical medications.

        Exclusion Criteria:

          1. Participation in a prior lebrikizumab clinical study.

          2. Treatment with the following prior to the baseline visit:

               1. An investigational drug within 8 weeks or within 5 half-lives (if known),
                  whichever is longer.

               2. Dupilumab within 8 weeks.

               3. B-cell-depleting biologics, including to rituximab, within 6 months.

               4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.

          3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or
             planned during the study.

          4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.

          5. Evidence of active acute or chronic hepatitis

          6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
             screening.

          7. 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.

          8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during the study.