A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Lebrikizumab; Placebo
Intervention description: Given SC; Given SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Eczema; Skin Diseases

Summary:

      The reason for this study is to assess the impact of lebrikizumab on vaccine immune response
      in adult participants with moderate to severe atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic atopic dermatitis (AD) according to American Academy of Dermatology Consensus
             Criteria that has been present for ≥1 year before screening.

          -  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 AD involvement at the baseline visit.

          -  History of inadequate response to treatment with topical medications; or determination
             that topical treatments are otherwise medically inadvisable.

          -  Have not received any tetanus-containing vaccine within approximately 5 years of
             baseline.

          -  Have never received a meningococcal conjugate vaccine or have received not more than 1
             prior MCV dose at least 4 years prior to baseline, of a vaccine containing 1 or more
             meningococcal serogroups (serogroups A, C, W, Y).

          -  Contraceptive use by men or women should be consistent with local regulations
             regarding the methods of contraception for those participating in clinical studies.

               -  a. Female participants of childbearing potential: must agree to remain abstinent
                  (refrain from heterosexual intercourse) or use a highly effective contraceptive
                  method during the treatment period and for at least 18 weeks after the last dose
                  of study drug. Women of non-childbearing potential (non-WOCBP) may participate
                  without any contraception requirements.

               -  b. Male participants are not required to use any contraception except in
                  compliance with specific local government study requirements.

        Exclusion Criteria:

          -  Recurring herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis

          -  Evidence of active or chronic hepatitis

          -  History of human immunodeficiency virus (HIV) infection or positive HIV serology.

          -  Presence of skin comorbidities that may interfere with study assessments.

          -  History of malignancy, including mycosis fungoides, within 5 years before screening,
             except completely treated in situ carcinoma of the cervix or completely treated and
             resolved non-metastatic squamous or basal cell carcinoma of the skin.

          -  Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g.,
             co-morbid severe uncontrolled asthma.

          -  Have a prior history of Guillain-Barre syndrome.

          -  Allergic to latex.

          -  History of past vaccination allergy or Arthus-type hypersensitivity.

          -  Have an uncontrolled seizure disorder.

          -  Have known hypogammaglobulinemia or a screening serum immunoglobulin G (IgG) or
             immunoglobulin A (IgA) concentration less than the lower limit of the reporting
             laboratory's reference range.

          -  Treated with topical corticosteroids (TCS), calcineurin inhibitors, or
             phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline
             visit.

          -  Treated with the following prior to baseline visit:

               -  a. An investigational drug within 8 weeks or within 5 half-lives (if known),
                  whichever is longer

               -  b. B Cell-depleting biologics, including rituximab, within 6 months

               -  c. Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer

          -  Received a Bacillus Calmette-Guerin (BCG) vaccination or treatment within 12 months of
             screening, or treated with a live (attenuated) vaccine within 12 weeks of the baseline
             visit or planned during the study.

          -  A contraindication to the Tdap vaccine or mean corpuscular volume (MCV).

          -  Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during the study.