A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema, Skin Diseases Read More

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.