Lebrikizumab in Moderate-to-severe Atopic Dermatitis

Inclusion Criteria:

• Established diagnosis of AD for at least 1 year before the screening visit andtopical treatment was inadequate or inadvisable.

• Moderate-to-severe AD with involvement > 10% of body-surface-area (BSA) andinvestigator global assessment (IGA) score =3 (based on the IGA scale ranging from 0to 4, in which 3 is moderate and 4 is severe) at both the screening and baselinevisits.

• Subject has an Eczema Area and Severity Index (EASI) score =16 at screening andbaseline.

• Subject has a pruritus NRS =4.

• Subject is biologic naïve.

• Female subjects of childbearing potential (i.e., fertile, following menarche anduntil becoming post-menopausal unless permanently sterile) must agree either tocommit to true abstinence throughout the study and for at least 17 weeks after thelast study drug (SD) injection, when this is in line with the preferred and usuallifestyle of the subject, or to use a highly-effective and approved method ofcontraception throughout the study and for at least 17 weeks after the last studydrug injection.

• Subject willing and able to comply with all of the clinical study protocol's timecommitments and procedural requirements.

• Understand and sign an informed consent form (ICF) (and assent form, whenapplicable) before any investigational procedure(s) are performed.

Exclusion Criteria:

• Previous treatment with lebrikizumab or participation in a lebrikizumab study.

• History of anaphylaxis as defined by the Sampson criteria.

• Treatment with topical corticosteroids, calcineurin inhibitors, Jak inhibitors, orcrisaborole within 1 week prior to the baseline visit.

• Prior treatment with dupilumab or tralokinumab.

• Treatment with any of the following agents within 4 weeks prior to the baselinevisit:

1. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,cyclosporine, mycophenolate-mofetil, IFN-., Janus kinase inhibitors (JAKi),azathioprine, methotrexate).

2. Phototherapy and photochemotherapy (PUVA) for AD.

• Treatment with the following prior to the baseline visit:

1. An investigational drug within 8 weeks or 5 half-lives (if known), whichever islonger.

2. Cell-depleting biologics, including to rituximab, within 6 months.

3. Other biologics within 5 half-lives (if known) or 16 weeks, whichever islonger.

• Use of prescription moisturizers within 7 days of the baseline visit.

• Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeksof the screening visit.

• Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit orplanned during the study.

• Uncontrolled chronic disease that might require bursts of oral corticosteroids,e.g., co-morbid severe uncontrolled asthma requiring systemic [oral and/orparenteral] corticosteroid treatment or hospitalization for > 24 hours).

• Active chronic or acute infection requiring treatment with systemic antibiotics,antivirals, anti-parasitics, antiprotozoals, or antifungals within 2 weeks beforethe baseline visit, or superficial skin infections within 1 week before the baselinevisit. NOTE: patients may be rescreened after infection resolves.

• Evidence of active acute or chronic hepatitis (as defined by the Department ofHealth & Human Services Centers for Disease Control and Prevention) or known livercirrhosis.

• Diagnosed active endoparasitic infections or at high risk of these infections.

• Known or suspected history of immunosuppression, including history of invasiveopportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis,coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution:or unusually frequent, recurrent, or prolonged infections, per the Investigator'sjudgment.

• History of human immunodeficiency virus (HIV) infection or positive HIV serology atscreening.

• In the Investigator's opinion, any clinically significant laboratory results fromthe chemistry, hematology or urinalysis tests available in the medical history.

• Presence of skin comorbidities that may interfere with study assessments.

• History of malignancy, including mycosis fungoides, within 5 years before thescreening visit, except completely treated in situ carcinoma of the cervix,completely treated and resolved non-metastatic squamous or basal cell carcinoma ofthe skin.

• Severe concomitant illness(es) that in the Investigator's judgment would adverselyaffect the patient's participation in the study. Any other medical or psychologicalcondition that in the opinion of the Investigator may suggest a new and/orinsufficiently understood disease, may present an unreasonable risk to the studypatient because of his/her participation in this clinical trial, may make patient'sparticipation unreliable, or may interfere with study assessments.

20. Pregnant or breastfeeding women, or women planning to become pregnant orbreastfeed during the study.