Ethnic Differences in Mechanisms of Action of Dupilumab

Inclusion Criteria:

• Established diagnosis of AD for at least 2 years before the screening visit andconfirmed according to the American Academy of Dermatology Consensus Criteria at thetime of the screening visit

• 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

• 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 12 weeks after the last studydrug injection or to use an adequate and approved method of contraception throughoutthe study and for 12 weeks after the last study drug injection

• Subject willing and able to comply with all of the time commitments and proceduralrequirements of the clinical study protocol

Exclusion Criteria:

• Body weight less than 30 kilogram

• Subjects meeting 1 or more of the following criteria at screening or baseline:

1. Had an exacerbation of asthma requiring hospitalization in the preceding 12months.

2. Reporting asthma that has not been well-controlled (ie, symptoms occurring on >2 days per week, nighttime awakenings 2 or more times per week, or someinterference with normal activities) during the preceding 3 months

3. Asthma Control Test (ACT) < 19 (only for subjects with a history of asthma).

4. Subjects with a current medical history of chronic obstructive pulmonarydisease and/or chronic bronchitis.

• Cutaneous infection within 1 week before the baseline visit, any infection requiringtreatment with oral or parenteral antibiotics, antivirals, antiparasitics, orantifungals within 2 weeks before the baseline visit.

• Confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 4 weeksbefore the screening or baseline visit

• Received COVID-19 vaccination within 4 weeks before baseline visit

• Previous treatment with dupilumab

• Pregnant women (positive serum pregnancy test result at the screening visit orpositive urine pregnancy test at the baseline visit), breastfeeding women, or womenplanning a pregnancy during the clinical study

• History of lymphoproliferative disease or history of malignancy of any organ systemwithin the last 5 years, except for basal cell carcinoma, squamous cell carcinoma insitu (Bowen's disease), or carcinomas in situ of the cervix that have been treatedand have no evidence of recurrence in the last 12 weeks before the baseline visit

• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, i.e., monoclonal antibody) or to lidocaine

• Known active or latent tuberculosis (TB) infection

• Known or suspected immunosuppression or unusually frequent, recurrent, severe, orprolonged infections as per investigator judgment

• History of or current confounding skin condition (i.e., Netherton syndrome,psoriasis, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], contactdermatitis, chronic actinic dermatitis, dermatitis herpetiformis)

• Planned or expected major surgical procedure during the study

• Currently participating or participated in any other study of a drug or device,within the past 8 weeks before the screening visit, or is in an exclusion period (ifverifiable) from a previous study

• History of alcohol or substance abuse within 6 months of the screening

• History of poor wound healing or keloid formation